Telerehabilitation and Biomarkers of Recovery After Stroke in Brazil

NCT07646522 | Not Yet Recruiting Phase 2

• 2 other identifiers: 90571225.4.0000.54402025/10298-4
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

stroke; telerehabilitation; functional recovery

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

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

Secondary Outcomes (2)

• Change in Action Research Arm Test (ARAT) Score from baseline to 1 month post-intervention.

  From baseline to 1 month post-intervention

• Treatment-related adverse events reported by the participants.

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

Other Outcomes (10)

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

  Baseline

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

  Baseline

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

  Baseline

Study Arms (2)

Usual Care

OTHER

Participants in the usual care group will receive no TR, but will continue with the recommendations made by their care team.

Other: Usual Care

Telerehabilitation + Usual Care

ACTIVE COMPARATOR

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.

Device: Telerehabilitation; Other: Usual Care

Interventions

Usual Care OTHER

Usual care rehabilitation refers to the recommendations made by their care team.

Telerehabilitation + Usual Care; Usual Care

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.

Telerehabilitation + Usual Care

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• Significant cognitive impairment, defined as Montreal Cognitive Assessment \[a lower score can be permitted at the discretion of the PI\].
• Deficits in communication that interfere with reasonable study participation.
• Severe UE spasticity, defined as presence of contracture or modified Ashworth Scale score=4 in either biceps or pectoralis.
• Modified Rankin Scale score \>2 prior to the index stroke.
• A new symptomatic stroke has occurred since the index stroke, or a separate stroke occurred within 30 days prior to the index stroke.
• Lacking visual acuity, with or without corrective lens, of 20/50 or better in at least one eye.
• Life expectancy \< 9 months
• Pregnancy; women of child-bearing potential must have a negative pregnancy test.
• Botulinum toxin to the paretic arm: received in the prior 3 months or expected by the 1-Month Visit.
• 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.
• Subject lacks sufficient Portuguese to comply with study procedures and TR instructions.

Sponsors & Collaborators

• University of Sao Paulo: lead
• 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

Study Sites (1)

Ribeirão Preto Medical School, University of São Paulo

Ribeirão Preto, São Paulo, 14049900, Brazil

Location

MeSH Terms

Conditions

Stroke

Interventions

Telerehabilitation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Taiza G. S. Edwards, PhD

  Ribeirão Preto Medical School, University of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Taiza G. S. Edwards, PhD

CONTACT

+5516-36021202; trbr1@usp.br

Antonio Carlos Santos, MD, PhD

CONTACT

+551636022964

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Statistician.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants are randomized to TR + usual care (intervention) or usual care alone (control)

Study Record Dates

• First Submitted: May 24, 2026
• First Posted: June 12, 2026
• Study Start: June 12, 2026
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): February 29, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Anytime after July, 2028.
• Access Criteria: Appropriate parties with appropriate intention for use of the data, starting 07/01/2028, with access to PHI-free data.

Locations

BR (1)