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

NCT03883217 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-03-16

Study results available
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Summary

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.

Conditions

  • Parkinson Disease

Interventions

DEVICE

Vibration Session

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.

DEVICE

No vibration session

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.

Sponsors & Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

    collaborator OTHER

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Ingrid Pretzer-Aboff, PhD, RN · Virginia Commonwealth University

  • Leslie Cloud, MD · Virginia Commonwealth University Health System

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-29
Primary Completion
2022-01-11
Completion
2022-01-11
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03883217 on ClinicalTrials.gov