Synergistic Bilateral Upper-Limb Stroke Rehabilitation Based on Robotic Priming Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 6
- 主要终点
- Change from Baseline ABILHAND Questionnaire at 6 weeks, and 18 weeks
研究概览
简要总结
This comparative efficacy study will be based on a 3-armed controlled trial: bilateral robotic priming combined with bilateral arm training (bilateral RT+BAT), bilateral robotic priming combined with mirror therapy (bilateral RT+MT), and the control intervention (bilateral RT+IOT). The goal of this 4-year project is to provide scientific evidence of the comparative efficacy research of hybrid interventions based on unilateral vs. bilateral approach to upper limb rehabilitation in subacute and chronic stroke.
详细描述
This proposed research fits in the NHRI research priority 4-1 by addressing innovative treatment strategies for stroke that is in desperate need of scientific scrutiny. Stroke is one of the major medical conditions that lead to long-term disability and causes heavy health care and financial burden. Advances in clinical and translational neurosciences have led to the new development of stroke rehabilitation. Current stroke rehabilitation programs such as robotic therapy, mirror therapy, and bilateral arm training are bilateral approaches to intensive practice based on the tenet of practice-dependent neuroplasticity. Bilateral robotic therapy can potentially be a movement-based priming technique to promote rebalancing of cortical excitability and create an enriched neuroplastic environment by priming the brain to facilitate motor and functional recovery. This proposed research project will: (1) examine the effects of bilateral robotic priming combined with bilateral arm training approach versus bilateral robotic priming combined with mirror therapy, relative to the control intervention approach (bilateral robotic priming combined with impairment-oriented training) on sensorimotor function, daily function, self-efficacy, quality of life, and motor control strategy in patients with stroke, (2) investigate the 3-month retention effects of robotic priming combined with contemporary rehabilitation approaches (i.e., bilateral arm training and mirror therapy) and the control intervention, and (3) identify the potential predictors of functionally relevant changes after therapy.
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
- Single (Outcomes Assessor)
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
- •(1) ⩾3 months onset from a first-ever unilateral stroke; (2) age range from 18 to 80 years; (3) baseline upper extremity motor score on the Fugl-Meyer Assessment >10 (Fugl-Meyer et al., 1975); (4) no severe spasticity in any joints of the affected arm (Modified Ashworth Scale ⩽ 3) (Charalambous, 2014); (5) able to follow study instructions (Mini Mental State Examination Score ⩾24) (Skidmore et al., 2010); (6) no serious vision deficits and no other neurologic or major orthopedic diseases; (7) able to participate in a rehabilitation intervention program for 6 weeks; and (8) no participation in other studies during the study period and willing to provide written informed consent.
排除标准
- •(1) acute inflammation and (2) major medical problems or poor physical conditions that might interfere with participation.
结局指标
主要结局
Change from Baseline ABILHAND Questionnaire at 6 weeks, and 18 weeks
时间窗: Baseline, 6 weeks, and 18 weeks
The ABILHAND Questionnaire will be used to evaluate the ability of the upper limb in functional activities. ABILHAND contains 23 items (scale 0-69). The higher average score means the greater recovery of the ability of the upper limb in functional activities.
Change from Baseline Stroke Impact Scale Version 3.0 (SIS 3.0) at 6 weeks, and 18 weeks
时间窗: Baseline, 6 weeks, and 18 weeks
The SIS 3.0 is a stroke-specific health-related quality of life instrument. It consists of 59 items assessing 8 domains (i.e., strength, hand function, activities of daily living/instrumental activities of daily living, mobility, communication, emotion. memory and thinking and participation). Items are rated on a 5-point Likert scale, with lower scores indicating greater difficulty in task completion during the past week.
Change from Baseline Fugl-Meyer Assessment (FMA) at 6 weeks, and 18 weeks
时间窗: Baseline, 6 weeks, and 18 weeks
The upper-extremity subscale of the FMA will be used to assess motor impairment. FMA contains 33 items (scale 0-66). The higher summed score means the greater recovery of motor impairment.
次要结局
- Change from Baseline Functional Independence Measure (FIM) at 6 weeks(Baseline and 6 weeks)
- Change from Baseline Possible adverse response at 6 weeks(Baseline and 6 weeks)
- Change from Baseline Activity level as evaluated by actigraphy at 6 weeks(Baseline and 6 weeks)
- Change from Baseline Chedoke Arm and Hand Activity Inventory (CAHAI) score at 6 weeks(Baseline and 6 weeks)
- Change from Baseline Goal Attainment Scaling (GAS) at 6 weeks.(Baseline and 6 weeks)
- Change from Baseline Wolf Motor Function Test (WMFT) score at 6 weeks(Baseline and 6 weeks)
- Change from Baseline Stroke Self Efficacy Questionnaire (SSEQ) at 6 weeks(Baseline and 6 weeks)
- Change from lateral pinch strength at 6 weeks(Baseline and 6 weeks)
- Change from Baseline Revised Nottingham Sensory Assessment (rNSA) at 6 weeks(Baseline and 6 weeks)
- Change from Baseline Medical Research Council scale (MRC) at 6 weeks(Baseline and 6 weeks)