跳至主要内容
临床试验/NCT01825486
NCT01825486已完成不适用

Balance and Gait Characteristics to Predict Accidental Falls in Community-dwelling Stroke Elderly

Changhua Christian Hospital1 个研究点 分布在 1 个国家开始时间: 2005年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
试验地点
1
主要终点
Computerized balance evaluation

研究概览

简要总结

Background: Accidental falls result in major physical and psychological morbidity in the elderly, especially stroke patients. To get optimal prevention of stroke falls, it is crucial to identify independent risk factors from multivariate analysis of related balance and gait parameters.

Aim: To evaluate the effects of balance and gait characteristics in determining whether or not accidental falls may happen. To investigate if the balance and gait parameters affect the time from lesion to when (and if) patients suffer from falls. To compare differences of balance and gait parameters in accidental fall patients between those with severe accidental injuries and those without severe injuries.

Methods: The 2-year observational cohort study will enroll 706 elderly stroke patients, who have not had a previous stroke. They will be retrieved from the Inpatient department and followed-up regularly in the Outpatient department when they are discharged. All subjects will be evaluated at 1 month and 6 months after stroke. These evaluations will include: mental, cognition and depression status; lower-limb muscle strength assessed by a dynamometer as well as range of motion of joints assessed by a biaxial electro-goniometry; functional independence measure; balance and gait pattern will be assessed by both clinical observation and objective laboratory examination (a dynamic posturography and computerized gait analysis system); falls and fall-related injuries during the proceeding year. Differences in baseline characteristics are tested by one-way ANOVA, Mann Whitney U or t tests, if appropriate. The investigators will identify the independent risk factors of accidental falls with logistic regression and use the log rank statistic of Kaplan-Meier survival curve to differentiate the risk of accidental falls or fall-related injuries in different groups.

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

入选标准

  • confirmed stroke by CT or MRI
  • first-ever stroke
  • with walking ability after stroke onset 1 month

排除标准

  • fall history before stroke
  • living in nursing home
  • unstable physical sign
  • seizure attack during study
  • impaired cognition

结局指标

主要结局

Computerized balance evaluation

时间窗: 1 month after the first stroke

computerized balance and gait evaluation by a posturography and gait analysis system

次要结局

  • Geriatric Depression Scale(1 month after the first stroke)

研究者

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

Ta-Sen Wei,MD

Director, Physical Medical and Rehabilitation, Principal Investigator, Clinical Professor

Changhua Christian Hospital

研究点 (1)

Loading locations...

相似试验