Rehabilitation Program With Robotic Assistance for the Improvement of Motor Performance and Functional Use of the Upper Limb in Subacute Hemiparetic. Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Functional performance score change on Modified Frenchay Scale
研究概览
简要总结
Hemiparesis is the most common motor disorder after a stroke. Most patients do not recover functional use of their paretic upper limb.
The use of robotic assistance provides intensive motor training through a large number of repetitive movements, usually oriented and interactive tasks (pointing tasks, tracking paths tasks...). These feature have been demonstrated to be critical to stimulate brain plasticity after a brain damage. The InMotion Arm 2.0 manipulator works with an adaptive algorithm that provide patients with real-time Assistance-as-Needed™ desgned to enhance motor performance.
Hypothesis: In the sub-acute phase of stroke, the structured practice of a large number of repeated movements will increase motor function of the upper limb compared to conventional rehabilitation. Secondly, this practice will be more effective in a free active mode (without assistance) than an active assisted mode (Assistance-as-Needed™).
Expected secondary benefits: Subjective impression of improved use of the upper limb in activities of daily living and reduction of spastic cocontractions affecting the agonist and antagonist muscles during movements of the upper limb.
Objectives: This randomized controlled trial will evaluate the effects of structured repetition programs of arm movements, on the function of the hemiparetic upper limb and motor control, between 4 and 10 weeks after the stroke, using a robotic device with or without assistance in partial substitution of conventional rehabilitation care, compared to a program with conventional care 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years;
- •Stroke hemiparesis on unilateral focal lesion dating from 4 to 10 weeks at baseline;
- •Active flexion of the paretic shoulder ≥15 °;
- •Average score on the modified scale of Frenchay <5;
- •Patient having agreed to sign an informed consent.
排除标准
- •Passive extension of the paretic elbow <120 °;
- •Passive extension of the paretic wrist <10 °;
- •Cognitive dysfunction or progressive intercurrent illness making effective communication or participation in the study impossible;
- •Infection, inflammation or complex regional pain syndrome of the paretic upper extremity;
- •Injection of botulinum toxin to the upper limb less than 3 months old;
- •Patient under safeguard of justice;
- •Patient include in an other clinical trial.
结局指标
主要结局
Functional performance score change on Modified Frenchay Scale
时间窗: Between the pre-rehabilitation state on the day of program start (Day1) and the state at the end of the program (Week6)
The scale measures active upper limb function in hemiparesis based on 10 everyday living tasks, each rated on a 10-point visual analogic scale. Six tasks are bimanual and four are unimanual performed with the paretic hand. Final score is an average of the 10 subscores (10 is the higher score).
次要结局
- Functional performance score change on Modified Frenchay Scale(between Day1 (day of program start) and Week22 (16 weeks after the end of the program))
- Change of motor performance score on the Fugl-Meyer score(between Day1(day of program start), Week6(end of the program) and Week22 (16 weeks after the end of the program))