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临床试验/NCT05251532
NCT05251532已完成不适用

The Efficacy of Distortion Taping on Balance, Performance, Gait, Spasticity and Quality of Life in Ankle Varus Deformity in Children With Cerebral Palsy

Muğla Sıtkı Koçman University2 个研究点 分布在 2 个国家目标入组 32 人开始时间: 2022年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
2
主要终点
TUG

研究概览

简要总结

The aim of the study is to compare the conventional rehabilitation program and the distortion taping applied with Kinesio Tex tape in addition to conventional rehabilitation in children with hemiplegic or monoplegic cerebral palsy with ankle varus deformity.

详细描述

Conventional rehabilitation practices will be applied to the control group. In addition to Kinesio Tex tape distortion taping, conventional rehabilitation will be applied to the intervention group. It is aimed to evaluate the patients' balance, quality of life, performance test, spasticity level and gait quality.

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
None

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

  • Children with cerebral palsy aged 4-12 years with unilateral involvement who are hemiplegic or monoplegic
  • Cases with Gross Motor Function Classification (GMFCS) level 1 or 2
  • Understanding simple commands and signing the consent form

排除标准

  • Presence of equinus deformity
  • Situations that may prevent assessments or communication
  • Lack of cooperation during work
  • Presence of surgery that may affect assessments, such as joint freezing
  • Presence of botulinum toxin administration in the last 6 months
  • Development of an allergic reaction on the skin to the tape

结局指标

主要结局

TUG

时间窗: Change from Baseline TUG at 3 days

Patients are asked to get up from a standard chair, walk 3 meters at a safe and comfortable pace, and return without stopping to sit back in the chair safely. The elapsed time is calculated. There is no score range in TUG.

Modified Ashworth Scale (MAS)

时间窗: Change from Baseline MAS at 3 days

The Modified Ashworth Scale is a 6-point rating scale for gauging muscle resistance to passive movement. MAS is scored from 0 to 4, where lower scores represent normal muscle tone and higher scores represent spasticity.

WGS

时间窗: Change from Baseline WGS at 3 days

The scale allows for a multifactorial gait analysis, takes in to account 14 observable gait parameters divided into four sub-scales referring to particular phases of gait, i.e. stance phase, toe off, swing phase, andheel strike. WGS is scored from 13.35 to 42.0. Higher scores indicate higher impairment.

CHQ

时间窗: Change from Baseline CHQ at 3 days

The CHQ is a validated multidimensional instrument that measures the functional health and well-being of children and young people. CHQ is scored from 0 to 100. Higher scores indicate better health status.

SLS

时间窗: Change from Baseline SLS at 3 days

The one-leg standing test measures the time one is able to stand on one lower limb without support. There is no score range in SLS.

次要结局

未报告次要终点

研究者

发起方
Muğla Sıtkı Koçman University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fatih Ozden

Principal Investigator

Muğla Sıtkı Koçman University

研究点 (2)

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