Survey of Sarcopenia and Osteopenia in Individuals With Cerebral Palsy and Examination of Influences After Botulinum Neurotoxin Type A Injection
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- DXA (dual-energy x-ray absorptiometry)
研究概览
简要总结
Botulinum neurotoxin type A (BoNT-A) intervention to control the hypertonia of muscles is one of the evidence-based managements for children with spastic cerebral palsy. However, BoNT-A injection in animal models to induce weakness had revealed some detrimental effects on muscular and skeletal systems. There are some objectives of this research. The first aim is to establish the baseline data of deficiencies in bone condition and muscle mass for individuals with cerebral palsy. To confirm the influences of intramuscular administration of Botox on muscular and bony health in this population is the other aim.
详细描述
Individuals with cerebral palsy is vulnerable to osteopenia and sarcopenia. Botulinum neurotoxin type A (BoNT-A) intervention to control the hypertonia of muscles is one of the evidence-based managements for children with spastic cerebral palsy. However, BoNT-A injection in animal models to induce weakness had revealed some detrimental effects on muscular and skeletal systems. There are some objectives of this research. The first aim is to establish the baseline data of deficiencies in bone condition and muscle mass for individuals with cerebral palsy. To confirm the influences of intramuscular administration of Botox on muscular and bony health in this population is the other aim.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 5 Years 至 18 Years(Child, Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of spastic CP (cerebral palsy)
- •moderate to severe spasticity over the limbs, Modified Ashworth Scale score≧2
排除标准
- •fixed contractures of the limbs
- •previous musculoskeletal surgery on the limbs
- •contraindications to botulinum toxin intervention
结局指标
主要结局
DXA (dual-energy x-ray absorptiometry)
时间窗: change from baseline at 24 weeks after botulinum neurotoxin type A injection
dual-energy x-ray absorptiometry
次要结局
未报告次要终点
