Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study

University of Florida

Status and phase

Not yet enrolling

Early Phase 1

Conditions

Multiple Sclerosis (MS) - Relapsing-remitting

Upper Extremity Dysfunction

Treatments

Device: wearable focal vibration therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT07376772

IRB202500995

Details and patient eligibility

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.

Enrollment

15 estimated patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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)