Telerehabilitation and Biomarkers of Recovery After Stroke in Brazil
ConditionStroke
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorUniversity of Sao Paulo
About this trial
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
Qualifiers
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.
Disqualifiers
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.
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.
A diagnosis (apart from the index stroke) that substantially affects paretic arm function.
Severe depression, defined as Geriatric Depression Scale Score >10/15 at Baseline Visit.
Trial design
Treatments tested in this trial
- Telerehabilitation
- Usual Care
Treatment groups
20 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Sao Paulo
Lead sponsor
Ribeirão Preto Medical School, University of São Paulo
Collaborator
Clinical Hospital, Ribeirão Preto Medical School, University of São Paulo
Collaborator
University of California, Los Angeles
Collaborator
Thomas Jefferson University
Collaborator
Athinoula A. Martinos Center for Biomedical Imaging, Department of Radiology, Massachusetts General Hospital, Harvard Medical School
Collaborator
Source ClinicalTrials.gov