Pure Global

Continuous Wearable Monitor for the Detection and Release of Freezing of Gait. - Trial NCT06385392

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.

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Trial Details
ClinicalTrials.gov โ€ข NCT06385392
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Continuous Wearable Monitor for the Detection and Release of Freezing of Gait.

Study Focus

Parkinson Disease

Haptic module and insole device

Observational

device

Sponsor & Location

HealthPartners Institute

Golden Valley,Saint Paul, United States of America

Timeline & Enrollment

N/A

May 01, 2024

May 01, 2025

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 disease
Parkinsonism in diseases classified elsewhere
Dementia in Parkinson disease
Secondary parkinsonism
Secondary parkinsonism, unspecified

Data Source

ClinicalTrials.gov

NCT06385392

Device Trial