CompletedNot Applicable

Forearm Rotation Orthosis for Stroke

United States18 participantsStarted 2015-08

Plain-language summary

The purpose of this study is to examine the efficacy of a forearm rotation orthosis combined with the occupational therapy task-oriented approach on functional performance for persons with a hemiparetic arm. Hypotheses of this study are: 1. participants who wear the forearm rotation orthosis will demonstrate significantly greater improvement in functional performance and active range of motion of forearm rotators compared to those who do not; 2. all participants who receive the occupational therapy task-oriented approach intervention will demonstrate significant improvement in functional performance; and 3. all participants who receive the occupational therapy task-oriented approach intervention will demonstrate improvement in motor function of the upper extremity.

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: * Have a diagnosis of stroke for at least three months * Be 18 years of age or older * Have sufficient cognitive function to follow three-step verbal instruction and provide independent consent * Have appropriate trunk and lower extremity function that does not interfere with performance of the upper extremity * Have at least minimum voluntary movement in the upper extremity (10 degrees of shoulder flex/ abduction, 10 degrees of elbow flexion/extension) * Not receive any rehabilitative interventions concurrent with the study Exclusion Criteria: * Severe joint deformities or contractures of the affected upper extremity that limit range of motion required for functional tasks * Capability of voluntarily extending the wrist and fingers through the full range * Other rehabilitation interventions concurrent with the study * Have serious uncontrolled medical problems, such as seizures and visual impairment

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

Canadian Occupational Performance Measure (COPM) - Performance

Timeframe: Week 1, 8, and 15

Canadian Occupational Performance Measure (COPM) - Satisfaction

Timeframe: Week 1, 8, and 15

Wolf Motor Function Test (WMFT) - Time

Timeframe: Week 1, 8, and 15

Wolf Motor Function Test (WMFT) - Function

Timeframe: Week 1, 8, and 15

Motor Activity Log (MAL) - Amount of Use

Timeframe: Week 1, 8, and 15

Motor Activity Log (MAL) - How Well

Timeframe: Week 1, 8, and 15

Trial details

NCT IDNCT01987414

SponsorUniversity of Minnesota

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2018-06

Results submitted2019-08-06

View on ClinicalTrials.gov More Stroke trials

Plain-language summary

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

Canadian Occupational Performance Measure (COPM) - Performance

Timeframe: Week 1, 8, and 15

Canadian Occupational Performance Measure (COPM) - Satisfaction

Timeframe: Week 1, 8, and 15

Wolf Motor Function Test (WMFT) - Time

Timeframe: Week 1, 8, and 15

Wolf Motor Function Test (WMFT) - Function

Timeframe: Week 1, 8, and 15

Motor Activity Log (MAL) - Amount of Use

Timeframe: Week 1, 8, and 15

Motor Activity Log (MAL) - How Well

Timeframe: Week 1, 8, and 15