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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Telerehabilitation
Device
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.
Usual Care
Other intervention
Usual care rehabilitation refers to the recommendations made by their care team.

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: Usual CareOther 1 intervention

Group B: Telerehabilitation + Usual CareActive comparator 2 interventions

Trial outcomes

Primary outcomes

Change in Action Research Arm Test (ARAT) Score from baseline to the early 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.

Time frame

From baseline to early (within 7 days) post-intervention

Study feasibility in the Brazilian context - recruitment.

Proportion of eligible participants who agree to take part in the study.

Time frame

Through recruitment completion - an average of 15 months

Study feasibility in the Brazilian context - adherence.

Proportion of participants who complete TR therapy with sessions of 40 minutes or longer.

Time frame

Through study completion (specifically end of therapy) - an average of 17 months

Study feasibility in the Brazilian context - retention.

Proportion of dropouts during the study participation period.

Time frame

Through study completion (specifically end of follow-up) - an average of 18 months

Secondary outcomes

Change in Action Research Arm Test (ARAT) Score 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.

Time frame

From baseline to 1 month post-intervention

Treatment-related adverse events reported by the participants.

Number and severity of adverse events related to the telerehabilitation intervention reported by the participants.

Time frame

From the start of TR to early (within 7 days) post-intervention

Other outcomes

White matter integrity assessed using diffusion tensor imaging (DTI) magnetic resonance imaging (MRI).

Cortical spinal tract integrity - lesion load (predictive factor).

Time frame

Baseline

Interhemispheric connectivity of motor cortices assessed using resting-state functional magnetic resonance imaging (rs-fMRI).

rs-fMRI interhemispheric functional connectivity in the primary motor cortex (predictive factor).

Time frame

Baseline

Motor cortex mapping and motor representation assessed using neuronavigated transcranial magnetic stimulation (nTMS).

nTMS motor mapping (predictive factor).

Time frame

Baseline

Interhemispheric connectivity of motor cortices assessed using resting-state functional electroencephalography (rsEEG).

rsEEG interhemispheric functional connectivity in the primary motor cortex (predictive factor).

Time frame

Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

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