NCT07646522 Telerehabilitation and Biomarkers of Recovery After Stroke in Brazil
| NCT ID | NCT07646522 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Sao Paulo |
| Condition | Stroke |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-06-12 |
| Primary Completion | 2027-09-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2026-06-12 with a primary completion date of 2027-09-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Taiza G. S. Edwards, PhD
PRINCIPAL INVESTIGATOR
University of Sao Paulo
Frequently Asked Questions
Who can join the NCT07646522 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07646522 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07646522 currently recruiting?
Yes, NCT07646522 is actively recruiting participants. Contact the research team at trbr1@usp.br for enrollment information.
Where is the NCT07646522 trial being conducted?
This trial is being conducted at Ribeirão Preto, Brazil.
Who is sponsoring the NCT07646522 clinical trial?
NCT07646522 is sponsored by University of Sao Paulo. The principal investigator is Taiza G. S. Edwards, PhD at University of Sao Paulo. The trial plans to enroll 20 participants.
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