Robotic Therapy and Transcranial Direct Current Stimulation in Patients With Stroke (ROTS)
研究概览
详细说明
Our main goal is to confirm the safety of robotic therapy associated with active tDCS and conventional therapy, compared to robotic therapy associated with sham tDCS and to conventional therapy, and to conventional therapy alone, for upper limb rehabilitation in an early phase (3-9 weeks) after stroke. Patients will be randomized to receive one of these three treatments, 3 times per week, for 6 weeks.
Data about eventual adverse effect will be collected in each session of treatment. The working hypothesis is that robotic therapy associated with active tDCS and conventional therapy will be as safe as robotic therapy associated with conventional therapy, and as conventional therapy alone.
We will aso preliminarily evaluate the efficacy of robotic therapy associated with active tDCS and conventional therapy, compared to robotic therapy associated with sham tDCS and to conventional therapy alone, in improvement of upper limb motor impairment.
Our secondary goals are: 1) To evaluate safety and upper limb motor impairments in patients submitted to each of the three interventions, 6 months after end of treatment; 2) To compare effects of the abovementioned interventions on disability, spasticity and quality of life, in patients at an early stage after stroke, immediately after treatment and 6 months later.
The working hypothesis is that the association of robotic therapy, tDCS and conventional therapy will lead to better outcomes than robotic therapy and conventional therapy, or conventional therapy alone.
Patients will be assessed before the first session and after the last session of treatment, as well as 6 months after the last session of treatment.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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SP
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São Paulo、SP、巴西、05403900
- Hospital das Clínicas
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Ischemic or hemorrhagic stroke onset 3 - 9 weeks before the recruiting, confirmed by computed tomography or magnetic resonance imaging.
- Moderate to severe motor impairment of an upper limb, defined as a score between 7 - 42 on the Upper Limb Subscale of Fugl Meyer Assessment of Sensorimotor Recovery after stroke.
- Ability to provide written informed consent (patient ou legal representative)
- Ability to comply with the schedule of interventions and evaluations in the protocol.
Exclusion Criteria:
- Severe spasticity at the paretic elbow, wrist or fingers, defined as a score of > 3 on the Modified Ashworth Spasticity Scale.
- Upper limb plegia
- Uncontrolled medical problems such as end-stage cancer or renal disease
- Pregnancy
- Seizures, except for a single seizure during the first week post stroke
- Pacemakers
- Other neurological disorders such as Parkinson's disease
- Psychiatric illness including severe depression
- Aphasia ou severe cognitive deficits that compromise comprehension of the experimental protocol or ability to provide consent.
- Hemineglect
- Drugs that interfere on cortical excitability, except for antidepressants
- Cerebellar lesions
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Active tDCS + robotic therapy + physical therapy
Active tDCS (transcranial direct current stimulation) will be applied prior to the robotic training. After robot training, the patient will receive physical therapy for 40 minutes. Number of treatment sessions: 18 (3 times a week, for 6 weeks). |
机器人疗法（麻省理工学院 - Manus，Interactive Motion Technologies）将对麻痹上肢进行 40 分钟。
Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).
Physical therapy will be administered for 40 minutes.
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有源比较器：sham tDCS + robotic therapy + physical therapy
Sham tDCS (transcranial direct current stimulation) will be applied prior to robotic training. After robot training, the patient will receive physical therapy for 40 minutes. Number of treatment sessions: 18 (3 times a week, for 6 weeks). |
机器人疗法（麻省理工学院 - Manus，Interactive Motion Technologies）将对麻痹上肢进行 40 分钟。
Physical therapy will be administered for 40 minutes.
In sham tDCS, no current will be delivered through the tDCS device.
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实验性的：sham tDCS + physical therapy + occupational therapy
Sham tDCS (transcranial direct current stimulation) will be applied prior to conventional therapy (40 minutes of physical therapy and 40 minutes of occupational therapy) Number of treatment sessions: 18 (3 times a week, for 6 weeks).
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Physical therapy will be administered for 40 minutes.
In sham tDCS, no current will be delivered through the tDCS device.
Occupational therapy will be administered for 40 minutes.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Upper Extremity Fugl Meyer Assessment
大体时间：6 weeks from baseline
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Change in Motor function subscale was assessed.
Scores range from 0 to 66. Lower scores indicate greater severity.
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6 weeks from baseline
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Percentage of Sessions With Adverse Events
大体时间：Post treatment (6 weeks from baseline).
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Post treatment (6 weeks from baseline).
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Modified Rankin Scale
大体时间：6 weeks from baseline
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Scores range from 0 to 6. Higher scores indicate greater severity.
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6 weeks from baseline
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Change in National Institutes of Health Stroke Scale
大体时间：6 weeks from baseline
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Scores range from 0 to 42.
Higher scores indicate greater severity.
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6 weeks from baseline
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Change in Stroke Impact Scale
大体时间：6 weeks from baseline
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Scores in each domain of the Stroke Impact Scale range from 0 to 100, with higher scores indicating a better quality of life.
The change was calculated as the value at the later time point minus the value at the earlier time point; so that, positive numbers represent increases and negative numbers represent decreases.
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6 weeks from baseline
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Number of Participants Who Presented Score on Modified Ashworth Scale >2
大体时间：6 weeks
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Scores range from 0 to 4, with 5 choices.
A score of 1 indicates no resistance, and 4 indicates rigidity.
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6 weeks
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Change in Motor Activity Log
大体时间：6 weeks from baseline
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Each domain contains taks scored on 0 to 5 ordinal scale.
Lower scores indicate greater severity.
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6 weeks from baseline
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Upper Extremity Fugl Meyer Assessment
大体时间：6 months follow-up
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Motor function subscale was assessed.
Scores range from 0 to 66. Lower scores indicate greater severity.
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6 months follow-up
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Number of Participants With Adverse Events
大体时间：6 months follow-up
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6 months follow-up
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Change in Fatigue Severity Scale
大体时间：6 weeks from baseline
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Fatigue Severity Scale is a 9 -item questionnaire. Each item scores on a 7-point scale. The total score range from 9 to 63 points. Higher scores indicate greater fatigue. |
6 weeks from baseline
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Change in Pittsburgh Sleep Quality Index
大体时间：6 weeks from baseline
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The global Pittsburgh Sleep Quality Index score is calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21. Lower scores denote a healthier sleep quality.
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6 weeks from baseline
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合作者和调查者
调查人员
- 首席研究员：Adriana B Conforto, MD Phd、University of Sao Paulo
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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