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临床试验/NCT07008521
NCT07008521进行中(未招募)不适用

EFFECT OF UNIVERSAL EXERCISE UNIT VERSUS REBOUND THERAPY ON GENU RECURVATUM IN CHILDREN WITH SPASTIC CEREBRAL PALSY

Cairo University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
degree of genu recurvatum

研究概览

简要总结

to investigate and compare between effectiveness of Universal Exercise Unit and Rebound Therapy on genu recurvatum, muscle strength, balance, functional mobility and quality of life in spastic cerebral palsy children

详细描述

Children will be equally assigned into three groups using simple randomization, control group, study group (A) and study group (B). Each group will consist of 20 children with spastic CP to overcome any drop out may occur.

Control group: Children in this group will receive a traditional physical therapy program.

Study group (A): Children in this group will receive a traditional physical therapy program in addition to universal exercise unit program.

Study group (B): Children in this group will receive the same traditional physical therapy program in addition to rebound therapy.

Evaluation will be carried out for each child individually before and after 3 months of treatment.

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
Double (Participant, Outcomes Assessor)

盲法说明

Participants will be assigned randomly into three groups of equal number (control group, study group A and study group B ) the randomization will be performed by simple randomization. Assessors will be blinded to the groups of the subjects.

入排标准

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

入选标准

  • •-Children with spastic CP both hemiplegic and diplegic.
  • •Their ages will be ranged from 5-7 years old.
  • •They will have mild spasticity (grade 1 and 1+) according to Modified Ashworth scale .
  • •They will be in level I and II according to gross motor function classification system (GMFCS) .
  • •They will be able to understand orders given to them.

排除标准

  • •Subjects will be excluded if they have the following:
  • •Visual or hearing impairment.
  • •Severe limb deformities as structural genurecurvatum.
  • •Surgical interference in the lower limbs for the last 6 months.
  • •Botulinum toxin injection of the spastic lower limb muscles during the last six months.

研究组 & 干预措施

control group

Active Comparator

Control group: Children in this group will receive a traditional physical therapy program.

干预措施: Traditional physical therapy program (Procedure)

study group A

Experimental

Study group (A): Children in this group will receive a traditional physical therapy program in addition to universal exercise unit program.

干预措施: Universal exercise unit (Procedure)

Study group B

Experimental

Study group (B): Children in this group will receive the same traditional physical therapy program in addition to rebound therapy

干预措施: Rebound Therapy (Procedure)

结局指标

主要结局

degree of genu recurvatum

时间窗: 10 minutes

degree of genu recurvatum will be measured by Radiological X-Ray

次要结局

  • muscle power(2 minutes)
  • balance(20 minutes)
  • functional mobility(20 minutes)
  • Quality of child life(20 minutes administration for each child)

研究者

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

Merhan Megahid Hamouda Bakr

assistant lecturer

Cairo University

研究点 (1)

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