Efficacy of a Mechanical Gait Repetitive Training Technique Compared With a Usual Rehabilitation Program on Gait Recovery in Hemiparetic Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 122
- 试验地点
- 24
- 主要终点
- Walking speed (time needed to walk 10 m) after the 4 week rehabilitation program
研究概览
简要总结
Modern concepts of gait rehabilitation after stroke favor a task-specific repetitive approach. This study aims to test the efficacy on gait recovery of a mechanized gait trainer enabling nonambulatory patients to have the repetitive practice of a gait-like movement.
详细描述
Modern concepts of gait rehabilitation after stroke favor a task-specific repetitive approach. The aim of the study is to test the efficacy of a body weight support treadmill training technique enabling nonambulatory patients to have the repetitive practice of a gait-like movement compared to a conventional rehabilitation program in the acute phase. Hemiparetic stroke patients will be randomly included in a 4 week rehabilitation program associating physiotherapy and gait trainer therapy or physiotherapy alone.
The primary endpoint will be the walking speed (time needed to walk 10 m) at the end of the rehabilitation program. Functional ambulatory category, walking endurance, time to self sufficient gait recovery, needing for mobility and self assistance, spasticity and economic evaluation of the two strategies will also be assessed.
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
- •Men or women aged 18 years or more
- •Hemiplegia secondary to stroke
- •Interval between stroke and study inclusion of 4 month or less
- •First supratentorial stroke or no motor sequelae in case of history of transient ischemic stroke
- •Non ambulatory patient (Functional Ambulatory Category Stage 0 or 1)
- •Being able to sit unsupported at the edge of the bed
- •No severe impairment of cognition or communication
- •Written informed consent
排除标准
- •Orthopedic and/or rheumatological disease impairing mobility
- •Other Neurological associated disease
- •History of myocardial infarction or deep venous embolism or pulmonary embolism less than 3 months before study inclusion
- •Chronic pulmonary disease
- •Intolerance to stand up
研究组 & 干预措施
Conventional rehabilitation program
Physiotherapeutic conventional rehabilitation program
干预措施: Conventional rehabilitation (Device)
Mechanical gait repetitive training
Body weight support treadmill training technique enabling nonambulatory patients to have the repetitive practice of a gate-like movement
干预措施: Gait trainer (Device)
结局指标
主要结局
Walking speed (time needed to walk 10 m) after the 4 week rehabilitation program
时间窗: after 4 weeks
次要结局
- Functional ambulatory category(Days 0, 15, 28 and 90.)
- Time to self sufficient gait recovery(Since inclusion Time)
- Spasticity (modified Ashworth score)(Days 0, 15, 28 and 90)
- Economic evaluation (healthcare requirements, rehabilitation unit length of stay)(At the end of the study)
- Need for mobility and self assistance (Barthel score, PMSI-SSR scores, need for physical assistance)(Days 0, 15, 28 and 90)
- Walking endurance (6 minute walk)(days 15, 28 and 90.)
- Motricity index(Days 0, 15, 28 and 90)