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

Official title

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

Overview

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.

Interventions

• Device 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 wi

Primary outcome measures

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

Secondary outcome measures (10)

• Arm Function in Multiple Sclerosis Questionnaire (AMSQ) [Time frame: Baseline, week 4, week 8]
• Box and Block Test (BBT) [Time frame: Baseline, week 4, week 8]
• Muscle Strength [Time frame: Baseline, week 4, week 8]
• Modified Ashworth Scale (MAS) [Time frame: Baseline, week 4, week 8]
• Visual Analog Scale (VAS) of Pain [Time frame: Baseline, week 4, week 8]
• Modified Fatigue Impact Scale (MFIS) [Time frame: Baseline, week 4, week 8]
• Usability [Time frame: week 4, week 8]
• Adherence [Time frame: week 4]
• Retention rate [Time frame: baseline, week 4, week 8]
• Adverse events [Time frame: week 4, week 8]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Device feasibility

Study locations

United States · 2 centers

• Norman Fixel Institute for Neurological Diseases — Gainesville
• University of Florida — Gainesville

Identifiers

NCT: NCT07376772 · IRB202500995

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗