Very Early Mobilisation Following Acute Stroke:A randomized controlled trial
试验速览
- 阶段
- 2/3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Functional status (Barthel Index score),
研究概览
简要总结
Aims and Objectives of the Study:
(1) To determine the effect of very early mobilisation on activities of daily living following acute stroke.
(2) To determine the potential adverse events after very early mobilisation following acute stroke.
(3) To determine the effect of very early mobilisation on quality of life following acute stroke.
(4) To determine the effect of very early mobilisation on psychological well being following acute stroke.
(5) To determine the effect of very early mobilisation on the level of disability following acute stroke.
Need for the Study:
There is paucity of data regarding the effect of very early mobilisation on functional status following acute stroke. Stroke patients are at very high risk of developing complications, with an estimated 85% experiencing hospital related health problems. There is considerable evidence that early mobilisation is feasible and safe. There is no evidence to suggest that the practice should be discontinued in countries where very early mobilisation is a well established intervention but at the same time there is scarcity of evidences to suggest that the practice should be adopted more broadly.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 随机化方法
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 19.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- Patient’s age above 18 years, Acute stroke patients admitted within 24 hours of symptom onset to the stroke unit, Able to react to verbal commands, Both sex (Male and Female), Systolic Blood Pressure between 120 and 180 mm Hg, Oxygen saturation > 92% (with or without supplementation), Heart rate between 40 and 100 beats per minute, Temperature < 38.5○C, Patients were recruited after attaining physician permission and if mobilisation within 24 hours of stroke is permitted.
排除标准
- Deterioration within ï¬rst hour of admission to hospital, Patients with pre morbid modified Rankin Scale (mRS) Score >3, Concurrent progressive neurological disorder Unstable coronary condition (e.g. acute myocardial infarction) or other medical condition that would impose hazard to the patient, Or if their physiological variables (blood pressure, oxygen, heart rate, temperature) fall outside set safety limits, Severe heart failure, Lower limb fracture preventing mobilisation, Terminal cancer patients.
结局指标
主要结局
Functional status (Barthel Index score),
时间窗: On Admission | At discharge | At three months follow up
Complications at 3 months,
时间窗: On Admission | At discharge | At three months follow up
Functional disability (The modified Rankin Scale (mRS))
时间窗: On Admission | At discharge | At three months follow up
次要结局
- Health related quality of life(SF-36),(Psychological well being (HOSPITAL ANXIETY AND DEPRESSION RATING SCALE))
研究者
研究点 (1)
标识符
- CTRI 编号
- CTRI/2016/04/006795
日期
- 最近更新
- (10年前)