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

Parkinson Disease Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

Enrolled patients with Parkinson's disease, Hoehn and Yahr Stage 2, will be randomized to receive either vibration or no vibration and then will be crossed over to receive the opposite intervention. The study will consist of two treatment periods of two days followed by a washout period of 2 weeks. Each treatment period will consist of four treatments within 2 days, no more than 2 sessions in one day.

Patients will participate in an additional day for screening and another for follow-up (6 days total). All visits will occur at the Virginia Commonwealth University Parkinson's Movement and Disorders Center in Richmond, VA. Participants will be asked to walk for a brief period of time while wearing the PDVibe2. The PDVibe2 will provide vibration therapy and study staff will measure the number of "freezes" before, during and after therapy. Participants will be asked to provide feedback on the device, the therapy session, and how they are feeling. ;

Related Conditions & MeSH terms

• Parkinson Disease

• NCT number: NCT03883217
• Study type: Interventional
• Source: Virginia Commonwealth University
• Status: Completed
• Phase: N/A
• Start date: June 29, 2021
• Completion date: January 11, 2022