The Effect of Botulinum Toxin Injection at Hip Adductor Muscles in Patients With Spastic Cerebral Palsy, Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change from hip adductor and spin muscles electromyography(EMG) test at a month
研究概览
简要总结
In children with cerebral palsy, secondary problems lead to hip dislocation. the purpose of this study is to find out the effects of botulinum toxin A on hip joint dislocation in cerebral palsy patients.
详细描述
- Design: Prospective study
- Inclusion criteria of patient group: who has a cerebral palsy and GMFCS level 3,4,5
- Intervention: applied medication Botulinum A injection (meditox 200unit)
- Main outcome measures: The investigators will measure for finding evidence by checking the x-ray photograph, hip adductor and muscles pressure test and electromyography(EMG test) test of hip adductor, abductor and spine muscles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Severe cerebral palsy patients(GMFCS level 3,4,5)
- •2 to 10 years old
排除标准
- •Those who disagree with the study.
- •other than cerebral palsy.
研究组 & 干预措施
cerebral palsy patients
cerebral palsy patients who have GMFCS level3,4,5 and 2 years old and under 10 years old apply an A injection of medication Botulinum A injection
干预措施: medication Botulinum A injection. (Drug)
结局指标
主要结局
Change from hip adductor and spin muscles electromyography(EMG) test at a month
时间窗: once at study, when patient enrolled and every once a month for one year
Use EMG to check the activity of the hip adductor and spine muscles of participants. This figures will give investigators a look at the association with a hip dislocation.
次要结局
- Whole spine AP and total Hip AP X-ray photograph(once at study, when patient enrolled and and after six month for one year)
- hip adductor muscles pressure meter test(once at study, when patient enrolled and every once a month for one year)
- Likert scale(once at study, when patient enrolled and every once a month for one year)
- Hip and knee joint Range of motion(ROM) test(once at study, when patient enrolled and every once a month for one year)
- CPCHILD sacle(once at study, when patient enrolled and every once a month for one year)
研究者
Ju Seok Ryu
associate professor
Seoul National University Hospital