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临床试验/NCT02650960
NCT02650960已完成不适用

Life Balance and Bimanual Activities After Stroke

Universitaire Ziekenhuizen KU Leuven3 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
92
试验地点
3
主要终点
Adult Assisting Hand Assessment - Stroke

研究概览

简要总结

The Flemish version of the Life Balance Inventory (LBI), measuring central constructs of life balance, will be validated in a stroke population. Upon approval by the ethical committee, stroke patients will be recruited when they are at least six months post stroke (n = 30). The LBI will be administered twice with one week interval, and demographic, socio-economic variables and other measures of health related quality of life will be collected.

Next, an observational prospective longitudinal study will be set up. We will recruit stroke patients in three rehabilitation centers within one week after admission in the rehabilitation center. Patients will undergo a baseline evaluation and will be re-assessed at discharge from the rehabilitation center, at six months and at 12 months post stroke. A standardized clinical assessment battery, measuring motor, sensory, cognitive, mental and functional outcomes as well as personal and environmental factors will be administered. This observational study will explore recovery patterns of bimanual activities after stroke from baseline evaluation to six and 12 months after stroke. Also the predictive value of motor, sensory, cognitive and mental outcomes on bimanual activities at six and 12 months post stroke is studied, based on data collected on admission to the rehabilitation center. Finally, changes over time in life balance and its determinants will be examined at six and 12 months post stroke. The predictive value of motor, cognitive and functional outcomes on life balance at one year post stroke will be examined, based on data collected on admission to the rehabilitation center. Furthermore the influence of bimanual activities on life balance will be explored in the chronic stage after stroke.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • first-ever stroke, as defined by the WHO criteria
  • assessed and included within the first week after admission in the rehabilitation center and within the first six weeks after stroke onset
  • unilateral motor impairment in the upper limb (UL - Fügl-Meyer score ≤ 60)
  • minimally 18 years old
  • substantial cooperation to perform the assessments
  • written informed consent

排除标准

  • other neurological impairments with permanent damage such as multiple sclerosis or Parkinson's disease
  • a subdural hematoma, tumor, encephalitis or trauma that lead to similar symptoms as a stroke

结局指标

主要结局

Adult Assisting Hand Assessment - Stroke

时间窗: 12 months post stroke

observation based performance assessment

Life Balance Inventory

时间窗: 12 months post stroke

questionnaire

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Geert Verheyden

Professor

Universitaire Ziekenhuizen KU Leuven

研究点 (3)

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