Telerehabilitation and Biomarkers of Recovery After Stroke in Brazil

This is a two-arm phase II randomized controlled trial with blinded outcome assessment. A total of 20 post-stroke participants will be randomized to either telerehabilitation added to usual care (TR+UC) or usual care alone (UC). The primary outcome measure is the Action Research Arm Test (ARAT), which assesses upper extremity motor function. Secondary measures will include feasibility and intervention-related outcomes.

Study participation will span approximately 4 months and includes 6 in-person assessment visits. At these visits, participants will complete a battery of assessments, including upper extremity motor function tests, resting-state functional electroencephalography (EEG), and a single magnetic resonance imaging (MRI) scan of the brain. Participants assigned to the TR+UC group will receive structured arm motor training consisting of 36 sessions of prescribed exercises, interactive games, and stroke education delivered over 6 weeks at a frequency of 6 days per week, with each session lasting approximately 70 minutes. TR+UC participants will continue all usual care concurrently. Participants in the UC group will continue all therapies recommended by their medical team without participating in telerehabilitation.

Inclusion criteria

• 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).

Exclusion criteria

• 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.
• Contraindication to MRI.
• Contraindication to TMS.
• Box and Block Test score of ≥30 blocks with the unaffected arm within 60 seconds at Baseline Visit;
• Spatial neglect interfering with reasonable participation in the study;
• On isolation precautions, e.g., due to active COVID-19.
• Expectation that participant will not have a single domicile address during the 6 weeks of therapy.
• Distance from the participant's home to the study site greater than 120 km [this can be waived at the discretion of the PI].

• Availability of a 2 m² space for a table and chair setup.