Robotic Therapy and Transcranial Direct Current Stimulation in Patients With Stroke
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Percentage of Sessions With Adverse Events
研究概览
简要总结
Stroke is the second cause of death worldwide and represented the first cause of death in Brazil between 2006 and 2010. Most patients survive, and there is a need to develop cost-effective rehabilitation strategies to decrease the burden of disability from stroke. This study addresses this important issue, by combining two different interventions in the early phase post-stroke: robotic therapy associated or not with transcranial direct current stimulation (tDCS), as adjuvant interventions to conventional physical therapy, for motor upper limb rehabilitation.
详细描述
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.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Percentage of Sessions With Adverse Events
时间窗: Post treatment (6 weeks from baseline).
Change in Upper Extremity Fugl Meyer Assessment
时间窗: 6 weeks from baseline
Change in Motor function subscale was assessed. Scores range from 0 to 66. Lower scores indicate greater severity.
次要结局
- Change in National Institutes of Health Stroke Scale(6 weeks from baseline)
- Upper Extremity Fugl Meyer Assessment(6 months follow-up)
- Change in Fatigue Severity Scale(6 weeks from baseline)
- Number of Participants Who Presented Score on Modified Ashworth Scale >2(6 weeks)
- Number of Participants With Adverse Events(6 months follow-up)
- Change in Stroke Impact Scale(6 weeks from baseline)
- Change in Pittsburgh Sleep Quality Index(6 weeks from baseline)
- Change in Modified Rankin Scale(6 weeks from baseline)
- Change in Motor Activity Log(6 weeks from baseline)