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

NCT07376772 | Recruiting FDA Device

• 1 other identifier: IRB202500995
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

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

Keywords

focal vibration therapy; multiple sclerosis; upper extremity function; wearable; feasbility

Outcome Measures

Primary Outcomes (1)

• Nine-Hole Peg Test (9HPT)

  The Nine-Hole Peg Test (9HPT) assesses fine motor coordination and dexterity by timing how quickly participants can place and remove nine pegs from a pegboard using one hand.

  Baseline, week 4, week 8

Secondary Outcomes (10)

• Arm Function in Multiple Sclerosis Questionnaire (AMSQ)

  Baseline, week 4, week 8

• Box and Block Test (BBT)

  Baseline, week 4, week 8

• Muscle Strength

  Baseline, week 4, week 8

• Modified Ashworth Scale (MAS)

  Baseline, week 4, week 8

• Visual Analog Scale (VAS) of Pain

  Baseline, week 4, week 8

Study Arms (1)

Intervention group

EXPERIMENTAL

Participants who will recieve the focal vibration therapy

Device: wearable focal vibration therapy

Interventions

wearable focal vibration therapy DEVICE

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Florida: lead

Study Sites (2)

Norman Fixel Institute for Neurological Diseases

Gainesville, Florida, 32608, United States

RECRUITING

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Hongwu Wang

  University of Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongwu Wang, PhD

CONTACT

352-273-9934; hongwu.wang@ufl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: January 29, 2026
• Study Start: March 4, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 6, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Scientific data will be shared as soon as possible. Scientific data included in published manuscripts will be available at the time of publication; all other generated scientific data will be shared no later than the end of the study. The study data will be stored in the public repository for at least 5 years.
• Access Criteria: Data will be stored in the UF system and sharing of de-identified data will be possible using a public repository such as the Institutional Repository at UF, as recommended by the UF Smathers Libraries Data Curation and Working Group. The study data will also be submitted to two generalist repositories participating in the NIH Generalist Repository Ecosystem Initiative, Synapse (for the wearable data) and Vivli. We will use the National Institute of Child Health and Human Development (NICHD) DASH (data and specimen hub) for repository. To promote the discoverability of the data, we will prepare a statement regarding data sharing and access to disseminate with presentations, publications, and public events related to this work. We will also submit metadata associated with the datasets to Synapse and Vivli. The repositories will provide metadata, persistent identifiers, and long-term access for open and controlled access.

Locations

US (2)