NCT03883217

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Virginia Commonwealth University · Academic / Other
• Sex: All
• Age: 21 Years – 95 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-29
• Primary completion: 2022-01-11
• Completion: 2022-01-11
• First posted: 2019-03-20
• Last updated: 2026-03-16
• Results posted: 2026-03-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study