Ischemic Stroke and Early Vertical Positioning, the SEVEL Study: a Randomised Controlled Trial Comparing the 3 Months Rankin Score Outcome in Ischemic Stroke Patients; in Whom Early or Delayed Mobilization is Performed
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 167
- 试验地点
- 12
- 主要终点
- To demonstrate that functional modified Rankin score at 3 months after stroke onset is better with an earlier mobilization protocol (Rankin score)
研究概览
简要总结
Even if it is a daily questioning for the stroke physician, no concrete recommendation exists regarding the time-point of the mobilization of stroke patients. In this study, we will compare two mobilisation strategies: early versus delayed "verticalisation". 400 ischemic stroke patients will be included in this prospective randomized controlled trial, equally distributed in two groups. In the early mobilisation procedure the patient is allowed to go and sit outside of the bed the day after the stroke onset, whereas in the other arm, this procedure is delayed to the third day after stroke onset. The outcome in both groups will be assessed by the modified Rankin Scale at 3 months, which is commonly used in stroke study to investigate the functional outcome of the patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- •Age 18 years or older
- •Persistent neurological impairment at the participated time, related to an ischemic stroke defined by a sudden neurological deficit. The neurological deficit must not accompany hemorrhage on cerebral tomodensitometry which occurs on the same day or the day previous to the participation
- •Patient hospitalized in Neurology department on the day of the participation
- •Patient affiliated to the social security
排除标准
- •Malignant cerebral infarction, loss of consciousness, comatose with GCS under 13, cerebral herniation, life- threatening infarction.
- •Minor neurological deficit defined by isolated facial palsy, dysarthria, hemianopia, sensitive impairment, or every clinical condition that let the physician thinks that the stay in the hospital would be less than 72 hours.
- •Known intracranial stenosis above 50% linked to the current infarction
- •History of orthostatic neurological degradation
- •Deep venous thrombosis or suspicion of.
- •Patients displaying a loss of autonomy with a Rankin score >3 previous to stroke onset.
- •Patient's refusal
- •Patient under legal protection
研究组 & 干预措施
Early vertical positioning
干预措施: Mobilization of stroke patients (Other)
Progressively vertical positioning
干预措施: Mobilization of stroke patients (Other)
结局指标
主要结局
To demonstrate that functional modified Rankin score at 3 months after stroke onset is better with an earlier mobilization protocol (Rankin score)
时间窗: 3 months
次要结局
- To assess the tolerance of an early mobilization(3 months)
- To demonstrate that neurological recovery is better at 7 days with an earlier mobilization protocol (NIHSS score)(7 days)
- To demonstrate that the autonomy is better at 7 days in the early mobilization group (Barthel score)(7 days)
- To assess the impact of an early mobilization on the post stroke fatigue(3 months)
- To demonstrate that neurological recovery is better at 3 months with an earlier mobilization protocol (NIHSS score)(3 months)
- To demonstrate that an earlier " verticalization " shortens the length of stay in hospital(7 days)
- To demonstrate that an earlier " verticalization " allows the patient to go back home sooner(7 days)
- To demonstrate that functional modified Rankin score at 7 days after stroke onset is better with an earlier mobilization protocol (Rankin score)(7 days)
- To demonstrate that the autonomy is better at 3 months in the early mobilization group (Barthel score)(3 months)