NCT04746846Completed
SCH: Context-aware Freezing of Gait Mitigation in Real-world Setting
Source: ClinicalTrials.gov · Last updated 22 Aug 2025
Brief summary (registry, in English)
People with Parkinson's disease (PD) may experience a walking problem called freezing of gait (FoG) that can interfere with the person's ability to conduct daily activities. FoG has been described as feeling like one's feet are glued or stuck to the floor. Drug treatments for PD rarely improve FoG. Researchers have found that vibration therapy may help improve FoG. The purpose of this research study is to test the safety, tolerability, and effectiveness of using a wearable device (UG motion sensor, that is the size of a watch) that will recognize FoG and then send a signal to another small watch-like device (PDVibe3) to deliver a vibration stimuli to participant's feet. The researchers believe the vibration stimulus (which feels like a phone on vibration mode) will help reduce FoG in persons with PD. The study is open to people who have been diagnosed with Parkinson's disease, have FoG, and meet the study entry requirements. The PDVibe3 is an investigational device, which means it has not been approved by the U.S. Food and Drug Administration (FDA). The UG motion sensor is also an investigational device.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 12 (actual)
- First submitted
- 4 Feb 2021
- Start date
- 11 Jun 2021
- Primary completion date
- 10 Mar 2025
- Lead sponsor
- Virginia Commonwealth University
- Diseases
- Parkinson disease
- NCT number
- NCT04746846
What you commit to
- Study type: Interventional
- Participants enrolled: 12
- From 11 Jun 2021 to the primary completion date, 10 Mar 2025
- 1 site 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.
Criteria the registry did not label
- Inclusion
- age \>18 years,
- Parkinson's disease (PD) diagnosed by a movement disorder specialist using UK Brain Bank criteria,
- are able to walk independently or with a simple device (e.g., cane or walker), and
- are observed by the research team to have PD-related FoG in at least two of the five previously described common trigger scenarios (i.e., freezing upon gait initiation, walking through tight quarters, freezing when changing directions, approaching a visual target, dual tasking, and stressful, time sensitive situations such as entering an elevator before the doors close).
- Exclusion
- individuals with known Parkinson plus syndrome,
- presence of dementia (Montreal Cognitive Assessment \< 21),
- an additional disorder (not related to PD) impairing gait,
- history of implantable cardiac device or any other implanted electronic device except DBS,
- peripheral neuropathy (determined by use of tuning fork to check for ability to feel vibration),
- any condition that, in the opinion of the PI, would compromise participant safety, data integrity, or data interpretation,
- pregnancy.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Virginia Commonwealth University Coordinator of this site? Confirm its status | Richmond | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.