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NCT04746846 · ClinicalTrials.gov registry record
SCH: Context-aware Freezing of Gait Mitigation in Real-world Setting
A clinical trial, sponsored by Virginia Commonwealth University.
- Completed
- Registry status
- 12
- Enrollment target
NCT04746846: Completed study, sponsored by Virginia Commonwealth University.
NCT04746846 is a clinical trial that has completed, run by Virginia Commonwealth University. The registered enrollment target is 12 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04746846 has completed, sponsored by Virginia Commonwealth University.
- COMPLETED
- Registry status
- 12 participants
- Enrollment target
Study 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.
Primary Outcome
Participants will be videotaped during each walking task and the number of FoG episodes will be counted. Change in number of FoG episodes will be calculated by subtracting the average number of FoG episodes while experiencing vibration vs the number of episodes without vibration. For this test, the null hypothesis of no difference between the treatments versus the alternative hypothesis that the two groups differed.
Interventions
- DEVICE UG motion sensor with PDVibe3
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2021-06-11 |
| Est. Completion | 2025-03-10 |
What the finished NCT04746846 record still lists
NCT04746846 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which UG motion sensor with PDVibe3 is the first listed.
NCT04746846 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04746846 about?
NCT04746846 is a clinical study titled "SCH: Context-aware Freezing of Gait Mitigation in Real-world Setting". 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. ...
What is the current status of trial NCT04746846?
This trial is currently completed. The enrollment target is 12 participants. The study started on 2021-06-11. Estimated completion is 2025-03-10.
What interventions are being tested in trial NCT04746846?
The interventions under investigation include: UG motion sensor with PDVibe3 (DEVICE).
Who is sponsoring clinical trial NCT04746846?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
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