RecruitingNot ApplicableNCT07376772

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

Feasibility, Preliminary Efficacy, and User Perspective Usability of Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study

Sponsor

University of Florida

Enrollment

15 participants

Start Date

Mar 4, 2026

Study Type

INTERVENTIONAL

Conditions

Multiple Sclerosis (MS) - Relapsing-remitting Upper Extremity Dysfunction

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

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria9

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 Criteria4

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

DEVICEwearable focal vibration therapy

The focal vibration intervention will be delivered using a modified MyoVolt wearable vibration therapy device. Each MyoVolt vibration device will be assigned to a single participant for individual use only and will be clearly labeled with a unique study ID. Devices will be distributed during the baseline training session and returned at the end of the study. To prevent unauthorized use: * Participants will receive training on the appropriate use and safe handling of the device. * Each device will be stored by the participant in their home in a designated area, along with written instructions and contact information in case of any issues. * The device operates only via a linked smartphone app. This will restrict unauthorized users from easily accessing or operating the device. * Participants will be instructed not to allow others to use the device and to report any device malfunction, loss, or suspected misuse immediately to the research team.