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临床试验/NCT03212846
NCT03212846已完成不适用

Muscle Spasticity Reduction in Children With Cerebral Palsy by Means of Hippotherapy: a Randomized Controlled Trial

University of Cadiz2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Modified Ashworth Scale (MAS)

研究概览

简要总结

The aim of this study is to evaluate if a intervention with hippotherapy will improve spasticity for children ages 3-14 who have cerebral palsy. The hip aductors spasticity will be measured using the Modified Ashworth Scale (MAS). The intervention will be performed in addition to traditional treatment.

详细描述

The main aim of the present study is to determine the effects of hippotherapy on the hip aductors spasticity in children with spastic cerebral palsy. Furthermore, as a secondary objective is to evaluate the changes in Modified Ashworth Scale (MAS) after intervention in children ages 3-14.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Single blind

入排标准

年龄范围
3 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Primor diagnosis of spastic cerebral palsy
  • Children aged 3-14

排除标准

  • Children with recent injection of botulinium toxin, surgery, or any planned medical or surgical interventions.

结局指标

主要结局

Modified Ashworth Scale (MAS)

时间窗: 12 weeks

The aim of the scale is to assess muscle tone by the joint range of motion, manually evaluated, and clinically recording passive movements' resistance. Each participant will be examined lying supine on a couch in a relaxed position. The MAS scale is, undoubtedly, the most widely used measure for the quantification of muscular hypertonia. The trunk and the head will be maintained in a neutral position to avoid eliciting tonic neck reflexes, and the passive speed movements will be made in the course of one second. It will be performed in left and right hip, independently, 5 to 8 times to obtain a more reliable result. This modified version adds a 1+ scoring category, in order to register resistance in less than half of the range of motion. Thus, the scores range is from 0 to 4, with 6 choices.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David Manuel Lucena Anton

PhD, Clinical Professor

University of Cadiz

研究点 (2)

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