NCT03104881已完成不适用
Comparisons of Two Types of Rehabilitation Robot for Upper Extremities: 3 Dimension Exoskeleton Type Upper Extremity Robot vs. 2 Dimension End-effector Type Robot): Randomized Controlled Trial
National Rehabilitation Center, Seoul, Korea2 个研究点 分布在 2 个国家目标入组 40 人开始时间: 2015年4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
- 40
- 试验地点
- 2
- 主要终点
- Change of Fugl-Meyer Assessment
研究概览
简要总结
Comparisons of two types of rehabilitation robot for upper extremities: 3 dimension exoskeleton type upper extremity robot vs. 2 dimension end-effector type robot)
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
- 18 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
- •Onset ≥ 3 months
- •8 ≤ Fugl-Meyer Assessment score ≤ 30
- •Shoulder or elbow flexor spasticity modified ashworth scale ≤ 3
- •Cognitively intact enough to understand and follow the instructions from the investigator
排除标准
- •History of surgery of affected upper limb
- •Fracture of affected upper limb
结局指标
主要结局
Change of Fugl-Meyer Assessment
时间窗: Fugl-Meyer Assessment change from baseline at 4 weeks
Wolf motor function test
时间窗: Fugl-Meyer Assessment change from baseline at 4 weeks
次要结局
- Motor status score(baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline)
- Pain of upper extremity(from baseline to 4 weeks after baseline)
- Reach Error(baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline)
- Path Error(baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline)
- Mean velocity(baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline)
- Cricle size(baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline)
- Beck depression index(baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline)
- Wolf motor function test(baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline)
- medical research council scale of upper extremity(baseline)
- Modified Ashworth scale of upeer extremity(baseline)
- Stroke impact scale(baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline)
- Smoothness(baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline)
- Maximum velocity(baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline)
- Cricle independence(baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline)
- Intrinsic motivation inventory(4 weeks after baseline)
- stroke rehabilitation motivation scale(baseline, 4 weeks after baseline, 8 weeks after baseline, 10 weeks after baseline)
研究者
Joon-Ho Shin
Team manager
National Rehabilitation Center, Seoul, Korea
研究点 (2)
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