Stroke Rehabilitation Program Based on a Powered Lower Extremity Exoskeleton in Chile
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Gait Deviation Index Post-Intervention
研究概览
简要总结
This research will study the effects of a rehabilitation program assisted by a powered lower extremity exoskeleton in patients after stroke. It will compare clinical and biomechanical features of patients at baseline and after intervention. Additionally, it will also examine the use of a brain-computer-interface (BCI) to command movements on the powered lower limb exoskeleton. The findings will be used to improve understanding human-robot interaction, to improve the design of the robotic devices and to improve rehabilitation services.
详细描述
Stroke is one of the leading causes of mortality, morbidity and disability in adults in developed countries. Survivors may suffer several neurological deficits or deficiencies, such as hemiparesis, communication disorders, cognitive deficits and visuospatial perception disorders. Hemiplegia is a par loss of hemi-body voluntary motricity following a brain injury, usually resulting in alterations of the locomotor system with persistent disorders of movement and posture. Hemiplegia significantly affects gait performance. Gait recovery is an important objective in the rehabilitation program for stroke patients.The currently available treatment techniques include classical techniques of gait rehabilitation, functional electrical stimulation, electromechanic devices, robotic devices and brain-computer interfaces, among others.The evidence suggest that the combination of different rehabilitation strategies is more effective than conventional rehabilitation techniques alone. Technology-based rehabilitation methods such as robotic devices need more research to demonstrate their effects on gait recovery.
This study will assess the effects of a rehabilitation program with a powered lower extremity exoskeleton in people with stroke. Additionally, it will also examine the use of a brain-computer-interface (BCI) to command movements on the powered lower limb exoskeleton. The findings will be used to improve understanding human-robot interaction, to improve the design of the robotic devices and to improve rehabilitation services.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •unilateral lower extremity paresis
- •haemorrhagic or ischemic stroke
- •a minimum of six months after the acute infarction/onset of the disease
- •full passive range of motion in lower extremity or at least at neutral position
- •be able to stand freely
- •be able to walk with or without aid for at least 20 meters in less than 2 minutes
排除标准
- •peripheral nervous system pathology
- •weight over 100 kg
- •no cognitive ability to follow the study instructions
- •pregnancy
- •use of implanted devices
- •instable lower extremity joints or fixed contracture
结局指标
主要结局
Gait Deviation Index Post-Intervention
时间窗: 12 weeks
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
Gait Deviation Index Baseline
时间窗: Baseline
Gait Deviation Index will be calculated for each patient using a 3D VICON infra-red camera system.
次要结局
- Muscle tone measured using modified ashworth scale (MAS) Post-Intervention(12 weeks)
- Passive range of motion Post-Intervention(12 weeks)
- Gait Speed Baseline(Baseline)
- Maximal muscle strength Baseline(Baseline)
- Distance in 6 Minute Walk Test (6MWT) Baseline(Baseline)
- Muscle tone measured using modified ashworth scale (MAS) Baseline(Baseline)
- Passive range of motion Baseline(Baseline)
- 10 meter walk test Baseline(Baseline)
- 10 meter walk test Post-Intervention(12 weeks)
- Timed Up and Go Baseline(Baseline)
- Maximal muscle strength Post-Intervention(12 weeks)
- Distance in 6 Minute Walk Test (6MWT) Post-Intervention(12 weeks)
- Timed Up and Go Post-Intervention(12 weeks)
- Gait Speed Post-intervention(12 weeks)
- Berg Balance Scale Baseline(Baseline)
- Functional Ambulation Classification (FAC) Baseline(Baseline)
- Berg Balance Scale Post-Intervention(12 weeks)
- Functional Ambulation Classification (FAC) Post-Intervention(12 weeks)
- Patient satisfaction with device: Quebec User Evaluation of Satisfaction with Assistive Technology(12 weeks)
- Medical Research Council test (MRC) Baseline(Baseline)
- Medical Research Council test (MRC) Post-Intervention(12 weeks)