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NCT06385392

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

HealthPartners Institute·ClinicalTrials.gov·device·Device trialNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Parkinson Disease
Drug/Device/Intervention
Haptic module and insole device
Study type
Observational
Intervention type
device
Sponsor & location
Primary sponsor
HealthPartners Institute
Location
Golden Valley,Saint Paul, United States of America
Timeline & enrollment
Phase
N/A
Start date
May 01, 2024
End date
May 01, 2025
Enrollment
36 participants
Primary outcome

To validate the haptic module and insole device system and evaluate its efficacy with an in-community clinical trial.

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.

ICD-10 classifications
Parkinson diseaseParkinsonism in diseases classified elsewhereDementia in Parkinson diseaseSecondary parkinsonismSecondary parkinsonism, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06385392
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06385392 through Pure Global AI's free database. This phase not specified trial is sponsored by HealthPartners Institute and is currently Not yet recruiting. The study focuses on Parkinson Disease. Target enrollment is 36 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.