Hybrid Approach to Unilateral vs. Bilateral Upper Limb Rehabilitation in Subacute and Chronic Stroke
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change in Fugl-Meyer Assessment (FMA)
研究概览
简要总结
In the unilateral vs. bilateral hybrid rehabilitation trials, we will conduct two separate clinical trials: one to recruit subacute stroke patients and another to recruit chronic stroke patients. The two trials will have identical study designs and interventions. The overall goal of this research project is to provide scientific evidence of the treatment effects of unilateral and bilateral hybrid therapies in subacute and chronic stroke patients and thus to contribute to evidence-based stroke rehabilitation and translational research for neurorehabilitation.
详细描述
The first aim of the project will be to compare treatment effects between hybrid rehabilitation and conventional rehabilitations (CR) on motor function, daily functions, mobility, quality of life, and kinematic variables. We hypothesize that patients receiving hybrid rehabilitation will gain more recovery than patients receiving CR in proximal (e.g., motor function) and in distal outcomes (e.g., quality of life) and that patients in the hybrid rehabilitation groups will show more genuine upper extremity motor recovery than those in conventional rehabilitation groups, as indicated by kinematic measures.
The second aim will be to examine the comparative treatment effects between unilateral hybrid and bilateral hybrid rehabilitation on various aspects of outcomes. We hypothesize that the unilateral group will improve more on outcomes associated with distal upper limb (UL) control and that the bilateral rehabilitation group will improve more on outcomes associated with proximal UL control.
Third, we will collect biomarker indexes before and after the interventions to monitor the changes of oxidative stress and inflammatory levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1 to 6 months onset from a first-ever unilateral stroke for the subacute randomized controlled trial (RCT), and more then 6 months after onset for the chronic RCT
- •minimal motor criteria to receive CIT (i.e., ≥10º wrist extension and ≥ 10º extension at the thumb and any two other digits)
- •an initial FMA-UE score of 18 to 56, indicating mild to moderate and moderate to severe upper extremity motor impairment
- •no excessive spasticity in any of the joints of the affected arm (shoulder, elbow, wrist, and fingers)
- •able to follow instructions and perform the study tasks (Mini Mental State Examination ≥ 24)
- •without upper extremity fracture within 3 months
- •no participation in any rehabilitation experiments or drug studies during the study period
- •willing to provide written informed consent
排除标准
- •acute inflammatory disease
- •major health problems or poor physical condition that might limit participation
研究组 & 干预措施
Unilateral Hybrid (InMotion3 plus CIT) Intervention
Participants will receive 3 weeks of robot-assisted therapy (RT) using the InMotion3 Wrist Robot, followed by 3 weeks of CIT training.
干预措施: Unilateral Hybrid (InMotion3 plus CIT) Intervention (Behavioral)
Bilateral Hybrid (BMT plus BAT) Intervention
Participants in this bilateral treatment group will receive 3 weeks of RT using the Bi-Manu-Track (BMT) robot (Reha-Stim Co., Berlin, Germany), followed by 3 weeks of therapist-based BAT.
干预措施: Bilateral Hybrid (BMT plus BAT) Intervention (Behavioral)
Conventional Rehabilitation (CR)
The CR intervention will be designed to match the duration and intensity of the hybrid interventions.
干预措施: Conventional Rehabilitation (Behavioral)
结局指标
主要结局
Change in Fugl-Meyer Assessment (FMA)
时间窗: Baseline, 3 weeks, 6 weeks, and 18 weeks
The upper-extremity subscale of the FMA will be used to assess motor impairment. The 33 upper limb items measure the movement and reflexes of the shoulder/elbow/forearm, wrist, hand, and coordination/speed. They are scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully). The maximum score is 66, indicating optimal recovery. The sub-score of a proximal shoulder/elbow (FMA s/e: 0-42) and a distal hand/wrist (FMA h/w: 0-24) will be also calculated to investigate the treatment effects on separate upper extremity elements. The reliability, validity, and responsiveness of the FMA in stroke patients have been shown to be good.
Change in Wolf Motor Function Test (WMFT)
时间窗: Baseline, 3 weeks, 6 weeks, and 18 weeks
The WMFT was originally designed to assess the effects of CIT on the return of arm function for stroke and traumatic brain injury. The assessment requires the participant to perform 15 function-based and 2 strength-based tasks. The tasks are averaged to produce a score in seconds that ranges from 0 to 120 seconds. For functional ability scoring, we used a 6-point ordinal scale where 0 indicates "does not attempt with the involved arm" and 5 indicates "arm does participate; movement appears to be normal." The clinimetrics of the WMFT has been ascertained in stroke patients.
次要结局
- Change in Functional Independence Measure (FIM)(Baseline, 3 weeks, 6 weeks, and 18 weeks)
- Change in Motor Activity Log (MAL)(Baseline, 3 weeks, 6 weeks, and 18 weeks)
- Change in Physiologic Response Measures (Biomarkers)(Baseline, 3 weeks, 6 weeks, and 18 weeks)
- Change in MyotonPro(Baseline, 3 weeks, 6 weeks, and 18 weeks)
- Change in 10-Meter Walk Test (10MWT)(Baseline, 3 weeks, 6 weeks, and 18 weeks)
- Change in Actigraphy(Baseline, 3 weeks, 6 weeks, and 18 weeks)
- Change in Stroke Impact Scale Version 3.0 (SIS 3.0)(Baseline, 3 weeks, 6 weeks, and 18 weeks)
- Change in Kinematic analysis(Baseline, 3 weeks, 6 weeks, and 18 weeks)
- Change in ABILHAND Questionnaire(Baseline, 3 weeks, 6 weeks, and 18 weeks)
- Change in Nottingham Extended Activities of Daily Living Scale (NEADL)(Baseline, 3 weeks, 6 weeks, and 18 weeks)