Wearable Focal Vibration Therapy on Upper Extremity Function of People

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

RecruitingNot a drug-phase studyRelapsing MSNCT07376772

What it found

Still running

No result yet.

What was tested

Treatment tested

  • wearable focal vibration therapy

What it measured

Main measures

  • Nine-Hole Peg Test (9HPT)

    Baseline, week 4, week 8

    Disability progressionArm and hand function

Other measures (10)

  • Arm Function in Multiple Sclerosis Questionnaire (AMSQ)

    Baseline, week 4, week 8

    Arm and hand functionQuality of life (reported by participants)

  • Box and Block Test (BBT)

    Baseline, week 4, week 8

  • Muscle Strength

    Baseline, week 4, week 8

    Arm and hand functionPhysical function

  • Modified Ashworth Scale (MAS)

    Baseline, week 4, week 8

    Spasticity

  • Visual Analog Scale (VAS) of Pain

    Baseline, week 4, week 8

    SpasticityPain

  • Modified Fatigue Impact Scale (MFIS)

    Baseline, week 4, week 8

    Thinking and memoryFatigue

  • Usability

    week 4, week 8

    Feasibility

  • Adherence

    week 4

    Quality of life (reported by participants)

  • Retention rate

    baseline, week 4, week 8

    Feasibility

  • Adverse events

    week 4, week 8

    Safety

Who could take part

Relapsing MS · 18 to 100

Show the full 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)

As registered. Criteria can change, so ask the trial team or your neurologist.

Contact details on the registry

About this trial

In the sponsor's words

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.

Loading reviews and guidelines…

History

  1. Primary completion date changed from 30 June 2026 to 28 February 2027
  2. Completion date changed from 30 June 2026 to 28 February 2027

  1. Started

    Mar 2026

  2. Main results due

    Feb 2027

  3. Finished

    Feb 2027

Assembled by software from public sources.