TerminatedNot Applicable

Evaluation of Vibration-based Wearable Upper Limb Rehabilitation Device

Stopped: The original PI left the institution and the remaining study team did not have the resources to continue. The data were not analyzed; there are no results to report.

United States4 participantsStarted 2021-08-30

Plain-language summary

The investigators will perform a pilot 4-week at home study with 48 individuals with stroke and 10 therapists working with stroke patients to examine the feasibility and effect of a wearable focal muscle vibration device on upper limb strength and function.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Ischemic or hemorrhagic stroke with Chedoke McMaster's Stroke Assessment (CMSA) level four or above; * over 18 years of age; * have been using a smartphone more than one year; * live within 40 miles from the University of Oklahoma Health Sciences Center (OUHSC) Exclusion Criteria: * a history of fractures or dislocations in the shoulder, elbow, or wrist from which the participant has not fully recovered, * severe impairment of verbal communication ability (for example, severe aphasia), * inability to consent (for example, dementia), * simultaneous participation in another treatment study targeting stroke recovery

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Usability of the WearUL as assessed by the System Usability Scale (SUS)

Timeframe: 4 weeks

Usability of the WearUL app as assessed by the mHealth App Usability Questionnaire (MAUQ)

Timeframe: 4 weeks

Changes in grip strength

Timeframe: Change from Baseline Grip Strength at 4 weeks

Changes in arm and hand function as assessed by CAHAI-7

Timeframe: Change from Baseline CAHAI-7 at 4 weeks

Changes in sensorimotor impairment as assessed by FMA-UE

Timeframe: Change from Baseline FMA-UE at 4 weeks

Changes in upper extremity performance as assessed by ARAT

Timeframe: Change from Baseline ARAT at 4 weeks

Changes in self-reported functional upper extremity performance as assessed by MAL

Timeframe: Change from Baseline MAL at 4 weeks

Trial details

NCT IDNCT04698369

SponsorUniversity of Oklahoma

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-30

View on ClinicalTrials.gov More Stroke trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Usability of the WearUL as assessed by the System Usability Scale (SUS)

Timeframe: 4 weeks

Usability of the WearUL app as assessed by the mHealth App Usability Questionnaire (MAUQ)

Timeframe: 4 weeks

Changes in grip strength

Timeframe: Change from Baseline Grip Strength at 4 weeks

Changes in arm and hand function as assessed by CAHAI-7

Timeframe: Change from Baseline CAHAI-7 at 4 weeks

Changes in sensorimotor impairment as assessed by FMA-UE

Timeframe: Change from Baseline FMA-UE at 4 weeks

Changes in upper extremity performance as assessed by ARAT

Timeframe: Change from Baseline ARAT at 4 weeks

Changes in self-reported functional upper extremity performance as assessed by MAL

Timeframe: Change from Baseline MAL at 4 weeks