NCT02228863Unknown4 期
Upper Extremity Rehabilitation Using Robot and Botulinum Toxin
National Rehabilitation Center, Seoul, Korea2 个研究点 分布在 1 个国家目标入组 348 人开始时间: 2014年3月1日最近更新:
适应症
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 348
- 试验地点
- 2
- 主要终点
- Change of Fugl-Meyer Assessment
研究概览
简要总结
Concomitant use of botulinum toxin and robot would make better results regarding upper extremity function compared to robot, botulinum toxin, or no intervention.
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
- 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
- •Shoulder or Elbow flexor spasticity above or 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
- •Recent history of botulinum toxin injection within 6 months
结局指标
主要结局
Change of Fugl-Meyer Assessment
时间窗: Fugl-Meyer Assessment change from baseline at 8 weeks
次要结局
- Kinematic data(Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline)
- surface electromyography data from bilateral upper extremities(baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline)
- Fugl-Meyer Assessment(Baseline, 4 weeks from baseline, 8 weeks from baseline, 12 weeks from baseline)
- Satisfaction about the intervention(baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline)
- Adverse event(From baseline to 12 weeks from the baseline)
- Spasticity of elbow and shoulder joint(baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline)
- Painless range of motion of elbow and shoulder joint(baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline)
- Associated reaction rating scale(baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline)
- Controlled Oral Word Association Test(baseline, 5ays of Inmotion, 20 days of Inmotion)
- Beck's depression index(baseline, 4 weeks, 8 weeks, and 12 weeks from baseline)
- Medical research council scale of elbow and shoulder joint strength(baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline)
- numeric rating scale of pain of elbow and shoulder joint(baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline)
- Behavioral activation system/behavioral inhition system scale(baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline)
- Stroke impact scale(baseline, 4 weeks after baseline, 8 weeks after baseline, 12 weeks after baseline)
- Digit span test(baseline, 5days after Inmotion, 20 days after Inmotion.)
研究者
Joon-Ho Shin
Team manager
National Rehabilitation Center, Seoul, Korea
研究点 (2)
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