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临床试验/NCT04978311
NCT04978311已完成不适用

The Effects of Mirror Feedback Augmented Task-Specific and Impairment-Oriented Therapy With Home Practice in Stroke Rehabilitation

National Taiwan University Hospital2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2021年7月29日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
21
试验地点
2
主要终点
Change from Baseline Motor Activity Log (MAL) at 6 weeks, and 18 weeks

研究概览

简要总结

In this study, the investigators will (1) examine immediate and long-term effects of MT priming with task-specific training versus MT-priming with impairment-oriented training, relative to a dose-matched control therapy on motor function, arm activities, quality of life, etc; (2) provide comprehensive evaluations based on the ICF model to identify the specific benefits of MT-priming regimens; and (3) explore demographic and clinical characteristics of participants that may predict treatment outcomes.

详细描述

Stroke is one of the major causes of long-term disability. Most stroke survivors suffer from arm paresis even in the chronic phase. There is a need to develop novel strategies to augment therapeutic efficacy in stroke rehabilitation. One potential method to enhance treatment efficacy is through the "priming" technique. Among all priming techniques, mirror therapy (MT) has been proposed to be a promising method to augment effects of motor re-training. The investigators propose a 3-year research project to determine the effects of MT-priming on augmenting stroke interventions. The investigators select two types of evidence-based neurorehabilitation, the task-specific training and the impairment-oriented training, to be primed by MT based on their unique treatment benefits on restoring arm ability. In addition, the investigators will provide customized home practice corresponding to each type of interventions. Specifically, the investigators will (1) examine immediate and long-term effects of MT priming with task-specific training versus MT-priming with impairment-oriented training, relative to a dose-matched control therapy on motor function, arm activities, quality of life, etc; (2) provide comprehensive evaluations based on the ICF model to identify the specific benefits of MT-priming regimens; and (3) explore demographic and clinical characteristics of participants that may predict treatment outcomes.

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
20 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •A first ever-stroke≧3 months
  • •Baseline Fugl-Meyer assessment of upper extremity scale (FMA-UE) between 18 to 56 (Fugl-Meyer et al. 1975)
  • •No excessive muscle spasticity of the affected arm (Modified Ashworth Scale < 3 at any joints of the affected arm) (Bohannon & Smith 1987)
  • •Able to follow examiners' commands and study instructions (Mini-Mental State Examination score≧22) (Folstein et al. 1975)
  • •No participation in any other experimental rehabilitation or drug studies during period of this project

排除标准

  • •Concomitant neurologic, neuromuscular or orthopedic conditions that may interfere with participation of this project
  • •Epilepsy within three months

研究组 & 干预措施

Mirror therapy (MT) priming with task-specific training

Experimental

In the regimen, participants will perform MT first followed by task-specific training. After completion of MT, participants will practice task-specific training that emphasizes on restoration of essential skills for daily activities. After that, the contents of home practice will be designed corresponding to treatment principles of the clinic-based intervention.

干预措施: Mirror therapy (MT) priming with task-specific training (Behavioral)

Mirror therapy priming with impairment-oriented training

Active Comparator

In the regimen, participants will perform MT first followed by impairment-oriented training. After completion of MT, participants will practice impairment-oriented training that emphasizes on restoration of movement. After that, the contents of home practice will be designed corresponding to treatment principles of the clinic-based intervention.

干预措施: Mirror therapy priming with impairment-oriented training (Behavioral)

Control therapy

Active Comparator

The control group will receive therapeutic training equivalent in duration to the two experimental groups. The control intervention will include practice of gross/fine motor activities, training of activities of daily living, practice to increase range of motions, muscle strengthening, as well as use of adaptive or compensatory technique to alleviate functional deficits. After that, the contents of home practice will be designed corresponding to treatment principles of the clinic-based intervention.

干预措施: Control therapy (Behavioral)

结局指标

主要结局

Change from Baseline Motor Activity Log (MAL) at 6 weeks, and 18 weeks

时间窗: Baseline, 6 weeks and 18 weeks

The MAL is a subjective outcome measure of an individual's real life functional upper limb performance. The MAL is administered by semi-structured interview to determine (a) how much (Amount of Use - AOU), and (b) how well the individual uses his upper limb (Quality of Movement - QOM) in real life.

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 Stroke Impact Scale Version 3.0 (SIS 3.0) at 6 weeks, and 18 weeks(Baseline, 6 weeks, and 18 weeks)
  • Change from Baseline Nottingham Extended Activities of Daily Living Scale (NEADL) at 6 weeks, and 18 weeks(Baseline, 6 weeks and 18 weeks)
  • Change from Baseline Chedoke Arm and Hand Activity Inventory (CAHAI) 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 Grip and Pinch strength at 6 weeks(Baseline and 6 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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