Randomized Clinical Trial of Very Early Rehabilitation Compared With Conventional Rehabilitation in Acute Ischemic Stroke in the Vascular Unit of the Hospital de Clínicas de Porto Alegre - HCPA
试验速览
- 阶段
- 1 期
- 入组人数
- 184
- 试验地点
- 1
- 主要终点
- Disability
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of a rehabilitation (physiotherapy) program in patients with acute ischemic stroke in Acute Vascular Unit and in general ward of Hospital de Clínicas de Porto Alegre, and to verify the degree of disability at fourteenth and third month, functional improvement at third month, the frequency of deaths and incidence of complications due to immobility and quantify the time spent in hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Patients with clinical diagnosis of acute ischemic stroke (first or recurrent) confirmed by CCT or MRI admitted to the Acute Vascular Unit of HCPA between the first 48 hours of onset of symptoms.
- •Patients older than 18 years.
- •Patients clinically and hemodynamically stable (SBP 120-220 mmHg, SatO2 up to 92% with or without supplementation, HR between 60 and 100 bmp, body temperature below 38 and RR below 25 bpm).
- •Patients are able to react to verbal commands even without being fully alert (Glasgow Scale above 8).
- •Prior Rankin until 3
- •Motor deficit and / or coordination measured by the NIHSS
排除标准
- •Patients with clinical and / or hemodynamic instability
- •Patients with hemorrhagic stroke or TIA (transient ischemic attack).
- •Patients with progressive neurological disease and acute coronary disease and / or unstable.
研究组 & 干预措施
Early mobilization
The Intervention Group - Early Mobilization - will follow the early physiotherapy program within the first 24 - 48 hours after stroke, five times per week for 30 plus a time spent out of bed (sitting).
干预措施: Early mobilization (Other)
Control
The Control Group will follow within the routines of the hospital as is usually done.
结局指标
主要结局
Disability
时间窗: three months
Outcome measure are assessed by Modified Rankin Scale. Good outcome was predefined as an mRS score of 0 to 2 and poor outcome of 3 to 6.
次要结局
- Minimum or no Disability(three months)
- Independence in activities of daily living(three months)
- Long of stay at hospital(three month)
- Death(three month)
- Incidence of complications(three month)