EUCTR2014-004474-42-DK进行中（未招募）1 期
Treatment of equinus gait caused by dynamic tightening of the calf muscles in children with cerebral palsy. A randomized, placebo controlled Botulinum toxin type A volume/response study.
Copenhagen University Hospital at Hvidovre0 个研究点目标入组 26 人开始时间: 2015年3月11日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Spastic cerebral palsy diagnosed by a neuro-pediatrician
- •- Spasticity/increased tone in m. triceps surae
- •- 3-8 years of age
- •- GMFCS level I or II
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 26
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Lacking ability to cooperate and take part in three-dimensional gait analysis
- •- More than five previous BoNT-A treatments or insufficient effect of the latest treatment
- •- Hypersensitivity caused by BoNT-A or one or more of the ancillary substances
- •- Infection at the intended injection site
- •- Injection treatment with BoNT-A within the previous four months
- •- Operations in the lower extremities within the previous year
- •- Planned operations in the lower extremities, that is deemed to interfere with research outcome parametres during the project period
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