Medical and Economical Evaluation of Upper Limb's Rehabilitation Robotics After a Stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 46
- 主要终点
- Fugl Meyer upper limb motor score
研究概览
简要总结
Upper limb motor control after a stroke may be improved with rehabilitation robotics at a subacute stage. The aim of this multicenter controled randomized single blind study is to define the place of rehabilitation robotics at this phase of the rehabilitation process. Both groups will realize the same time of rehabilitation. The cost benefit ratio will be compared in each group through medical assessment of improvement and definition of the costs due to the rehabilitation process.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ischemic or hemorrhagic stroke of the middle cerebral arteria territory
- •18 to 80 years old
- •stroke onset between 3 weeks to 3 months,with or without aphasia, with or without lateral neglect and homonymous hemianopia, with or without visual neglect
- •10<or= Fugl Meyer upper limb Score <or= 40
- •upper limbs pain less or equal than 3/10 (VAS)
- •inpatient or outpatient rehabilitation
- •signed inform consent
排除标准
- •ischemic or hemorrhagic stroke of anterior or posterior cerebral artery
- •ischemic or hemorrhagic stroke of the brainstem
- •major aphasia evaluated by a Boston Diagnostic Aphasia Examination (BDAE) score less or equal to 3
- •asthenia not allowing to work 60 minutes with the robot.
- •serious visual deficiency not allowing to use the robot
- •impossibility to install the arm on the robot because of a serious and uncontrolled spasticity or for any other reason
- •pronounced and constant muscular contractures, or deformation affecting the use of the extremity
- •upper limb's pain superior to 3/10 and/or being worse at the active and passive mobilization
- •serious infection and/or instability of vital functions
- •perfusion of the affected upper limb not removable
- •incapacity to stay on a chair
- •contraindicated sitting position
- •permanent deviation of the head and\or of the eyes
- •perturbed or non-cooperative patient
- •patients that must have to be isolated due to an infection process
- •bone fracture of the paretic limb with an onset less than 3 months stabilized or not
研究组 & 干预措施
Rehabilitation robotics
Subjects will be practicing an Armeo Spring rehabilitation program in addition to their usual care (1.5h/day,5d/week) 1h/day 5d/week 4 weeks.
干预措施: ARMEO Spring (Device)
Self-rehabilitation
Subject will associated to there classical care 1 hours, 5 days per week during 4 weeks, of self rehabilitation.
干预措施: Self rehabilitation (Other)
Healthy volunteer
20 healthy volunteer will be recruiting and using ARMEO Spring. All volunteer will repeat 5 times the same program on the medical device.
干预措施: ARMEO Spring (Device)
结局指标
主要结局
Fugl Meyer upper limb motor score
时间窗: Day 30
Increase of the Fugl Meyer score between day 0 and day 30 with a difference between groups by at least 4 points
次要结局
- Stroke impact scale (SIS)(One year)
- Visual analog scale (VAS)(Day 7,14,21,30, 90,180, 360)
- Modification of motor control(Day 30)
- Costs(One year)