Telerehabilitation to boost arm recovery after stroke in Brazil

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase II, two-arm randomized trial in Brazil. It compares telerehabilitation plus usual care to usual care alone for improving upper-extremity function after stroke. The primary outcome is the ARAT score, with secondary measures including feasibility, safety, and intervention-related outcomes, plus neuroimaging and neurophysiological assessments. The study plans 20 participants over about 4 months, with 6 in-person visits and 36 telerehabilitation sessions delivered over six weeks.

Why it matters

Who can join: the full rules

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.

Where it's running

• Ribeirão Preto Medical School, University of São Paulo
  Ribeirão Preto, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Taiza G. S. Edwards, PhD — University of Sao Paulo
• Study coordinator: Taiza G. S. Edwards, PhD
• Email: trbr1@usp.br
• Phone: +5516-36021202

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Deep phenotyping to explore recovery in young adults after stroke

  This project will test whether a detailed health and sample-collection approach (deep phenotyping) is practical and acceptable for people aged 18–55 who have had a stroke.

  Recruiting The Florey Institute of Neuroscience and Mental Health · Heidelberg, Victoria and 1 other locations · NCT07019493

• Stem cell therapy for chronic stroke recovery

  This study is testing whether using a patient's own stem cells can help people with long-term stroke recovery feel better and improve their daily functioning.

  Recruiting Phase 2 Hokkaido University Hospital · Sapporo, Hokkaido · NCT06752720

• AI-based tools to help diagnose, treat and predict stroke outcomes across multiple hospitals

  This study tests AI-powered tools on real-world stroke patients to see if they can improve pre-hospital triage, diagnosis, and outcome prediction while data stay securely within each hospital.

  Recruiting at 2 sites Hospital Universitari Vall d'Hebron Research Institute · Leuven and 6 other locations · NCT07924371

• Web-based therapy using action observation and mirror therapy for arm weakness after stroke

  This trial tests whether a mobile telerehabilitation app delivering action observation therapy (AOT) alone or combined AOT with mirror therapy (AOT-MT) can improve upper limb function in people with subacute stroke.

  Recruiting Chang Gung Memorial Hospital · Taoyuan · NCT07921108

• Remote Ischaemic Conditioning for Fatigue After Stroke 2

  Aat least 12 weeks after stroke, adults with post-stroke fatigue will try a simple hand-arm cuff treatment at home to see if it helps reduce fatigue.

  Recruiting Phase 2 Sheffield Teaching Hospitals NHS Foundation Trust · Sheffield, South Yorkshire · NCT07914647

• Dual-task balance training plus computer-based cognitive training after stroke

  In adults who recently had a stroke, the study tests whether adding computerized cognitive exercises to balance training improves balance and other recovery outcomes.

  Recruiting Matia Foundation · San Sebastián, GUIPUZCOA · NCT07913620

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.