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Clinical Trials/NCT07376772
NCT07376772
Recruiting
Not Applicable

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

University of Florida2 sites in 1 country15 target enrollmentStarted: March 4, 2026Last updated:
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Interventionswearable focal vibration therapy

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
15
Locations
2
Primary Endpoint
Nine-Hole Peg Test (9HPT)
OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Device Feasibility
Masking
None

Eligibility Criteria

Ages
18 Years to 100 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Arms & Interventions

Intervention group

Experimental

Participants who will recieve the focal vibration therapy

Intervention: wearable focal vibration therapy (Device)

Outcomes

Primary Outcomes

Nine-Hole Peg Test (9HPT)

Time Frame: Baseline, week 4, week 8

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.

Secondary Outcomes

  • 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)
  • Modified Fatigue Impact Scale (MFIS)(Baseline, week 4, week 8)
  • Usability(week 4, week 8)
  • Adherence(week 4)
  • Retention rate(baseline, week 4, week 8)
  • Adverse events(week 4, week 8)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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