Trial Outcomes & Findings for walk2Wellness: Long-term Effects of Walkasins® Wearable Sensory Prosthesis (NCT NCT03538756)
NCT ID: NCT03538756
Last Updated: 2022-12-22
Results Overview
The Functional Gait Assessment (FGA) is a 10-item scale that measures postural stability while individuals perform walking tasks that are scored from 0 to 3 (3 = normal, 2 = mild impairment, 1 = moderate impairment, 0 = severe impairment). Scores range from a minimum of 0 to a maximum of 30. Higher scores indicate better postural stability. (Participants scoring 23 or higher on the baseline FGA were not included in this study because their peripheral neuropathy was not yet affecting their gait/balance significantly.)
COMPLETED
NA
69 participants
Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52
2022-12-22
Participant Flow
Participants were recruited at five sites through various methods, including physician referral and recruitment posters. The first participant was enrolled on October 22, 2018, and the last participant was enrolled in April 2021.
Sixty-nine participants met the eligibility criteria and received Walkasins, the study device, to be worn on both feet for the duration of their participation. Primary reasons for exclusion were participants' inability to feel the Walkasins stimuli, participants' need of an assistive device to complete the functional assessments, or FGA scores 23 or higher, indicating only limited gait impairments.
Participant milestones
| Measure |
Baseline Cross-over Group A--Walkasins ON Then OFF
Subjects will first wear Walkasins and receive vibrotactile feedback that reflects real changes in center of pressure sway. Following a one-hour rest period, they will be retested with Walkasins turned off.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Baseline Cross-over Group B--Walkasins OFF Then ON
Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a one-hour rest period, they will be retested with Walkasins turned on.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Single-Arm Long-Term Follow-up (Walkasins ON)
The randomized cross-over group assignments applied only to the baseline visit. After the baseline visit, participants received Walkasins to wear over the next 52 weeks. They returned for follow-up visits at weeks 2, 6, 10, 26, and 52. Between weeks 10 and 26 and 26 and 52, they were contacted periodically to remind them of study requirements and to collect follow-up information regarding health changes, adverse events, pain scores, and device usage and functioning.
|
|---|---|---|---|
|
Baseline Cross-over
STARTED
|
36
|
33
|
0
|
|
Baseline Cross-over
COMPLETED
|
36
|
33
|
0
|
|
Baseline Cross-over
NOT COMPLETED
|
0
|
0
|
0
|
|
Long-Term Follow-up
STARTED
|
0
|
0
|
69
|
|
Long-Term Follow-up
COMPLETED
|
0
|
0
|
36
|
|
Long-Term Follow-up
NOT COMPLETED
|
0
|
0
|
33
|
Reasons for withdrawal
| Measure |
Baseline Cross-over Group A--Walkasins ON Then OFF
Subjects will first wear Walkasins and receive vibrotactile feedback that reflects real changes in center of pressure sway. Following a one-hour rest period, they will be retested with Walkasins turned off.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Baseline Cross-over Group B--Walkasins OFF Then ON
Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a one-hour rest period, they will be retested with Walkasins turned on.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Single-Arm Long-Term Follow-up (Walkasins ON)
The randomized cross-over group assignments applied only to the baseline visit. After the baseline visit, participants received Walkasins to wear over the next 52 weeks. They returned for follow-up visits at weeks 2, 6, 10, 26, and 52. Between weeks 10 and 26 and 26 and 52, they were contacted periodically to remind them of study requirements and to collect follow-up information regarding health changes, adverse events, pain scores, and device usage and functioning.
|
|---|---|---|---|
|
Long-Term Follow-up
Adverse Event
|
0
|
0
|
6
|
|
Long-Term Follow-up
Death
|
0
|
0
|
1
|
|
Long-Term Follow-up
Withdrawal by Subject
|
0
|
0
|
5
|
|
Long-Term Follow-up
COVID-19 Disruptions at Sites
|
0
|
0
|
13
|
|
Long-Term Follow-up
Device Dissatisfaction
|
0
|
0
|
8
|
Baseline Characteristics
walk2Wellness: Long-term Effects of Walkasins® Wearable Sensory Prosthesis
Baseline characteristics by cohort
| Measure |
Single-Arm Long-Term Use
n=69 Participants
After the baseline visit, participants will receive Walkasins to wear over the next 52 weeks. They will return for follow-up visits at weeks 2, 6, 10, 26, and 52. Between weeks 10 and 26 and 26 and 52, they will be contacted periodically to remind them of study requirements and to collect follow-up information regarding health changes, adverse events, pain scores, device usage, and device functioning.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
62 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
65 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
69 participants
n=5 Participants
|
|
Weight (kg)
|
89.7 Kilograms
STANDARD_DEVIATION 18.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52Population: Because of study disruptions due to COVID-19, some participants were unable to attend in-person visits; others withdrew from the study for various reasons. The data reported at Weeks 2, 6, 10, 26, and 52 (the protocol-specified assessment times) reflect only the active participants who completed the outcome measure at the specified timepoint. (The protocol stated that no imputation methods would be used to infer missing values of any outcome measures.)
The Functional Gait Assessment (FGA) is a 10-item scale that measures postural stability while individuals perform walking tasks that are scored from 0 to 3 (3 = normal, 2 = mild impairment, 1 = moderate impairment, 0 = severe impairment). Scores range from a minimum of 0 to a maximum of 30. Higher scores indicate better postural stability. (Participants scoring 23 or higher on the baseline FGA were not included in this study because their peripheral neuropathy was not yet affecting their gait/balance significantly.)
Outcome measures
| Measure |
Baseline Cross-over Group A--Walkasins ON Then OFF
n=36 Participants
Subjects will first wear Walkasins and receive vibrotactile feedback that reflects real changes in center of pressure sway. Following a one-hour rest period, they will be retested with Walkasins turned off.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Baseline Cross-over Group B--Walkasins OFF Then ON
n=33 Participants
Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a one-hour rest period, they will be retested with Walkasins turned on.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Single-Arm Long-Term Follow-up (Walkasins ON)
n=69 Participants
The randomized cross-over group assignments applied only to the baseline visit. After the baseline visit, participants received Walkasins to wear over the next 52 weeks. They returned for follow-up visits at weeks 2, 6, 10, 26, and 52. Between weeks 10 and 26 and 26 and 52, they were contacted periodically to remind them of study requirements and to collect follow-up information regarding health changes, adverse events, pain scores, and device usage and functioning.
|
|---|---|---|---|
|
Functional Gait Assessment
Baseline
|
14.8 score on a scale
Standard Deviation 4.1
|
14.8 score on a scale
Standard Deviation 4.1
|
14.8 score on a scale
Standard Deviation 4.1
|
|
Functional Gait Assessment
Baseline Crossover--Walkasins ON
|
17.0 score on a scale
Standard Deviation 4.5
|
18.2 score on a scale
Standard Deviation 3.8
|
—
|
|
Functional Gait Assessment
Baseline Crossover--Walkasins OFF
|
17.14 score on a scale
Standard Deviation 4.5
|
16.3 score on a scale
Standard Deviation 3.9
|
—
|
|
Functional Gait Assessment
Week 2
|
—
|
—
|
17.9 score on a scale
Standard Deviation 4.7
|
|
Functional Gait Assessment
Week 6
|
—
|
—
|
18.2 score on a scale
Standard Deviation 4.4
|
|
Functional Gait Assessment
Week 10
|
—
|
—
|
19.2 score on a scale
Standard Deviation 5
|
|
Functional Gait Assessment
Week 26
|
—
|
—
|
19.1 score on a scale
Standard Deviation 4
|
|
Functional Gait Assessment
Week 52
|
—
|
—
|
20.7 score on a scale
Standard Deviation 5.3
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52Population: Because of study disruptions due to COVID-19, some participants were unable to attend in-person visits; others withdrew from the study for various reasons. The data reported at Weeks 2, 6, 10, 26, and 52 (the protocol-specified assessment times) reflect only the active participants who completed the outcome measure at the specified timepoint. (The protocol stated that no imputation methods would be used to infer missing values of any outcome measures.)
Gait speed (10-meter walk, timing the middle 6 meters) is assessed under two conditions: Participants are instructed (1) to walk at normal speed and (2) to walk as fast as they can. Higher numbers indicate faster speeds (i.e., more meters per second).
Outcome measures
| Measure |
Baseline Cross-over Group A--Walkasins ON Then OFF
n=36 Participants
Subjects will first wear Walkasins and receive vibrotactile feedback that reflects real changes in center of pressure sway. Following a one-hour rest period, they will be retested with Walkasins turned off.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Baseline Cross-over Group B--Walkasins OFF Then ON
n=33 Participants
Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a one-hour rest period, they will be retested with Walkasins turned on.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Single-Arm Long-Term Follow-up (Walkasins ON)
n=69 Participants
The randomized cross-over group assignments applied only to the baseline visit. After the baseline visit, participants received Walkasins to wear over the next 52 weeks. They returned for follow-up visits at weeks 2, 6, 10, 26, and 52. Between weeks 10 and 26 and 26 and 52, they were contacted periodically to remind them of study requirements and to collect follow-up information regarding health changes, adverse events, pain scores, and device usage and functioning.
|
|---|---|---|---|
|
10-Meter Walk Test
Baseline Normal Gait Speed
|
0.90 Meters/Second
Standard Deviation 0.29
|
0.85 Meters/Second
Standard Deviation 0.19
|
0.88 Meters/Second
Standard Deviation 0.25
|
|
10-Meter Walk Test
Baseline Crossover--Walkasins ON
|
0.92 Meters/Second
Standard Deviation 0.28
|
0.91 Meters/Second
Standard Deviation 0.19
|
—
|
|
10-Meter Walk Test
Baseline Crossover--Walkasins OFF
|
0.95 Meters/Second
Standard Deviation 0.29
|
0.90 Meters/Second
Standard Deviation 0.17
|
—
|
|
10-Meter Walk Test
Week 2 Normal Gait Speed
|
—
|
—
|
0.94 Meters/Second
Standard Deviation 0.28
|
|
10-Meter Walk Test
Week 6 Normal Gait Speed
|
—
|
—
|
0.95 Meters/Second
Standard Deviation 0.27
|
|
10-Meter Walk Test
Week 10 Normal Gait Speed
|
—
|
—
|
0.97 Meters/Second
Standard Deviation 0.26
|
|
10-Meter Walk Test
Week 26 Normal Gait Speed
|
—
|
—
|
0.97 Meters/Second
Standard Deviation 0.28
|
|
10-Meter Walk Test
Week 52 Normal Gait Speed
|
—
|
—
|
1.02 Meters/Second
Standard Deviation 0.30
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52Population: Because of study disruptions due to COVID-19, some participants were unable to attend in-person visits; others withdrew from the study for various reasons. The data reported at Weeks 2, 6, 10, 26, and 52 (the protocol-specified assessment times) reflect only the active participants who completed the outcome measure at the specified timepoint. (The protocol stated that no imputation methods would be used to infer missing values of any outcome measures.)
The Timed Up and Go Test is part of the Centers for Disease Control (CDC)-recommended STEADI test protocol for balance function. From a seated position in a standard armchair, the participant is asked to stand up from the chair, walk to a line on the floor 10 feet away at normal pace, turn, walk back to the chair at normal pace, and sit down again. The tester records the time taken from the command "Go" until the subject sits down again. Lower times indicate better/faster performance.
Outcome measures
| Measure |
Baseline Cross-over Group A--Walkasins ON Then OFF
n=36 Participants
Subjects will first wear Walkasins and receive vibrotactile feedback that reflects real changes in center of pressure sway. Following a one-hour rest period, they will be retested with Walkasins turned off.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Baseline Cross-over Group B--Walkasins OFF Then ON
n=33 Participants
Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a one-hour rest period, they will be retested with Walkasins turned on.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Single-Arm Long-Term Follow-up (Walkasins ON)
n=69 Participants
The randomized cross-over group assignments applied only to the baseline visit. After the baseline visit, participants received Walkasins to wear over the next 52 weeks. They returned for follow-up visits at weeks 2, 6, 10, 26, and 52. Between weeks 10 and 26 and 26 and 52, they were contacted periodically to remind them of study requirements and to collect follow-up information regarding health changes, adverse events, pain scores, and device usage and functioning.
|
|---|---|---|---|
|
Timed Up and Go Test (TUG)
Baseline
|
13.9 Seconds
Standard Deviation 6.2
|
13.5 Seconds
Standard Deviation 4.5
|
13.7 Seconds
Standard Deviation 5.5
|
|
Timed Up and Go Test (TUG)
Baseline Crossover--Walkasins ON
|
13.7 Seconds
Standard Deviation 5.2
|
12.8 Seconds
Standard Deviation 3.9
|
—
|
|
Timed Up and Go Test (TUG)
Baseline Crossover--Walkasins OFF
|
13.2 Seconds
Standard Deviation 5.8
|
12.7 Seconds
Standard Deviation 3.7
|
—
|
|
Timed Up and Go Test (TUG)
Week 2
|
—
|
—
|
12.8 Seconds
Standard Deviation 4.2
|
|
Timed Up and Go Test (TUG)
Week 6
|
—
|
—
|
12.4 Seconds
Standard Deviation 4.2
|
|
Timed Up and Go Test (TUG)
Week 10
|
—
|
—
|
12.1 Seconds
Standard Deviation 3.6
|
|
Timed Up and Go Test (TUG)
Week 26
|
—
|
—
|
12.3 Seconds
Standard Deviation 3.4
|
|
Timed Up and Go Test (TUG)
Week 52
|
—
|
—
|
12.2 Seconds
Standard Deviation 3.7
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52Population: Because of study disruptions due to COVID-19, some participants were unable to attend in-person visits; others withdrew from the study for various reasons. The data reported at Weeks 2, 6, 10, 26, and 52 (the protocol-specified assessment times) reflect only the active participants who completed the outcome measure at the specified timepoint. (The protocol stated that no imputation methods would be used to infer missing values of any outcome measures.)
The 4-Stage Balance Test is part of the Centers for Disease Control's recommended test protocol for balance function. It includes four gradually more challenging postures the subject is exposed to: (1) Stand with feet side by side. (2) Stand with feet in semi-tandem stance. (3) Stand with feet in tandem stance. (4) Stand on one leg. Participants pass each level if they can hold the stance for 10 seconds and then move on to the next stance. If they cannot hold the stance, the test ends. Higher times indicate better balance than lower times.
Outcome measures
| Measure |
Baseline Cross-over Group A--Walkasins ON Then OFF
n=36 Participants
Subjects will first wear Walkasins and receive vibrotactile feedback that reflects real changes in center of pressure sway. Following a one-hour rest period, they will be retested with Walkasins turned off.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Baseline Cross-over Group B--Walkasins OFF Then ON
n=33 Participants
Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a one-hour rest period, they will be retested with Walkasins turned on.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Single-Arm Long-Term Follow-up (Walkasins ON)
n=69 Participants
The randomized cross-over group assignments applied only to the baseline visit. After the baseline visit, participants received Walkasins to wear over the next 52 weeks. They returned for follow-up visits at weeks 2, 6, 10, 26, and 52. Between weeks 10 and 26 and 26 and 52, they were contacted periodically to remind them of study requirements and to collect follow-up information regarding health changes, adverse events, pain scores, and device usage and functioning.
|
|---|---|---|---|
|
Four-Stage Balance Test
Baseline
|
24.2 Seconds
Standard Deviation 6.9
|
26.5 Seconds
Standard Deviation 8.0
|
25.3 Seconds
Standard Deviation 7.5
|
|
Four-Stage Balance Test
Baseline Crossover--Walkasins ON
|
25.4 Seconds
Standard Deviation 7.5
|
26.6 Seconds
Standard Deviation 6.4
|
—
|
|
Four-Stage Balance Test
Baseline Crossover--Walkasins OFF
|
26.0 Seconds
Standard Deviation 6.9
|
27.7 Seconds
Standard Deviation 6.6
|
—
|
|
Four-Stage Balance Test
Week 2
|
—
|
—
|
27.1 Seconds
Standard Deviation 8.0
|
|
Four-Stage Balance Test
Week 6
|
—
|
—
|
27.4 Seconds
Standard Deviation 7.4
|
|
Four-Stage Balance Test
Week 10
|
—
|
—
|
27.3 Seconds
Standard Deviation 6.9
|
|
Four-Stage Balance Test
Week 26
|
—
|
—
|
28.4 Seconds
Standard Deviation 5.6
|
|
Four-Stage Balance Test
Week 52
|
—
|
—
|
31.1 Seconds
Standard Deviation 6.8
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52Population: IBecause of study disruptions due to COVID-19, some participants were unable to attend in-person visits; others withdrew from the study for various reasons. The data reported at Weeks 2, 6, 10, 26, and 52 (the protocol-specified assessment times) reflect only the active participants who completed the outcome measure at the specified timepoint. (The protocol stated that no imputation methods would be used to infer missing values of any outcome measures.)
Powell and Myers (1995) developed the Activities-specific Balance Confidence (ABC) Scale to detect levels of balance confidence in elderly persons. The ABC scale is a one-page questionnaire that asks questions about balance confidence when performing 16 different tasks. The items are rated on a scale of 0 to 100; a score of 0 indicates no confidence and a score of 100 indicates complete confidence when performing the task. The overall score is calculated by adding the individual items then dividing by the total number of items (16). The higher the score, the greater the person's balance confidence; thus, higher scores indicate that subjects are more confident of their balance.
Outcome measures
| Measure |
Baseline Cross-over Group A--Walkasins ON Then OFF
n=36 Participants
Subjects will first wear Walkasins and receive vibrotactile feedback that reflects real changes in center of pressure sway. Following a one-hour rest period, they will be retested with Walkasins turned off.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Baseline Cross-over Group B--Walkasins OFF Then ON
n=33 Participants
Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a one-hour rest period, they will be retested with Walkasins turned on.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Single-Arm Long-Term Follow-up (Walkasins ON)
n=69 Participants
The randomized cross-over group assignments applied only to the baseline visit. After the baseline visit, participants received Walkasins to wear over the next 52 weeks. They returned for follow-up visits at weeks 2, 6, 10, 26, and 52. Between weeks 10 and 26 and 26 and 52, they were contacted periodically to remind them of study requirements and to collect follow-up information regarding health changes, adverse events, pain scores, and device usage and functioning.
|
|---|---|---|---|
|
Activities-specific Balance Confidence (ABC) Scale
Baseline Crossover
|
58.2 score on a scale
Standard Deviation 17.3
|
61.2 score on a scale
Standard Deviation 16.2
|
59.6 score on a scale
Standard Deviation 16.7
|
|
Activities-specific Balance Confidence (ABC) Scale
Week 2
|
—
|
—
|
62.5 score on a scale
Standard Deviation 15.2
|
|
Activities-specific Balance Confidence (ABC) Scale
Week 6
|
—
|
—
|
62.3 score on a scale
Standard Deviation 16.9
|
|
Activities-specific Balance Confidence (ABC) Scale
Week 10
|
—
|
—
|
63.6 score on a scale
Standard Deviation 14.8
|
|
Activities-specific Balance Confidence (ABC) Scale
Week 26
|
—
|
—
|
62.1 score on a scale
Standard Deviation 16.5
|
|
Activities-specific Balance Confidence (ABC) Scale
Week 52
|
—
|
—
|
65.2 score on a scale
Standard Deviation 16.7
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52Population: Because of study disruptions due to COVID-19, some participants were unable to attend in-person visits; others withdrew from the study for various reasons. The data reported at Weeks 2, 6, 10, 26, and 52 (the protocol-specified assessment times) reflect only the active participants who completed the outcome measure at the specified timepoint. (The protocol stated that no imputation methods would be used to infer missing values of any outcome measures.)
The Vestibular Activities of Daily Living Scale (VADL) is a self-reported questionnaire that was developed to assess self-perceived disability in individuals with vestibular impairment. It evaluates the effects of vertigo and balance disorders on independence in 28 activities of daily living. Participants selected a number ranging from 1 = "Independent" to 10 = "Too Difficult, No Longer Perform." The scores on the 28 activities were averaged. The higher the score (up to 10), the greater is the person's self-perceived disability (i.e., the person feels less independence in activities of daily living). Lower averages of the 28 items indicate greater independence in activities of daily living (e.g., a healthy adult's VADL score most likely would be between 1.0 and 2.0).
Outcome measures
| Measure |
Baseline Cross-over Group A--Walkasins ON Then OFF
n=36 Participants
Subjects will first wear Walkasins and receive vibrotactile feedback that reflects real changes in center of pressure sway. Following a one-hour rest period, they will be retested with Walkasins turned off.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Baseline Cross-over Group B--Walkasins OFF Then ON
n=33 Participants
Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a one-hour rest period, they will be retested with Walkasins turned on.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Single-Arm Long-Term Follow-up (Walkasins ON)
n=69 Participants
The randomized cross-over group assignments applied only to the baseline visit. After the baseline visit, participants received Walkasins to wear over the next 52 weeks. They returned for follow-up visits at weeks 2, 6, 10, 26, and 52. Between weeks 10 and 26 and 26 and 52, they were contacted periodically to remind them of study requirements and to collect follow-up information regarding health changes, adverse events, pain scores, and device usage and functioning.
|
|---|---|---|---|
|
Vestibular Activities of Daily Living Scale (VADL)
Baseline
|
3.97 score on a scale
Standard Deviation 1.13
|
3.82 score on a scale
Standard Deviation 1.15
|
3.89 score on a scale
Standard Deviation 1.14
|
|
Vestibular Activities of Daily Living Scale (VADL)
Week 2
|
—
|
—
|
3.49 score on a scale
Standard Deviation 1.1
|
|
Vestibular Activities of Daily Living Scale (VADL)
Week 6
|
—
|
—
|
3.66 score on a scale
Standard Deviation 1.09
|
|
Vestibular Activities of Daily Living Scale (VADL)
Week 10
|
—
|
—
|
3.78 score on a scale
Standard Deviation 1.03
|
|
Vestibular Activities of Daily Living Scale (VADL)
Week 26
|
—
|
—
|
3.66 score on a scale
Standard Deviation 1.22
|
|
Vestibular Activities of Daily Living Scale (VADL)
Week 52
|
—
|
—
|
3.62 score on a scale
Standard Deviation 1.12
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52Population: Because of study disruptions due to COVID-19, some participants were unable to attend in-person visits; others withdrew from the study for various reasons. The data reported at Weeks 2, 6, 10, 26, and 52 (the protocol-specified assessment times) reflect only the active participants who completed the outcome measure at the specified timepoint. (The protocol stated that no imputation methods would be used to infer missing values of any outcome measures.)
The PHQ-9 is a nine-question tool for assessing depression and emotional well-being. Participants rate nine areas on a 0 to 3 scale in response to the question, "Over the last 2 weeks, how often have you been bothered by any of the following problems?" The rating scale is as follows: 0 = "Not at All," 1 = "Several Days," 2 = "More Than Half the Days," and 3 = "Nearly Every Day." A PHQ-9 total score of 0-4 points indicates "normal" or minimal depression. Scores between 5-9 points indicate mild depression; 10-14 points, moderate depression; 15-19 points, moderately severe depression; and 20 or more points, severe depression. (The minimum score on the PHQ-9 is 0; the maximum score is 27.) In short, lower scores indicate less depression.
Outcome measures
| Measure |
Baseline Cross-over Group A--Walkasins ON Then OFF
n=36 Participants
Subjects will first wear Walkasins and receive vibrotactile feedback that reflects real changes in center of pressure sway. Following a one-hour rest period, they will be retested with Walkasins turned off.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Baseline Cross-over Group B--Walkasins OFF Then ON
n=33 Participants
Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a one-hour rest period, they will be retested with Walkasins turned on.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Single-Arm Long-Term Follow-up (Walkasins ON)
n=69 Participants
The randomized cross-over group assignments applied only to the baseline visit. After the baseline visit, participants received Walkasins to wear over the next 52 weeks. They returned for follow-up visits at weeks 2, 6, 10, 26, and 52. Between weeks 10 and 26 and 26 and 52, they were contacted periodically to remind them of study requirements and to collect follow-up information regarding health changes, adverse events, pain scores, and device usage and functioning.
|
|---|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9)
Baseline
|
5.19 score on a scale
Standard Deviation 4.63
|
4.30 score on a scale
Standard Deviation 3.53
|
4.77 score on a scale
Standard Deviation 4.13
|
|
Patient Health Questionnaire-9 (PHQ-9)
Week 2
|
—
|
—
|
3.97 score on a scale
Standard Deviation 3.96
|
|
Patient Health Questionnaire-9 (PHQ-9)
Week 6
|
—
|
—
|
4.12 score on a scale
Standard Deviation 4.16
|
|
Patient Health Questionnaire-9 (PHQ-9)
Week 10
|
—
|
—
|
4.18 score on a scale
Standard Deviation 4.62
|
|
Patient Health Questionnaire-9 (PHQ-9)
Week 26
|
—
|
—
|
4.19 score on a scale
Standard Deviation 4.03
|
|
Patient Health Questionnaire-9 (PHQ-9)
Week 52
|
—
|
—
|
4.83 score on a scale
Standard Deviation 4.95
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52Population: Because of study disruptions due to COVID-19, some participants were unable to attend in-person visits; others withdrew from the study for various reasons. The data reported at Weeks 2, 6, 10, 26, and 52 (the protocol-specified assessment times) reflect only the active participants who completed the outcome measure at the specified timepoint. (The protocol stated that no imputation methods would be used to infer missing values of any outcome measures.)
The Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6b measures the self-reported consequences of pain on relevant aspects of a person's life over the past 7 days and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. PROMIS measures are scored on the T-score metric (mean = 50, standard deviation = 10). Higher scores (i.e., those greater than 50, the mean) indicate that the participants perceive their pain as interfering in their daily lives more than average; lower scores (i.e., those less than 50, the mean) indicate that the participants perceive their pain as interfering less than average in their daily lives, which would be considered a better outcome.
Outcome measures
| Measure |
Baseline Cross-over Group A--Walkasins ON Then OFF
n=36 Participants
Subjects will first wear Walkasins and receive vibrotactile feedback that reflects real changes in center of pressure sway. Following a one-hour rest period, they will be retested with Walkasins turned off.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Baseline Cross-over Group B--Walkasins OFF Then ON
n=33 Participants
Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a one-hour rest period, they will be retested with Walkasins turned on.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Single-Arm Long-Term Follow-up (Walkasins ON)
n=69 Participants
The randomized cross-over group assignments applied only to the baseline visit. After the baseline visit, participants received Walkasins to wear over the next 52 weeks. They returned for follow-up visits at weeks 2, 6, 10, 26, and 52. Between weeks 10 and 26 and 26 and 52, they were contacted periodically to remind them of study requirements and to collect follow-up information regarding health changes, adverse events, pain scores, and device usage and functioning.
|
|---|---|---|---|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6b
Baseline
|
52.6 T-score
Standard Deviation 8.3
|
50.1 T-score
Standard Deviation 8.7
|
51.4 T-score
Standard Deviation 8.5
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6b
Week 2
|
—
|
—
|
51.7 T-score
Standard Deviation 7.8
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6b
Week 6
|
—
|
—
|
51.1 T-score
Standard Deviation 8.9
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6b
Week 10
|
—
|
—
|
52.2 T-score
Standard Deviation 8.5
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6b
Week 26
|
—
|
—
|
51.2 T-score
Standard Deviation 8.5
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form 6b
Week 52
|
—
|
—
|
52.8 T-score
Standard Deviation 9.1
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52Population: IBecause of study disruptions due to COVID-19, some participants were unable to attend in-person visits; others withdrew from the study for various reasons. The data reported at Weeks 2, 6, 10, 26, and 52 (the protocol-specified assessment times) reflect only the active participants who completed the outcome measure at the specified timepoint. (The protocol stated that no imputation methods would be used to infer missing values of any outcome measures.)
The PROMIS Pain Intensity Form 1a instrument asks participants to rate the intensity of their pain on average over the previous 7 days. It is universal rather than disease specific. The higher the score on a scale of 0 ("no pain") to 10 ("worst pain imaginable), the more intense is the person's perception of pain; lower scores indicate less intense perception of pain, a better outcome.
Outcome measures
| Measure |
Baseline Cross-over Group A--Walkasins ON Then OFF
n=36 Participants
Subjects will first wear Walkasins and receive vibrotactile feedback that reflects real changes in center of pressure sway. Following a one-hour rest period, they will be retested with Walkasins turned off.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Baseline Cross-over Group B--Walkasins OFF Then ON
n=33 Participants
Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a one-hour rest period, they will be retested with Walkasins turned on.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Single-Arm Long-Term Follow-up (Walkasins ON)
n=69 Participants
The randomized cross-over group assignments applied only to the baseline visit. After the baseline visit, participants received Walkasins to wear over the next 52 weeks. They returned for follow-up visits at weeks 2, 6, 10, 26, and 52. Between weeks 10 and 26 and 26 and 52, they were contacted periodically to remind them of study requirements and to collect follow-up information regarding health changes, adverse events, pain scores, and device usage and functioning.
|
|---|---|---|---|
|
PROMIS Pain Intensity Form 1a
Baseline
|
3.2 score on a scale
Standard Deviation 2.6
|
2.4 score on a scale
Standard Deviation 2.0
|
2.8 score on a scale
Standard Deviation 2.3
|
|
PROMIS Pain Intensity Form 1a
Week 2
|
—
|
—
|
2.6 score on a scale
Standard Deviation 2.1
|
|
PROMIS Pain Intensity Form 1a
Week 6
|
—
|
—
|
2.8 score on a scale
Standard Deviation 2.5
|
|
PROMIS Pain Intensity Form 1a
Week 10
|
—
|
—
|
2.7 score on a scale
Standard Deviation 2.4
|
|
PROMIS Pain Intensity Form 1a
Week 26
|
—
|
—
|
2.7 score on a scale
Standard Deviation 2.1
|
|
PROMIS Pain Intensity Form 1a
Week 52
|
—
|
—
|
3.2 score on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52Population: Because of study disruptions due to COVID-19, some participants were unable to attend in-person visits; others withdrew from the study for various reasons. The data reported at Weeks 2, 6, 10, 26, and 52 (the protocol-specified assessment times) reflect only the active participants who completed the outcome measure at the specified timepoint. (The protocol stated that no imputation methods would be used to infer missing values of any outcome measures.)
The PROMIS Ability to Participate in Social Roles and Activities assesses the participants' perceived ability to perform their usual social roles and activities. PROMIS measures are scored on the T-score metric (mean = 50, standard deviation = 10). A higher score (i.e., greater than 50, the mean) indicates participants perceive they have a better ability to participate in their roles and activities (i.e., a better outcome).
Outcome measures
| Measure |
Baseline Cross-over Group A--Walkasins ON Then OFF
n=36 Participants
Subjects will first wear Walkasins and receive vibrotactile feedback that reflects real changes in center of pressure sway. Following a one-hour rest period, they will be retested with Walkasins turned off.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Baseline Cross-over Group B--Walkasins OFF Then ON
n=33 Participants
Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a one-hour rest period, they will be retested with Walkasins turned on.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Single-Arm Long-Term Follow-up (Walkasins ON)
n=69 Participants
The randomized cross-over group assignments applied only to the baseline visit. After the baseline visit, participants received Walkasins to wear over the next 52 weeks. They returned for follow-up visits at weeks 2, 6, 10, 26, and 52. Between weeks 10 and 26 and 26 and 52, they were contacted periodically to remind them of study requirements and to collect follow-up information regarding health changes, adverse events, pain scores, and device usage and functioning.
|
|---|---|---|---|
|
PROMIS Ability to Participate Short Form 8a
Baseline
|
48.8 score on a scale
Standard Deviation 7.7
|
50.7 score on a scale
Standard Deviation 8.7
|
49.7 score on a scale
Standard Deviation 8.2
|
|
PROMIS Ability to Participate Short Form 8a
Week 2
|
—
|
—
|
51.1 score on a scale
Standard Deviation 7.5
|
|
PROMIS Ability to Participate Short Form 8a
Week 6
|
—
|
—
|
50.9 score on a scale
Standard Deviation 7.3
|
|
PROMIS Ability to Participate Short Form 8a
Week 10
|
—
|
—
|
51.1 score on a scale
Standard Deviation 7.9
|
|
PROMIS Ability to Participate Short Form 8a
Week 26
|
—
|
—
|
52.0 score on a scale
Standard Deviation 8.1
|
|
PROMIS Ability to Participate Short Form 8a
Week 52
|
—
|
—
|
48.7 score on a scale
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: Baseline, Week 2, Week 6, Week 10 (Primary Endpoint), Week 26, and Week 52Population: Because of study disruptions due to COVID-19, some participants were unable to attend in-person visits; others withdrew from the study for various reasons. The data reported at Weeks 2, 6, 10, 26, and 52 (the protocol-specified assessment times) reflect only the active participants who completed the outcome measure at the specified timepoint. (The protocol stated that no imputation methods would be used to infer missing values of any outcome measures.)
The PROMIS Satisfaction with Social Roles and Activities items assess satisfaction with performing one's usual social roles and activities (e.g., "I am satisfied with my ability to participate in family activities"). PROMIS measures are scored on the T-score metric (mean = 50, standard deviation = 10). A higher score (i.e., those greater than 50, the mean) indicates the respondents' greater satisfaction in regard to their ability to participate in their roles and activities (i.e., a better outcome).
Outcome measures
| Measure |
Baseline Cross-over Group A--Walkasins ON Then OFF
n=36 Participants
Subjects will first wear Walkasins and receive vibrotactile feedback that reflects real changes in center of pressure sway. Following a one-hour rest period, they will be retested with Walkasins turned off.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Baseline Cross-over Group B--Walkasins OFF Then ON
n=33 Participants
Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a one-hour rest period, they will be retested with Walkasins turned on.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Single-Arm Long-Term Follow-up (Walkasins ON)
n=69 Participants
The randomized cross-over group assignments applied only to the baseline visit. After the baseline visit, participants received Walkasins to wear over the next 52 weeks. They returned for follow-up visits at weeks 2, 6, 10, 26, and 52. Between weeks 10 and 26 and 26 and 52, they were contacted periodically to remind them of study requirements and to collect follow-up information regarding health changes, adverse events, pain scores, and device usage and functioning.
|
|---|---|---|---|
|
PROMIS Satisfaction With Participation in Social Roles Short Form 8a
Baseline
|
47.7 score on a scale
Standard Deviation 6.3
|
49.9 score on a scale
Standard Deviation 8.1
|
48.7 score on a scale
Standard Deviation 7.3
|
|
PROMIS Satisfaction With Participation in Social Roles Short Form 8a
Week 2
|
—
|
—
|
49.2 score on a scale
Standard Deviation 7.5
|
|
PROMIS Satisfaction With Participation in Social Roles Short Form 8a
Week 6
|
—
|
—
|
50.1 score on a scale
Standard Deviation 7.9
|
|
PROMIS Satisfaction With Participation in Social Roles Short Form 8a
Week 10
|
—
|
—
|
50.4 score on a scale
Standard Deviation 8.4
|
|
PROMIS Satisfaction With Participation in Social Roles Short Form 8a
Week 26
|
—
|
—
|
51.0 score on a scale
Standard Deviation 8.3
|
|
PROMIS Satisfaction With Participation in Social Roles Short Form 8a
Week 52
|
—
|
—
|
49.4 score on a scale
Standard Deviation 8.5
|
SECONDARY outcome
Timeframe: Baseline and 26 WeeksPopulation: Data on falls were collected and analyzed for 44 participants who completed at least 26 weeks of the study. (At baseline subjects reported the number of falls they had experienced in the six months prior to their participation in the trial.)
Subjects were asked about the number of times they have fallen in the past 6 and 12 months and whether they incurred an injury from falling. (For this study, the researchers used the World Health Organization's definition of a fall: "an event which results in a person coming to rest inadvertently on the ground or floor or other lower level.") These data were compared to falls during their participation in the trial as tracked with a calendar and reported as adverse events. Falls data were monitored as overall number of falls and fallers pre-and post-study participation as well as the number of falls/1000 patient days. A lower number indicates fewer falls over 26 weeks (6 months).
Outcome measures
| Measure |
Baseline Cross-over Group A--Walkasins ON Then OFF
Subjects will first wear Walkasins and receive vibrotactile feedback that reflects real changes in center of pressure sway. Following a one-hour rest period, they will be retested with Walkasins turned off.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Baseline Cross-over Group B--Walkasins OFF Then ON
Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a one-hour rest period, they will be retested with Walkasins turned on.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Single-Arm Long-Term Follow-up (Walkasins ON)
n=44 Participants
The randomized cross-over group assignments applied only to the baseline visit. After the baseline visit, participants received Walkasins to wear over the next 52 weeks. They returned for follow-up visits at weeks 2, 6, 10, 26, and 52. Between weeks 10 and 26 and 26 and 52, they were contacted periodically to remind them of study requirements and to collect follow-up information regarding health changes, adverse events, pain scores, and device usage and functioning.
|
|---|---|---|---|
|
Falls
Pre-Study/Baseline
|
—
|
—
|
53 Number of Participant Falls
|
|
Falls
Week 26
|
—
|
—
|
39 Number of Participant Falls
|
Adverse Events
Baseline Cross-over Group A--Walkasins ON Then OFF
Baseline Cross-over Group B--Walkasins OFF Then ON
Single-Arm Long-Term Follow-up (Walkasins ON)
Serious adverse events
| Measure |
Baseline Cross-over Group A--Walkasins ON Then OFF
Subjects will first wear Walkasins and receive vibrotactile feedback that reflects real changes in center of pressure sway. Following a one-hour rest period, they will be retested with Walkasins turned off.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Baseline Cross-over Group B--Walkasins OFF Then ON
Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a one-hour rest period, they will be retested with Walkasins turned on.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Single-Arm Long-Term Follow-up (Walkasins ON)
n=69 participants at risk
During the baseline visit, participants were randomized to two groups that applied to the first visit only. After the baseline visit, all the participants received Walkasins to wear over the next 52 weeks (single arm). They returned for follow-up visits at weeks 2, 6, 10, 26, and 52. Between weeks 10 and 26 and 26 and 52, they were contacted periodically to remind them of study requirements and to collect follow-up information regarding health changes, adverse events, pain scores, device usage, and device functioning.
|
|---|---|---|---|
|
Cardiac disorders
Hospitalizations
|
—
0/0 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
|
—
0/0 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
|
2.9%
2/69 • Number of events 5 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalizations
|
—
0/0 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
|
—
0/0 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
|
2.9%
2/69 • Number of events 3 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
|
|
Injury, poisoning and procedural complications
Hospitalizations
|
—
0/0 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
|
—
0/0 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
|
2.9%
2/69 • Number of events 2 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
|
|
Blood and lymphatic system disorders
Hospitalization
|
—
0/0 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
|
—
0/0 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
|
1.4%
1/69 • Number of events 1 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
|
|
Cardiac disorders
Hospitalization
|
—
0/0 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
|
—
0/0 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
|
1.4%
1/69 • Number of events 1 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
|
|
Psychiatric disorders
Hospitalization
|
—
0/0 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
|
—
0/0 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
|
1.4%
1/69 • Number of events 1 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
|
|
Surgical and medical procedures
Hospitalization
|
—
0/0 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
|
—
0/0 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
|
1.4%
1/69 • Number of events 1 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
|
Other adverse events
| Measure |
Baseline Cross-over Group A--Walkasins ON Then OFF
Subjects will first wear Walkasins and receive vibrotactile feedback that reflects real changes in center of pressure sway. Following a one-hour rest period, they will be retested with Walkasins turned off.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Baseline Cross-over Group B--Walkasins OFF Then ON
Subjects will first wear Walkasins turned off and not receive any vibrotactile feedback. Following a one-hour rest period, they will be retested with Walkasins turned on.
After the baseline visit, subjects will take the devices home for long-term use and return for periodic follow-up visits.
|
Single-Arm Long-Term Follow-up (Walkasins ON)
n=69 participants at risk
During the baseline visit, participants were randomized to two groups that applied to the first visit only. After the baseline visit, all the participants received Walkasins to wear over the next 52 weeks (single arm). They returned for follow-up visits at weeks 2, 6, 10, 26, and 52. Between weeks 10 and 26 and 26 and 52, they were contacted periodically to remind them of study requirements and to collect follow-up information regarding health changes, adverse events, pain scores, device usage, and device functioning.
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General disorders
Falls with Minor Injuries
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0/0 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
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0/0 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
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34.8%
24/69 • Number of events 48 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
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Musculoskeletal and connective tissue disorders
Hip Pain
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0/0 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
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0/0 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
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5.8%
4/69 • Number of events 4 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
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Musculoskeletal and connective tissue disorders
Knee Pain
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0/0 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
|
—
0/0 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
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7.2%
5/69 • Number of events 7 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
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Skin and subcutaneous tissue disorders
Skin Irritation
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0/0 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
|
—
0/0 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
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13.0%
9/69 • Number of events 12 • Adverse events were collected during the period of each subject's participation, a maximum of 52 weeks per participant. (The average duration of subjects' participation in the study was 271 days.)
The randomized cross-over assignments applied only to the baseline visit. Adverse events were not collected or analyzed by the randomized groups; they were collected for all participants in the single arm long-term portion of this study.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The publication of the principal results from any single center experience within the study can occur following the preparation and publication of the multicenter results. (This restriction no longer applies since the multicenter results have been published.)
- Publication restrictions are in place
Restriction type: OTHER