Trial Outcomes & Findings for SCH: Context-aware Freezing of Gait Mitigation in Real-world Setting (NCT NCT04746846)
NCT ID: NCT04746846
Last Updated: 2025-08-22
Results Overview
Participants will be videotaped during each walking task and the number of FoG episodes will be counted. Change in number of FoG episodes will be calculated by subtracting the average number of FoG episodes while experiencing vibration vs the number of episodes without vibration. For this test, the null hypothesis of no difference between the treatments versus the alternative hypothesis that the two groups differed.
COMPLETED
12 participants
Baseline to final walk task - up to 5 hours
2025-08-22
Participant Flow
Participant milestones
| Measure |
Vibration Therapy
5-meter walk scenarios with vibration therapy
UG motion sensor with PDVibe3: UG motion sensor (which detects FoG) on worn each ankle.
PDVibe3 (which provides vibration) on worn each ankle
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
SCH: Context-aware Freezing of Gait Mitigation in Real-world Setting
Baseline characteristics by cohort
| Measure |
Vibration Therapy
n=12 Participants
5-meter walk scenarios with vibration therapy
UG motion sensor with PDVibe3: UG motion sensor (which detects FoG) on worn each ankle.
PDVibe3 (which provides vibration) on worn each ankle
|
|---|---|
|
Age, Continuous
|
70.9 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 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
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
11 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
|
12 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to final walk task - up to 5 hoursParticipants will be videotaped during each walking task and the number of FoG episodes will be counted. Change in number of FoG episodes will be calculated by subtracting the average number of FoG episodes while experiencing vibration vs the number of episodes without vibration. For this test, the null hypothesis of no difference between the treatments versus the alternative hypothesis that the two groups differed.
Outcome measures
| Measure |
Vibration Therapy
n=12 Participants
5-meter walk scenarios with vibration therapy
UG motion sensor with PDVibe3: UG motion sensor (which detects FoG) on worn each ankle.
PDVibe3 (which provides vibration) on worn each ankle
|
|---|---|
|
Number of Freezing of Gait (FoG) Episodes
no vibration 540 degree turn/number of freezes
|
3.75 number of freezes
Standard Error .765
|
|
Number of Freezing of Gait (FoG) Episodes
vibration 540 degree turn/number of freezes
|
5.17 number of freezes
Standard Error .765
|
|
Number of Freezing of Gait (FoG) Episodes
no vibration narrow path/number of freezes
|
4.0 number of freezes
Standard Error 1.205
|
|
Number of Freezing of Gait (FoG) Episodes
vibration narrow path/number of freezes
|
3.63 number of freezes
Standard Error 1.205
|
PRIMARY outcome
Timeframe: Baseline to final walk task - up to 5 hoursParticipants will be videotaped during each walking task and the duration of each FoG episodes will be calculated. Change in duration of FoG episodes will be calculated by subtracting the average duration of FoG episodes while experiencing vibration vs the average duration without vibration.
Outcome measures
| Measure |
Vibration Therapy
n=12 Participants
5-meter walk scenarios with vibration therapy
UG motion sensor with PDVibe3: UG motion sensor (which detects FoG) on worn each ankle.
PDVibe3 (which provides vibration) on worn each ankle
|
|---|---|
|
Duration of Freezing of Gait (FoG) Episodes.
540 degree turn/no vibration/ total freezing time
|
47.67 minutes
Standard Error 12.06
|
|
Duration of Freezing of Gait (FoG) Episodes.
540 degree turn/ vibration/ total freezing time
|
52.14 minutes
Standard Error 12.06
|
|
Duration of Freezing of Gait (FoG) Episodes.
Narrow path/no vibration/ total freezing time
|
34.565 minutes
Standard Error 17.2
|
|
Duration of Freezing of Gait (FoG) Episodes.
Narrow path/ vibration/ total freezing time
|
43.505 minutes
Standard Error 17.2
|
Adverse Events
Vibration Therapy
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vibration Therapy
n=12 participants at risk
5-meter walk scenarios with vibration therapy
UG motion sensor with PDVibe3: UG motion sensor (which detects FoG) on worn each ankle.
PDVibe3 (which provides vibration) on worn each ankle
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Fall
|
83.3%
10/12 • Number of events 10 • Baseline to final walk test, up to 5 hours
|
Additional Information
Ingrid Pretzer-Aboff, Ph.D., RN , FGSA, FAAN
Virginia Commonwealth University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place