跳至主要内容
临床试验/NCT05251519
NCT05251519已完成不适用

The Efficacy of Derotation Taping on Balance, Performance, Gait, Spasticity and Quality of Life in Femoral Internal Rotation Deformity in Children With Cerebral Palsy

Muğla Sıtkı Koçman University2 个研究点 分布在 1 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
PBBT

研究概览

简要总结

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

详细描述

Conventional rehabilitation (CR) practices will be applied to the control group. Conventional rehabilitation (KT) application will be applied to the study group in addition to Kinesio Tex tape derotation banding. With the kinesio tape application, it is aimed to provide economical, ergonomic and effective support to the patients in non-clinical times. 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 a static cause of femoral internal rotation 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

PBBT

时间窗: Change from Baseline PBBT at 3 days

PBBT is a 14-item, criterion-referenced measure and examines functional balance in the context of everyday tasks. PBBT is scored between 0 to 56. Higher scores indicate better function.

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.

EVGS

时间窗: Change from Baseline EVGS at 3 days

EVGS was developed to evaluate gait in children with CP using video recordings. It includes 17 variables, and each of these variables can be scored as 0, 1, or 2 based on movement deviation from normal. enced measure and examines functional balance in the context of everyday tasks. EVGS is scored between 0 to 34. Higher scores indicate worse gait function.

KINDL

时间窗: Change from Baseline KINDL at 3 days

The KINDL was derived from a conceptual model, in which the four main components of quality of life, namely psychological well-being, social relationships, physical function and everyday life activities, were included in interviews with children. KINDL is scored between 0 to 100. Higher scores indicate better quality of life.

6MWT

时间窗: Change from Baseline 6MWT at 3 days

The 6-meter course was mapped as 10 meters in length with a 2-meter acceleration interval and a 6-meter testing interval. There is no scoring range for the 6MWT.

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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