NCT03465267Unknown不适用
Comparing of Effects of Upper Extremity Rehabilitation on Upper Extremity Rehabilitation Robot Therapy Using Armeo Power and Armeo Spring - Randomized Controlled Trial
National Rehabilitation Center, Seoul, Korea2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年6月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change of Wolf motor function test
研究概览
简要总结
Comparison of two types of robot (Armeo power vs Armeo spring) for upper extremity rehabilitation on upper extremity function
详细描述
The purpose of this study is to compare two types of robot. The robot used in this experiment was Armeo power and Armeo spring. Armeo power could provide assistive force via motor, on the other hand, Armeo spring could not provide any assist.
Thus the results from this study might suggest usefulness of motorized 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 (Outcomes Assessor)
盲法说明
Outcome assessor does not know the allocation of participants.
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
- •Onset ≥ 3 months
- •26 ≤ Fugl-Meyer Assessment score ≤ 50
- •3 ≤ Shoulder or elbow MRC scale ≤ 4
- •Shoulder or elbow flexor spasticity modified ashworth scale ≤ 1+
- •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
研究组 & 干预措施
Armeo power
Experimental
Armeo power robot for upper extremity
干预措施: Armeo power (Device)
Armeo spring
Experimental
Armeo spring robot for upper extremity
干预措施: Armeo spring (Device)
结局指标
主要结局
Change of Wolf motor function test
时间窗: change from baseline at 4 weeks
Change of Wolf motor function test
次要结局
- Stroke impact scale(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Motor activity log(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Mean velocity of upper extremity during reaching task(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Curvature of upper extremity during reaching task(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Jerk of upper extremity during reaching task(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- % maximal voluntary contraction of upper extremity muscles during reaching task(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)
- Intrinsic motivation inventory(baseline, 4 weeks after baseline, 8 weeks after baseline)
- Stroke rehabilitation motivation scale(baseline, 4 weeks after baseline, 8 weeks after baseline)
- Behavioral activation system/behavioral inhibition system scale(baseline, 2 weeks after baseline, 4 weeks after baseline, 8 weeks after baseline)
- Beck depression 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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