SCH: Context-aware Freezing of Gait Mitigation in Real-world Setting

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT04746846
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • UG motion sensor with PDVibe3 — DEVICE
    UG motion sensor (which detects FoG) on worn each ankle. PDVibe3 (which provides vibration) on worn each ankle

Study Details

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.

Key Dates

Start date
Jun 11, 2021
Status verified
Aug 2025
Primary completion
Mar 10, 2025
Completion
Mar 10, 2025

Study Design

Enrollment
12 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Vibration therapy
    5-meter walk scenarios with vibration therapy

Primary Outcome Measure

Number of Freezing of Gait (FoG) Episodes [ Time Frame: Baseline to final walk task - up to 5 hours ]

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniversityRichmondVirginia23298-

Find similar trials in Richmond, VA

By condition
Parkinson's disease
By specialty
NeurologyBrain disorders
By research site
Virginia Commonwealth University· Richmond, VA

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