Evaluation of Robotic Arm Rehabilitation in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment
研究概览
简要总结
The purpose of this study is to compare 2 training programs using robotic exercise devices to supervised arm exercises in stroke patients with chronic stable deficits.
详细描述
A robotic exercise device has been developed(MIT-MANUS)capable of providing therapy to the arm for patients with weakness due to stroke. The randomized trial will compare conventional care, planar robot intervention and an intervention of planar and vertical robot training among patients with chronic, stable deficits. We will evaluate motor outcomes, effectiveness, cost, patient satisfaction and quality of life. The study will determine the efficacy of upper extremity robot therapy compared to supervised self-administered exercise therapy in patients with deficits due to stroke.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects must have a clinically, defined, unilateral, hemiparetic stroke with radiologic exclusion of other diagnoses
- •Stroke onset greater than six months before randomization for ischemic stroke patients and one year before randomization for hemorrhagic stroke patients
- •A grade 3 or lower in Manual Muscle Test in the hemiparetic elbow flexion and shoulder abduction
排除标准
- •Subjects unable to give informed consent
- •Serious complicating medical illness
- •Contracture or orthopedic problems limiting the range of joint movement in the study arm
- •Visual loss
- •Stroke occurred within 6 months for ischemic stroke patients, one year for hemorrhagic patients
- •Botox treatment within 3 months of enrollment
结局指标
主要结局
Upper Extremity Portion of the Fugl-Meyer Motor Performance Assessment
时间窗: Baseline to Final Training (6 weeks)
The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia (Fugl-Meyer, Jaasko, Leyman, Olsson, \& Steglind, 1975; Gladstone, Danells, \& Black, 2002). Sections can be administered separately and the upper extremity motor portion of this measure was used as our primary outcome. Assessment items included movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. These items were scored on the basis of ability to complete using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. The total possible score for the upper extremity is 66 with a minimum range of 0 and maximum of 66. A higher score indicates a better outcome.
次要结局
未报告次要终点