Continuous Wearable Monitor for the Detection and Release of Freezing of Gait.
NCT06385392 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 31
Last updated 2025-06-22
Summary
The proposed system (haptic module and insole device) for daily in-community use that detects the occurrence of freezing of gait (FOG) in people with Parkinson's disease (PD). and triggers external cueing stimuli to unfreeze the individual. The purpose of the overall Phase II study is to: (1) Develop a production ready system, (2) Develop a companion mobile app for the proposed system and refine previously developed FOG detection algorithms, and (3) Validate the proper operation of the system and demonstrate its efficacy through lab and in-community testing. This study will focus on validating the system and demonstrating efficacy through in-community testing.
Conditions
- Parkinson Disease
Interventions
- DEVICE
-
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.
Sponsors & Collaborators
-
HealthPartners Institute
lead OTHER
Principal Investigators
-
Martha A Nance, MD · Struthers Parkinson's Center
Eligibility
- Min Age
- 45 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-11
- Primary Completion
- 2025-04-28
- Completion
- 2025-04-28
Countries
- United States
Study Locations
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