Evaluation of Stroke Patient Screening in an Acute Stroke Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 845
- 试验地点
- 1
- 主要终点
- Reasons why participants are not eligible for an early rehabilitation trial
研究概览
简要总结
Background and Rationale:
Traditionally, stroke rehabilitation studies have been performed in stroke patients beyond the first one to three months poststroke [Stinear et al. 2013; Veerbeek et al. 2014]. Acknowledging that early stroke rehabilitation should be initiated soon after stroke onset to optimize stroke outcomes, it is has been stressed that stroke rehabilitation trials should be initiated within the first month [Stinear 2013].
Early stroke rehabilitation trials face difficulties regarding patient recruitment with corresponding low enrollment rates [AVERT 2015; Winters 2015]. Explanations are for example priority given to (sub)acute medical interventions, highly dynamic situation at a stroke unit, and a more rapid change in patients' abilities when compared to patients in later stages poststroke. With the low enrollment rates (~7%), the generalizability of study results is questionable.
Participant screening methods and procedures for research eligibility are part of the patient selection and recruitment process in clinical trials. However, no information is available regarding screening procedures and methods for these early initiated stroke rehabilitation trials, including reasons for not enrolling patients. This knowledge is essential to improve screening procedures and methods, in order to optimize patient enrollment and with that, increase the generalizability of study results.
Objective:
The objective of this project is to evaluate screening methods and procedures for stroke rehabilitation research.
Study Design:
Observational study
详细描述
Objective:
The objective of this project is to evaluate screening methods and procedures for stroke rehabilitation research in the Department of Neurology, University Hospital Zurich.
Outcome:
Enrollment rates (defined as the number of patients enrolled per month of recruitment), reasons for non-enrollment, and estimated costs for screening for early stroke rehabilitation studies.
Study Design:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •First-ever unilateral ischemic stroke <48 hours, confirmed by MRI-DWI and/or CT
- •Age 18 years or older
- •Able to follow one-staged commands
- •NIHSS arm score ≥1
- •Informed consent after participants' information
排除标准
- •Modified Rankin Scale score >2 before stroke
- •Neurological or other diseases affecting the upper limb(s) before stroke
- •Intravenous line in the upper limb(s) which limits assessment
- •Contra-indications on ethical grounds
- •Expected or known non-compliance to participate in the observational study, severe drug or/and alcohol abuse
结局指标
主要结局
Reasons why participants are not eligible for an early rehabilitation trial
时间窗: 1 Day
The reasons for non-enrollment will be measured by counting, based on the inclusion and exclusion criteria of the aRISE study
次要结局
- Enrolment rate(1 Month)
- Estimated personnel expenses in Swiss Francs for screening(1 Month)