CompletedPhase 1

Dose Optimization for Stroke Evaluation

United States60 participantsStarted 2012-03

Plain-language summary

This study is about rehabilitation of arm function after a stroke. The investigators are testing the dosage of therapy that is needed for meaningful recovery of arm and hand function. Dosage of therapy refers to the amount of time (in this case, the total number of hours) that a person participates in treatment. The investigators hope to learn how much therapy time is needed in order for change to occur in arm and hand function after a person has had a stroke. Eligible candidates must have had a stroke affecting the use of an arm or hand at least 6 months ago.

Who can participate

Age range

21 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 that occured at least 6 months ago. * At least 21 years of age * Persistent arm and hand weakness, with some ability to release a grasp * Able to provide consent to participate * No history of a medical condition that limited arm or hand use prior to the stroke * Medically stable * Able to participate for 10 months and attend evaluations at the University of Southern California (USC) Health Sciences Campus. * Able to communicate in English or Spanish. Exclusion criteria: * Severe upper extremity sensory impairment * Neglect * Current major depressive disorder * Severe arthritis or orthopedic problems that limit arm or hand movement * Pain that interferes with daily activities * Currently enrolled in other rehabilitation or drug intervention studies * Living too far from the training site to participate reliably * Receiving oral or injected anti-spasticity medications during study treatment. * Pregnancy.

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

Bilateral Arm Reaching Test (BART)

Timeframe: Change from Baseline to up to 4 months post-randomization

Wolf Motor Function Test (WMFT)

Timeframe: Change from Baseline to up to 4 months post-randomization

Motor Activity Log (MAL)

Timeframe: Change from Baseline to up to 4 months post-randomization

Bilateral Arm Reaching Test (BART)

Timeframe: Change from Baseline to up to 10 months post-randomization

Wolf Motor Function Test (WMFT)

Timeframe: Change from Baseline to up to 10 months post-randomization

Motor Activity Log (MAL)

Timeframe: Change from Baseline to up to 10 months post-randomization

Trial details

NCT IDNCT01749358

SponsorUniversity of Southern California

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-08

View on ClinicalTrials.gov More Stroke trials

Plain-language summary

Who can participate

Age range

21 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

Bilateral Arm Reaching Test (BART)

Timeframe: Change from Baseline to up to 4 months post-randomization

Wolf Motor Function Test (WMFT)

Timeframe: Change from Baseline to up to 4 months post-randomization

Motor Activity Log (MAL)

Timeframe: Change from Baseline to up to 4 months post-randomization

Bilateral Arm Reaching Test (BART)

Timeframe: Change from Baseline to up to 10 months post-randomization

Wolf Motor Function Test (WMFT)

Timeframe: Change from Baseline to up to 10 months post-randomization

Motor Activity Log (MAL)

Timeframe: Change from Baseline to up to 10 months post-randomization