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COMPLETED
NCT06385392

Continuous Wearable Monitor for the Detection and Release of Freezing of Gait.

Sponsor: HealthPartners Institute

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

45 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

31

Start Date

2024-09-11

Completion Date

2025-04-28

Last Updated

2026-05-28

Healthy Volunteers

No

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.

Locations (2)

Struthers Parkinson's Center

Golden Valley, Minnesota, United States

HealthPartners Neuroscience Center

Saint Paul, Minnesota, United States