N/A
N=12
SCH: Context-aware Freezing of Gait Mitigation in Real-world Setting
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT04746846 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Number of Freezing of Gait (FoG) Episodes — 3.75; 5.17; 4.0; 3.63 number of freezes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- UG motion sensor with PDVibe3 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Mar 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Freezing of Gait (FoG) Episodes |
3.75; 5.17; 4.0; 3.63 | — |
| PRIMARY Duration of Freezing of Gait (FoG) Episodes. |
47.67; 52.14; 34.565; 43.505 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT04746846). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.