What Should be the Best Physiotherapy Early After Stroke ?
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARK
研究概览
简要总结
This study is designed to observe the respective effects of 2 types of physiotherapy early after a cerebral stroke. The hypothesis is that an intensive physiotherapy early delivered (Day 2 to D15) after a stroke could induce faster motor control recovery than a conservative physiotherapy aiming at preventing complications.
详细描述
Hypothesis:
An intensive and active physiotherapy delivered as soon as D2 post stroke could induce faster motor control recovery and autonomy than could do an usual conservative treatment aiming at preventing complications. The benefits could be a shortened inpatient stay (both in stroke unit and rehabilitation centre), a reduction of the secondary complications with a cut in of the total cost of care.
Primary objective:
To compare two strategies of physiotherapy on the evolution of motor control recovery during the first 3 months post stroke.
Secondary objectives :
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
- 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
- •Patients informed and giving their written consent.First
- •Ever ischemic hemispheric or haemorrhagic stroke, unilateral, occurred between the 25th and the 72nd previous hours
- •Age ≥ 18 years old
- •Motricity quoted by an NIHSS >=2 in the upper limb or in the lower limb
排除标准
- •Patient without health insurance.
- •Coma (NIHSS consciousness > or = 2)
- •Total recovery within the 24 first hours
- •Brain stem or cerebellar stroke
- •Previous neurological history, specially stroke or dementia
- •Inability to understand the study
- •Surgical treatment of the stroke
- •Autonomy before stroke assessed by Rankin score different from 0
- •Scheduled surgery in the following 15 days
研究组 & 干预措施
group 1: standard physiotherapy
daily physiotherapy aiming at preventing complications, going with the patient progress capacities, passive mobilisation, sitting as soon as possible, walking when possible, respiratory physiotherapy. 15-20 minutes total per day.
干预措施: standard physiotherapy (Procedure)
group 2: experimental physiotherapy
physiotherapy as described above added to verticalisation as soon as possible; active, intense and repeated motor exercises for limbs and trunk with all the available techniques. 60 minutes total per day.
干预措施: experimental physiotherapy (Procedure)
结局指标
主要结局
Evolution of the motor control deficiency assessed by the Fugl Meyer (FM) scale modified by LINDMARK
时间窗: between day 0 and month 3
次要结局
- Unexpected events(at D30 and M3)
- Scale PASS(at D30 and M3)
- Quality of life assessed by the Stroke Impact Scale(at M3)
- Residency(at M3)
- Total length of stay as inpatient(up to D30)
- Autonomy assessed by the Rankin scale(at D15, D30, D45, M3.)
- Motor control deficiency assessed by the FM scale(at D15, D30, D45, M3)
- Autonomy assessed by the Functional Independence Measure (motor subscale)(at D30 and M3)