Stroke
Conditions
Keywords
stroke, telerehabilitation, functional recovery
Brief 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.
Detailed description
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.
Interventions
DEVICETelerehabilitation
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.
OTHERUsual Care
Usual care rehabilitation refers to the recommendations made by their care team.
Sponsors
University of Sao Paulo
Ribeirão Preto Medical School, University of São Paulo
Clinical Hospital, Ribeirão Preto Medical School, University of São Paulo
University of California, Los Angeles
Thomas Jefferson University
Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Statistician.
Intervention model description
Participants are randomized to TR + usual care (intervention) or usual care alone (control)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Age 18-80 years at the time of randomization. 2. The index stroke was radiologically verified, due to ischemia, and had time of onset 120±30 days prior to randomization. 3. The stroke caused upper extremity deficits as defined by Action Research. 4. Arm Test score 18-44 (out of 57) at Baseline Visit. 5. Box \& Block Test score with affected arm is ≥1 block in 60 seconds at Baseline Visit. 6. Able to successfully perform all 3 rehabilitation exercise test examples (simple commands) at Baseline Visit. 7. Informed consent and behavioral contract signed by the subject (i.e., no surrogate consent).
Exclusion criteria
1. 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. 2. 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. 3. A diagnosis (apart from the index stroke) that substantially affects paretic arm function. 4. Severe depression, defined as Geriatric Depression Scale Score \>10/15 at Baseline Visit. 5. Significant cognitive impairment, defined as Montreal Cognitive Assessment \[a lower score can be permitted at the discretion of the PI\]. 6. Deficits in communication that interfere with reasonable study participation. 7. Severe UE spasticity, defined as presence of contracture or modified Ashworth Scale score=4 in either biceps or pectoralis. 8. Modified Rankin Scale score \>2 prior to the index stroke. 9. A new symptomatic stroke has occurred since the index stroke, or a separate stroke occurred within 30 days prior to the index stroke. 10. Lacking visual acuity, with or without corrective lens, of 20/50 or better in at least one eye. 11. Life expectancy \< 9 months 12. Pregnancy; women of child-bearing potential must have a negative pregnancy test. 13. Botulinum toxin to the paretic arm: received in the prior 3 months or expected by the 1-Month Visit. 14. Concurrent enrollment in another therapy-based investigational study where the duration of the investigational therapy's activity is likely to occur during the subject's participation in the study. 15. Subject lacks sufficient Portuguese to comply with study procedures and TR instructions. 16. Contraindication to MRI. 17. Contraindication to TMS. 18. Box and Block Test score of ≥30 blocks with the unaffected arm within 60 seconds at Baseline Visit; 19. Spatial neglect interfering with reasonable participation in the study; 20. On isolation precautions, e.g., due to active COVID-19. 21. Expectation that participant will not have a single domicile address during the 6 weeks of therapy. 22. Distance from the participant's home to the study site greater than 120 km \[this can be waived at the discretion of the PI\]. 22\. Availability of a 2 m² space for a table and chair setup.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Action Research Arm Test (ARAT) Score from baseline to the early post-intervention. | From baseline to early (within 7 days) 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. |
| Study feasibility in the Brazilian context - recruitment. | Through recruitment completion - an average of 15 months | Proportion of eligible participants who agree to take part in the study. |
| Study feasibility in the Brazilian context - adherence. | Through study completion (specifically end of therapy) - an average of 17 months | Proportion of participants who complete TR therapy with sessions of 40 minutes or longer. |
| Study feasibility in the Brazilian context - retention. | Through study completion (specifically end of follow-up) - an average of 18 months | Proportion of dropouts during the study participation period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Action Research Arm Test (ARAT) Score from baseline to 1 month post-intervention. | 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. |
| Treatment-related adverse events reported by the participants. | From the start of TR to early (within 7 days) post-intervention | Number and severity of adverse events related to the telerehabilitation intervention reported by the participants. |
Countries
Brazil
Contacts
CONTACTTaiza G. S. Edwards, PhD
CONTACTAntonio Carlos Santos, MD, PhD
PRINCIPAL_INVESTIGATORTaiza G. S. Edwards, PhD
Ribeirão Preto Medical School, University of São Paulo
Outcome results
None listed