Wearable focal vibration to improve arm and hand function in relapsing-remitting MS
Feasibility, Preliminary Efficacy, and User Perspective Usability of Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
This pilot will try a home-based wearable focal vibration device on arm muscles to see if it improves arm and hand function in adults with relapsing-remitting multiple sclerosis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Florida Academic / other |
| Locations | 2 sites (Gainesville, Florida and 1 other locations) |
| Trial ID | NCT07376772 on ClinicalTrials.gov |
What this trial studies
This mixed-methods pilot will enroll 15 adults with relapsing-remitting MS and self-reported upper extremity impairments to test a 4-week home-based program using Myovolt wearable focal vibration devices applied to arm muscles. Participants will be trained on device use, complete home therapy sessions, and attend laboratory visits at the University of Florida for baseline and follow-up assessments. Outcomes include feasibility metrics, preliminary measures of upper extremity motor function, and qualitative interviews about user experience. The protocol excludes recent relapses and significant cognitive or other neurological comorbidities to maintain symptom stability.
Who should consider this trial
Good fit: Adults with relapsing-remitting MS who report arm or hand impairments, have been stable (no relapse in the past 6 months), can use the device after training, and can attend lab visits in Gainesville are the ideal candidates.
Not a fit: People with recent MS relapses, significant cognitive impairment, other neurological conditions affecting the upper limb, or those unable to operate the device at home are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this could provide a simple, home-delivered therapy to improve arm and hand strength, coordination, or function for people with MS.
How similar studies have performed: Prior small studies of focal or whole-body vibration report mixed but sometimes promising effects on spasticity and motor function, yet wearable home-based focal vibration for MS remains novel with limited direct evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Gainesville, Florida and 1 other locations
- Norman Fixel Institute for Neurological Diseases — Gainesville, Florida, United States (Recruiting)
- University of Florida — Gainesville, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Hongwu Wang — University of Florida
- Study coordinator: Hongwu Wang, PhD
- Email: hongwu.wang@ufl.edu
- Phone: 352-273-9934
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.