跳至主要内容
临床试验/NCT05207124
NCT05207124Enrolling By Invitation不适用

Survey of Sarcopenia and Osteopenia in Individuals With Cerebral Palsy and Examination of Influences After Botulinum Neurotoxin Type A Injection

National Cheng-Kung University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年9月2日最近更新:
适应症

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

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

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验