Telerehabilitation and Biomarkers of Functional Recovery After Stroke in Brazil: TR-BR-1 Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Statistician.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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-
- •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.
研究组 & 干预措施
Usual Care
Participants in the usual care group will receive no TR, but will continue with the recommendations made by their care team.
干预措施: Usual Care (Other)
Telerehabilitation + Usual Care
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.
干预措施: Telerehabilitation (Device)
Telerehabilitation + Usual Care
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.
干预措施: Usual Care (Other)
研究者
Taiza G. S. Edwards, PhD
Professor
University of Sao Paulo