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临床试验/NCT03037697
NCT03037697已完成不适用

Efficacy of Axial Stability on Improving Gait and Balance Performance in Children With Dyskinetic Cerebral Palsy

Umm Al-Qura University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年1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
40
试验地点
1
主要终点
Change from baseline gait parameters at 3 months

研究概览

简要总结

The aim of this study will be to evaluate the effect of TheraTogs orthotic undergarment and strapping system on increasing axial stability that will reflect on improving balance and walking performance in children with dyskinetic cerebral palsy.

详细描述

The aim of this study will be to evaluate the effect of TheraTogs orthotic undergarment and strapping system on increasing axial stability that will reflect on improving balance and walking performance in children with dyskinetic cerebral palsy. Forty children with dyskinetic CP will be assigned randomly into two groups (A & B). Control group (A) will receive conventional rehabilitation program for postural correction 2 hours/3 sessions weekly/3 successive months. Study group (B) will receive conventional rehabilitation program as in group (A) in addition to wearing Thera Togs soft orthotic undergarment. Patients evaluation will be carried out before and after the intervention programs to assess gait and balance performance using Noraxons myo pressure plate and Biodex balance system.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
8 Years 至 12 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The levels of gross motor function will be selected between levels I and II according to Gross Motor Function Classification System (GMFCS); have the ability to walk 10 m independently without an orthosis; should be cognitively competent and able to understand and follow instructions; height will be more than 100 cm to fit with the Biodex balance equipment.

排除标准

  • If participants use an assistive mobility device; GMFCS levels III, IV, and V; fixed contractures of lower limb musculature; hip dislocation; significant spinal deformities.

结局指标

主要结局

Change from baseline gait parameters at 3 months

时间窗: Baseline and 3 months post-intervention

Gait parameters will be evaluated for every child at baseline and 3 months post-intervention using the Pro-Reflex motion analysis system (Qualisys; Qualisys Inc, Goeteborg, Sweden).

次要结局

  • Change from baseline postural stability at 3 months(Baseline and 3 months post-intervention)

研究者

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

Shamekh Mohamed El-Shamy

Associate Professor

Umm Al-Qura University

研究点 (1)

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