An Innovative Home Stroke Rehabilitation and Monitoring System
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 99
- 试验地点
- 4
- 主要终点
- Action Research Arm Test (ARAT)
研究概览
简要总结
The purpose of this research is to evaluate a therapy delivery system for stroke patients that provide accessible, affordable stroke care. User-friendly home therapy robots and a telerehabilitation system are combined to monitor and provide therapy that is accessible for patients in rural and underserved locations. The robotic-based home therapy intervention will produce significantly greater improvement in upper extremity motor function than Usual and Customary Care enhanced with a (non-robotic) home therapy upper extremity rehabilitation program at the end of 8 weeks of home therapy.
详细描述
The primary purpose of this proposal is to evaluate a combined clinic/home robotic-based stroke therapy delivery and monitoring system in rural and underserved locations that provides accessible, effective and affordable care for stroke survivors with residual limb impairment. The study is a prospective, single-blind, multi-site Randomized Controlled Trial. A total of 96 patients within 6 months post-stroke will be enrolled and randomly assigned to one of two groups: robotic based home therapy or a self administered (non-robotic) home therapy 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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral ischemic or hemorrhagic stroke
- •within 6 months of admission to in-patient rehabilitation
- •Persistent hemiparesis
- •Proximal Upper Extremity voluntary activity
- •Preserved cognitive function
- •Difficult access to an organized stroke rehabilitation program
排除标准
- •Not independent before stroke
- •Hemispatial neglect
- •Significant other illnesses
结局指标
主要结局
Action Research Arm Test (ARAT)
时间窗: End of treatment at 8 weeks post enrolment
The amount of recovery of arm-hand function is measured with the Action Research Arm Test (ARAT). The ARAT assesses activity limitations of the upper extremity. It includes 19 items divided into four subscales: grasp, grip, pinch, and gross movement. Scores range from 0-to-57 with a higher score indicating a better outcome.
次要结局
- Wolf Motor Function Test(End of treatment at 8 weeks post enrolment)
- Fugl-Meyer Upper Extremity Test(End of Treatment at 8 weeks post enrolment)
- Stroke Impact Scale (SIS)(End of treatment at 8 weeks post enrolment)