Effects of Robotic Therapy and Transcranial Direct Current Stimulation on Motor Performance of the Paretic Upper Limb in the Early Phase After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Movement Smoothness
研究概览
简要总结
Stroke is the second cause of death worldwide and the majority of the survivors remain with motor impairments. Inhibition of the motor cortex of the unaffected hemisphere has emerged as a potential intervention to enhance effects of other rehabilitation strategies on improvement of motor performance of the paretic upper limb. In this proof-of-concept study we will evaluate the effects of inhibition of the motor cortex of the unaffected hemisphere associated with robotic therapy on improvement of motor performance of the paretic upper limb in the early phase post-stroke.
详细描述
The main goal of this study is to test the proof of concept of benefits of inhibition of the motor cortex of the unaffected hemisphere on learning evaluated by improvement in kinematics of motor performance, in patients with upper limb paresis in the early phase post-stroke. For this purpose, patients will be randomized to receive real or sham transcranial direct current stimulation before a session of robotic therapy. Data will be collected by kinematic assessment performed automatically by the robot at baseline, immediately after and 24h after the intervention.
The working hypothesis is that one session of upper limb motor training will lead to improvement of performance in metrics of kinematics, and this improvement will be maintained up to 24h after the end of the training.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Ischemic or hemorrhagic stroke onset from 3 days to 9 weeks before, confirmed by computed tomography or magnetic resonance imaging.
- •Motor impairment of an upper limb, defined as a score between 1 - 3 in the Medical Research Council Scale, for at lest one the following movements: elbow extension, shoulder flexion, or shoulder extension.
- •Ability to provide written informed consent.
- •Ability to comply with the schedule of interventions and evaluations in the protocol.
排除标准
- •Severe spasticity at the paretic elbow, wrist or fingers, defined as a score of > 3 in the Modified Ashworth Spasticity Scale.
- •No active shoulder and elbow movements
- •Uncontrolled medical problems such as end-stage cancer or renal disease
- •Potential contraindications to transcranial direct current stimulation: history of seizures, lesions on the scalp, intracranial metal implants, prior intracranial surgery, use of drugs that interfere on cortical excitability (such as antiepileptic drugs, benzodiazepines)
- •Other neurological disorders such as Parkinson's disease
- •Psychiatric illness
- •Aphasia or severe cognitive deficits that compromise comprehension of the experimental protocol or ability to provide consent.
- •Hemineglect
- •Cerebellar lesions or on cerebellar pathways
- •Contact precautions
结局指标
主要结局
Movement Smoothness
时间窗: Kinematic assessment at baseline, immediately after intervention; and 24h after.
The speed shape, calculated as mean speed divided by peak speed.
次要结局
- Number of peaks of the movement(kinematic assessment at baseline, immediately after intervention; and 24h after.)
- Jerk metric of the movement(kinematic assessment at baseline, immediately after intervention; and 24h after)