Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Recruiting · NCT07376772 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Florida
View the official record on ClinicalTrials.gov →Interventions studied
wearable focal vibration therapy
What this trial is about
This pilot mixed-method study will evaluate the feasibility, preliminary efficacy, and user experience of a home-based wearable Focal Vibration Therapy (FVT) intervention for improving upper extremity (UEx) function in people with multiple sclerosis (MS). Fifteen adults with relapsing-remitting MS (PRMS) and self-reported UEx impairments will participate in a 4-week FVT program using MyovoltTM wearable FVT devices applied to arm muscles.
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Aged over 18 years
- Confirmed diagnosis of RRMS according to the McDonald criteria (33)
- No MS relapse or exacerbation within the past 6 months (ensuring stability of symptoms)
- Self-report on clinical evidence of UEx impairment (including reduced arm/hand function, muscle weakness, spasticity, or pain).
- Stable on MS treatment for at least four weeks before recruitment, with no plans to initiate new treatments (participants may continue current treatments during the study)
- Agree and are able to use the FVT device after training.
- Sufficient proficiency in English to participate in interviews and follow instructions
- Able to visit the laboratory for assessments
- Able to provide written informed consent
Exclusion criteria
- Evidence of cognitive impairment that could interfere with following instructions (Mini-Montreal Cognitive Assessment score (Mini-MoCA) \< 12)
- Comorbid neurological or psychiatric conditions affecting the UEx (including stroke and severe carpal tunnel syndrome) that would confound results or make FVT unsafe
- Unstable cardiac disease or any major medical illness that would preclude participation
- Any known contraindications to vibration therapy (pregnancy, acute deep vein thrombosis, severe osteoporosis, chronic migraines, epilepsy, active malignancy in the target area, unstable cardiac disease, or an implanted pacemaker without clearance)
Where it is running
2 locations listed across 1 US state.
- Norman Fixel Institute for Neurological Diseases - Gainesville, Florida, United States
- University of Florida - Gainesville, Florida, United States