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临床试验/NCT01409265
NCT01409265已完成不适用

The Impact of Perceptual Impairment on Social Participation in Stroke Patients

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2010年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Fugl-Meyer Assessment (FMA)

研究概览

简要总结

The perceptual change on stroke patients during the movement recovery and its relationship with social participation still remain unclear. The purposes of this study are: 1) to observe the progression of perception deficit and 2) to understand the relationships among perception deficit and other functional indicators.

A total of 90 stroke patients will be recruited. Each patient will receive three times evaluation, including perception tests, motor function test, daily living ability tests and social leisure participation questionnaires.

详细描述

According to motor control theory, perception plays an important role in the execution of motion. Although the effect of rehabilitation for motor recovery on stroke patients has been well established, the perceptual change during the movement recovery and its relationship with social participation still remain unclear.

A total of 90 stroke patients will be recruited. Each patient will receive initial evaluation, first follow-up evaluation after four weeks and second follow-up evaluation after five months. The contents include basic clinical screen tests, perception tests, motor function test, daily living ability tests and social leisure participation questionnaires.

The purposes of this study are: 1) to observe the change of the during the experiment and clarify the progression of perception deficit and 2) to understand the relationships among perception deficit and the other functional indicators and determine the impact of perception deficit on activities and participation in stroke patients.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • the age over 40 years old
  • the time of onset more than 3 months
  • no cognitive dysfunction
  • cerebral stroke
  • clinical diagnosis of a first or recurrent unilateral stroke

排除标准

  • recurrent of the stroke or epilepsy during the intervention
  • patients with the neurological or psychical history, for example, alcoholism, drug poisoning or bipolar disorder
  • participate in the other interventional study in the same time
  • refuse subscribed the informed consent

结局指标

主要结局

Fugl-Meyer Assessment (FMA)

时间窗: Up to 3 years

The FMA is used to evaluate stroke-related motor impairment, including upper- and lower-extremity movements, sensation, and balance. The whole FMA takes approximately 30 to 40 minutes to administer. The upper-extremity subscale of the FMA contains 33 items to assess motor impairment. Each item is scored on a 3-point ordinal scale (0-cannot perform, 1-performs partially, 2-performs fully and correctly). It is administered 3 times during the study period.

次要结局

  • Modified Ashworth Scale (MAS)(Up to 3 years)
  • Box and Block Test (BBT)(Up to 3 years)
  • Medical Research Council scale (MRC)(Up to 3 years)
  • Action Research Arm Test (ARAT)(Up to 3 years)
  • Adelaide Activities Profile (AAP)(Up to 3 years)
  • Wolf Motor Function Test (WMFT)(Up to 3 years)
  • Nottingham Extended Activities of Daily Living Scale (NEADL)(Up to 3 years)
  • Nottingham Leisure Questionnaire (NLQ)(Up to 3 years)
  • ABILHAND questionnaire(Up to 3 years)
  • Motor Activity Log (MAL)(Up to 3 years)
  • Stroke Impact Scale Version 3.0 (SIS 3.0)(Up to 3 years)
  • Leisure Satisfaction Scale (LSS)(Up to 3 years)
  • Reintegration to Normal Living Index (RNLI)(Up to 3 years)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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