intenSive UpPer Extremity Recovery Program for Chronic Stroke (SUPER)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Change in functional arm movements as assessed by the Fugl Meyer-Upper Extremity Assessment
研究概览
简要总结
The purpose of this study is to Investigate the feasibility of a high-quality, high-dose, high-intensity upper extremity therapy program and to assess the treatment effects of a high-quality, high-dose, high-intensity upper extremity therapy program on functional outcomes, motor impairment, and quality of life
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •Single qualifying stroke event as confirmed by CT or MRI
- •At least 6 months post stroke
- •Fugl-Meyer upper extremity (UE) score of 20-45
- •Able to follow written instructions
- •Able to tolerate 6 hours of therapy a day
排除标准
- •Prior arm injury impacting available passive or active range of motion or significant arm pain with movement
- •Active drug or alcohol abuse
- •Diagnosed with advanced dementia
- •Pre-stroke baseline mRS>3
- •History of clinically significant ischemic or hemorrhagic stroke resulting in prior arm weakness in the same territory as the index stroke
- •Medical instability assessed by the treating stroke physician to participate to the study.
研究组 & 干预措施
Treatment
干预措施: Treatment (Device)
结局指标
主要结局
Change in functional arm movements as assessed by the Fugl Meyer-Upper Extremity Assessment
时间窗: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
This is a 66 item questionnaire and each is scored from 0(cannot perform)-2(performs fully) a higher score indicating better outcome
Change in functional gross and fine motor coordination as assessed by the Action Research Arm Test (ARAT)
时间窗: Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention
This test has 4 subscales and each measures grasp, grip, pinch and gross movement. The Grasp subscale has 6 questions and is scored from 0-18, higher score indicating better outcome The Grip subscale has 4 items and is scored from 0-12, higher score indicating better outcome The Pinch subscale has 6 items and is scored from 0-18, higher score indicating better outcome The Gross movement subscale has 3 items and is scored from 0-9, higher score indicating better outcome
Change in integrity of the contralateral corticospinal tract fibers as assessed by the MRI with Diffusion Tensor Imaging (DTI) evaluation
时间窗: Baseline(1 week prior to intervention),within 1 week after intervention
次要结局
- Change in anxiety as assessed by the Hospital Anxiety and Depression Scale (HADS)(Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention)
- Change in cognitive impairment as measured by the Montreal Cognitive Assessment (MoCA)(Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention)
- Change in performance in activities of daily living as assessed by the Barthel Index (BI)(Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention)
- Change in depression as assessed by the Hospital Anxiety and Depression Scale (HADS)(Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention)
- Change in difficulty to care for the affected arm as assessed by the Arm Activity Measure A(Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention)
- Change in degree of disability as assessed by the Modified Rankin Scale (mRS)(Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention)
- Change in fatigue as assessed by the Neurological Fatigue Index (NFI)(Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention)
- Change in functional ability of the hemiplegic arm and hand to perform meaningful tasks as assessed by the Chedoke Arm and Hand Inventory (CAHAI)(Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention)
- Change in difficulty in completing functional tasks with the affected arm as assessed by the Arm Activity Measure B(Baseline (1 week prior to the intervention), within 1 week after the intervention, 6 weeks after intervention, 6 months after intervention)
研究者
Sean Savitz
Professor
The University of Texas Health Science Center, Houston