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

NCT ID: NCT03883217

Last Updated: 2022-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-29
• Study Completion Date: 2022-01-11

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

PDVibe2

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

PDVibe2

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

VibeForward

Eligibility Criteria

Inclusion Criteria

• age 21 years or older
• PD diagnosed by a movement disorder specialist for 3 months or longer prior to recruitment
• PD medication regimen is stable over the last 3 months with no changes
• Hoehn & Yahr stage 2 (N = 13)
• able to walk independently or with a simple assistive device (e.g., cane, walker)
• observed by the research team to have PD related gait disturbance such as FOG, shortened or irregular stride lengths, irregular step cadence, slowed speed while on their regular treatment regimen.

Exclusion Criteria

• diagnosed with a known Parkinson plus syndrome
• were previously exposed to vibration treatment for gait and balance
• presence of dementia (Montreal Cognitive Assessment < 21)
• additional disorders (not related to PD)impairing gait, stance, balance or coordination (e.g. stroke, leg amputations, or multiple sclerosis)
• history of implantable cardiac device or any other implanted electronic device except a deep brain stimulator (DBS)
• use of braces/orthotics that assist with walking
• are currently in physical therapy (PT) treatment for balance or gait
• peripheral neuropathy by exam
• any condition that, in the opinion of the PIs, would compromise participant safety, data integrity, or data interpretation.
• Children under the age of 18
• Prisoners
• Women who are pregnant or may become pregnant during the course of this study since the safety of this device for an unborn child is unknown.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Michael J. Fox Foundation for Parkinson's Research

OTHER

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ingrid Pretzer-Aboff, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Leslie Cloud, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University Health System

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Countries

United States

Other Identifiers

HM20015593

Identifier Type: -

Identifier Source: org_study_id