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NCT07376772NARecruiting

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

University of Florida

Start Date

3/4/2026

Completion Date

6/30/2026

Summary

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.

Eligibility Criteria

Age Range: 18 years to 100 years

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)

Interventions

DEVICE

wearable focal vibration therapy

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Conditions

Multiple Sclerosis (MS) - Relapsing-remittingUpper Extremity Dysfunction

Locations

Norman Fixel Institute for Neurological Diseases

Gainesville, Florida 32608

United States

University of Florida

Gainesville, Florida 32610

United States