Multiple Sclerosis (MS) - Relapsing-remittingNCT07376772
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
A study testing wearable focal vibration therapy in people with Multiple Sclerosis (MS) - Relapsing-remitting and Upper Extremity Dysfunction, run by University of Florida at 2 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
- What is being tested?
- wearable focal vibration therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesUnited States
- Study dates
- 4 Mar 2026to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- Sufficient proficiency in English to participate in interviews and follow instructions
- Able to visit the laboratory for assessments
- Able to provide written informed consent
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Norman Fixel Institute for Neurological Diseases
Gainesville, Florida, 32608
Yun Chan Shin, 352-273-8433, yunchan.shin@ufl.edu
- Recruiting
University of Florida
Gainesville, Florida, 32610
Hongwu Wang, PhD, 352-273-9934 ext. 352-273-8433, hongwu.wang@ufl.edu
About this 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
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.
- Being tested
- wearable focal vibration therapy
- Keywords
- focal vibration therapy, multiple sclerosis, upper extremity function, wearable, feasbility
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
wearable focal vibration therapyDevice
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 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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Participants who will recieve the focal vibration therapy Receives: Device: wearable focal vibration therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, week 4, week 8
Secondary outcomes (10)
Arm Function in Multiple Sclerosis Questionnaire (AMSQ)
AMSQ is a 31-item MS-specific patient-reported outcome measure assessing arm and hand function.
Measured: Baseline, week 4, week 8
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.
Measured: Baseline, week 4, week 8
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.
Measured: Baseline, week 4, week 8
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) .
Measured: Baseline, week 4, week 8
Visual Analog Scale (VAS) of Pain
Subjective pain intensity will be measured by VAS on a scale from 0, indicating "no pain," to 10, indicating "worst possible pain". Participants will be asked about their neuropathic extremity pain in the UEx (manifesting as burning, tingling, and/or stabbing sensations), as well as pain caused by spasticity in the UEx (such as muscle stiffness or cramping). They will also be asked about instances where neuropathic pain occurs due to nonpainful stimulation such as light touch or non-extreme temperatures. Participants will rate their current UEx pain intensity, as well as the average level of UEx pain experienced over the past two weeks. Additionally, to evaluate how UEx pain has impacted their daily activities during the same period, participants will answer a modified question derived from the Chronic Pain Grade Scale.
Measured: Baseline, week 4, week 8
Modified Fatigue Impact Scale (MFIS)
MFIS is a validated self-report questionnaire designed to evaluate the perceived impact of fatigue in people with MS. The MFIS consists of 21 items, including 9 physical, 10 cognitive, and 2 psychosocial subscale items, and assesses fatigue experienced over the past 4 weeks.
Measured: Baseline, week 4, week 8
Usability
Semi-structured interviews will be conducted with participants to explore their experiences with FVT after the post-intervention assessment and follow-up assessment. Each interview will be one-on-one, conducted by a single researcher. An open-ended interview guide will be developed to direct the conversation, covering domains of usability, acceptability, and perceived benefit of FVT.
Measured: week 4, week 8
Adherence
Adherence to the 4-week FVT intervention will be tracked using multiple methods to ensure accuracy. Each participant will use the MyoVolt smartphone app, which automatically logs session attendance (date, time, intensity, and duration of each FVT session). The app data provides an objective record of when the device is activated. The MyoVolt app's built-in monitoring will serve as the primary source of adherence data. Participants will also fill out a simple daily adherence log immediately after each session. In this log, they will record the date and time of the session, the muscle sites stimulated (e.g., wrist extensors, biceps). This self-report acts as a cross-check against the app data and captures which muscle groups were targeted each day. Participants will be provided with a printed log template with spaces to fill in each field for every day of the 4-week intervention. This log will be collected at the post-intervention visit.
Measured: week 4
Retention rate
Retention will be assessed by recording which participants complete the intervention and all outcome assessments. A retention log will note the status of each participant (Completed, Dropped Early, Lost to Follow-Up) and the reasons for drop-out.
Measured: baseline, week 4, week 8
Adverse events
Participant safety will be closely monitored throughout the study. Adverse event documentation guidelines in the Agency for Healthcare Research and Quality manual were adopted. Participants will receive comprehensive information on adverse events and will be provided with diaries to record any occurrences, along with the contact information of the researcher. If an adverse event occurs, participants are instructed to immediately stop applying for FVT and contact the research team.
Measured: week 4, week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start4 Mar 2026
- Primary completion28 Feb 2027 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS) - Relapsing-remittingStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hongwu Wang, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07376772
- Sponsor's protocol ID
- IRB202500995
- Status last verified
- Nov 2026
- First submitted
- 21 Jan 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: This study will collect data from a research lab and home environment. Demographics, patient-reported and clinician-performed outcome assessments on upper extremity function, and technology-based vibration dosage and usage data will be acquired from 15 participants with multiple sclerosis both in-person and remotely. Identifiable data will be de-identified prior to repository submission. The study protocol, data collection forms/case report forms, data dictionary, manual of operations, and a glossary of domain-specific terms will be submitted. Participant age, sex, ethnicity, height, weight, socioeconomic status, medication usage, upper extremity motor fuction, gross motion fuction, strength, spasticity, and pain data will be collected and shared.
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07376772
- Acronym / sponsor ID
- IRB202500995
- Keywords
- focal vibration therapy, multiple sclerosis, upper extremity function, wearable, feasbility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 4 Mar 2026 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 29 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: wearable focal vibration therapyParticipants who will recieve the focal vibration therapy |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| wearable focal vibration therapyThe 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. | Device | Intervention group |
Primary outcome
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: Yes. This study will collect data from a research lab and home environment. Demographics, patient-reported and clinician-performed outcome assessments on upper extremity function, and technology-based vibration dosage and usage data will be acquired from 15 participants with multiple sclerosis both in-person and remotely. Identifiable data will be de-identified prior to repository submission. The study protocol, data collection forms/case report forms, data dictionary, manual of operations, and a glossary of domain-specific terms will be submitted. Participant age, sex, ethnicity, height, weight, socioeconomic status, medication usage, upper extremity motor fuction, gross motion fuction, strength, spasticity, and pain data will be collected and shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hongwu Wang principal investigator
University of Florida
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing wearable focal vibration therapy in people with Multiple Sclerosis (MS) - Relapsing-remitting and Upper Extremity Dysfunction, run by University of Florida at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hongwu Wang, PhD (352-273-9934, hongwu.wang@ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nine-Hole Peg Test (9HPT) (time frame: Baseline, week 4, week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.