CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 31 enrolled
Drug / intervention
Haptic module and insole devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06385392
NCT06385392N/ACompleted

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

HealthPartners Institute·observational·Posted Apr 26, 2024·Updated May 28, 2026

In Brief

An observational study evaluating Haptic module and insole device for Parkinson Disease. Completed, enrolled 31 participants across 2 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20252026
First PostedApr 26, 2024
Enrollment StartSep 11, 2024
Primary CompletionApr 28, 2025
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 2.2 years ago

Interventions

Haptic module and insole devicedevice

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.