Transcranial Direct Current Stimulation Associate to Constraint Induced Movement Therapy Over Premotor Cortex in Severe Stroke
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Functional Independence measured by Barthel Index
研究概览
简要总结
The purpose is to compare the effects of tDCS and constraint induced movement therapy (CIMT) in the premotor cortex vs. primary motor cortex in severely subacute stroke survivors.
详细描述
Stroke survivors experience one or more movement-related impairments and activity limitations. In this sense, the premotor cortex (PMC) can be considered as an alternative locus for post-stroke rehabilitation. In relation to physical rehabilitation protocols, associate to neuromodulation, the investigators have chosen a standardized physical therapy protocol for this study, the Constraint Induced Movement Therapy (CIMT), which presents evidence of good therapeutic results. The investigators hypothesized that applying tDCS and CIMT over the PMC promotes motor restoration in stroke patients.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 65 years
- •Diagnosis of unilateral, non-recurring, subacute stroke
- •Participants also had to be able, by using any method of pinch, to grasp a washcloth from a table top, lift it up a few inches, and release it.
排除标准
- •Patients with difficulty to follow the procedures or understand the instructions; cognitive deficits
- •tDCS criteria:
- •use of modulators of the Central Nervous System drugs
- •patients with implanted metallic or electronic devices
- •pacemaker
- •pregnancy
- •any other condition that might limit or interfere in the sensorimotor system
结局指标
主要结局
Functional Independence measured by Barthel Index
时间窗: Change for functional independence at baseline and week 2
次要结局
- Muscle strength (Medical Research Council Scale)(Baseline and Week 2)
- Spasticity (Modified Ashworth Scale)(Baseline and Week 2)
研究者
Suellen Marinho Andrade
PhD
Federal University of Paraíba