NCT06385392

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 31 (actual)
• Sponsor: HealthPartners Institute · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2024-09-11
• Primary completion: 2025-04-28
• Completion: 2025-04-28
• First posted: 2024-04-26
• Last updated: 2025-06-22

Locations

2 sites across 1 country: United States