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临床试验/NCT05348135
NCT05348135已完成不适用

Synergistic Effect of Functional Strength Training and Cognitive Intervention on Motor and Cognitive Functions in Children With Cerebral Palsy

Cairo University1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
change in attention / concentration measures

研究概览

简要总结

Cerebral palsy is primarily a disorder of movement and posture however; it often involves disorder of different aspects of cognitive function.

详细描述

This study evaluated the effect of FST and cognitive intervention and their combined effect on motor and cognitive functions in children with spastic diplegia. A convenient sample of spastic diplegic CP children, with their age ranging from 8 to 12 years were assigned randomly into four treatment groups

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
Triple (Participant, 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

  • chronological age ranged from 8 to 12 years,
  • spasticity grade in affected lower limbs ranged between 1 + and 2 according to MAS
  • can follow instructions given to them,
  • their intelligence level ranged from 65 to 80 according to Stanford Binet intelligence scale, - -- their motor function ranged between Level II & III according to Gross Motor Functional Classification System Expanded and Revised (GMFCS E&R).

排除标准

  • children who had visual or auditory problems
  • children who took any medicine affecting alertness
  • fixed deformities in the joints of upper & lower limbs
  • any orthopedic surgery in lower limbs within 6 months before study
  • epileptic children.

结局指标

主要结局

change in attention / concentration measures

时间窗: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up

* Computer based RehaCom software used to assess attention / concentration cognitive domain of function. It is clinically proven and evidence-based software. * minimum reaction time ( in seconds) of attention / concentration program was assessed

change in GMFM-88 measures

时间窗: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up

criterion-referenced scale that measure gross motor function in children with CP.

change in figural memory measures

时间窗: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up

* Computer based RehaCom software used to assess figural memory cognitive domain of function.It is clinically proven and evidence-based software. * minimum reaction time ( in seconds) of figural memory program was assessed

change in reaction behavior measures

时间窗: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up

Computer based RehaCom software used to assess reaction behavior cognitive domain of function. It is clinically proven and evidence-based software. - minimum reaction time ( in seconds) of reaction behavior program was assessed

change in logical reasoning measures

时间窗: The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up

Computer based RehaCom software used to assess logical reasoning cognitive domain of function. It is clinically proven and evidence-based software. - minimum reaction time ( in seconds) of logical reasoning program was assessed

次要结局

  • change in Timed up and go test (TUG)measure(The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up)
  • change in Five times sit to stand test (FTSST) measure(The assessment was performed 3 times; at baseline, 6 months (post-treatment) and at 6 months follow up)

研究者

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

Alaa Fahmy Hassan Al Nemr

principal investigator

Cairo University

研究点 (1)

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