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临床试验/NCT05751122
NCT05751122已完成不适用

Effects of Dynamic Flex Cast With Neurodevelopmental Treatment on Gross Motor Functions in Children With Cerebral Palsy

Riphah International University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年2月25日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Clinical Gait Assessment Scale

研究概览

简要总结

The study aims to determine the effects of dynamic flex cast with neurodevelopmental treatment on gross motor functions and gait in children with cerebral palsy.

详细描述

The study aims to determine the effects of dynamic flex cast with neurodevelopmental treatment on gross motor functions and gait in children with cerebral palsy. Combination of Dynamic flex cast with neurodevelopmental treatment will be a novel potential treatment to improve gross motor functions in cerebral palsy. We shall try to fill the gaps of previous studies. It will help in facilitating children to perform their activities, restoring normal ranges and treatment of spasticity in cerebral palsy.

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, Care Provider, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 8 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children with cerebral palsy
  • •Age 3-8 years
  • •Spastic diplegic/ hemiplegic CP
  • •Ankle dorsiflexion 5-10 degrees
  • •GMFCS level 1-3
  • •Modified Ashworth's scale level 1+ - 3

排除标准

  • •Congenital foot deformities
  • •Cognitive impairments
  • •Secondary orthopedic, auditory and severe visual impairments
  • •Unwilling patients or parents
  • •Recent surgical interventions

研究组 & 干预措施

Dynamic flex cast with neurodevelopmental Group

Experimental

Dynamic flex cast with neurodevelopmental treatment

干预措施: Dynamic flex cast with neurodevelopmental treatment (Other)

Rigid Ankle foot Orthosis with neurodevelopmental Group

Active Comparator

Rigid Ankle foot Orthosis with neurodevelopmental treatment

干预措施: Rigid Ankle foot Orthosis with neurodevelopmental treatment (Other)

结局指标

主要结局

Clinical Gait Assessment Scale

时间窗: 12 weeks

It is used to assess gait deviation. Temporal distance factors including velocity, cadence, stride length, stride width will be assessed.

Gross Motor Function Measure-88

时间窗: 12 weeks

The original GMFM has 88 items each scored on a 4-point ordinal scale of 0 to 3, where 0 indicates that the child does not initiate the task; 1 indicates that the child initiates the task (completes \< 10% activity); 2 indicates that the child partially completes the task (completes from 10 to 99% of activity); 3 indicates that the child completes the task (100%); and NT indicates that the child was not tested. The 88 items are grouped into five dimensions: 1) lying and rolling, 2) sitting, 3) crawling and kneeling, 4) standing, and 5) walking, running and jumping. Reliability with intraclass correlation coeffcient greater than .98 with 0.965--.994 95% confidence interval.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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