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临床试验/NCT04263701
NCT04263701已完成不适用

Effects of Dual Task Training on Gait Parameters in Spastic Diplegic Cerebral Palsy

Kutahya Health Sciences University2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年7月1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
10
试验地点
2
主要终点
Gate speed of time-distance gait parameters

研究概览

简要总结

This study aims to investigate the effects of dual task training on gait and balance parameters, gross motor function skills, functional mobility skills, functional independence levels and health-related quality of life o in children with spastic diplegic cerebral palsy. The clinical study's hypothesis is the dual task training programs are superior to conventional physiotherapy programs to improve the parameters in spastic diplegic cerebral palsy.

详细描述

In this self-controlled study, children with spastic diplegic cerebral palsy, aged 7-16, who were at level 1 or 2 according to the Gross Motor Function Classification System, scored 27 and above from the Modified Mini Mental Test were included.

Children are recruited to the routine physiotherapy program 45 minutes 2 days a week for 8 weeks, and in addition to the routine physiotherapy program dual task training program 45 minutes 2 days a week for the next 8 weeks. The children will evaluate at baseline, after the routine physiotherapy program and after the dual task training program. Children will be evaluate with Gross Motor Function Measurement-88,Modified Ashworth Scale , gait platform, Edinburgh Visual Gait Score, Pediatric Berg Balance Scale,1 Minute Walk Test, Functional Independence Measure, Pediatric Quality of Life Inventory TM-Cerebral Palsy Module.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
7 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Having been diagnosed with spastic diplegic cerebral palsy,
  • Being at level 1 or 2 according to the Gross Motor Function Classification System,
  • Being at level 1 according to Communication Function Classification System,
  • To adapt to the evaluations,
  • To get 27 points or above from the Modified Mini Mental Test (MMMT).

排除标准

  • Having had injuries such as strains, sprains or fractures of the lower extremity in the last six months,
  • Having undergone a surgical intervention or Botulinum toxin in the last six months,
  • Having any known chronic systemic problems,
  • Having uncontrollable seizures,
  • Having vision or hearing problems.

结局指标

主要结局

Gate speed of time-distance gait parameters

时间窗: Change from baseline time-distance gait parameters at 8th week and 16th week

Gate speed will be evaluated using with gait platform. The software gives the outcome as km/h.

Visual gait analysis

时间窗: Change from baseline visual gait analysis at 8th week and 16th week

Visual gait analysis will be performed with Edinburgh Visual Gait Score. Edinburg Visual Gait Score is scoring between 0 to 34 for each lower extremity. The higher scores points above 0 means abnormal gate.

Stride length of time-distance gait parameters

时间窗: Change from baseline time-distance gait parameters at 8th week and 16th week

Stride length will be evaluated using with gait platform.The software gives the outcome as cm.

Functional balance

时间窗: Change from baseline functional balance at 8th week and 16th week

Functional balance will be evaluate using with Pediatric Berg Balance Scale. The scale is scoring 0-56. The higher scores indicate better functional balance.

Step time of time-distance gait parameters

时间窗: Change from baseline time-distance gait parameters at 8th week and 16th week

Step time will be evaluated using with gait platform.The software gives the outcome as sec and calcules for each lower extremity.

Cadance of time-distance gait parameters

时间窗: Change from baseline time-distance gait parameters at 8th week and 16th week

Step time will be evaluated using with gait platform.The software gives the outcome as steps/min.

Center of Pressure path length of balance parameters

时间窗: Change from baseline balance parameters at 8th week and 16th week.

Center of Pressure path length will be evaluated using with gait platform. The software gives the outcome as mm.

Step length of time-distance gait parameters

时间窗: Change from baseline time-distance gait parameters at 8th week and 16th week

Step lengt will be evaluated using with gait platform. The software gives the outcome as cm and calcules for each lower extremity.

Stride time of time-distance gait parameters

时间窗: Change from baseline time-distance gait parameters at 8th week and 16th week

Step time will be evaluated using with gait platform.The software gives the outcome as sec.

Ellipse area of balance parameters

时间窗: Change from baseline balance parameters at 8th week and 16th week.

Ellipse area will be evaluated using with gait platform. The software gives the outcome as mm2.

次要结局

  • Functional Mobility Skills(Change from baseline Functional Mobility Skills at 8th week and 16th week)
  • Gross Motor Function Measurement(Change from baseline Gross Motor Function Measurement at 8th week and 16th week)
  • Muscle Tonus(Change from baseline Muscle Tonus at 8th week and 16th week)
  • Health-related quality of life(Change from baseline health-related quality of life at 8th week and 16th week)
  • Functional Independence Levels(Change from baseline Functional Independence Levels at 8th week and 16th week)

研究者

发起方
Kutahya Health Sciences University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Eda Ozge OKUR

Principal Investigator

Kutahya Health Sciences University

研究点 (2)

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