Telerehabilitation and Biomarkers of Recovery After Stroke in Brazil

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Telerehabilitation
  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.
• Другое Usual Care
  Usual care rehabilitation refers to the recommendations made by their care team.

Первичные конечные точки

• Change in Action Research Arm Test (ARAT) Score from baseline to the early post-intervention. [Срок оценки: From baseline to early (within 7 days) post-intervention]
• Study feasibility in the Brazilian context - recruitment. [Срок оценки: Through recruitment completion - an average of 15 months]
• Study feasibility in the Brazilian context - adherence. [Срок оценки: Through study completion (specifically end of therapy) - an average of 17 months]
• Study feasibility in the Brazilian context - retention. [Срок оценки: Through study completion (specifically end of follow-up) - an average of 18 months]

Вторичные конечные точки (2)

• Change in Action Research Arm Test (ARAT) Score from baseline to 1 month post-intervention. [Срок оценки: From baseline to 1 month post-intervention]
• Treatment-related adverse events reported by the participants. [Срок оценки: From the start of TR to early (within 7 days) post-intervention]

Критерии участия

Критерии включения

• 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).

Критерии исключения

• 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 \[this can be waived at the discretion of the PI\].

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бразилия · 1 центр

• Ribeirão Preto Medical School, University of São Paulo — Ribeirão Preto

Идентификаторы

NCT: NCT07646522 · 90571225.4.0000.5440 · 2025/10298-4

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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