Feasibility and Efficacy of HABIT for Enhancing Daily Hand-Use Post Stroke (NCT06455241) | Clinical Trial Compass
CompletedNot Applicable
Feasibility and Efficacy of HABIT for Enhancing Daily Hand-Use Post Stroke
Israel11 participantsStarted 2024-06-02
Plain-language summary
This experimental design will assess the feasibility \& initial effectiveness of HABIT - a novel occupational therapy to increase the daily hand-use of the affected upper extremity post stroke.
Assessments will be conducted at four time points: baseline, pre, post the HABIT intervention and follow-up (by phone) .
Who can participate
Age range
18 Years – 100 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:
* Adults aged 18 and above residing in their own homes
* Hebrew speakers
* Up to 10 years post-stroke
* Mild upper extremity motor impairment but still report difficulty using their hand. This will be determined by a total score of 43/66, including the Hand subtest score of 7/14 points of the Fugl-Meyer Motor Assessment.
* No significant cognitive decline (score of 19 and above on Montreal Cognitive Assessment)
* Able to walk with or without assistive devices
* Able to provide informed consent by signing a consent form
* Full function of both hands and independent in daily function prior to stroke
Exclusion Criteria:
* Other neurological conditions or psychiatrists
* with moderate or significant proprioception deficit (Thumb Localization Test \>1)
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
1
Change in scores of the Rating of Everyday Arm-Use in the Community and Home (REACH)
Timeframe: no change from baseline (0 week) to pre intervention (3 week) but change from pre to post intervention (8 week) and change from post to follow-up (3-6 months)
2
Change in scores of the Canadian Occupational Performance Measure (COPM)
Timeframe: no change from baseline (0 week) to pre intervention (3 week) but change from pre to post intervention (8 week) and change from post to follow-up (3-6 months)