Clinical Feasibility and Efficacy of Robot-assisted Gait Training for Improving Motor Functions in Patients With Stroke
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Fugl-Meyer Assessment, lower extremity subscale
研究概览
简要总结
Investigation of the clinical feasibility and efficacy of a newly developed robot-assisted gait training system for stroke survivors. It is anticipated that robot-assisted gait rehabilitation in combination with standard hospital based rehabilitation will achieve significantly better gait outcomes than standard hospital based rehabilitation alone.
详细描述
Stroke is the leading cause of permanent disability in most developed countries world wide with one-third of the surviving patients from stroke fail to regain independent walking ability. Robot-assisted gait rehabilitation that is able to deliver high intensity and consistent repeatability in a safe and controlled environment are gaining traction and advocators for its inclusion as part of the routine post-stroke rehabilitation program. However, despite the recent technological advances in the development and design of better robotics, the exact benefit of the robot-assisted therapy over traditional rehabilitation remain sparse and unclear. It is therefore the aim of the proposed project to fulfil this important gap in our clinical knowledge by comparatively investigate the clinical feasibility and efficacy of a recently developed HIWIN Robotic Gait Training System (MRG-P100) against the traditional rehabilitation program with an emphasis on the determination of functional recovery and the appropriate gait adaptation of such robotic system for stroke survivors.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between the age of 20-65 years;
- •Diagnosis of first, single unilateral cortical-subcortical stroke verified by brain imaging;
- •Paresis of a lower limb;
- •Inability to walk without aid or device.
排除标准
- •Deemed by a physician to be medically unstable;
- •Other prior musculoskeletal conditions that affected gait capacity;
- •Co-existence of other neurological diseases;
- •Cognitive impairments that would impact on the safe participation in the study (MMSE<23) -
结局指标
主要结局
Fugl-Meyer Assessment, lower extremity subscale
时间窗: Assessing change from baseline after 1 month of intervention
Lower limb function as measured by Fugl-Meyer Assessment, lower extremity subscale
次要结局
- Functional Ambulation Categories(Assessing change from baseline after 1 month of intervention)
- 10 Meters Walking Test(Assessing change from baseline after 1 month of intervention)
- Berg Balance Scale(Assessing change from baseline after 1 month of intervention)
- Timed Up and Go test(Assessing change from baseline after 1 month of intervention)
- Kinetic and Kinematic Gait Analysis(Assessing change from baseline after 1 month of intervention)