跳至主要内容
临床试验/NCT00133861
NCT00133861已完成2 期

Botulinum Toxin Efficiency on Spasticity of Rectus Femoris and Semitendinosus Muscles as Functional Agonist and Antagonist Muscles. Assessment of Efficiency of Botulinum Toxin on Spasticity in Agonist and Antagonist Muscles Using Clinical Assessment and Gait Analysis in Cerebral Palsy Children: Rectus Femoris and Semitendinosus

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2005年4月1日最近更新:
适应症
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
23
试验地点
2
主要终点
Clinical evaluation of the passive range of motion of the lower limbs

研究概览

简要总结

The aim of the study is to confirm the functional improvement obtained through treatment of spasticity on 2 agonist and antagonist muscles. The hypothesis is that treatment of both muscles gives a better and longer functional improvement than treatment of only one muscle. The target muscles are the rectus femoris and semitendinosus and the treatment is botulinum toxin. Clinical assessment (passive range of motion of the lower limbs, spasticity level, functional scales and subjective feeling) and gait analysis data (kinematics and kinetics data) are collected. Evaluations take place before treatment, 2 months and 6 months after treatment.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients between 7 to 17 years old
  • Cerebral palsy children with walking ability (even with crutch or knee-walker) allowing gait analysis.
  • Patients with functional status allowing the use of botulinum toxin on target muscles.

排除标准

  • Patients under 7 years old
  • Patients up to 17 years old
  • Patients in whom botulinum toxin is contra-indicated
  • Patients who received botulinum toxin within a 6 month period before the beginning of the study

结局指标

主要结局

Clinical evaluation of the passive range of motion of the lower limbs

次要结局

  • Evaluation of the spasticity using Tardieu Scale, Ashworth Scale and Ely test
  • Evaluation of functional outcome using Gross Motor Function Measure and Gillette Functional Assessment, subjective evaluation, physiological cost index

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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