NCT04054739已完成不适用
Effects of Robotic Gait Training on Cortical Activity and Gait Function in Hemiparetic Stroke
National Rehabilitation Center, Seoul, Korea2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Range of motion of ankle, knee, and hip joint
研究概览
简要总结
Effects of robot-assisted gait training on cortical activity and gait function in hemiparetic stroke
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 (Participant)
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
- •Hemiplegic patients secondary to first cerebrovascular accidents
- •Functional ambulation category score 3
- •3 months ≤ Onset ≤ 12 months
- •Korean Mini-Mental State Examination score > 24
排除标准
- •History of surgery of affected lower limb
- •Fracture of affected lower limb
结局指标
主要结局
Range of motion of ankle, knee, and hip joint
时间窗: 4 weeks from baseline
ankle, knee, and hip joint motion of sagittal plane during gait
oxygenated hemoglobin levels
时间窗: 4 weeks from baseline
cortical activity of primary sensorimotor cortex, premotor cortex, supplementary motor areas, pre-supplementary motor areas, prefrontal cortex during gait
次要结局
- Plantar pressure(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Functional ambulation category(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Timed up and go test(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Balance test using force plate(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Fugl-Meyer Assessment(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Stroke impact scale(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- dual task - COWAT(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Electromyography of lower extremities(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- modified Barthel index(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Spatiotemporal gait parameter data(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- total hemoglobin levels(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Range of motion of ankle, knee, and hip joint(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- dual task - digit span test(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- deoxygenated hemoglobin levels(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- oxygenated hemoglobin levels(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Berg Balance Scale(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- 10m walk test(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Falls efficacy scale(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Beck depression inventory(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Dynamic gait index(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
研究者
Joon-Ho Shin
Team manager
National Rehabilitation Center, Seoul, Korea
研究点 (2)
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