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临床试验/NCT07111091
NCT07111091已完成不适用

Comparison of the Effects of Unilateral and Bilateral Plastic Ankle Foot Orthosis on Gait and Balance in Children With Hemiparatic Cerebral Palsy

Istanbul Medipol University Hospital1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2019年12月19日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
19
试验地点
1
主要终点
balance

研究概览

简要总结

Background: Ankle-foot orthoses are frequently prescribed to reduce spasticity, position the extremity more properly, and regulate gait during the rehabilitation process of children with cerebral palsy.

Objective: To investigate the effects of unilateral or bilateral use of plastic ankle-foot orthoses (AFO) used in children with hemiparetic cerebral palsy (CP) on the child's gait and balance.

The aim of this study is to investigate the effects of unilateral and bilateral use of AFOs used in children with hemiparetic cerebral palsy on gait and balance.

Methods: 19 cooperative children aged 4-12 years, with gross motor function classification system levels 1 and 2, using bilateral AFOs were included in the study. Children were evaluated with bilateral AFOs, unilateral AFOs, and without AFOs. Trunk sway assessment was performed on the Bertec Balance force platform with eyes open and closed, and time-spatial characteristics of gait were evaluated with the GAITRite electronic walkway.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Single (Participant)

入排标准

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

入选标准

  • Diagnosed with Hemiparatic SP
  • Cooperative
  • Classified as 1 or 2 levels in GMFCS
  • Lower extremity muscles with spasticity severity of up to 2 according to Modified Ashworth
  • Using Bilateral Plastic AFO Orthosis for the last 6 months

排除标准

  • foot deformity
  • using walking aids
  • unable to walk independently

结局指标

主要结局

balance

时间窗: From enrollment to the end of treatment at 4 weeks

Balance assessments were conducted using the Bertec Balance Check Screener™ force platform. Oscillations during the assessment were recorded for each participant. For safety reasons, the researcher stood close to the participant without contact during the balance assessment.

次要结局

  • demographic information form(From enrollment to the end of treatment at 4 weeks)
  • Gait assessments(From enrollment to the end of treatment at 4 weeks)

研究者

发起方
Istanbul Medipol University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

merve yılmaz

Istanbul Medipol University

Istanbul Medipol University Hospital

研究点 (1)

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