Transcranial Direct Current Stimulation and Robotic Therapy in Upper Limb Motor Recovery After Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection)
研究概览
简要总结
The objective of the study is to evaluate the effectiveness of transcranial direct current stimulation (tDCS) integrated with wrist robot-assisted treatment. In detail, the anodal stimulation on the impaired hemisphere will be used associated with a robotic treatment.
详细描述
As for transcranial direct current stimulation a HDC kit (ATES/EB NEURO, Firenze, Italy) will be used as device. It is a new device generation of stimulator able to provide an effective stimulation pattern.
As robotic device the InMotion wrist robot (Interactive Motion Technologies Inc., Watertown, MA, USA) will be used. It is an end-effector robotic device able to assist as needed the wrist movements.
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
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •persons affected by first supratentorial stroke, whose onset time is 25±7 days;
- •upper limb hemiparesis;
- •cognitive and speech abilities sufficient to understand instructions and to provide informed consent;
- •absence of intense pain due to passive wrist mobilization assessed by VAS < 3 (range 0-10);
- •ability to provide written informed consent.
排除标准
- •previous epilepsy seizures;
- •severe electroencephalographic anomalies;
- •previous neurosurgery interventions involving metallic elements placement;
- •ongoing anticonvulsant drugs treatment
- •inability to keep sitting posture;
- •severe sensory deficits;
- •general clinical complication preventing delivery of rehabilitation treatment.
结局指标
主要结局
Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection)
时间窗: 6 weeks
Impairment level measure according to ICF
次要结局
- Change from Baseline in the motor impairment as assessed by the Fugl-Meyer Motor Assessment Scale (upper extremity subsection)(6 months)
- Change from Baseline in the upper limb functional and motor abilities as assessed by the Motricity Index(6 months)
- Change from Baseline in the upper limb spasticity as assessed by the Modified Ashworth Scale(6 months)
- Change from Baseline in the unilateral gross manual dexterity as assessed by the Block and Box test(6 months)
研究者
federico posteraro
Medical Doctor
Auxilium Vitae Volterra