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.
This is a two-arm phase II randomized controlled trial with blinded outcome assessment. A total of 20 post-stroke participants will be randomized to either telerehabilitation added to usual care (TR+UC) or usual care alone (UC). The primary outcome measure is the Action Research Arm Test (ARAT), which assesses upper extremity motor function. Secondary measures will include feasibility and intervention-related outcomes. Study participation will span approximately 4 months and includes 6 in-person assessment visits. At these visits, participants will complete a battery of assessments, including upper extremity motor function tests, resting-state functional electroencephalography (EEG), and a single magnetic resonance imaging (MRI) scan of the brain. Participants assigned to the TR+UC group will receive structured arm motor training consisting of 36 sessions of prescribed exercises, interactive games, and stroke education delivered over 6 weeks at a frequency of 6 days per week, with each session lasting approximately 70 minutes. TR+UC participants will continue all usual care concurrently. Participants in the UC group will continue all therapies recommended by their medical team without participating in telerehabilitation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
20
Participants will receive 36 telerehabilitation sessions targeting arm motor function in addition to their usual care. TR consists of 70 minutes/day of activities targeting arm function, 6 days/week for 6 weeks. Half of these sessions are supervised by a licensed therapist, and the other half are done independently.
Usual care rehabilitation refers to the recommendations made by their care team.
Ribeirão Preto Medical School, University of São Paulo
Ribeirão Preto, São Paulo, Brazil
RECRUITINGChange in Action Research Arm Test (ARAT) Score from baseline to the early post-intervention.
Change in Action Research Arm Test (ARAT) Score from baseline to the early post-intervention. The ARAT scale measures arm function using a scale that runs from 0 to 57 points, with higher numbers reflecting better arm function.
Time frame: From baseline to early (within 7 days) post-intervention
Study feasibility in the Brazilian context - recruitment.
Proportion of eligible participants who agree to take part in the study.
Time frame: Through recruitment completion - an average of 15 months
Study feasibility in the Brazilian context - adherence.
Proportion of participants who complete TR therapy with sessions of 40 minutes or longer.
Time frame: Through study completion (specifically end of therapy) - an average of 17 months
Study feasibility in the Brazilian context - retention.
Proportion of dropouts during the study participation period.
Time frame: Through study completion (specifically end of follow-up) - an average of 18 months
Change in Action Research Arm Test (ARAT) Score from baseline to 1 month post-intervention.
Change in Action Research Arm Test (ARAT) Score from baseline to 1 month post-intervention. The ARAT scale measures arm function using a scale that runs from 0 to 57 points, with higher numbers reflecting better arm function.
Time frame: From baseline to 1 month post-intervention
Treatment-related adverse events reported by the participants.
Number and severity of adverse events related to the telerehabilitation intervention reported by the participants.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: From the start of TR to early (within 7 days) post-intervention