Impact of Non-invasive Brain Stimulation, Associated With Upper Limb Robot-assisted Therapy, on Motor Recuperation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 3
- 主要终点
- Upper Limb Kinematics
研究概览
简要总结
tDCS (transcranial direct current stimulation) and robot assisted therapy (RAT) will be used in chronic stroke patients to improve a variety of functions with upper limb.
详细描述
tDCS and RAT will be used in chronic stroke patients to improve a variety of functions such as motor functions with upper limb.
tDCS will be applied in a placebo-controlled, double-blind, randomised fashion. A session of RAT will be associated with tDCS/placebo. Behavioural data will be collected before and after tDCS, associated with RAT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stroke with at least slight deficit in upper limb
排除标准
- •contraindication to tDCS
- •presence of metal in the head
- •inability to understand/complete behavioural tasks
- •chronic intake of alcohol or recreative drugs
- •major health condition (e.g. terminal renal failure, instable heart failure etc ...)
- •pregnancy
研究组 & 干预措施
Real stimulation
real tDCS associated with robot-assisted therapy (RAT)
干预措施: tDCS (ELDITH) and RAT (REAplan) (Device)
Sham stimulation
Sham tDCS associated with RAT
干预措施: tDCS (ELDITH) and RAT (REAplan) (Device)
结局指标
主要结局
Upper Limb Kinematics
时间窗: kinematic assessment of the upper limb at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT)
次要结局
- Box and Block test(Manual dexterity assessment at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT))
- Purdue Pegboard Test(Digital dexterity assessment at Baseline (>6 months after stroke), immediately after intervention (20min of tDCS+RAT))