Trial Outcomes & Findings for Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. (NCT NCT06385392)
NCT ID: NCT06385392
Last Updated: 2026-05-28
Results Overview
Change in duration of FOG events. Decreased duration of FOG events indicates higher efficacy of device system.
Recruitment status
COMPLETED
Target enrollment
31 participants
Primary outcome timeframe
5 weeks
Results posted on
2026-05-28
Participant Flow
Participant milestones
| Measure |
People With Parkinson's Disease and Freezing of Gait Using Experimental Insole and Haptic Module
Haptic module and insole device: System for use in daily in-community use that detects the occurrence of freezing of gait (FOG) and triggers external cueing stimuli to unfreeze the individual.
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|---|---|
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Overall Study
STARTED
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31
|
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Overall Study
COMPLETED
|
19
|
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Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
People With Parkinson's Disease and Freezing of Gait Using Experimental Insole and Haptic Module
Haptic module and insole device: System for use in daily in-community use that detects the occurrence of freezing of gait (FOG) and triggers external cueing stimuli to unfreeze the individual.
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|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
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Overall Study
Device Issues
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6
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Baseline Characteristics
Continuous Wearable Monitor for the Detection and Release of Freezing of Gait.
Baseline characteristics by cohort
| Measure |
People With Parkinson's Disease and Freezing of Gait Using Experimental Insole and Haptic Module
n=31 Participants
Haptic module and insole device: System for use in daily in-community use that detects the occurrence of freezing of gait (FOG) and triggers external cueing stimuli to unfreeze the individual.
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|---|---|
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Age, Categorical
<=18 years
|
0 Participants
n=51 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=51 Participants
|
|
Age, Categorical
>=65 years
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25 Participants
n=51 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=51 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=51 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=51 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=51 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=51 Participants
|
|
Education Level
No formal education
|
0 Participants
n=51 Participants
|
|
Education Level
Primary level education
|
0 Participants
n=51 Participants
|
|
Education Level
Secondary level education/GED/Equivalent
|
1 Participants
n=51 Participants
|
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Education Level
Some College
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6 Participants
n=51 Participants
|
|
Education Level
Associate's Degree
|
6 Participants
n=51 Participants
|
|
Education Level
Trad/Vocational Training
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2 Participants
n=51 Participants
|
|
Education Level
Bachelor's Degree or Higher
|
16 Participants
n=51 Participants
|
PRIMARY outcome
Timeframe: 5 weeksPopulation: Some withdrawn participants and those with device issues were not included in the analysis as we were unable to calculate the freezing of gait (FOG) events.
Change in duration of FOG events. Decreased duration of FOG events indicates higher efficacy of device system.
Outcome measures
| Measure |
On-Cue Phase
n=24 Participants
Haptic module and insole device: System for use in daily in-community use that detects the occurrence of freezing of gait (FOG) and triggers external cueing stimuli to unfreeze the individual.
|
Off-Cue Phase
n=24 Participants
Haptic module and insole device: System for use in daily in-community use that detects the occurrence of freezing of gait (FOG) and triggers external cueing stimuli to unfreeze the individual.
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|---|---|---|
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To Validate the Haptic Module and Insole Device System and Evaluate Its Efficacy With an In-community Clinical Trial.
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4.40 seconds
Standard Deviation 6.135
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5.69 seconds
Standard Deviation 7.458
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Adverse Events
People With Parkinson's Disease and Freezing of Gait Using Experimental Insole and Haptic Module
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
People With Parkinson's Disease and Freezing of Gait Using Experimental Insole and Haptic Module
n=31 participants at risk
Haptic module and insole device: System for use in daily in-community use that detects the occurrence of freezing of gait (FOG) and triggers external cueing stimuli to unfreeze the individual.
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|---|---|
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Respiratory, thoracic and mediastinal disorders
Pneumonia
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3.2%
1/31 • Number of events 1 • 5 weeks
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Other adverse events
| Measure |
People With Parkinson's Disease and Freezing of Gait Using Experimental Insole and Haptic Module
n=31 participants at risk
Haptic module and insole device: System for use in daily in-community use that detects the occurrence of freezing of gait (FOG) and triggers external cueing stimuli to unfreeze the individual.
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|---|---|
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General disorders
Fall
|
16.1%
5/31 • Number of events 9 • 5 weeks
|
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Skin and subcutaneous tissue disorders
Skin Irritation
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3.2%
1/31 • Number of events 1 • 5 weeks
|
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Musculoskeletal and connective tissue disorders
Pain (e.g. joint, muscle, nerve)
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6.5%
2/31 • Number of events 2 • 5 weeks
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Additional Information
Clinical Trial Coordinator
HealthPartners Institute Neuroscience Research
Phone: 6514956363
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place