Optimizing Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease - Phase 1
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Virginia Commonwealth University
- Primary Endpoint
- Functional Ambulation Profile (FAP) Score
- Status
- Withdrawn
- Last Updated
- last year
Overview
Brief 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.
Detailed Description
Participation will require up to 8 treatment sessions within 5 days (no more than 2 sessions in one day) plus an additional day for screening and another for follow-up (7 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
- Not provided
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
Outcomes
Primary Outcomes
Functional Ambulation Profile (FAP) Score
Time Frame: Throughout study completion, from 9 to 34 days.
The FAP score is the gold standard for spatiotemporal gait parameter analysis. For this study, it will be calculated by participants walking on the Zeno walkway, which will measure the patient's physical measurements, step length, step time and degree of symmetry.Step length, step time, 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 instrumented walkway containing sensor pads.
Secondary Outcomes
- Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) Part III(Throughout study completion, between 9 to 34 days.)
- Berg Balance Scale(Throughout study completion, between 9 to 34 days.)
- Freezing of Gait Questionnaire(Throughout study completion, between 9 to 34 days)
- Fall Efficacy Scale - International(Throughout study completion, between 9 to 34 days.)
- Timed Up and Go Test(Throughout study completion, between 9 to 34 days.)
- Parkinson's Disease Questionnaire - 39(Throughout study completion, between 9 to 34 days.)