Trial Outcomes & Findings for Monitoring Activity And Gait In Children (NCT NCT04823650)
NCT ID: NCT04823650
Last Updated: 2025-12-11
Results Overview
Gait speed was the time taken to walk a specified distance. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).
Recruitment status
COMPLETED
Target enrollment
87 participants
Primary outcome timeframe
Up to 20 minutes on Day 1
Results posted on
2025-12-11
Participant Flow
In this observational study, healthy pediatric participants (aged 3-17) were enrolled in 2 cohorts: Cohort A and B. A total of 87 participants (Cohort A: 40 and Cohort B: 47) were screened and enrolled in the study. No intervention was administered during this study.
Participant milestones
| Measure |
Cohort A: Participants Aged 3-5 Years
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort B: Participants Aged 3-5 Years
Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort B: Participants Aged 6-11 Years
Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort B: Participants Aged 12-17 Years
Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
13
|
14
|
13
|
13
|
17
|
17
|
|
Overall Study
COMPLETED
|
13
|
14
|
13
|
13
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Cohort A: Participants Aged 3-5 Years
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort B: Participants Aged 3-5 Years
Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort B: Participants Aged 6-11 Years
Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort B: Participants Aged 12-17 Years
Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
Baseline characteristics by cohort
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort B: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort B: Participants Aged 6-11 Years
n=17 Participants
Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort B: Participants Aged 12-17 Years
n=17 Participants
Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Total
n=87 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
Cohort A
|
4.38 Years
STANDARD_DEVIATION 0.65 • n=13 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
9.00 Years
STANDARD_DEVIATION 1.80 • n=14 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
14.77 Years
STANDARD_DEVIATION 1.59 • n=13 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
—
|
—
|
—
|
9.38 Years
STANDARD_DEVIATION 4.48 • n=40 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Age, Continuous
Cohort B
|
—
|
—
|
—
|
4.00 Years
STANDARD_DEVIATION 0.82 • n=13 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
8.53 Years
STANDARD_DEVIATION 1.62 • n=17 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
13.94 Years
STANDARD_DEVIATION 1.68 • n=17 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
9.23 Years
STANDARD_DEVIATION 4.26 • n=47 Participants • Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows.
|
|
Sex: Female, Male
Female
|
7 Participants
n=13 Participants
|
6 Participants
n=14 Participants
|
9 Participants
n=13 Participants
|
8 Participants
n=13 Participants
|
8 Participants
n=17 Participants
|
11 Participants
n=17 Participants
|
49 Participants
n=87 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=13 Participants
|
8 Participants
n=14 Participants
|
4 Participants
n=13 Participants
|
5 Participants
n=13 Participants
|
9 Participants
n=17 Participants
|
6 Participants
n=17 Participants
|
38 Participants
n=87 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=13 Participants
|
1 Participants
n=14 Participants
|
2 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
4 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
9 Participants
n=87 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=13 Participants
|
11 Participants
n=14 Participants
|
11 Participants
n=13 Participants
|
13 Participants
n=13 Participants
|
13 Participants
n=17 Participants
|
17 Participants
n=17 Participants
|
76 Participants
n=87 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
2 Participants
n=14 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
2 Participants
n=87 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=87 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=13 Participants
|
3 Participants
n=14 Participants
|
5 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
3 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
15 Participants
n=87 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=87 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=13 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=13 Participants
|
1 Participants
n=13 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
3 Participants
n=87 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=13 Participants
|
10 Participants
n=14 Participants
|
8 Participants
n=13 Participants
|
8 Participants
n=13 Participants
|
12 Participants
n=17 Participants
|
16 Participants
n=17 Participants
|
62 Participants
n=87 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=13 Participants
|
1 Participants
n=14 Participants
|
0 Participants
n=13 Participants
|
3 Participants
n=13 Participants
|
1 Participants
n=17 Participants
|
1 Participants
n=17 Participants
|
7 Participants
n=87 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=87 Participants
|
PRIMARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A.
Gait speed was the time taken to walk a specified distance. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Slow Speed
|
0.49 Meters per second
Standard Deviation 0.159
|
0.45 Meters per second
Standard Deviation 0.153
|
0.66 Meters per second
Standard Deviation 0.196
|
|
Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
ActiGraph: Natural Speed
|
0.83 Meters per second
Standard Deviation 0.192
|
1.00 Meters per second
Standard Deviation 0.142
|
1.04 Meters per second
Standard Deviation 0.174
|
|
Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Natural Speed
|
0.93 Meters per second
Standard Deviation 0.234
|
1.13 Meters per second
Standard Deviation 0.127
|
1.21 Meters per second
Standard Deviation 0.177
|
|
Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Natural Speed
|
0.81 Meters per second
Standard Deviation 0.213
|
1.02 Meters per second
Standard Deviation 0.119
|
1.10 Meters per second
Standard Deviation 0.171
|
|
Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
ActiGraph: Fast Speed
|
1.03 Meters per second
Standard Deviation 0.231
|
1.22 Meters per second
Standard Deviation 0.129
|
1.30 Meters per second
Standard Deviation 0.115
|
|
Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Fast Speed
|
1.32 Meters per second
Standard Deviation 0.268
|
1.49 Meters per second
Standard Deviation 0.252
|
1.56 Meters per second
Standard Deviation 0.161
|
|
Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Fast Speed
|
1.00 Meters per second
Standard Deviation 0.218
|
1.36 Meters per second
Standard Deviation 0.247
|
1.43 Meters per second
Standard Deviation 0.139
|
|
Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
ActiGraph: Slow Speed
|
0.56 Meters per second
Standard Deviation 0.150
|
0.58 Meters per second
Standard Deviation 0.173
|
0.64 Meters per second
Standard Deviation 0.173
|
|
Cohort A: Gait Speed Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Slow Speed
|
0.57 Meters per second
Standard Deviation 0.164
|
0.54 Meters per second
Standard Deviation 0.151
|
0.75 Meters per second
Standard Deviation 0.204
|
PRIMARY outcome
Timeframe: Up to 20 minutes on Day 1Population: Full Analysis Set (FAS) included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A.
Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
ActiGraph: Natural Speed
|
0.26 Seconds
Standard Deviation 0.031
|
0.27 Seconds
Standard Deviation 0.029
|
0.30 Seconds
Standard Deviation 0.022
|
|
Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Natural Speed
|
0.28 Seconds
Standard Deviation 0.096
|
0.26 Seconds
Standard Deviation 0.053
|
0.31 Seconds
Standard Deviation 0.049
|
|
Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Natural Speed
|
0.22 Seconds
Standard Deviation 0.081
|
0.17 Seconds
Standard Deviation 0.033
|
0.21 Seconds
Standard Deviation 0.048
|
|
Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
ActiGraph: Fast Speed
|
0.23 Seconds
Standard Deviation 0.020
|
0.24 Seconds
Standard Deviation 0.028
|
0.27 Seconds
Standard Deviation 0.020
|
|
Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Fast Speed
|
0.18 Seconds
Standard Deviation 0.048
|
0.20 Seconds
Standard Deviation 0.057
|
0.24 Seconds
Standard Deviation 0.042
|
|
Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Fast Speed
|
0.16 Seconds
Standard Deviation 0.027
|
0.13 Seconds
Standard Deviation 0.031
|
0.14 Seconds
Standard Deviation 0.039
|
|
Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
ActiGraph: Slow Speed
|
0.29 Seconds
Standard Deviation 0.024
|
0.32 Seconds
Standard Deviation 0.039
|
0.32 Seconds
Standard Deviation 0.034
|
|
Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Slow Speed
|
0.45 Seconds
Standard Deviation 0.155
|
0.60 Seconds
Standard Deviation 0.192
|
0.53 Seconds
Standard Deviation 0.139
|
|
Cohort A: Double Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Slow Speed
|
0.36 Seconds
Standard Deviation 0.150
|
0.41 Seconds
Standard Deviation 0.144
|
0.38 Seconds
Standard Deviation 0.126
|
PRIMARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A.
Single support time referred to the time when only one limb was in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometery data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
ActiGraph: Natural Speed
|
0.36 Seconds
Standard Deviation 0.054
|
0.38 Seconds
Standard Deviation 0.050
|
0.42 Seconds
Standard Deviation 0.028
|
|
Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Natural Speed
|
0.36 Seconds
Standard Deviation 0.034
|
0.37 Seconds
Standard Deviation 0.037
|
0.40 Seconds
Standard Deviation 0.027
|
|
Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Natural Speed
|
0.39 Seconds
Standard Deviation 0.045
|
0.42 Seconds
Standard Deviation 0.042
|
0.46 Seconds
Standard Deviation 0.022
|
|
Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
ActiGraph: Fast Speed
|
0.31 Seconds
Standard Deviation 0.036
|
0.34 Seconds
Standard Deviation 0.042
|
0.37 Seconds
Standard Deviation 0.026
|
|
Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Fast Speed
|
0.30 Seconds
Standard Deviation 0.031
|
0.34 Seconds
Standard Deviation 0.039
|
0.38 Seconds
Standard Deviation 0.029
|
|
Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Fast Speed
|
0.36 Seconds
Standard Deviation 0.027
|
0.39 Seconds
Standard Deviation 0.042
|
0.42 Seconds
Standard Deviation 0.024
|
|
Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
ActiGraph: Slow Speed
|
0.47 Seconds
Standard Deviation 0.080
|
0.59 Seconds
Standard Deviation 0.140
|
0.58 Seconds
Standard Deviation 0.123
|
|
Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Slow Speed
|
0.43 Seconds
Standard Deviation 0.058
|
0.51 Seconds
Standard Deviation 0.074
|
0.48 Seconds
Standard Deviation 0.045
|
|
Cohort A: Single Limb Support Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Slow Speed
|
0.48 Seconds
Standard Deviation 0.062
|
0.59 Seconds
Standard Deviation 0.112
|
0.55 Seconds
Standard Deviation 0.055
|
PRIMARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A.
Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
ActiGraph: Natural Speed
|
0.63 Seconds
Standard Deviation 0.085
|
0.65 Seconds
Standard Deviation 0.072
|
0.72 Seconds
Standard Deviation 0.054
|
|
Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Natural Speed
|
0.64 Seconds
Standard Deviation 0.129
|
0.64 Seconds
Standard Deviation 0.082
|
0.72 Seconds
Standard Deviation 0.062
|
|
Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Natural Speed
|
0.60 Seconds
Standard Deviation 0.119
|
0.59 Seconds
Standard Deviation 0.070
|
0.66 Seconds
Standard Deviation 0.065
|
|
Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
ActiGraph: Fast Speed
|
0.56 Seconds
Standard Deviation 0.063
|
0.58 Seconds
Standard Deviation 0.075
|
0.65 Seconds
Standard Deviation 0.046
|
|
Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Fast Speed
|
0.49 Seconds
Standard Deviation 0.070
|
0.55 Seconds
Standard Deviation 0.087
|
0.62 Seconds
Standard Deviation 0.057
|
|
Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Fast Speed
|
0.52 Seconds
Standard Deviation 0.050
|
0.50 Seconds
Standard Deviation 0.075
|
0.56 Seconds
Standard Deviation 0.056
|
|
Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
ActiGraph: Slow Speed
|
0.75 Seconds
Standard Deviation 0.081
|
0.91 Seconds
Standard Deviation 0.127
|
0.83 Seconds
Standard Deviation 0.166
|
|
Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Slow Speed
|
0.88 Seconds
Standard Deviation 0.207
|
1.11 Seconds
Standard Deviation 0.265
|
1.02 Seconds
Standard Deviation 0.178
|
|
Cohort A: Stance Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Slow Speed
|
0.84 Seconds
Standard Deviation 0.205
|
1.00 Seconds
Standard Deviation 0.227
|
0.94 Seconds
Standard Deviation 0.181
|
PRIMARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A.
Swing time was defined as the time during which the foot was not in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
Swing Duration Measured by Actigraph for Walk at Natural Speed
|
0.36 Seconds
Standard Deviation 0.054
|
0.38 Seconds
Standard Deviation 0.050
|
0.42 Seconds
Standard Deviation 0.028
|
|
Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
Swing Duration Measured by GAITRite for Walk at Natural Speed
|
0.35 Seconds
Standard Deviation 0.034
|
0.37 Seconds
Standard Deviation 0.037
|
0.40 Seconds
Standard Deviation 0.027
|
|
Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
Swing Duration Measured by APDM for Walk at Natural Speed
|
0.39 Seconds
Standard Deviation 0.047
|
0.42 Seconds
Standard Deviation 0.041
|
0.45 Seconds
Standard Deviation 0.021
|
|
Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
Swing Duration Measured by Actigraph for Walk at Fast Speed
|
0.31 Seconds
Standard Deviation 0.030
|
0.33 Seconds
Standard Deviation 0.043
|
0.37 Seconds
Standard Deviation 0.027
|
|
Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
Swing Duration Measured by GAITRite for Walk at Fast Speed
|
0.30 Seconds
Standard Deviation 0.029
|
0.34 Seconds
Standard Deviation 0.039
|
0.38 Seconds
Standard Deviation 0.028
|
|
Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
Swing Duration Measured by APDM for Walk at Fast Speed
|
0.35 Seconds
Standard Deviation 0.025
|
0.39 Seconds
Standard Deviation 0.042
|
0.42 Seconds
Standard Deviation 0.025
|
|
Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
Swing Duration Measured by Actigraph for Walk at Slow Speed
|
0.45 Seconds
Standard Deviation 0.067
|
0.53 Seconds
Standard Deviation 0.096
|
0.56 Seconds
Standard Deviation 0.106
|
|
Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
Swing Duration Measured by GAITRite for Walk at Slow Speed
|
0.43 Seconds
Standard Deviation 0.058
|
0.50 Seconds
Standard Deviation 0.074
|
0.48 Seconds
Standard Deviation 0.045
|
|
Cohort A: Swing Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
Swing Duration Measured by APDM for Walk at Slow Speed
|
0.47 Seconds
Standard Deviation 0.063
|
0.60 Seconds
Standard Deviation 0.116
|
0.55 Seconds
Standard Deviation 0.056
|
PRIMARY outcome
Timeframe: Up to 20 minutes of Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A.
Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
ActiGraph: Natural Speed
|
0.80 Meters
Standard Deviation 0.112
|
1.01 Meters
Standard Deviation 0.139
|
1.16 Meters
Standard Deviation 0.146
|
|
Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Natural Speed
|
0.89 Meters
Standard Deviation 0.113
|
1.13 Meters
Standard Deviation 0.127
|
1.35 Meters
Standard Deviation 0.116
|
|
Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Natural Speed
|
0.78 Meters
Standard Deviation 0.126
|
1.02 Meters
Standard Deviation 0.114
|
1.22 Meters
Standard Deviation 0.118
|
|
Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
ActiGraph: Fast Speed
|
0.88 Meters
Standard Deviation 0.141
|
1.12 Meters
Standard Deviation 0.155
|
1.31 Meters
Standard Deviation 0.109
|
|
Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Fast Speed
|
1.02 Meters
Standard Deviation 0.130
|
1.32 Meters
Standard Deviation 0.195
|
1.54 Meters
Standard Deviation 0.104
|
|
Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Fast Speed
|
0.85 Meters
Standard Deviation 0.144
|
1.20 Meters
Standard Deviation 0.196
|
1.40 Meters
Standard Deviation 0.110
|
|
Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
ActiGraph: Slow Speed
|
0.67 Meters
Standard Deviation 0.122
|
0.75 Meters
Standard Deviation 0.104
|
0.90 Meters
Standard Deviation 0.142
|
|
Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Slow Speed
|
0.71 Meters
Standard Deviation 0.116
|
0.82 Meters
Standard Deviation 0.136
|
1.08 Meters
Standard Deviation 0.155
|
|
Cohort A: Stride Length Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Slow Speed
|
0.61 Meters
Standard Deviation 0.118
|
0.68 Meters
Standard Deviation 0.129
|
0.94 Meters
Standard Deviation 0.155
|
PRIMARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A.
Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants had a single in-laboratory visit on Day 1 during which they performed gait monitoring procedures. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Natural Speed
|
0.50 Seconds
Standard Deviation 0.081
|
0.50 Seconds
Standard Deviation 0.055
|
0.56 Seconds
Standard Deviation 0.041
|
|
Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
ActiGraph: Fast Speed
|
0.44 Seconds
Standard Deviation 0.061
|
0.45 Seconds
Standard Deviation 0.059
|
0.51 Seconds
Standard Deviation 0.037
|
|
Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Fast Speed
|
0.39 Seconds
Standard Deviation 0.048
|
0.44 Seconds
Standard Deviation 0.058
|
0.50 Seconds
Standard Deviation 0.037
|
|
Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Fast Speed
|
0.43 Seconds
Standard Deviation 0.035
|
0.44 Seconds
Standard Deviation 0.058
|
0.50 Seconds
Standard Deviation 0.038
|
|
Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
ActiGraph: Natural Speed
|
0.50 Seconds
Standard Deviation 0.072
|
0.51 Seconds
Standard Deviation 0.061
|
0.57 Seconds
Standard Deviation 0.046
|
|
Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Natural Speed
|
0.49 Seconds
Standard Deviation 0.080
|
0.51 Seconds
Standard Deviation 0.058
|
0.56 Seconds
Standard Deviation 0.043
|
|
Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
ActiGraph: Slow Speed
|
0.62 Seconds
Standard Deviation 0.088
|
0.76 Seconds
Standard Deviation 0.142
|
0.74 Seconds
Standard Deviation 0.109
|
|
Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Slow Speed
|
0.65 Seconds
Standard Deviation 0.128
|
0.80 Seconds
Standard Deviation 0.163
|
0.75 Seconds
Standard Deviation 0.116
|
|
Cohort A: Step Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Slow Speed
|
0.66 Seconds
Standard Deviation 0.137
|
0.80 Seconds
Standard Deviation 0.165
|
0.74 Seconds
Standard Deviation 0.116
|
PRIMARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A.
Cadence referred to the number of steps taken per minute during gait cycle. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Fast Speed
|
139.50 Steps per minute
Standard Deviation 10.993
|
137.06 Steps per minute
Standard Deviation 17.574
|
122.30 Steps per minute
Standard Deviation 9.326
|
|
Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Slow Speed
|
91.77 Steps per minute
Standard Deviation 16.656
|
76.61 Steps per minute
Standard Deviation 17.346
|
81.53 Steps per minute
Standard Deviation 11.926
|
|
Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
ActiGraph: Natural Speed
|
123.07 Steps per minute
Standard Deviation 17.515
|
118.17 Steps per minute
Standard Deviation 13.763
|
106.00 Steps per minute
Standard Deviation 7.971
|
|
Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Natural Speed
|
120.57 Steps per minute
Standard Deviation 17.555
|
117.97 Steps per minute
Standard Deviation 14.652
|
104.23 Steps per minute
Standard Deviation 9.496
|
|
Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Natural Speed
|
124.09 Steps per minute
Standard Deviation 20.093
|
120.04 Steps per minute
Standard Deviation 13.073
|
107.97 Steps per minute
Standard Deviation 7.556
|
|
Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
ActiGraph: Fast Speed
|
139.59 Steps per minute
Standard Deviation 17.740
|
134.16 Steps per minute
Standard Deviation 17.301
|
118.24 Steps per minute
Standard Deviation 8.667
|
|
Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Fast Speed
|
147.26 Steps per minute
Standard Deviation 19.313
|
130.42 Steps per minute
Standard Deviation 16.612
|
113.16 Steps per minute
Standard Deviation 9.725
|
|
Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
ActiGraph: Slow Speed
|
98.12 Steps per minute
Standard Deviation 14.187
|
81.48 Steps per minute
Standard Deviation 16.704
|
82.59 Steps per minute
Standard Deviation 11.866
|
|
Cohort A: Cadence Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Slow Speed
|
94.57 Steps per minute
Standard Deviation 17.679
|
78.38 Steps per minute
Standard Deviation 18.100
|
82.55 Steps per minute
Standard Deviation 12.486
|
PRIMARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A.
Stride duration refers to the duration between successive heel contacts of the same foot. Participants had to walk on GAITRite walkway (20 feet\*3) wearing ActiGraph and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from GAITRite walkway and APDM sensors (reference).
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
ActiGraph: Natural Speed
|
0.99 Seconds
Standard Deviation 0.150
|
1.02 Seconds
Standard Deviation 0.118
|
1.13 Seconds
Standard Deviation 0.082
|
|
Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Natural Speed
|
0.99 Seconds
Standard Deviation 0.162
|
1.01 Seconds
Standard Deviation 0.118
|
1.12 Seconds
Standard Deviation 0.091
|
|
Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Natural Speed
|
0.99 Seconds
Standard Deviation 0.163
|
1.01 Seconds
Standard Deviation 0.111
|
1.12 Seconds
Standard Deviation 0.084
|
|
Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
ActiGraph: Fast Speed
|
0.88 Seconds
Standard Deviation 0.132
|
0.91 Seconds
Standard Deviation 0.115
|
1.01 Seconds
Standard Deviation 0.073
|
|
Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Fast Speed
|
0.78 Seconds
Standard Deviation 0.093
|
0.89 Seconds
Standard Deviation 0.123
|
0.99 Seconds
Standard Deviation 0.079
|
|
Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Fast Speed
|
0.87 Seconds
Standard Deviation 0.070
|
0.89 Seconds
Standard Deviation 0.113
|
0.99 Seconds
Standard Deviation 0.076
|
|
Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
ActiGraph: Slow Speed
|
1.22 Seconds
Standard Deviation 0.155
|
1.39 Seconds
Standard Deviation 0.210
|
1.41 Seconds
Standard Deviation 0.149
|
|
Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Slow Speed
|
1.30 Seconds
Standard Deviation 0.258
|
1.61 Seconds
Standard Deviation 0.327
|
1.49 Seconds
Standard Deviation 0.226
|
|
Cohort A: Stride Duration Measured by APDM, GAITRite Walkway and ActiGraph Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Slow Speed
|
1.31 Seconds
Standard Deviation 0.265
|
1.60 Seconds
Standard Deviation 0.331
|
1.49 Seconds
Standard Deviation 0.233
|
PRIMARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
APDM: Activity Block 1
|
0.22 Seconds
Standard Deviation 0.029
|
0.21 Seconds
Standard Deviation 0.061
|
0.22 Seconds
Standard Deviation 0.046
|
|
Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
ActiGraph Lumbar: Activity Block 1
|
0.25 Seconds
Standard Deviation 0.013
|
0.26 Seconds
Standard Deviation 0.022
|
0.30 Seconds
Standard Deviation 0.022
|
|
Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
APDM: Activity Block 2
|
0.21 Seconds
Standard Deviation 0.034
|
0.19 Seconds
Standard Deviation 0.19
|
0.21 Seconds
Standard Deviation 0.039
|
|
Cohort A: Double Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
ActiGraph Lumbar: Activity Block 2
|
0.24 Seconds
Standard Deviation 0.012
|
0.27 Seconds
Standard Deviation 0.020
|
0.30 Seconds
Standard Deviation 0.023
|
PRIMARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
Single support time referred to the time when only one limb was in contact with the ground. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
APDM: Activity Block 1
|
0.37 Seconds
Standard Deviation 0.024
|
0.41 Seconds
Standard Deviation 0.038
|
0.45 Seconds
Standard Deviation 0.021
|
|
Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
ActiGraph Lumbar: Activity Block 1
|
0.34 Seconds
Standard Deviation 0.017
|
0.36 Seconds
Standard Deviation 0.031
|
0.40 Seconds
Standard Deviation 0.022
|
|
Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
APDM: Activity Block 2
|
0.36 Seconds
Standard Deviation 0.015
|
0.41 Seconds
Standard Deviation 0.028
|
0.44 Seconds
Standard Deviation 0.017
|
|
Cohort A: Single Limb Support Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
ActiGraph Lumbar: Activity Block 2
|
0.34 Seconds
Standard Deviation 0.020
|
0.36 Seconds
Standard Deviation 0.032
|
0.40 Seconds
Standard Deviation 0.024
|
PRIMARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants had a single in-lab visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
ActiGraph Lumbar: Activity Block 2
|
0.60 Seconds
Standard Deviation 0.029
|
0.63 Seconds
Standard Deviation 0.051
|
0.71 Seconds
Standard Deviation 0.041
|
|
Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
APDM: Activity Block 1
|
0.59 Seconds
Standard Deviation 0.044
|
0.62 Seconds
Standard Deviation 0.072
|
0.66 Seconds
Standard Deviation 0.060
|
|
Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
ActiGraph Lumbar: Activity Block 1
|
0.60 Seconds
Standard Deviation 0.022
|
0.63 Seconds
Standard Deviation 0.055
|
0.72 Seconds
Standard Deviation 0.046
|
|
Cohort A: Stance Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
APDM: Activity Block 2
|
0.57 Seconds
Standard Deviation 0.042
|
0.60 Seconds
Standard Deviation 0.053
|
0.65 Seconds
Standard Deviation 0.053
|
PRIMARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
Swing duration was defined as the time during which the foot was not in contact with the ground. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Swing Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
ActiGraph Lumbar: Activity Block 1
|
0.33 Seconds
Standard Deviation 0.017
|
0.36 Seconds
Standard Deviation 0.034
|
0.40 Seconds
Standard Deviation 0.022
|
|
Cohort A: Swing Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
APDM: Activity Block 2
|
0.35 Seconds
Standard Deviation 0.021
|
0.40 Seconds
Standard Deviation 0.029
|
0.43 Seconds
Standard Deviation 0.019
|
|
Cohort A: Swing Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
ActiGraph Lumbar: Activity Block 2
|
0.33 Seconds
Standard Deviation 0.019
|
0.36 Seconds
Standard Deviation 0.030
|
0.40 Seconds
Standard Deviation 0.020
|
|
Cohort A: Swing Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
APDM: Activity Block 1
|
0.36 Seconds
Standard Deviation 0.020
|
0.40 Seconds
Standard Deviation 0.036
|
0.44 Seconds
Standard Deviation 0.024
|
PRIMARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Stride Length Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
APDM: Activity Block 2
|
0.71 Meter
Standard Deviation 0.134
|
0.93 Meter
Standard Deviation 0.165
|
1.14 Meter
Standard Deviation 0.084
|
|
Cohort A: Stride Length Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
ActiGraph Lumbar: Activity Block 2
|
0.86 Meter
Standard Deviation 0.094
|
1.02 Meter
Standard Deviation 0.096
|
1.05 Meter
Standard Deviation 0.132
|
|
Cohort A: Stride Length Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
APDM: Activity Block 1
|
0.73 Meter
Standard Deviation 0.090
|
0.89 Meter
Standard Deviation 0.185
|
1.12 Meter
Standard Deviation 0.089
|
|
Cohort A: Stride Length Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
ActiGraph Lumbar: Activity Block 1
|
0.86 Meter
Standard Deviation 0.087
|
0.99 Meter
Standard Deviation 0.097
|
1.05 Meter
Standard Deviation 0.110
|
PRIMARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants had a single in-lab visit during which they performed gait monitoring procedures. For in-lab simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Step Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
APDM: Activity Block 1
|
0.46 Seconds
Standard Deviation 0.022
|
0.50 Seconds
Standard Deviation 0.048
|
0.55 Seconds
Standard Deviation 0.039
|
|
Cohort A: Step Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
ActiGraph Lumbar: Activity Block 1
|
0.47 Seconds
Standard Deviation 0.019
|
0.49 Seconds
Standard Deviation 0.045
|
0.56 Seconds
Standard Deviation 0.036
|
|
Cohort A: Step Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
APDM: Activity Block 2
|
0.45 Seconds
Standard Deviation 0.021
|
0.49 Seconds
Standard Deviation 0.038
|
0.54 Seconds
Standard Deviation 0.035
|
|
Cohort A: Step Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
ActiGraph Lumbar: Activity Block 2
|
0.46 Seconds
Standard Deviation 0.024
|
0.49 Seconds
Standard Deviation 0.040
|
0.55 Seconds
Standard Deviation 0.034
|
PRIMARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
Cadence referred to the number of steps taken per minute during gait cycle. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Cadence Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
APDM: Activity Block 1
|
126.97 Steps per minute
Standard Deviation 7.487
|
118.54 Steps per minute
Standard Deviation 11.395
|
109.47 Steps per minute
Standard Deviation 7.972
|
|
Cohort A: Cadence Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
ActiGraph Lumbar: Activity Block 1
|
128.71 Steps per minute
Standard Deviation 5.515
|
122.32 Steps per minute
Standard Deviation 11.001
|
108.15 Steps per minute
Standard Deviation 6.842
|
|
Cohort A: Cadence Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
APDM: Activity Block 2
|
130.96 Steps per minute
Standard Deviation 7.346
|
120.51 Steps per minute
Standard Deviation 8.758
|
110.84 Steps per minute
Standard Deviation 7.109
|
|
Cohort A: Cadence Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
ActiGraph Lumbar: Activity Block 2
|
129.90 Steps per minute
Standard Deviation 6.846
|
122.49 Steps per minute
Standard Deviation 9.919
|
109.63 Steps per minute
Standard Deviation 6.715
|
PRIMARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
Gait speed was the time taken to walk a specified distance. Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Gait Speed Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
APDM: Activity Block 1
|
0.72 Meters per second
Standard Deviation 0.111
|
0.80 Meters per second
Standard Deviation 0.210
|
0.97 Meters per second
Standard Deviation 0.109
|
|
Cohort A: Gait Speed Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
ActiGraph Lumbar: Activity Block 1
|
0.91 Meters per second
Standard Deviation 0.084
|
0.98 Meters per second
Standard Deviation 0.085
|
0.95 Meters per second
Standard Deviation 0.104
|
|
Cohort A: Gait Speed Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
APDM: Activity Block 2
|
0.73 Meters per second
Standard Deviation 0.158
|
0.85 Meters per second
Standard Deviation 0.161
|
0.98 Meters per second
Standard Deviation 0.106
|
|
Cohort A: Gait Speed Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
ActiGraph Lumbar: Activity Block 2
|
0.92 Meters per second
Standard Deviation 0.097
|
1.03 Meters per second
Standard Deviation 0.090
|
0.96 Meters per second
Standard Deviation 0.130
|
PRIMARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
Participants had a single in-laboratory visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities
ActiGraph Lumbar: Activity Block 2
|
125.46 Steps
Standard Deviation 71.906
|
172.79 Steps
Standard Deviation 72.707
|
109.15 Steps
Standard Deviation 72.281
|
|
Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities
ActiGraph Wrist: Activity Block 2
|
210.92 Steps
Standard Deviation 109.188
|
275.14 Steps
Standard Deviation 87.960
|
225.69 Steps
Standard Deviation 98.155
|
|
Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities
APDM: Activity Block 1
|
109.23 Steps
Standard Deviation 42.540
|
123.00 Steps
Standard Deviation 51.067
|
154.62 Steps
Standard Deviation 49.399
|
|
Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities
ActiGraph Lumbar: Activity Block 1
|
103.00 Steps
Standard Deviation 72.623
|
163.43 Steps
Standard Deviation 75.572
|
114.46 Steps
Standard Deviation 87.498
|
|
Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities
ActiGraph Wrist: Activity Block 1
|
187.38 Steps
Standard Deviation 67.463
|
242.86 Steps
Standard Deviation 73.539
|
211.15 Steps
Standard Deviation 80.045
|
|
Cohort A: Total Number of Steps Measured by APDM, ActiGraph Lumbar and ActiGraph Wrist for In-lab Simulated Activities
APDM: Activity Block 2
|
120.77 Steps
Standard Deviation 57.727
|
130.57 Steps
Standard Deviation 56.896
|
154.15 Steps
Standard Deviation 47.430
|
PRIMARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
Stride duration refers to the duration between successive heel contacts of the same foot. Participants had a single in-lab visit during which they performed gait monitoring procedures. For in-laboratory simulated activities, participants were required to alternate between activity blocks through a random path created by dice roll while wearing devices. Activities were done for approximately 20 minutes (approximately 7 minutes of activities \[activity block 1\], approximately 5 minutes of break and approximately 7 minutes of activities \[activity block 2\]). Activities: 2 sitting (e.g., look through a book, draw/write), 2 standing (e.g., turn a switch or hang a coat), 2 walking (e.g., move blocks/objects, toss a beanbag and pick it up). Raw accelerometry data collected by ActiGraph devices (comparator) was processed by the GaitPy algorithm to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors (reference).
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Stride Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
APDM: Activity Block 1
|
0.95 Seconds
Standard Deviation 0.060
|
1.02 Seconds
Standard Deviation 0.099
|
1.10 Seconds
Standard Deviation 0.081
|
|
Cohort A: Stride Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
ActiGraph Lumbar: Activity Block 1
|
0.94 Seconds
Standard Deviation 0.047
|
0.99 Seconds
Standard Deviation 0.088
|
1.10 Seconds
Standard Deviation 0.069
|
|
Cohort A: Stride Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
APDM: Activity Block 2
|
0.92 Seconds
Standard Deviation 0.050
|
1.00 Seconds
Standard Deviation 0.076
|
1.09 Seconds
Standard Deviation 0.070
|
|
Cohort A: Stride Duration Measured by APDM and ActiGraph Lumbar for In-lab Simulated Activities
ActiGraph Lumbar: Activity Block 2
|
0.93 Seconds
Standard Deviation 0.055
|
0.99 Seconds
Standard Deviation 0.079
|
1.09 Seconds
Standard Deviation 0.067
|
PRIMARY outcome
Timeframe: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActivPopulation: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Overall Number of Participants Analyzed ' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B.
Total sleep time for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's total sleep opportunity (TSO) window and computing sleep metrics within that window.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=16 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=17 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort B: Total Sleep Time During the At-Home Period
Panoramic Bracelet
|
561.21 Minutes
Standard Deviation 43.476
|
520.34 Minutes
Standard Deviation 26.680
|
459.92 Minutes
Standard Deviation 44.421
|
|
Cohort B: Total Sleep Time During the At-Home Period
GENEActiv
|
567.48 Minutes
Standard Deviation 40.483
|
524.57 Minutes
Standard Deviation 42.583
|
450.53 Minutes
Standard Deviation 54.944
|
PRIMARY outcome
Timeframe: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActivPopulation: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Overall Number of Participants Analyzed ' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B.
The percentage of time asleep for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=16 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=17 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort B: Percentage of Time Asleep During the At-Home Period
Panoramic Bracelet
|
95.65 Percentage of time
Standard Deviation 1.745
|
94.93 Percentage of time
Standard Deviation 2.049
|
94.85 Percentage of time
Standard Deviation 2.481
|
|
Cohort B: Percentage of Time Asleep During the At-Home Period
GENEActiv
|
94.85 Percentage of time
Standard Deviation 2.258
|
94.94 Percentage of time
Standard Deviation 2.402
|
94.08 Percentage of time
Standard Deviation 2.762
|
PRIMARY outcome
Timeframe: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActivPopulation: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Overall Number of Participants Analyzed ' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B.
Number of wake bouts for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=16 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=17 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort B: Number of Wake Bouts During the At-Home Period
Panoramic Bracelet
|
8.74 Wake bouts
Standard Deviation 2.895
|
9.59 Wake bouts
Standard Deviation 4.436
|
9.40 Wake bouts
Standard Deviation 4.171
|
|
Cohort B: Number of Wake Bouts During the At-Home Period
GENEActiv
|
9.69 Wake bouts
Standard Deviation 2.579
|
9.57 Wake bouts
Standard Deviation 4.979
|
9.37 Wake bouts
Standard Deviation 4.651
|
PRIMARY outcome
Timeframe: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActivPopulation: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Overall Number of Participants Analyzed ' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B.
Sleep onset latency which is time to transition from full wakefulness to sleep, for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=16 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=17 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort B: Sleep Onset Latency During the At-Home Period
Panoramic Bracelet
|
2.64 Minutes
Standard Deviation 0.868
|
3.82 Minutes
Standard Deviation 1.118
|
2.39 Minutes
Standard Deviation 1.428
|
|
Cohort B: Sleep Onset Latency During the At-Home Period
GENEActiv
|
3.69 Minutes
Standard Deviation 1.966
|
4.01 Minutes
Standard Deviation 1.425
|
3.64 Minutes
Standard Deviation 2.291
|
PRIMARY outcome
Timeframe: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActivPopulation: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Overall Number of Participants Analyzed ' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B.
Wake after sleep onset is time for which participants were awake after having initially fallen asleep, for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=16 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=17 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort B: Wake After Sleep Onset During the At-Home Period
GENEActiv
|
26.44 Minutes
Standard Deviation 13.112
|
23.58 Minutes
Standard Deviation 15.339
|
22.01 Minutes
Standard Deviation 12.396
|
|
Cohort B: Wake After Sleep Onset During the At-Home Period
Panoramic Bracelet
|
22.38 Minutes
Standard Deviation 9.022
|
24.36 Minutes
Standard Deviation 12.820
|
21.62 Minutes
Standard Deviation 12.976
|
PRIMARY outcome
Timeframe: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActivPopulation: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Overall Number of Participants Analyzed ' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B.
Total scratch duration for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=16 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=17 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort B: Total Scratch Duration During the At-Home Period
Panoramic Bracelet
|
2.45 Minutes
Standard Deviation 0.785
|
3.29 Minutes
Standard Deviation 1.453
|
3.35 Minutes
Standard Deviation 1.576
|
|
Cohort B: Total Scratch Duration During the At-Home Period
GENEActiv
|
3.17 Minutes
Standard Deviation 1.138
|
3.19 Minutes
Standard Deviation 1.456
|
3.75 Minutes
Standard Deviation 2.032
|
PRIMARY outcome
Timeframe: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActivPopulation: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Overall Number of Participants Analyzed ' signifies number of participants evaluable for this outcome measure and 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B.
Total scratch episodes for GeneActiv and Panoramic Bracelet was derived by the SleepPy algorithm. SleepPy algorithm was used for detecting a participant's TSO window and computing sleep metrics within that window.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=16 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=17 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort B: Total Scratch Episodes During the At-Home Period
GENEActiv
|
43.81 Scratch episodes
Standard Deviation 14.447
|
43.45 Scratch episodes
Standard Deviation 16.683
|
49.74 Scratch episodes
Standard Deviation 25.354
|
|
Cohort B: Total Scratch Episodes During the At-Home Period
Panoramic Bracelet
|
34.74 Scratch episodes
Standard Deviation 9.585
|
45.60 Scratch episodes
Standard Deviation 17.613
|
46.04 Scratch episodes
Standard Deviation 19.338
|
PRIMARY outcome
Timeframe: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActivPopulation: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B.
Available minutes represented any recorded accelerometer data per day per device in minutes. Number of available minutes for GENEActiv and Panoramic Bracelet was derived by the in-house built Sci-kit Digital Health (SKDH) package.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=17 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=17 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort B: Number of Available Minutes During the At-Home Period
Panoramic Bracelet
|
1389.08 Minutes
Standard Deviation 28.718
|
1386.44 Minutes
Standard Deviation 50.327
|
1385.76 Minutes
Standard Deviation 28.941
|
|
Cohort B: Number of Available Minutes During the At-Home Period
GENEActiv
|
1234.49 Minutes
Standard Deviation 173.436
|
1260.18 Minutes
Standard Deviation 129.136
|
1310.20 Minutes
Standard Deviation 86.365
|
PRIMARY outcome
Timeframe: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActivPopulation: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B.
Number of minutes of wear include the total number of minutes the device is worn including sleep time and awake time. The wear time parameter (number of minutes of wear) for GENEActiv and Panoramic Bracelet was derived by the in-house built SKDH package.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=17 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=17 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort B: Number of Minutes of Wear During the At-Home Period
Panoramic Bracelet
|
1095.45 Minutes
Standard Deviation 145.296
|
1099.07 Minutes
Standard Deviation 185.868
|
1044.66 Minutes
Standard Deviation 153.988
|
|
Cohort B: Number of Minutes of Wear During the At-Home Period
GENEActiv
|
727.98 Minutes
Standard Deviation 226.617
|
785.81 Minutes
Standard Deviation 195.558
|
789.37 Minutes
Standard Deviation 181.889
|
PRIMARY outcome
Timeframe: From Day 1 to Day 15 (+ 3 days) for Panoramic Bracelet; Day 7 (+ 2 days) to Day 15 (+ 2 days) for GENEActivPopulation: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants analyzed for specified rows. The outcome measure was planned to be evaluated only for Cohort B.
The wear time parameter (number of wear minutes while awake) for GENEActiv and Panoramic Bracelet was derived by the in-house built SKDH package.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=17 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=17 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort B: Number of Wear Minutes While Awake During the At-Home Period
Panoramic Bracelet
|
813.15 Minutes
Standard Deviation 47.851
|
883.23 Minutes
Standard Deviation 73.627
|
845.01 Minutes
Standard Deviation 85.179
|
|
Cohort B: Number of Wear Minutes While Awake During the At-Home Period
GENEActiv
|
706.48 Minutes
Standard Deviation 85.259
|
768.64 Minutes
Standard Deviation 99.152
|
775.16 Minutes
Standard Deviation 152.259
|
PRIMARY outcome
Timeframe: Day 7Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort B.
Wearability/comfort questionnaire included a total of 10 items for which the participants (12 to 17 years) or their caregivers (participants aged 3 to 11 years) were required to provide a response on a scale of 0 to 4, where 0 = strongly disagree, and 4 = strongly agree, higher scores indicated more comfort, except for questions 5 ("The device changes the way I move") and 6 ("The device changes the way I behave") , where 0 = strongly agree and 4 = strongly disagree, higher scores indicate more comfort. Number of participants according to response to each item of the wearability/comfort questionnaire is reported.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=17 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=17 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Comfortable to Wear · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Willing to Wear for > 7 Days · 1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
If the device could follow my progress during a treatment (ttmt), I would wear it · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
If the device could follow my progress during a treatment (ttmt), I would wear it · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
If the device could follow my progress during a treatment (ttmt), I would wear it · 2
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
If the device could follow my progress during a treatment (ttmt), I would wear it · 3
|
5 Participants
|
8 Participants
|
6 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
If the device could follow my progress during a treatment (ttmt), I would wear it · 4
|
7 Participants
|
8 Participants
|
11 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
If device could follow my progress during ttmt, I would want my doctor to have access to my results · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
If device could follow my progress during ttmt, I would want my doctor to have access to my results · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
If device could follow my progress during ttmt, I would want my doctor to have access to my results · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
If device could follow my progress during ttmt, I would want my doctor to have access to my results · 3
|
6 Participants
|
9 Participants
|
6 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
If device could follow my progress during ttmt, I would want my doctor to have access to my results · 4
|
7 Participants
|
8 Participants
|
11 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Changes the Way I Behave · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Comfortable to Wear · 1
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Comfortable to Wear · 2
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Comfortable to Wear · 3
|
6 Participants
|
8 Participants
|
11 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Comfortable to Wear · 4
|
5 Participants
|
7 Participants
|
5 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Easy to Put On · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Easy to Put On · 1
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Easy to Put On · 2
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Easy to Put On · 3
|
9 Participants
|
7 Participants
|
7 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Easy to Put On · 4
|
4 Participants
|
6 Participants
|
7 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Easy to Take Off · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Easy to Take Off · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Easy to Take Off · 2
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Easy to Take Off · 3
|
7 Participants
|
7 Participants
|
7 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Easy to Take Off · 4
|
6 Participants
|
7 Participants
|
10 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Easy to Wear · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Easy to Wear · 1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Easy to Wear · 2
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Easy to Wear · 3
|
8 Participants
|
7 Participants
|
6 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Easy to Wear · 4
|
3 Participants
|
7 Participants
|
11 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Changes the Way I Move · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Changes the Way I Move · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Changes the Way I Move · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Changes the Way I Move · 3
|
6 Participants
|
5 Participants
|
3 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Changes the Way I Move · 4
|
7 Participants
|
12 Participants
|
14 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Changes the Way I Behave · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Changes the Way I Behave · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Changes the Way I Behave · 3
|
6 Participants
|
7 Participants
|
4 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Changes the Way I Behave · 4
|
7 Participants
|
10 Participants
|
13 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Willing to Wear for 4 to 7 Days · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Willing to Wear for 4 to 7 Days · 1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Willing to Wear for 4 to 7 Days · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Willing to Wear for 4 to 7 Days · 3
|
7 Participants
|
5 Participants
|
8 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Willing to Wear for 4 to 7 Days · 4
|
6 Participants
|
11 Participants
|
9 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Willing to Wear for > 7 Days · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Willing to Wear for > 7 Days · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Willing to Wear for > 7 Days · 3
|
9 Participants
|
8 Participants
|
9 Participants
|
|
Cohort B: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for Panoramic Bracelet Device at Day 7
Willing to Wear for > 7 Days · 4
|
4 Participants
|
8 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Up to approximately 8 monthsPopulation: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
Number of days to complete enrollment corresponded to the total number of days it took to enroll all study participants within the age groups of 3-5 years, 6-11 years and 12-17 years.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Number of Days to Complete Enrollment
|
232 Days
|
101 Days
|
77 Days
|
SECONDARY outcome
Timeframe: Up to approximately 8 monthsPopulation: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
Number of participants enrolled at specified month intervals in the study is reported in this outcome measure.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Number of Participants Enrolled Over Time
23-Feb-2022 to 22-Mar-2022
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants Enrolled Over Time
23-Mar-2022 to 22-Apr-2022
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants Enrolled Over Time
23-Aug-2021 to 22-Sep-2021
|
5 Participants
|
3 Participants
|
5 Participants
|
|
Cohort A: Number of Participants Enrolled Over Time
23-Sep-2021 to 22-Oct-2021
|
2 Participants
|
6 Participants
|
5 Participants
|
|
Cohort A: Number of Participants Enrolled Over Time
23-Jan-2022 to 22-Feb-2022
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants Enrolled Over Time
23-Oct-2021 to 22-Nov-2021
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Cohort A: Number of Participants Enrolled Over Time
23-Nov-2021 to 22-Dec-2021
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Cohort A: Number of Participants Enrolled Over Time
23-Dec-2021 to 22-Jan-2022
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
Number of participants who were able to perform each of the 7 tasks (i.e., walking at natural, slow and fast speeds, tile and carpet walks, 2 sessions of in-lab simulated activities) is reported in this outcome measure.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks
Activity Block 1
|
13 Participants
|
14 Participants
|
13 Participants
|
|
Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks
Activity Block 2
|
13 Participants
|
14 Participants
|
13 Participants
|
|
Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks
Natural Walk
|
13 Participants
|
14 Participants
|
13 Participants
|
|
Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks
Fast Walk
|
13 Participants
|
14 Participants
|
13 Participants
|
|
Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks
Slow Walk
|
13 Participants
|
14 Participants
|
13 Participants
|
|
Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks
Carpet Walk
|
13 Participants
|
14 Participants
|
13 Participants
|
|
Cohort A: Number of Participants Able to Perform Each of the 7 Lab-Based Tasks
Tile Walk
|
13 Participants
|
14 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
Percentage of tasks completed from a total of 7 tasks (i.e., walking at natural, slow and fast speeds, tile and carpet walks, 2 sessions of in-lab simulated activities) is reported in this outcome measure.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Percentage of Tasks Completed (From a Total of 7 Tasks)
|
100 Percentage of tasks
Interval 100.0 to 100.0
|
100 Percentage of tasks
Interval 100.0 to 100.0
|
100 Percentage of tasks
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: From Day 1 to Day 15 (+ 3 days)Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Number of Hours Per Day Wearing the Lumbar and Wrist Devices
Wrist device
|
21.05 Hours per day
Standard Deviation 2.461
|
21.80 Hours per day
Standard Deviation 1.947
|
22.01 Hours per day
Standard Deviation 2.169
|
|
Cohort A: Number of Hours Per Day Wearing the Lumbar and Wrist Devices
Lumbar device
|
7.24 Hours per day
Standard Deviation 4.293
|
12.51 Hours per day
Standard Deviation 3.630
|
14.24 Hours per day
Standard Deviation 4.574
|
SECONDARY outcome
Timeframe: From Day 1 to Day 15 (+ 3 days)Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Number of Days With More Than 10 Hours of Wear Time for Lumbar Device
|
6.15 Days
Standard Deviation 4.413
|
11.71 Days
Standard Deviation 3.561
|
11.69 Days
Standard Deviation 2.250
|
SECONDARY outcome
Timeframe: From Day 1 to Day 15 (+ 3 days)Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Number of Days With More Than 18 Hours of Wear Time for Wrist Device
|
12.38 Days
Standard Deviation 2.534
|
13.21 Days
Standard Deviation 1.718
|
12.54 Days
Standard Deviation 2.436
|
SECONDARY outcome
Timeframe: Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort A.
Wearability/comfort questionnaire included a total of 10 items for which the participants (12 to 17 years) or their caregivers (participants aged 3 to 11 years) were required to provide a response on a scale of 0 to 4, where 0 = strongly disagree, and 4 = strongly agree, higher scores indicate more comfort except for questions 5 ("The device changes the way I move") and 6 ("The device changes the way I behave") , where 0 = strongly agree and 4 = strongly disagree, higher scores indicate more comfort. Number of participants according to response to each item of the wearability/comfort questionnaire is reported.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Comfortable to Wear · 0
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Comfortable to Wear · 1
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Comfortable to Wear · 2
|
2 Participants
|
1 Participants
|
5 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Comfortable to Wear · 3
|
4 Participants
|
9 Participants
|
6 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Comfortable to Wear · 4
|
6 Participants
|
4 Participants
|
1 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Easy to Put On · 0
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Easy to Put On · 1
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Easy to Put On · 2
|
1 Participants
|
4 Participants
|
5 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Easy to Put On · 3
|
5 Participants
|
4 Participants
|
6 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Easy to Put On · 4
|
6 Participants
|
6 Participants
|
1 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Easy to Take Off · 0
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Easy to Take Off · 1
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Easy to Take Off · 2
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Easy to Take Off · 3
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Easy to Take Off · 4
|
6 Participants
|
7 Participants
|
2 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Easy to Wear · 0
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Easy to Wear · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Easy to Wear · 2
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Easy to Wear · 3
|
7 Participants
|
6 Participants
|
9 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Easy to Wear · 4
|
4 Participants
|
6 Participants
|
3 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Changes the Way I Move · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Changes the Way I Move · 1
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Changes the Way I Move · 2
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Changes the Way I Move · 3
|
7 Participants
|
2 Participants
|
6 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Changes the Way I Move · 4
|
4 Participants
|
11 Participants
|
3 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Changes the Way I Behave · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Changes the Way I Behave · 1
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Changes the Way I Behave · 2
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Changes the Way I Behave · 3
|
6 Participants
|
1 Participants
|
7 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Changes the Way I Behave · 4
|
5 Participants
|
13 Participants
|
5 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Willing to Wear for 4 to 7 Days · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Willing to Wear for 4 to 7 Days · 1
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Willing to Wear for 4 to 7 Days · 2
|
0 Participants
|
3 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Willing to Wear for 4 to 7 Days · 3
|
6 Participants
|
4 Participants
|
9 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Willing to Wear for 4 to 7 Days · 4
|
4 Participants
|
7 Participants
|
3 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Willing to Wear for > 7 Days · 0
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Willing to Wear for > 7 Days · 1
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Willing to Wear for > 7 Days · 2
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Willing to Wear for > 7 Days · 3
|
3 Participants
|
6 Participants
|
7 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: Willing to Wear for > 7 Days · 4
|
4 Participants
|
6 Participants
|
2 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: If the device could follow my progress during a treatment, I would wear it · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: If the device could follow my progress during a treatment, I would wear it · 1
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: If the device could follow my progress during a treatment, I would wear it · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: If the device could follow my progress during a treatment, I would wear it · 3
|
5 Participants
|
6 Participants
|
5 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: If the device could follow my progress during a treatment, I would wear it · 4
|
6 Participants
|
8 Participants
|
8 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: If device could follow my progress during ttmt, I want my doctor to have access to my results · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: If device could follow my progress during ttmt, I want my doctor to have access to my results · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: If device could follow my progress during ttmt, I want my doctor to have access to my results · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: If device could follow my progress during ttmt, I want my doctor to have access to my results · 3
|
5 Participants
|
5 Participants
|
6 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
APDM: If device could follow my progress during ttmt, I want my doctor to have access to my results · 4
|
8 Participants
|
9 Participants
|
7 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ActiGraph (ACT) Lumbar (L): Comfortable to Wear · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ActiGraph (ACT) Lumbar (L): Comfortable to Wear · 1
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ActiGraph (ACT) Lumbar (L): Comfortable to Wear · 2
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ActiGraph (ACT) Lumbar (L): Comfortable to Wear · 3
|
6 Participants
|
8 Participants
|
8 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ActiGraph (ACT) Lumbar (L): Comfortable to Wear · 4
|
6 Participants
|
5 Participants
|
1 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Easy to Put On · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Easy to Put On · 1
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Easy to Put On · 2
|
0 Participants
|
1 Participants
|
4 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Easy to Put On · 3
|
5 Participants
|
4 Participants
|
7 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Easy to Put On · 4
|
7 Participants
|
9 Participants
|
2 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Easy to Take Off · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Easy to Take Off · 2
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Easy to Take Off · 3
|
5 Participants
|
2 Participants
|
7 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Easy to Take Off · 4
|
8 Participants
|
11 Participants
|
5 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Easy to Wear · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Easy to Wear · 2
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Easy to Wear · 3
|
5 Participants
|
6 Participants
|
8 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Easy to Wear · 4
|
7 Participants
|
8 Participants
|
4 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Changes the Way I Move · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Changes the Way I Move · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Changes the Way I Move · 2
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Changes the Way I Move · 3
|
4 Participants
|
2 Participants
|
7 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Changes the Way I Behave · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Changes the Way I Behave · 2
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Changes the Way I Behave · 3
|
3 Participants
|
1 Participants
|
5 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Changes the Way I Behave · 4
|
9 Participants
|
13 Participants
|
8 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Willing to Wear for 4 to 7 Days · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Willing to Wear for 4 to 7 Days · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Willing to Wear for 4 to 7 Days · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Willing to Wear for 4 to 7 Days · 3
|
6 Participants
|
3 Participants
|
5 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Willing to Wear for 4 to 7 Days · 4
|
7 Participants
|
11 Participants
|
8 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Willing to Wear for > 7 Days · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Willing to Wear for > 7 Days · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Willing to Wear for > 7 Days · 2
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Willing to Wear for > 7 Days · 3
|
7 Participants
|
4 Participants
|
3 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Willing to Wear for > 7 Days · 4
|
6 Participants
|
10 Participants
|
8 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: If the device could follow my progress during a treatment, I would wear it · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: If the device could follow my progress during a treatment, I would wear it · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: If the device could follow my progress during a treatment, I would wear it · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: If the device could follow my progress during a treatment, I would wear it · 3
|
6 Participants
|
4 Participants
|
5 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: If the device could follow my progress during a treatment, I would wear it · 4
|
7 Participants
|
10 Participants
|
8 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results · 3
|
4 Participants
|
5 Participants
|
6 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results · 4
|
9 Participants
|
9 Participants
|
7 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ActiGraph (ACT) Wrist (W): Comfortable to Wear · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ActiGraph (ACT) Wrist (W): Comfortable to Wear · 1
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ActiGraph (ACT) Wrist (W): Comfortable to Wear · 2
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ActiGraph (ACT) Wrist (W): Comfortable to Wear · 3
|
3 Participants
|
4 Participants
|
8 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ActiGraph (ACT) Wrist (W): Comfortable to Wear · 4
|
8 Participants
|
8 Participants
|
3 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Easy to Put On · 0
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Easy to Put On · 1
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Easy to Put On · 3
|
2 Participants
|
6 Participants
|
5 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Easy to Put On · 4
|
9 Participants
|
8 Participants
|
5 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Easy to Take Off · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Easy to Take Off · 1
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Easy to Take Off · 2
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Easy to Take Off · 3
|
4 Participants
|
8 Participants
|
4 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Easy to Take Off · 4
|
9 Participants
|
6 Participants
|
7 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Easy to Wear · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Easy to Wear · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Easy to Wear · 2
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Changes the Way I Move · 0
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Changes the Way I Move · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Changes the Way I Move · 2
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Changes the Way I Move · 3
|
4 Participants
|
4 Participants
|
5 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Changes the Way I Move · 4
|
7 Participants
|
10 Participants
|
7 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Changes the Way I Behave · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Changes the Way I Behave · 1
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Changes the Way I Behave · 2
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Changes the Way I Behave · 3
|
2 Participants
|
3 Participants
|
3 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Changes the Way I Behave · 4
|
8 Participants
|
11 Participants
|
10 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Willing to Wear for 4 to 7 Days · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Willing to Wear for 4 to 7 Days · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Willing to Wear for 4 to 7 Days · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Willing to Wear for 4 to 7 Days · 3
|
4 Participants
|
3 Participants
|
4 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Willing to Wear for 4 to 7 Days · 4
|
9 Participants
|
11 Participants
|
9 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Willing to Wear for > 7 Days · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Willing to Wear for > 7 Days · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Willing to Wear for > 7 Days · 2
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Willing to Wear for > 7 Days · 3
|
7 Participants
|
3 Participants
|
4 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Willing to Wear for > 7 Days · 4
|
5 Participants
|
11 Participants
|
9 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: If the device could follow my progress during a ttmt, I would wear it · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: If the device could follow my progress during a ttmt, I would wear it · 4
|
8 Participants
|
11 Participants
|
9 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results · 3
|
3 Participants
|
4 Participants
|
6 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results · 4
|
10 Participants
|
10 Participants
|
7 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Easy to Take Off · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Easy to Wear · 1
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Changes the Way I Move · 4
|
9 Participants
|
12 Participants
|
5 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT L: Changes the Way I Behave · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Easy to Put On · 2
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Easy to Wear · 3
|
7 Participants
|
6 Participants
|
6 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: Easy to Wear · 4
|
6 Participants
|
7 Participants
|
6 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: If the device could follow my progress during a ttmt, I would wear it · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: If the device could follow my progress during a ttmt, I would wear it · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to In Lab Wearability/Comfort Questionnaire for APDM Device and for ActiGraph Lumbar and Wrist Device at Day 1
ACT W: If the device could follow my progress during a ttmt, I would wear it · 3
|
5 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 15 (+ 3 days)Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A.
Wearability/comfort questionnaire included a total of 10 items for which the participants (12 to 17 years) or their caregivers (participants aged 3 to 11 years) were required to provide a response on a scale of 0 to 4, where 0 = strongly disagree, and 4 = strongly agree, higher scores indicate more comfort except for questions 5 ("The device changes the way I move") and 6 ("The device changes the way I behave") , where 0 = strongly agree and 4 = strongly disagree, higher scores indicate more comfort. Number of participants according to response to each item of the wearability/comfort questionnaire is reported.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ActiGraph (ACT) Lumbar (L): Comfortable to Wear · 0
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ActiGraph (ACT) Lumbar (L): Comfortable to Wear · 1
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ActiGraph (ACT) Lumbar (L): Comfortable to Wear · 2
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ActiGraph (ACT) Lumbar (L): Comfortable to Wear · 3
|
7 Participants
|
8 Participants
|
3 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ActiGraph (ACT) Lumbar (L): Comfortable to Wear · 4
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Easy to Put On · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Easy to Put On · 1
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Easy to Put On · 2
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Easy to Wear · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Easy to Wear · 1
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Easy to Wear · 3
|
7 Participants
|
5 Participants
|
2 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Changes the Way I Move · 1
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Changes the Way I Move · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Willing to Wear for 4 to 7 Days · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Willing to Wear for 4 to 7 Days · 3
|
7 Participants
|
6 Participants
|
5 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Willing to Wear for > 7 Days · 3
|
5 Participants
|
8 Participants
|
4 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: If the device could follow my progress during a treatment, I would wear it · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: If the device could follow my progress during a treatment, I would wear it · 3
|
6 Participants
|
5 Participants
|
3 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: If the device could follow my progress during a treatment, I would wear it · 4
|
6 Participants
|
9 Participants
|
10 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ActiGraph (ACT) Wrist (W): Comfortable to Wear · 2
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ActiGraph (ACT) Wrist (W): Comfortable to Wear · 4
|
7 Participants
|
9 Participants
|
7 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Easy to Put On · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Easy to Put On · 1
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Easy to Put On · 2
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Easy to Put On · 3
|
4 Participants
|
6 Participants
|
5 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Easy to Take Off · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Easy to Take Off · 1
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Easy to Take Off · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Easy to Take Off · 3
|
4 Participants
|
8 Participants
|
4 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Easy to Take Off · 4
|
8 Participants
|
6 Participants
|
9 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Easy to Wear · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Easy to Wear · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Easy to Wear · 3
|
5 Participants
|
5 Participants
|
4 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Easy to Wear · 4
|
8 Participants
|
9 Participants
|
8 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Changes the Way I Move · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Changes the Way I Move · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Changes the Way I Move · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Changes the Way I Behave · 1
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Changes the Way I Behave · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Changes the Way I Behave · 4
|
8 Participants
|
11 Participants
|
10 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Willing to Wear for 4 to 7 Days · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Willing to Wear for 4 to 7 Days · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Willing to Wear for 4 to 7 Days · 3
|
3 Participants
|
5 Participants
|
5 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: If the device could follow my progress during a ttmt, I would wear it · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: If the device could follow my progress during a ttmt, I would wear it · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: If the device could follow my progress during a ttmt, I would wear it · 4
|
9 Participants
|
9 Participants
|
10 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Willing to Wear for 4 to 7 Days · 4
|
3 Participants
|
7 Participants
|
8 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Willing to Wear for > 7 Days · 0
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Willing to Wear for > 7 Days · 1
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Willing to Wear for > 7 Days · 2
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Willing to Wear for > 7 Days · 4
|
3 Participants
|
5 Participants
|
8 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: If the device could follow my progress during a treatment, I would wear it · 1
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: If the device could follow my progress during a treatment, I would wear it · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results · 3
|
3 Participants
|
4 Participants
|
4 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L:If device could follow my progress during ttmt, I want my doctor to have access to my results · 4
|
10 Participants
|
10 Participants
|
9 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ActiGraph (ACT) Wrist (W): Comfortable to Wear · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ActiGraph (ACT) Wrist (W): Comfortable to Wear · 1
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ActiGraph (ACT) Wrist (W): Comfortable to Wear · 3
|
5 Participants
|
5 Participants
|
5 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Easy to Put On · 4
|
8 Participants
|
6 Participants
|
7 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Easy to Wear · 2
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Changes the Way I Move · 3
|
4 Participants
|
2 Participants
|
2 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Changes the Way I Move · 4
|
9 Participants
|
12 Participants
|
11 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Changes the Way I Behave · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Changes the Way I Behave · 3
|
5 Participants
|
2 Participants
|
3 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Willing to Wear for 4 to 7 Days · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Willing to Wear for 4 to 7 Days · 4
|
10 Participants
|
9 Participants
|
8 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Willing to Wear for > 7 Days · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Willing to Wear for > 7 Days · 1
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Willing to Wear for > 7 Days · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Willing to Wear for > 7 Days · 3
|
4 Participants
|
5 Participants
|
5 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: Willing to Wear for > 7 Days · 4
|
8 Participants
|
9 Participants
|
8 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: If the device could follow my progress during a ttmt, I would wear it · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W: If the device could follow my progress during a ttmt, I would wear it · 3
|
4 Participants
|
5 Participants
|
3 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results · 2
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results · 3
|
3 Participants
|
3 Participants
|
4 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT W:If device could follow my progress during ttmt, I want my doctor to have access to my results · 4
|
10 Participants
|
11 Participants
|
9 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Easy to Put On · 3
|
5 Participants
|
5 Participants
|
3 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Easy to Put On · 4
|
7 Participants
|
8 Participants
|
8 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Easy to Take Off · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Easy to Take Off · 1
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Easy to Take Off · 2
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Easy to Take Off · 3
|
4 Participants
|
5 Participants
|
3 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Easy to Take Off · 4
|
8 Participants
|
9 Participants
|
10 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Easy to Wear · 2
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Easy to Wear · 4
|
3 Participants
|
6 Participants
|
6 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Changes the Way I Move · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Changes the Way I Move · 3
|
6 Participants
|
3 Participants
|
6 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Changes the Way I Move · 4
|
6 Participants
|
9 Participants
|
7 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Changes the Way I Behave · 0
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Changes the Way I Behave · 1
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Changes the Way I Behave · 2
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Changes the Way I Behave · 3
|
5 Participants
|
2 Participants
|
4 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Changes the Way I Behave · 4
|
7 Participants
|
10 Participants
|
9 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Willing to Wear for 4 to 7 Days · 0
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Cohort A: Number of Participants According to Response to At-home Wearability/Comfort Questionnaire for ActiGraph Lumbar and Wrist Device at Final Study Evaluation
ACT L: Willing to Wear for 4 to 7 Days · 1
|
2 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.
Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had a single in-lab visit during which they performed gait monitoring procedures. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=40 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Double Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
APDM: Carpet
|
0.20 Seconds
Standard Error 0.007
|
—
|
—
|
|
Cohort A: Double Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
ActiGraph: Carpet
|
0.28 Seconds
Standard Error 0.007
|
—
|
—
|
|
Cohort A: Double Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
ActiGraph: Tile
|
0.28 Seconds
Standard Error 0.007
|
—
|
—
|
|
Cohort A: Double Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
APDM: Tile
|
0.19 Seconds
Standard Error 0.007
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.
Single limb support time referred to the time when only one limb was in contact with the ground. Participants had a single in-lab visit during which they performed gait monitoring procedures. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=40 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Single Limb Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
ActiGraph: Carpet
|
0.39 Seconds
Standard Error 0.006
|
—
|
—
|
|
Cohort A: Single Limb Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
APDM: Carpet
|
0.42 Seconds
Standard Error 0.006
|
—
|
—
|
|
Cohort A: Single Limb Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
ActiGraph: Tile
|
0.38 Seconds
Standard Error 0.006
|
—
|
—
|
|
Cohort A: Single Limb Support Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
APDM: Tile
|
0.42 Seconds
Standard Error 0.006
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.
Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=40 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Stance Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
ActiGraph: Carpet
|
0.67 Seconds
Standard Error 0.012
|
—
|
—
|
|
Cohort A: Stance Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
APDM: Carpet
|
0.62 Seconds
Standard Error 0.012
|
—
|
—
|
|
Cohort A: Stance Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
ActiGraph: Tile
|
0.66 Seconds
Standard Error 0.012
|
—
|
—
|
|
Cohort A: Stance Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
APDM: Tile
|
0.61 Seconds
Standard Error 0.012
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.
Swing time was defined as the time during which the foot was not in contact with the ground. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=40 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Swing Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
ActiGraph: Tile
|
0.38 Seconds
Standard Error 0.006
|
—
|
—
|
|
Cohort A: Swing Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
ActiGraph: Carpet
|
0.39 Seconds
Standard Error 0.006
|
—
|
—
|
|
Cohort A: Swing Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
APDM: Carpet
|
0.42 Seconds
Standard Error 0.006
|
—
|
—
|
|
Cohort A: Swing Time Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
APDM: Tile
|
0.42 Seconds
Standard Error 0.006
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.
Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. Participants had a single in-lab visit during which they performed gait monitoring procedures. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=40 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Stride Length Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
ActiGraph: Tile
|
1.00 Meters
Standard Error 0.016
|
—
|
—
|
|
Cohort A: Stride Length Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
ActiGraph: Carpet
|
1.00 Meters
Standard Error 0.016
|
—
|
—
|
|
Cohort A: Stride Length Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
APDM: Carpet
|
1.01 Meters
Standard Error 0.017
|
—
|
—
|
|
Cohort A: Stride Length Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
APDM: Tile
|
1.01 Meters
Standard Error 0.016
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.
Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=40 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Step Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
ActiGraph: Carpet
|
0.53 Seconds
Standard Error 0.009
|
—
|
—
|
|
Cohort A: Step Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
APDM: Carpet
|
0.52 Seconds
Standard Error 0.009
|
—
|
—
|
|
Cohort A: Step Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
ActiGraph: Tile
|
0.52 Seconds
Standard Error 0.009
|
—
|
—
|
|
Cohort A: Step Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
APDM: Tile
|
0.51 Seconds
Standard Error 0.009
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.
Cadence referred to the number of steps taken per minute during gait cycle. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=40 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Cadence Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
APDM: Carpet
|
116.79 Steps per minute
Standard Error 2.240
|
—
|
—
|
|
Cohort A: Cadence Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
APDM: Tile
|
119.62 Steps per minute
Standard Error 2.236
|
—
|
—
|
|
Cohort A: Cadence Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
ActiGraph: Tile
|
117.56 Steps per minute
Standard Error 2.236
|
—
|
—
|
|
Cohort A: Cadence Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
ActiGraph: Carpet
|
115.08 Steps per minute
Standard Error 2.236
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.
Gait speed was the time taken to walk a specified distance. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=40 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Gait Speed Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
ActiGraph: Tile
|
0.97 Meters per second
Standard Error 0.027
|
—
|
—
|
|
Cohort A: Gait Speed Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
APDM: Tile
|
1.00 Meters per second
Standard Error 0.027
|
—
|
—
|
|
Cohort A: Gait Speed Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
ActiGraph: Carpet
|
0.95 Meters per second
Standard Error 0.027
|
—
|
—
|
|
Cohort A: Gait Speed Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
APDM: Carpet
|
0.97 Meters per second
Standard Error 0.027
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort A. Mixed model regression analysis did not use age group as a grouping variable and was performed across all participants independent of age groups; hence, combined data is reported for participants aged 3 to 17 years.
Stride duration refers to the duration between successive heel contacts of the same foot. Participants were required to work on tile and carpet at their natural speed while wearing the device under study (ActiGraph) and APDM system. Raw accelerometry data collected by ActiGraph devices was processed by GaitPy to generate gait quality metrics (lumbar position). Gait metrics data was directly extracted from APDM sensors. Analysis was performed using mixed model regression analyses with device, floor type, and their interaction as fixed effects, and participant as random effect.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=40 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort A: Stride Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
ActiGraph: Carpet
|
1.05 Seconds
Standard Error 0.018
|
—
|
—
|
|
Cohort A: Stride Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
APDM: Carpet
|
1.04 Seconds
Standard Error 0.018
|
—
|
—
|
|
Cohort A: Stride Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
ActiGraph: Tile
|
1.04 Seconds
Standard Error 0.018
|
—
|
—
|
|
Cohort A: Stride Duration Measured by ActiGraph and APDM Devices Across Different Floor Surfaces Using Mixed Model Regression Analysis
APDM: Tile
|
1.02 Seconds
Standard Error 0.018
|
—
|
—
|
SECONDARY outcome
Timeframe: From Day 1 up to Day 7Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. The outcome measure was planned to be evaluated only for Cohort B.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=17 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=17 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort B: Number of Hours Per Day Wearing the Panoramic Bracelet Devices at Home
|
22.65 Hours per day
Standard Deviation 1.051
|
22.80 Hours per day
Standard Deviation 1.317
|
22.60 Hours per day
Standard Deviation 1.590
|
SECONDARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B.
Double support time referred to the phase during walking when both feet were in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=17 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=17 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Natural Speed
|
0.16 Seconds
Standard Deviation 0.031
|
0.17 Seconds
Standard Deviation 0.039
|
0.19 Seconds
Standard Deviation 0.041
|
|
Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Fast Speed
|
0.15 Seconds
Standard Deviation 0.040
|
0.18 Seconds
Standard Deviation 0.041
|
0.24 Seconds
Standard Deviation 0.030
|
|
Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Slow Speed
|
0.34 Seconds
Standard Deviation 0.179
|
0.37 Seconds
Standard Deviation 0.199
|
0.37 Seconds
Standard Deviation 0.122
|
|
Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Panoramic Bracelet: Natural Speed
|
0.29 Seconds
Standard Deviation 0.063
|
0.32 Seconds
Standard Deviation 0.031
|
0.34 Seconds
Standard Deviation 0.035
|
|
Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Natural Speed
|
0.20 Seconds
Standard Deviation 0.038
|
0.25 Seconds
Standard Deviation 0.041
|
0.31 Seconds
Standard Deviation 0.032
|
|
Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Panoramic Bracelet: Fast Speed
|
0.24 Seconds
Standard Deviation 0.056
|
0.26 Seconds
Standard Deviation 0.047
|
0.30 Seconds
Standard Deviation 0.030
|
|
Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Fast Speed
|
0.13 Seconds
Standard Deviation 0.032
|
0.12 Seconds
Standard Deviation 0.027
|
0.15 Seconds
Standard Deviation 0.031
|
|
Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Panoramic Bracelet: Slow Speed
|
0.42 Seconds
Standard Deviation 0.166
|
0.50 Seconds
Standard Deviation 0.183
|
0.51 Seconds
Standard Deviation 0.121
|
|
Cohort B: Double Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Slow Speed
|
0.37 Seconds
Standard Deviation 0.181
|
0.47 Seconds
Standard Deviation 0.243
|
0.52 Seconds
Standard Deviation 0.148
|
SECONDARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B.
Single support time referred to the time when only one limb was in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=17 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=17 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Fast Speed
|
0.30 Seconds
Standard Deviation 0.027
|
0.32 Seconds
Standard Deviation 0.030
|
0.37 Seconds
Standard Deviation 0.025
|
|
Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Slow Speed
|
0.43 Seconds
Standard Deviation 0.088
|
0.52 Seconds
Standard Deviation 0.151
|
0.58 Seconds
Standard Deviation 0.112
|
|
Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Panoramic Bracelet: Natural Speed
|
0.31 Seconds
Standard Deviation 0.111
|
0.34 Seconds
Standard Deviation 0.036
|
0.39 Seconds
Standard Deviation 0.026
|
|
Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Natural Speed
|
0.31 Seconds
Standard Deviation 0.016
|
0.37 Seconds
Standard Deviation 0.031
|
0.39 Seconds
Standard Deviation 0.027
|
|
Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Natural Speed
|
0.36 Seconds
Standard Deviation 0.021
|
0.41 Seconds
Standard Deviation 0.034
|
0.45 Seconds
Standard Deviation 0.027
|
|
Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Panoramic Bracelet: Fast Speed
|
0.26 Seconds
Standard Deviation 0.052
|
0.29 Seconds
Standard Deviation 0.029
|
0.35 Seconds
Standard Deviation 0.029
|
|
Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Fast Speed
|
0.34 Seconds
Standard Deviation 0.018
|
0.37 Seconds
Standard Deviation 0.031
|
0.42 Seconds
Standard Deviation 0.028
|
|
Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Panoramic Bracelet: Slow Speed
|
0.50 Seconds
Standard Deviation 0.356
|
0.48 Seconds
Standard Deviation 0.140
|
0.51 Seconds
Standard Deviation 0.102
|
|
Cohort B: Single Limb Support Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Slow Speed
|
0.36 Seconds
Standard Deviation 0.079
|
0.46 Seconds
Standard Deviation 0.141
|
0.50 Seconds
Standard Deviation 0.095
|
SECONDARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B.
Stance duration was defined as the duration of time the foot is in contact with the ground in a step during gait. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=17 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=17 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Natural Speed
|
0.52 Seconds
Standard Deviation 0.048
|
0.63 Seconds
Standard Deviation 0.064
|
0.71 Seconds
Standard Deviation 0.051
|
|
Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Slow Speed
|
0.78 Seconds
Standard Deviation 0.256
|
0.89 Seconds
Standard Deviation 0.352
|
0.95 Seconds
Standard Deviation 0.228
|
|
Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Panoramic Bracelet: Natural Speed
|
0.61 Seconds
Standard Deviation 0.186
|
0.66 Seconds
Standard Deviation 0.062
|
0.73 Seconds
Standard Deviation 0.055
|
|
Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Natural Speed
|
0.52 Seconds
Standard Deviation 0.044
|
0.58 Seconds
Standard Deviation 0.061
|
0.64 Seconds
Standard Deviation 0.054
|
|
Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Panoramic Bracelet: Fast Speed
|
0.52 Seconds
Standard Deviation 0.100
|
0.55 Seconds
Standard Deviation 0.069
|
0.64 Seconds
Standard Deviation 0.048
|
|
Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Fast Speed
|
0.44 Seconds
Standard Deviation 0.063
|
0.51 Seconds
Standard Deviation 0.064
|
0.62 Seconds
Standard Deviation 0.050
|
|
Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Fast Speed
|
0.47 Seconds
Standard Deviation 0.037
|
0.48 Seconds
Standard Deviation 0.050
|
0.56 Seconds
Standard Deviation 0.044
|
|
Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Panoramic Bracelet: Slow Speed
|
0.91 Seconds
Standard Deviation 0.452
|
0.99 Seconds
Standard Deviation 0.340
|
1.03 Seconds
Standard Deviation 0.230
|
|
Cohort B: Stance Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Slow Speed
|
0.74 Seconds
Standard Deviation 0.245
|
0.93 Seconds
Standard Deviation 0.342
|
1.03 Seconds
Standard Deviation 0.232
|
SECONDARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B.
Swing time was defined as the time during which the foot was not in contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=17 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=17 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Panoramic Bracelet: Fast Speed
|
0.26 Seconds
Standard Deviation 0.051
|
0.29 Seconds
Standard Deviation 0.029
|
0.34 Seconds
Standard Deviation 0.029
|
|
Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Fast Speed
|
0.30 Seconds
Standard Deviation 0.026
|
0.33 Seconds
Standard Deviation 0.029
|
0.37 Seconds
Standard Deviation 0.026
|
|
Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Fast Speed
|
0.34 Seconds
Standard Deviation 0.017
|
0.37 Seconds
Standard Deviation 0.031
|
0.42 Seconds
Standard Deviation 0.026
|
|
Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Panoramic Bracelet: Slow Speed
|
0.39 Seconds
Standard Deviation 0.182
|
0.48 Seconds
Standard Deviation 0.137
|
0.51 Seconds
Standard Deviation 0.102
|
|
Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Slow Speed
|
0.43 Seconds
Standard Deviation 0.087
|
0.52 Seconds
Standard Deviation 0.140
|
0.57 Seconds
Standard Deviation 0.109
|
|
Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Panoramic Bracelet: Natural Speed
|
0.30 Seconds
Standard Deviation 0.085
|
0.34 Seconds
Standard Deviation 0.036
|
0.38 Seconds
Standard Deviation 0.026
|
|
Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Natural Speed
|
0.32 Seconds
Standard Deviation 0.016
|
0.37 Seconds
Standard Deviation 0.032
|
0.39 Seconds
Standard Deviation 0.026
|
|
Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Natural Speed
|
0.36 Seconds
Standard Deviation 0.015
|
0.41 Seconds
Standard Deviation 0.034
|
0.45 Seconds
Standard Deviation 0.027
|
|
Cohort B: Swing Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Slow Speed
|
0.36 Seconds
Standard Deviation 0.081
|
0.46 Seconds
Standard Deviation 0.139
|
0.50 Seconds
Standard Deviation 0.095
|
SECONDARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B.
Stride length was defined as the distance covered when two steps were taken, one with each foot. It was measured from the heel of one foot to the heel of same foot when it came into contact with the ground. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=17 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=17 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Panoramic Bracelet: Natural Speed
|
1.01 Meters
Standard Deviation 0.182
|
1.24 Meters
Standard Deviation 0.166
|
1.29 Meters
Standard Deviation 0.149
|
|
Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Natural Speed
|
0.88 Meters
Standard Deviation 0.122
|
1.20 Meters
Standard Deviation 0.093
|
1.37 Meters
Standard Deviation 0.094
|
|
Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Natural Speed
|
0.78 Meters
Standard Deviation 0.104
|
1.09 Meters
Standard Deviation 0.091
|
1.23 Meters
Standard Deviation 0.093
|
|
Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Panoramic Bracelet: Fast Speed
|
1.17 Meters
Standard Deviation 0.320
|
1.33 Meters
Standard Deviation 0.163
|
1.48 Meters
Standard Deviation 0.197
|
|
Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Fast Speed
|
1.02 Meters
Standard Deviation 0.101
|
1.34 Meters
Standard Deviation 0.106
|
1.56 Meters
Standard Deviation 0.159
|
|
Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Fast Speed
|
0.88 Meters
Standard Deviation 0.073
|
1.23 Meters
Standard Deviation 0.109
|
1.39 Meters
Standard Deviation 0.120
|
|
Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Panoramic Bracelet: Slow Speed
|
0.85 Meters
Standard Deviation 0.211
|
0.99 Meters
Standard Deviation 0.244
|
1.06 Meters
Standard Deviation 0.127
|
|
Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Slow Speed
|
0.61 Meters
Standard Deviation 0.174
|
0.90 Meters
Standard Deviation 0.217
|
1.11 Meters
Standard Deviation 0.122
|
|
Cohort B: Stride Length Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Slow Speed
|
0.51 Meters
Standard Deviation 0.157
|
0.78 Meters
Standard Deviation 0.194
|
0.94 Meters
Standard Deviation 0.112
|
SECONDARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B.
Step duration was the period between the first contact of a foot and the first following contact of the contralateral foot. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=17 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=17 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Panoramic Bracelet: Natural Speed
|
0.46 Seconds
Standard Deviation 0.152
|
0.50 Seconds
Standard Deviation 0.046
|
0.55 Seconds
Standard Deviation 0.037
|
|
Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Natural Speed
|
0.42 Seconds
Standard Deviation 0.030
|
0.49 Seconds
Standard Deviation 0.044
|
0.55 Seconds
Standard Deviation 0.037
|
|
Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Natural Speed
|
0.44 Seconds
Standard Deviation 0.024
|
0.50 Seconds
Standard Deviation 0.046
|
0.55 Seconds
Standard Deviation 0.037
|
|
Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Panoramic Bracelet: Fast Speed
|
0.39 Seconds
Standard Deviation 0.074
|
0.42 Seconds
Standard Deviation 0.042
|
0.50 Seconds
Standard Deviation 0.038
|
|
Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Fast Speed
|
0.37 Seconds
Standard Deviation 0.044
|
0.42 Seconds
Standard Deviation 0.047
|
0.49 Seconds
Standard Deviation 0.036
|
|
Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Fast Speed
|
0.40 Seconds
Standard Deviation 0.026
|
0.43 Seconds
Standard Deviation 0.042
|
0.49 Seconds
Standard Deviation 0.033
|
|
Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Panoramic Bracelet: Slow Speed
|
0.70 Seconds
Standard Deviation 0.418
|
0.74 Seconds
Standard Deviation 0.241
|
0.77 Seconds
Standard Deviation 0.164
|
|
Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Slow Speed
|
0.54 Seconds
Standard Deviation 0.157
|
0.70 Seconds
Standard Deviation 0.229
|
0.76 Seconds
Standard Deviation 0.165
|
|
Cohort B: Step Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Slow Speed
|
0.60 Seconds
Standard Deviation 0.171
|
0.71 Seconds
Standard Deviation 0.247
|
0.76 Seconds
Standard Deviation 0.162
|
SECONDARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B.
Cadence referred to the number of steps taken per minute during gait cycle. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=17 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=17 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Panoramic Bracelet: Natural Speed
|
138.45 Steps per minute
Standard Deviation 26.272
|
119.94 Steps per minute
Standard Deviation 10.909
|
108.89 Steps per minute
Standard Deviation 7.163
|
|
Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Natural Speed
|
144.80 Steps per minute
Standard Deviation 11.373
|
122.16 Steps per minute
Standard Deviation 10.433
|
109.98 Steps per minute
Standard Deviation 7.504
|
|
Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Natural Speed
|
136.44 Steps per minute
Standard Deviation 7.962
|
122.15 Steps per minute
Standard Deviation 10.904
|
110.45 Steps per minute
Standard Deviation 7.473
|
|
Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Panoramic Bracelet: Fast Speed
|
158.13 Steps per minute
Standard Deviation 28.017
|
144.41 Steps per minute
Standard Deviation 14.793
|
121.24 Steps per minute
Standard Deviation 9.227
|
|
Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Fast Speed
|
166.43 Steps per minute
Standard Deviation 20.297
|
145.96 Steps per minute
Standard Deviation 16.900
|
122.86 Steps per minute
Standard Deviation 9.042
|
|
Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Fast Speed
|
147.01 Steps per minute
Standard Deviation 11.303
|
141.76 Steps per minute
Standard Deviation 13.502
|
122.66 Steps per minute
Standard Deviation 8.589
|
|
Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Panoramic Bracelet: Slow Speed
|
106.99 Steps per minute
Standard Deviation 45.694
|
88.81 Steps per minute
Standard Deviation 24.208
|
81.21 Steps per minute
Standard Deviation 16.065
|
|
Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Slow Speed
|
119.25 Steps per minute
Standard Deviation 36.642
|
93.91 Steps per minute
Standard Deviation 25.728
|
82.24 Steps per minute
Standard Deviation 16.459
|
|
Cohort B: Cadence Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Slow Speed
|
106.81 Steps per minute
Standard Deviation 28.903
|
92.80 Steps per minute
Standard Deviation 25.727
|
82.07 Steps per minute
Standard Deviation 16.271
|
SECONDARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B.
Gait speed was the time taken to walk a specified distance. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=17 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=17 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task
APDM: Natural Speed
|
0.89 Meters per second
Standard Deviation 0.147
|
1.11 Meters per second
Standard Deviation 0.144
|
1.13 Meters per second
Standard Deviation 0.120
|
|
Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task
Panoramic Bracelet: Natural Speed
|
1.15 Meters per second
Standard Deviation 0.209
|
1.24 Meters per second
Standard Deviation 0.228
|
1.17 Meters per second
Standard Deviation 0.176
|
|
Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task
GAITRite: Natural Speed
|
1.07 Meters per second
Standard Deviation 0.211
|
1.21 Meters per second
Standard Deviation 0.144
|
1.25 Meters per second
Standard Deviation 0.124
|
|
Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task
Panoramic Bracelet: Fast Speed
|
1.50 Meters per second
Standard Deviation 0.345
|
1.57 Meters per second
Standard Deviation 0.191
|
1.50 Meters per second
Standard Deviation 0.262
|
|
Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task
GAITRite: Fast Speed
|
1.41 Meters per second
Standard Deviation 0.234
|
1.63 Meters per second
Standard Deviation 0.205
|
1.59 Meters per second
Standard Deviation 0.225
|
|
Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task
APDM: Fast Speed
|
1.07 Meters per second
Standard Deviation 0.105
|
1.45 Meters per second
Standard Deviation 0.130
|
1.43 Meters per second
Standard Deviation 0.162
|
|
Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task
Panoramic Bracelet: Slow Speed
|
0.77 Meters per second
Standard Deviation 0.298
|
0.72 Meters per second
Standard Deviation 0.223
|
0.73 Meters per second
Standard Deviation 0.171
|
|
Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task
GAITRite: Slow Speed
|
0.59 Meters per second
Standard Deviation 0.256
|
0.70 Meters per second
Standard Deviation 0.280
|
0.76 Meters per second
Standard Deviation 0.174
|
|
Cohort B: Gait Speed Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Task
APDM: Slow Speed
|
0.47 Meters per second
Standard Deviation 0.224
|
0.61 Meters per second
Standard Deviation 0.273
|
0.65 Meters per second
Standard Deviation 0.168
|
SECONDARY outcome
Timeframe: Up to 20 minutes on Day 1Population: FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study. Here, 'Number Analyzed' signifies number of participants evaluable for the specified rows. The outcome measure was planned to be evaluated only for Cohort B.
Stride duration refers to the duration between successive heel contacts of the same foot. Participants had to walk on GAITRite walkway (20 feet\*3) wearing Panoramic bracelet device and APDM devices at participant's natural speed and at varied speeds. Natural speed was participant's self-chosen pace for 3 rounds. Varied speeds included participant's self-chosen slow pace ("Walk slow") and fast pace ("Walk fast") for 3 rounds. Raw accelerometry data collected by devices were processed by manufacturer's algorithm for APDM and SKDH gait algorithm for Panoramic bracelet device to generate gait metrics.
Outcome measures
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 Participants
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=17 Participants
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=17 Participants
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|
|
Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Panoramic Bracelet: Natural Speed
|
0.90 Seconds
Standard Deviation 0.257
|
1.00 Seconds
Standard Deviation 0.093
|
1.11 Seconds
Standard Deviation 0.078
|
|
Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Natural Speed
|
0.84 Seconds
Standard Deviation 0.070
|
0.99 Seconds
Standard Deviation 0.091
|
1.10 Seconds
Standard Deviation 0.073
|
|
Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Natural Speed
|
0.88 Seconds
Standard Deviation 0.055
|
0.99 Seconds
Standard Deviation 0.093
|
1.09 Seconds
Standard Deviation 0.074
|
|
Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Panoramic Bracelet: Fast Speed
|
0.78 Seconds
Standard Deviation 0.140
|
0.84 Seconds
Standard Deviation 0.093
|
0.99 Seconds
Standard Deviation 0.075
|
|
Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Fast Speed
|
0.73 Seconds
Standard Deviation 0.085
|
0.83 Seconds
Standard Deviation 0.094
|
0.98 Seconds
Standard Deviation 0.071
|
|
Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Fast Speed
|
0.82 Seconds
Standard Deviation 0.063
|
0.85 Seconds
Standard Deviation 0.079
|
0.98 Seconds
Standard Deviation 0.069
|
|
Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
Panoramic Bracelet: Slow Speed
|
1.24 Seconds
Standard Deviation 0.552
|
1.46 Seconds
Standard Deviation 0.477
|
1.53 Seconds
Standard Deviation 0.326
|
|
Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
GAITRite: Slow Speed
|
1.12 Seconds
Standard Deviation 0.352
|
1.40 Seconds
Standard Deviation 0.473
|
1.52 Seconds
Standard Deviation 0.330
|
|
Cohort B: Stride Duration Measured by APDM, GAITRite Walkway and Panoramic Bracelet Devices for Walk at Natural, Slow and Fast Speed Tasks
APDM: Slow Speed
|
1.20 Seconds
Standard Deviation 0.336
|
1.42 Seconds
Standard Deviation 0.489
|
1.52 Seconds
Standard Deviation 0.330
|
Adverse Events
Cohort A: Participants Aged 3-5 Years
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort A: Participants Aged 6-11 Years
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort A: Participants Aged 12-17 Years
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Cohort B: Participants Aged 3-5 Years
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Cohort B: Participants Aged 6-11 Years
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Cohort B: Participants Aged 12-17 Years
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cohort A: Participants Aged 3-5 Years
n=13 participants at risk
Participants aged 3 to 5 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the Ambulatory Parkinson's Disease Monitoring System (APDM) Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 6-11 Years
n=14 participants at risk
Participants aged 6 to 11 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort A: Participants Aged 12-17 Years
n=13 participants at risk
Participants aged 12 to 17 years wore the ActiGraph CenterPoint Insight Watch on the non-dominant wrist (worn continuously) and lumbar region (worn after waking up in the morning and removed while sleeping at night or nap during daytime) for approximately 15 days (+ 3 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort B: Participants Aged 3-5 Years
n=13 participants at risk
Participants aged 3 to 5 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort B: Participants Aged 6-11 Years
n=17 participants at risk
Participants aged 6 to 11 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
Cohort B: Participants Aged 12-17 Years
n=17 participants at risk
Participants aged 12 to 17 years wore the Panoramic Digital Health Bracelet on the non-dominant wrist for approximately 15 days (+ 3 days). GENEActiv device was also worn on the same non-dominant wrist from Day 7 (+ 2 days) to Day 15 (+ 2 days). Participants wore the APDM Opal sensors on each wrist, chest, lumbar, and above each shoe, only on Day 1.
|
|---|---|---|---|---|---|---|
|
General disorders
Medical device site bruise
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/14 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
5.9%
1/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
|
General disorders
Pyrexia
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
7.1%
1/14 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
7.7%
1/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
5.9%
1/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
|
Infections and infestations
COVID-19
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/14 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
7.7%
1/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/14 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
5.9%
1/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/14 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
5.9%
1/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/14 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
5.9%
1/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/14 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
7.7%
1/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/14 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
5.9%
1/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.7%
1/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/14 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
11.8%
2/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
5.9%
1/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
|
Skin and subcutaneous tissue disorders
Skin indentation
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/14 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
7.7%
1/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
7.1%
1/14 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
|
General disorders
Medical device site irritation
|
7.7%
1/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/14 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
|
General disorders
Medical device site rash
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/14 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
7.7%
1/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
|
Infections and infestations
Upper respiratory tract infection
|
23.1%
3/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/14 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/14 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
7.7%
1/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
7.1%
1/14 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/13 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
0.00%
0/17 • From Day 1 to Day 15 (+3 days)
FAS included all participants who had a signed and dated informed consent document, had assented to the study and were enrolled in the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place