N/A
N=12
Optimizing Vibrational Therapy to Improve Gait and Balance in Parkinson's Disease
Parkinson Disease
Bottom Line
View on ClinicalTrials.gov: NCT03883217 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Functional Ambulation Profile (FAP) Score — 99.2; 86.8 FAP score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vibration Session (Device); No vibration session (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Virginia Commonwealth University
- Primary completion
- Jan 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Ambulation Profile (FAP) Score |
99.2; 86.8 | — |
| PRIMARY Movement Disorder Society Unified Parkinson Disease Rating Scale (MDS-UPDRS) |
14.1; 12.8; 14.0; 13.0; 34.6; 37.0 | — |
| SECONDARY Timed Up and Go (TUG) Test |
10.5; 10.4; 10.7; 10.9 | — |
| SECONDARY Berg Balance Scale (BBS) |
50.4; 51.4; 51.4; 52.1 | — |
| SECONDARY New Freezing of Gait Questionnaire (nFOG-Q) |
10.0; 8.7; 8.2; 9.0 | — |
| SECONDARY Fall Efficacy Scale - International |
29.2; 8.7; 28.7; 28.4 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT03883217). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.