NCT06385392Completed
Continuous Wearable Monitor for the Detection and Release of Freezing of Gait.
Source: ClinicalTrials.gov · Last updated 28 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 31 (actual)
- First submitted
- 22 Apr 2024
- Start date
- 11 Sept 2024
- Primary completion date
- 28 Apr 2025
- Lead sponsor
- HealthPartners Institute
- Diseases
- Parkinson disease
- NCT number
- NCT06385392
What you commit to
- Study type: Observational
- Participants enrolled: 31
- From 11 Sept 2024 to the primary completion date, 28 Apr 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
- 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.
Other
- Non-English speaking
- Neuropathy at the ankle assessed at the pre-treatment visit using the haptic module.
- Hallucinations
- Non-ambulatory
- Legally Blind
- Symptomatic hypotension
Who the study is looking for
- 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.
Age in the registry: 45 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Struthers Parkinson's Center Coordinator of this site? Confirm its status | Golden Valley | United States | Unknown status |
| HealthPartners Neuroscience Center Coordinator of this site? Confirm its status | Saint Paul | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.