Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorUniversity of Florida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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)
Trial design
Design model
Single group
Treatments tested in this trial
wearable focal vibration therapy
DeviceThe 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.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Intervention groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Nine-Hole Peg Test (9HPT)
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.
Time frame
Baseline, week 4, week 8Secondary outcomes
1
Arm Function in Multiple Sclerosis Questionnaire (AMSQ)
AMSQ is a 31-item MS-specific patient-reported outcome measure assessing arm and hand function.
Time frame
Baseline, week 4, week 82
Box and Block Test (BBT)
The Box and Block Test (BBT) measures gross motor function with high test-retest reliability by counting the number of blocks a participant can transfer over a partition from one compartment to another within 60 seconds.
Time frame
Baseline, week 4, week 83
Muscle Strength
Muscle strength will be evaluated using a handheld dynamometer. For grip strength assessment, participants will be seated with the shoulder adducted and neutrally rotated, the elbow flexed at 90 degrees, and the forearm and wrist in a neutral position. They will be instructed to squeeze the dynamometer with maximal effort for 3 seconds. Elbow flexion and extension strength will be assessed by applying the dynamometer to the distal part of the forearm as the participant resists the examiner's force for 3 seconds. The highest value from three trials in each arm and strength will be recorded and 60 seconds of recovery time will be applied between trials.
Time frame
Baseline, week 4, week 84
Modified Ashworth Scale (MAS)
The Modified Ashworth Scale (MAS) is a widely used tool that assesses spasticity by measuring resistance during passive muscle stretching, graded on a scale from 0 (no increase in muscle tone) to 4 (rigid in flexion or extension) .
Time frame
Baseline, week 4, week 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov