Effect of Early Rehabilitation in Patients With Acute Subarachnoid Hemorrhage
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 2
- 主要终点
- Glasgow Coma Scale (GCS)
研究概览
简要总结
The study's main objective will be to assess which effect early initiated rehabilitation has on the frequency of complications and the level of physical and cognitive functioning after aneurysmal subarachnoid hemorrhage (SAH).
To this end the following aspects will be investigated:
The frequency of complications (with special emphasis on pulmonary complications,thromboembolic events, cerebral vasospasm, unintended discontinuation of drains and lines)
- Length of stay in hospitals and socio-economic impact
- Physical and cognitive function in the early and chronic phase after SAH
- Health-related quality of life and participation in society in the chronic phase
详细描述
Oslo University Hospital (OUS) is the primary hospital for Health Region South-East regarding treatment of patients with SAH. Approximately 120 patients are referred annually. OUS,Rikshospitalet, Dept of Neurosurgery offers 24/7 service of surgical and vascular aneurysm repair performed by a dedicated vascular team.
Patients admitted in 2012 are treated in accordance to the standard institutional protocol plus an early rehabilitation model adapted to SAH, while patients admitted in 2011 who did not receive any early rehabilitation, but apart from that were treated identically, serve as a control group.
All patients admitted to the intermediate unit at OUS in 2011 and 2012 with aneurysmal SAH and repaired aneurysm will be invited to participate in this study. Examination of the patients from both 2011 and 2012 will be performed as part of routine, neurosurgical follow- up which is in the early phase at 3-6 months and in the chronic phase at least 12 months post SAH. Exclusion criteria for participation in the study: unsecured ruptured aneurysm, symptomatic aneurysm without rupture, previous SAH or brain injury, diagnosis of a neurodegenerative disorder, patients from other health regions or tourists, patients that were treated at the intensive care unit (ICU )only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •All patients admitted to the intermediate unit at OUS in 2011 and 2012 with aneurysmal SAH and repaired aneurysm will be invited to participate in this study.
排除标准
- •Unsecured ruptured aneurysm,
- •Symptomatic aneurysm without rupture
- •Previous SAH or brain injury, diagnosis of a neurodegenerative disorder
- •Patients from other health regions or tourists
- •Patients that were treated at the intensive care unit (ICU )only.
结局指标
主要结局
Glasgow Coma Scale (GCS)
时间窗: up to 10 weeks
次要结局
- Disability Rating Scale (DRS)(3-6 and 12 months after SAH)
- High Level Mobility Assessment Tool (HIMAT)(3-6 and 12 months after SAH)
- Glasgow Outcome Scale Extended (GOSE)(3-6 months and 12 months after SAH)
- Functional Independence Measure (FIM)(3-6 months and 12 months after SAH)
- Coma Recovery Scale (CRS)(3-6 and 12 months after SAH)
研究者
Tanja Karic
medical doctor
Oslo University Hospital