Recruiting

Focal Vibration Therapy

Sponsor:

University of Florida

Code:

NCT07376772

Conditions

Multiple Sclerosis (MS) - Relapsing-remitting

Upper Extremity Dysfunction

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

wearable focal vibration therapy

Study Details

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

Study ID

NCT07376772

Start date

Mar 4, 2026

Status verified date

Oct, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Intervention group

Participants who will recieve the focal vibration therapy

Interventions

wearable 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.

Primary outcome measure

  • Nine-Hole Peg Test (9HPT) [ Time Frame: Baseline, week 4, week 8 ]

Central Contacts and Locations

Central contacts

Hongwu Wang, PhD

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

Locations

Norman Fixel Institute for Neurological Diseases

Recruiting

Gainesville, Florida, United States, 32608

Contacts

Yun Chan Shin

352-273-8433yunchan.shin@ufl.edu

University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Hongwu Wang, PhD

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

More Information

Sponsor

University of Florida

Last update posted

Mar 6, 2026

Last verified

Oct, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-03-06.