Effect of the Home-based Exercise Program With Smart Rehabilitation System on Balance and Gait Functions in Stroke Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Timed Up and Go test
研究概览
简要总结
A lot of patients suffer the balance and gait disorders after stroke. Many rehabilitation therapies have been provided to improve the balance and gait function in stroke patients. However, most rehabilitation therapies are performed in only hospitals, in spite of the difficulty of moving from home to hospitals for stroke patients. Home-based smart rehabilitation system (Uincare®, D-gate Co.) can provide the specific rehabilitation training program to stroke patients in their home. This study aims to investigate the effects of the home-based exercise program with smart rehabilitation system on balance and gait functions in stroke patients.
详细描述
The total 100 patients with stroke will be divided into each the intervention group and the control group. The intervention group will be provided the home-based smart rehabilitation system for 4 weeks, and the control group will be educated the conventional home rehabilitation exercise at once. The immediate effects of the home-based smart rehabilitation system on the balance and gait function will be assessed at 4 weeks after exercise and the long-term carry-over effects will be also assesed at 4 weeks after cessation of exercise.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult stroke patients (more than 18 years old)
- •less than 6 months after stroke onset
- •discharged to home or the plan to discharge to home less than 3 days
- •independent ambulatory function on even level (4 or more than 4 in Functional Ambulatory Category)
排除标准
- •Advanced liver, kidney, cardiac, or pulmonary disease
- •A terminal medical diagnosis consistent with survival < 1 year)
- •Pre-existing and active major neurological disease
- •Pre-existing and active major psychiatric disease
- •Severe language disorders
- •Severe cognitive disorders (10 or less than 10 in K-MMSE)
结局指标
主要结局
Timed Up and Go test
时间窗: Change from baseline Timed Up and Go test at 4 weeks
Assessment of balance and gait function
次要结局
- EQ-5D(Change from baseline Timed Up and Go test at 4 weeks)
- Tinetti Performance Oriented Mobility Assessment(Change from baseline Timed Up and Go test at 4 weeks)
- Berg Balance scale(Change from baseline Timed Up and Go test at 4 weeks)
- Korean-Geriatric Depression Scale- Short Form(Change from baseline Timed Up and Go test at 4 weeks)
- Falls Efficacy Scale(Change from baseline Timed Up and Go test at 4 weeks)
- Korean version of Physical Activity Scale for the Elderly(Change from baseline Timed Up and Go test at 4 weeks)
研究者
Won Hyuk Chang
Associate Professor
Samsung Medical Center