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Telerehabilitation and Biomarkers of Functional Recovery After Stroke in Brazil: TR-BR-1 Clinical Trial

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Brazil
Ribeirão Preto Medical School, University of São Paulo
RECRUITING
Ribeirão Preto
Contact Information
Primary
Taiza G. S. Edwards, PhD
trbr1@usp.br
+5516-36021202
Backup
Antonio Carlos Santos, MD, PhD
+551636022964
Time Frame
Start Date: 2026-06-12
Estimated Completion Date: 2028-02-29
Participants
Target number of participants: 20
Treatments
Other: Usual Care
Participants in the usual care group will receive no TR, but will continue with the recommendations made by their care team.
Active_comparator: Telerehabilitation + Usual Care
In addition to the usual care, patients 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.
Related Therapeutic Areas
Sponsors
Leads: University of Sao Paulo
Collaborators: Thomas Jefferson University, Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School, University of California, Los Angeles

This content was sourced from clinicaltrials.gov