Functional Recovery in Stroke Patients With Task-Specific Robot-Aided Arm Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Fugl Meyer Assessment Scale
研究概览
简要总结
The goal of this study is to determine whether task-oriented, robot-aided therapy is more effective than conventional physical and occupational therapy at promoting functional recovery of the affected arm in chronic hemiparetic stroke patients.
详细描述
Robotic therapy will be performed with ARMin, which is a robotic arm exoskeleton that permits 3D movements of both proximal and distal arm joints. Combined with an audiovisual display, this device allows virtual training of Activities of Daily Living (ADL) and therapeutic gaming. A patient-responsive controller enables the assistance of the device only as needed. Chronic stroke patients (>6 months post stroke) will be randomly assigned to either an experimental or a control group. The experimental group will perform task-related intensive therapy with the support of ARMin. Therapists will treat the patients of the control group with standard motor relearning therapy.
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
- Double (Investigator, 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
- •Age 18 or more
- •first-ever stroke (hemorrhagic or ischemic), verified by brain imaging
- •stroke more than six months prior to the study
- •termination of conventional therapy and stable recovery stage (outpatients)
- •moderate to severe motor impairment of the arm (upper limb portion of FMA score between 8 and 38)
- •ability to sit in a chair without any additional support and without leaning on the back rest
- •written informed consent signed by the subject (or an authorized representative)
排除标准
- •Excessive spasticity of the affected arm (mAS ≥ 3)
- •any serious medical or psychiatric illness
- •participation in any clinical investigation within 4 weeks prior to the start of this study
- •anticipated need for any major surgery during the study
- •women known to be pregnant or lactating
- •Orthopedic, rheumatologic or other disease restricting movements of the paralyzed upper extremity
- •shoulder subluxation (palpatory > 2 fingers)
- •diseased or damaged skin at the paralyzed arm
- •inability to communicate effectively with the neurological examiner such that the validity of the patient's data could be compromised
- •cyber sickness
- •pace-maker or other implanted electric devices
- •body weight > 120kg
- •serious cognitive deficits and aphasia preventing the performance of the ARMin treatment
- •participation in any therapeutic treatment ("outside therapy") performed with the paralyzed arm during the planned study - including baseline and follow up.
研究组 & 干预措施
1
干预措施: robot therapy (ARMin) (Device)
2
干预措施: conventional therapy (Other)
结局指标
主要结局
Fugl Meyer Assessment Scale
时间窗: four and one weeks prior to intervention, four weeks after intervention started, at the end of intervention(eight weeks), two months and six months follow-up
次要结局
- Wolf Motor Function Test, Stroke Impact Scale, Motor Activity Log, modified Ashworth Scale, abnormal joint synergies, active range of motion (ROM), muscle strength, and spatial precision of hand positioning.(three and one weeks prior to intervention, four weeks after intervention started, at the end of intervention(eight weeks), two months and six months follow-up)
- fMRI(before and after 8 weeks therapy, 2-months follow-up)