Telerehabilitation and Biomarkers of Recovery After Stroke in Brazil (NCT07646522) | Clinical Trial Compass
RecruitingPhase 2
Telerehabilitation and Biomarkers of Recovery After Stroke in Brazil
Brazil20 participantsStarted 2026-06-12
Plain-language summary
The purpose of this research study is to provide preliminary evidence of whether telerehabilitation targeting arm movement, when added to usual care, improves arm function and reduces global disability after stroke, compared to usual care alone in Brazil. Evaluate the safety and feasibility of telerehabilitation in the Brazilian context. Explore the clinical, neuroimaging, neurophysiological, and economic factors that influence telerehabilitation efficacy in functional recovery following stroke.
Who can participate
Age range
18 Years – 80 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
. Age 18-80 years at the time of randomization.
. The index stroke was radiologically verified, due to ischemia, and had time of onset 120±30 days prior to randomization.
. The stroke caused upper extremity deficits as defined by Action Research.
. Arm Test score 18-44 (out of 57) at Baseline Visit.
. Box \& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit.
. Able to successfully perform all 3 rehabilitation exercise test examples (simple commands) at Baseline Visit.
. Informed consent and behavioral contract signed by the subject (i.e., no surrogate consent).
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 Action Research Arm Test (ARAT) Score from baseline to the early post-intervention.
Timeframe: From baseline to early (within 7 days) post-intervention
2
Study feasibility in the Brazilian context - recruitment.
Timeframe: Through recruitment completion - an average of 15 months
3
Study feasibility in the Brazilian context - adherence.
Timeframe: Through study completion (specifically end of therapy) - an average of 17 months
4
Study feasibility in the Brazilian context - retention.
Timeframe: Through study completion (specifically end of follow-up) - an average of 18 months
. A major, active, coexistent neurological, psychiatric, or medical disease that reduces the likelihood that a subject will be able to comply with all study procedures.
. Unable or unwilling to perform study procedures/therapy, or expectation of noncompliance with study procedures/therapy, or expectation that subject cannot participate in all study visits.
. A diagnosis (apart from the index stroke) that substantially affects paretic arm function.
. Severe depression, defined as Geriatric Depression Scale Score \>10/15 at Baseline Visit.
. Significant cognitive impairment, defined as Montreal Cognitive Assessment \[a lower score can be permitted at the discretion of the PI\].
. Deficits in communication that interfere with reasonable study participation.
. Severe UE spasticity, defined as presence of contracture or modified Ashworth Scale score=4 in either biceps or pectoralis.
. Modified Rankin Scale score \>2 prior to the index stroke.