Evaluation of Robotic Upper Extremity Neuro-Rehabilitation
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Upper limb Motor Status Score, Wolf Motor Function Test, Motor Power Assessment, and Fugl-Meyer Upper Extremity Motor Performance Test
研究概览
简要总结
We have established the feasibility and effectiveness of robot-aided rehabilitation in stroke patients using a robot for neurological rehabilitation designed and built by MIT. Results of a pilot study of 20 patients were promising and showed that robot therapy is safe, tolerated by patients and produces a significant, measurable benefit. We propose to test that the robotic upper extremity trainer is an acceptable cost effective adjunct to standard occupational therapy for patients with dysfunction of the shoulder and elbow due to hemiparetic stroke in a VA rehabilitation program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (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
- •Chronic Stroke
- •Manual Muscle Score of Grade 3 or lower in at least one muscle of the affected arm
排除标准
- •Acute Stroke
- •Contracture or orthopedic problems limiting the movement of the affected arm
- •Visual deficit such that the participant cannot see the test pattern on the robot trainer
- •Serious complicating medical illness
- •Botox treatment to the involved arm within three months of enrollment
结局指标
主要结局
Upper limb Motor Status Score, Wolf Motor Function Test, Motor Power Assessment, and Fugl-Meyer Upper Extremity Motor Performance Test
时间窗: The Primary Outcome measures were performed at baseline, after completion of 18 sessions of intervention and at 3 months follow-up.
次要结局
未报告次要终点