Ischemic Stroke and Early Vertical Positioning (SEVEL) (SEVEL)
2014年12月16日 更新者：Nantes University Hospital
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
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.
研究概览
研究类型
介入性
注册 (实际的)
167
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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-
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Angers、法国
- University Hospital
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Chateaubriand、法国
- Hospital
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La Roche-sur-Yon、法国
- Hospital
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Le Mans、法国
- Hospital
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Lorient、法国
- Hospital
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Nantes、法国
- University Hospital
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Quimper、法国
- Hospital Cornouaille
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Rennes、法国
- University Hospital
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St Brieuc、法国
- Hospital Yves LeFoll
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St Nazaire、法国
- Hospital
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Tours、法国
- University Hospital
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Vannes、法国
- Hospital Bretagne Atlantique
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Vomiting
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Early vertical positioning
|
In the first group (early vertical positioning)the patient can sit outside of the bed, the day after stroke onset.
In the second group (progressively vertical positioning), the patient is progressively "verticalised" and is allowed to sit outside of the bed on the third day after the stroke onset.
|
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有源比较器：Progressively vertical positioning
|
In the first group (early vertical positioning)the patient can sit outside of the bed, the day after stroke onset.
In the second group (progressively vertical positioning), the patient is progressively "verticalised" and is allowed to sit outside of the bed on the third day after the stroke onset.
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
To demonstrate that functional modified Rankin score at 3 months after stroke onset is better with an earlier mobilization protocol (Rankin score)
大体时间：3 months
|
3 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
To demonstrate that neurological recovery is better at 7 days with an earlier mobilization protocol (NIHSS score)
大体时间：7 days
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7 days
|
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To demonstrate that neurological recovery is better at 3 months with an earlier mobilization protocol (NIHSS score)
大体时间：3 months
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3 months
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To demonstrate that functional modified Rankin score at 7 days after stroke onset is better with an earlier mobilization protocol (Rankin score)
大体时间：7 days
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7 days
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To demonstrate that the autonomy is better at 7 days in the early mobilization group (Barthel score)
大体时间：7 days
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7 days
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To demonstrate that the autonomy is better at 3 months in the early mobilization group (Barthel score)
大体时间：3 months
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3 months
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To demonstrate that an earlier " verticalization " shortens the length of stay in hospital
大体时间：7 days
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7 days
|
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To demonstrate that an earlier " verticalization " allows the patient to go back home sooner
大体时间：7 days
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7 days
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To assess the tolerance of an early mobilization
大体时间：3 months
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3 months
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To assess the impact of an early mobilization on the post stroke fatigue
大体时间：3 months
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3 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Fanny HERISSON, Doctor、Nantes University Hospital
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年11月1日
初级完成 (实际的)
2014年8月1日
研究完成 (实际的)
2014年8月1日
研究注册日期
首次提交
2012年4月5日
首先提交符合 QC 标准的
2012年4月5日
首次发布 (估计)
2012年4月9日
研究记录更新
最后更新发布 (估计)
2014年12月17日
上次提交的符合 QC 标准的更新
2014年12月16日
最后验证
2014年12月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.