EUCTR2009-009868-31-NL进行中(未招募)不适用
Quality of life, gross motor function, and actual everyday physical activity level in children with spastic Cerebral Palsy: (cost)effectiveness of combined treatment with multilevel botulinum-toxin injections and intensive functional physiotherapy.
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- ZonMW
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
- •Children with spastic Cerebral Palsy aged 4-12 years whose lower extremity is involved and who have been selected for treatment with multilevel botulinum toxin injections followed by intensive physiotherapy are eligible candidates.
- •Spastic CP will be diagnosed according to the guidelines of the Dutch Institute for Healthcare Improvement. Only children classified as levels I-III with the Gross Motor Function Classification System (GMFCS) will be included for the study because they are (household) ambulators.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •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
- •The children’s´ motor selectivity should be sufficient (to be measured by valid selectivity test), and they are excluded in case of surgery <12 months before the study and in case of BtA treatment <6 months preceding the study. Children will also be excluded when severe contractures are present, when they are cognitively unable to understand instructions, or when there is co-morbidity (e.g. visual disability, severe epilepsis) that affects their everyday functioning.
研究者
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