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

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT06385392
• Lead Sponsor: HealthPartners Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-04-22
• Study First Submitted QC: 2024-04-22
• Study First Posted: 2024-04-26
• Study Start: 2024-09-11
• Primary Completion: 2025-04-28
• Study Completion: 2025-04-28
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-19
• Last Update Posted: 2025-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• Ability to provide and provision of signed and dated informed consent form.
• Age 45 or older
• Diagnosis of idiopathic PD, as determined by a movement disorders neurologist in accordance with the PD Society Brain Bank diagnostic criteria.
• Evidence of presence of freezing gait as a symptom. Determined from combination of clinical examination (observation of freezing) and New Freezing of Gait Questionnaire (NFOG).
• Able to complete a 2-minute walk test at the pre-treatment visit.
• Currently on a stable prescription medication regimen for PD and willing to adhere to the regimen during the study.
• Ability to don and doff the insole and haptic module independently or have daily assistance during the study intervention.

Exclusion Criteria

• Non-English speaking
• History of musculoskeletal disorders that significantly affect movement of lower limbs as determined at the time of enrollment.
• Other significant neurological disorders that may affect participation or performance in the study.
• Neuropathy at the ankle assessed at the pre-treatment visit using the haptic module.
• Hallucinations
• Non-ambulatory
• Legally Blind
• Symptomatic hypotension
• Any condition which would limit sensation in the legs or requires use of wraps, bandages or other items which may limit sensation in the legs (e.g., lymphedema) that would interfere with the performance of the haptic device, in the opinion of the investigator.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To validate the haptic module and insole device system and evaluate its efficacy with an in-community clinical trial.	5 weeks	Change in duration of FOG events. Decreased duration of FOG events indicates higher efficacy of device system.

Trial Locations

Locations (2)

Struthers Parkinson's Center; 🇺🇸 Golden Valley, Minnesota, United States

HealthPartners Neuroscience Center; 🇺🇸 Saint Paul, Minnesota, United States