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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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 100 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Wearing a device

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study tests whether a wearable device that gently vibrates arm muscles can help people with multiple sclerosis (MS) use their arms and hands. It is for 15 adults with relapsing-remitting MS, a type with flare-ups and periods of recovery, who report arm or hand problems. Participants will use Myovolt devices at home for 4 weeks, and researchers will study how well the program works and what users think of it.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18 and have a confirmed diagnosis of relapsing-remitting MS.
  • Have had no MS flare-up or worsening in the past 6 months.
  • Report arm or hand problems, such as trouble using them, weakness, stiff muscles, or pain.
  • Have been on stable MS treatment for at least 4 weeks, with no plans to start new treatments.
  • Be willing and able to use the vibration device after training.
  • Know enough English to answer interview questions and follow instructions.
  • Be able to visit the lab for tests.
  • Be able to give written consent to join the study.

Who can't join

  • Have thinking or memory problems that could make it hard to follow instructions, shown by a Mini-MoCA test score below 12.
  • Have another brain, nerve, or mental health condition affecting the arms or hands that could affect study results or make treatment unsafe, such as stroke or severe carpal tunnel syndrome (a pinched nerve at the wrist).
  • Have unstable heart disease or another major illness that prevents participation.
  • Be pregnant or have a new blood clot in a deep vein.
  • Have severe osteoporosis (weak bones), long-term migraines, or epilepsy (a condition that causes seizures).
  • Have active cancer in the area being treated.
  • Have an implanted pacemaker without medical clearance for vibration therapy.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (2)

FL