Optimizing Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease

Part of paid clinical trials in Richmond, Virginia.

Sponsor
Virginia Commonwealth University
Study ID
NCT03883217
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
21 Years - 95 Years
Healthy Volunteers
Not accepted

Interventions

  • Vibration Session — DEVICE
    The PDVibe2 is owned by Resonate Forward, LLC and will be loaned to Virginia Commonwealth University (VCU) for this project. The device is non-invasive, lightweight, untethered, contains a rechargeable battery, and is worn on both feet and ankles. PDVibe2 delivers vibration when activated by an easy to access switch on the device or by remote. The internal circuitry has been miniaturized, is encased in a small box, and is attached to the ankle using a soft flexible band.
  • No vibration session — DEVICE
    The PDVibe2 is owned by Resonate Forward, LLC and will be loaned to Virginia Commonwealth University (VCU) for this project. The device is non-invasive, lightweight, untethered, contains a rechargeable battery, and is worn on both feet and ankles. During this session, PDVibe2 delivers no vibration but is still worn. The internal circuitry has been miniaturized, is encased in a small box, and is attached to the ankle using a soft flexible band.

Study Details

The purpose of this research study is to test the safety, tolerability, and the effect of vibration (delivered by an experimental device called PDVibe2) on freezing of gait (FOG) in persons with Parkinson's disease (PD). The PDVibe2 was developed by Resonate Forward, LLC (RF). This PDVibe2 was designed to administer vibration therapy to the wearer to improve gait and balance in persons with PD while wearing the device.

Key Dates

Start date
Jun 29, 2021
Status verified
Mar 2026
Primary completion
Jan 11, 2022
Completion
Jan 11, 2022

Study Design

Enrollment
12 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Vibration first then no vibration
    A session with PDVibe2 vibration turned on first, followed by (after a 2 week washout period) a session with PDVibe2 vibration turned off. The two arms both get a session with the PDVibe2 vibration turned on and turned off, but the order is reversed depending on the arm.
  • Experimental: No vibration first then vibration
    A session with PDVibe2 vibration turned off first, followed by (after a 2 week washout period) a session with PDVibe2 vibration turned on. The two arms both get a session with the PDVibe2 vibration turned on and turned off, but the order is reversed depending on the arm.

Primary Outcome Measure

Functional Ambulation Profile (FAP) Score [ Time Frame: Throughout study completion, from 9 to 34 days. ]

Locations (1)

FacilityCityStateZIP
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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