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

NCT03872115 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2024-10-15

No results posted yet for this study

Summary

The purpose of this research study is to determine optimum dose of vibration delivered by an experimental device called PDVibe2 required to treat freezing of gait 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

PDVibe2

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.

Sponsors & Collaborators

  • Michael J. Fox Foundation for Parkinson's Research

    collaborator OTHER

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Ingrid A Pretzer-Aboff, PhD, RN · Virginia Commonweatlh University

  • Leslie Cloud, MD · Virginia Commonweatlh University Health System

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-04-18
Primary Completion
2020-04-30
Completion
2020-04-30
FDA Device
Yes

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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 NCT03872115 on ClinicalTrials.gov