Optimizing Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease
Overview
- Phase
- N/A
- Intervention
- Vibration Session
- Conditions
- Parkinson Disease
- Sponsor
- Virginia Commonwealth University
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Functional Ambulation Profile (FAP) Score
- Status
- Completed
- Last Updated
- last month
Overview
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.
Investigators
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
Arms & Interventions
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. The two arms both get a session with the PDVibe2 vibration turned on and turned off, but the order is reversed depending on the arm.
Intervention: Vibration Session
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. The two arms both get a session with the PDVibe2 vibration turned on and turned off, but the order is reversed depending on the arm.
Intervention: No vibration session
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. The two arms both get a session with the PDVibe2 vibration turned on and turned off, but the order is reversed depending on the arm.
Intervention: Vibration Session
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. The two arms both get a session with the PDVibe2 vibration turned on and turned off, but the order is reversed depending on the arm.
Intervention: No vibration session
Outcomes
Primary Outcomes
Functional Ambulation Profile (FAP) Score
Time Frame: Throughout study completion, from 9 to 34 days.
The Functional Ambulation Profile (FAP) score is the gold standard for spatiotemporal gait parameter analysis. For this study, it will be mean calculated by participants walking on the Zeno walkway, which will measure the patient's physical measurements, step length, step time and degree of symmetry., dynamic base of support and the use of ambulatory aids are factored into the score. The Zeno instrumented walkway (PKMAS) is a 20-foot computerized walkway containing sensor pads. A full FAP (Functional Ambulation Profile) score is calculated by deducting points from a maximum score of 100 and the minimum is a 0, with points being subtracted based on deviations from normal gait patterns observed during a self-selected velocity walking trial; essentially, a higher score (closer to 100) indicates closer to normal gait function while a lower score (closer to 0) represents greater gait impairments. No subscales. This is reported as the mean of the two scores for each session aggregated.
Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS)
Time Frame: Throughout study completion, from 9 to 34 days.
The "Movement Disorder Society Unified Parkinson Disease Rating Scale" (MDS-UPDRS),will be used to assess the total burden of motor Parkinson Disease (PD) symptoms and impact on activities of daily living. There are four sections to this scale and all sections use a scale of 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe)lower scores are better and indicate less disability. Part II: 13 items about Activities of Daily Living, score range 0-52. Part III: 18 items PD motor signs, score range is 0-72, Each item has 0-4 ratings: 0 (normal), 1 (slight), 2 (mild), 3 (moderate), and 4 (severe). Part IV: 6 items, assesses dyskinesia (excessive motion) and motor fluctuations (medication is working or not), range is 0-24. Parts II-IV total scores. This is reported as the mean of the scores for each session aggregated. The smaller the overall number (closer to 0), the less disability and the greater the number (closer to 148) the greater the disability.
Secondary Outcomes
- Timed Up and Go (TUG) Test(Throughout study completion, between 9 to 34 days.)
- Berg Balance Scale (BBS)(Throughout study completion, between 9 to 34 days.)
- New Freezing of Gait Questionnaire (nFOG-Q)(Throughout study completion, between 9 to 34 days.)
- Fall Efficacy Scale - International(Throughout study completion, between 9 to 34 days)