Gait Training Early After Stroke - a Comparison Between Training With the Exoskeleton Hybrid Assistive Limb and Conventional Gait Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Change in Functional Ambulation Categories (FAC)
研究概览
简要总结
Overall aim is to evaluate HAL for gait training early after stroke and the effect of HAL on short- and long-term functioning, disability and health compared to conventional gait training as part of an inpatient rehabilitation program early after stroke.
详细描述
To compare outcome after 4 weeks of gait training with HAL vs. 4 weeks of conventional gait training as part of a regular inpatient rehabilitation program for hemiparetic patients with severely limited mobility early after stroke.
Study design: Randomized, controlled study with blinded outcome assessment.
Conventional gait training is individualized and performed according to current practice (approximately 30-60 minutes/session, 5 days a week) and may include standing, weight shifting, stepping, over ground walking with assistance and/or assistant devices as well as the use of a treadmill and body weight support. Conventional gait training is offered to both study groups.
Training with HAL is performed in 1 session per day, 4 days per week during 4 weeks. Time for each session is individualised but does not exceed 60 minutes/session (effective time). Training with HAL is performed in combination with body-weight support system and on a treadmill. The training program is performed by 2 physiotherapists, who have been trained in the HAL method.
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 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •less than 8 weeks since stroke onset; inability to walk independently due to lower extremity paresis (i.e. FAC score 0-1), able to sit on a bench with or-without supervision at least five minutes; sufficient postural control to allow upright position in standing with aids and/or manual support; ability to understand training instructions as well as written and oral study information and to express informed consent; body size compatible with the HAL suit.
排除标准
- •contracture restricting gait movements at any lower limb joint; cardiovascular or other somatic condition incompatible with intensive gait training; and severe, contagious infections.
研究组 & 干预措施
Study Group
Intervention: Hybrid Assistive Limb (HAL); gait training in combination with conventional training. Training with the exosceleton Hybrid Assistive Limb (HAL) is performed in 1 session per day, 4 days per week during 4 weeks. Time for each session is individualised but does not exceed 60 minutes/session (effective time). Training with HAL is performed in combination with body-weight support system and on a treadmill. The training program is performed by 2 physiotherapists, who have been trained in the HAL method.
干预措施: Hybrid Assistive Limb (HAL); gait training (Device)
Control Group
Intervention: Conventional gait training is individualized and performed according to current practice (approximately 30-60 minutes/session, 5 days a week) and may include standing, weight shifting, stepping, over ground walking with assistance and/or assistant devices as well as the use of a treadmill and body weight support. Conventional gait training is offered to both study groups.
干预措施: Control Group; Conventional gait training (Other)
结局指标
主要结局
Change in Functional Ambulation Categories (FAC)
时间窗: Assessed at baseline, after 4 weeks of training and 6 months after stroke
Level of independence in walking, range 0-5
次要结局
未报告次要终点
研究者
Susanne Palmcrantz
PhD, Reg. Physiotherapist
Danderyd Hospital