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临床试验/NCT02548234
NCT02548234已完成不适用

Effect of Mirror Therapy Versus Bilateral Arm Training for Rehabilitation After Chronic Stroke: a Pilot Randomized-controlled Trial

China Medical University Hospital2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2015年9月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
The efficacy of mirror therapy versus bilateral arm training on sensorimotor functions

研究概览

简要总结

The study purpose is to compare the efficacy of mirror therapy and bilateral arm training on movement strategies of the affected upper extremity and functional outcome in chronic stroke patients.

详细描述

Study background: Approximately 80% of stroke survivors have an upper and/or lower limb impairment (Barker 1997), and impairment of the arm explains up to 50% of the variance in functional limitation after stroke. Brain imaging research using magnetoencephalography found that mirror therapy combined with bilateral arm training could potentially aid stroke rehabilitation by normalizing an asymmetrical pattern of movement-related beta desynchronization in primary motor cortex. However, different neural mechanisms may cause different effect of motor control recovery after the two different approaches, which have yet to be studied. Study purpose:To compare the efficacy of mirror therapy and bilateral arm training on movement strategies of the affected upper extremity and functional outcome in chronic stroke patients. Study method: This was a single-blind, randomized, comparative efficacy research. Sixty participants with chronic stroke will be recruited in the occupational therapy clinics at four hospitals and randomly assigned to the mirror therapy and bilateral arm training groups. The intervention will consist of 1.5 hrs/day, 5 days/wk for 4 wks, including 3 days of hospital-based therapy and 5 days of home practice. Primary outcomes were muscular properties (grip strength) and sensorimotor measurements. Secondary outcomes included measures of daily functions to gain insight about movement capabilities. The validity and reliability of all measurements have been proposed. Finally, the Mann-Whitney U test and the Fisher exact test will be used to compare the significant differences between the two approaches. The effect size of dependent variables will be reported also.

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
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • more than 6 months after onset of an ischemic or hemorrhage stroke
  • no excessive spasticity on all joints of the affected arm

排除标准

  • history of stroke or other neurologic, neuromuscular, or orthopedic disease
  • participation in other experimental rehabilitation or drug studies concurrent with this study

结局指标

主要结局

The efficacy of mirror therapy versus bilateral arm training on sensorimotor functions

时间窗: within four weeks (plus or minus 3 days) after intervention

Revised Nottingham Sensory Assessment and Fugl-Meyer Assessment will be used to measure sensorimotor functions. The statistical analysis will be performed to compare the significant differences for the efficacy of mirror therapy versus bilateral arm training.

次要结局

  • The efficacy of mirror therapy versus bilateral arm training on quality of life(within four weeks (plus or minus 3 days) after intervention)
  • The efficacy of mirror therapy versus bilateral arm training on motor performance(within four weeks (plus or minus 3 days) after intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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