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临床试验/NCT07110025
NCT07110025尚未招募不适用

Functional Electrical Stimulation With Core Stabilization Exercises in Children With Spastic Diplegia

Cairo University1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2025年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
36
试验地点
1
主要终点
Assessment of muscle tone

研究概览

简要总结

This study was done to:

  • investigate the combined effect of functional electrical stimulation with core stabilization exercises on pelvic tilting in children with spastic diplegia.
  • To investigate the combined effect of functional electrical stimulation with core stabilization exercises on standing balance in children with spastic diplegia.

详细描述

Spastic diaplegia in children affects motor development and muscle tone. Functional electrical stimulation can improve range of motion, muscle strength, walking speed, and gait. Correcting pelvic position is crucial for treating postural weaknesses. Core stability programs are recommended for spastic cerebral palsy children. Rehabilitation programs should focus on restoring normal pelvic alignment to improve overall balance and functional abilities. This study investigates the effect of functional electrical stimulation on rectus abdominis and gluteus maximus muscles and core stabilization exercises in spastic diplegic cerebral palsy children.

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
Single (Participant)

入排标准

年龄范围
4 Years 至 6 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Their age will range from 4 to 6 years.
  • •Their degree of spasticity will range from 1 to 1+, according to the modified Ashworth scale.
  • •Their motor function will be at level Ⅰ & Ⅱ according to gross motor function classification system.
  • •Their pelvic tilting angle will be more than 7.6°

排除标准

  • •Musculoskeletal fixed deformities in lower limbs and spine
  • •Visual or hearing problems
  • •Botulinum toxin injection or orthopedic surgery within past 6 months or within study period

研究组 & 干预措施

functional electrical stimulation and designed physiotherapy program

Experimental

Children in this group will receive the same training program as control group for 30-minutes in addition to functional electrical stimulation using EV-906 DIGITAL transcutaneous electrical nerve stimulation/EMS neuromuscular stimulator device during core stability exercises for 30-minutes 3 sessions/week for 3 months

干预措施: designed physical therapy program (Other)

functional electrical stimulation and designed physiotherapy program

Experimental

Children in this group will receive the same training program as control group for 30-minutes in addition to functional electrical stimulation using EV-906 DIGITAL transcutaneous electrical nerve stimulation/EMS neuromuscular stimulator device during core stability exercises for 30-minutes 3 sessions/week for 3 months

干预措施: core stabilization exercise with neuromuscular electrical stimulation (Other)

designed physiotherapy program

Active Comparator

Children in this group will receive designed physiotherapy program for 1 hour including core stability exercises focusing on correcting pelvic tilting and standing balance. Each child will participate for 1 hour, 3 sessions/week for 3 months

干预措施: designed physical therapy program (Other)

结局指标

主要结局

Assessment of muscle tone

时间窗: at baseline and after 12 weeks

The modified Ashworth scale will be used to determine the degree of spasticity of the affected lower limb; the child will be in supine position with head in neutral position, and the examiner will moves the knee of affected side through full range of flexion and extensions the child is instructed to stay relaxed and to avoid resisting or facilitating the joint movement applied by the examiner; children with grades 1 or 1+ will be included

Assessment of gross motor function level

时间窗: at baseline and after 12 weeks

The Gross Motor Function Classification System is a clinical classification system with five levels based on functional limitations, the need for handheld mobility devices, and movement quality. It includes children with level I and II and those transported in a manual wheelchair.

次要结局

  • Assessment of change of pelvic tilting(at baseline and after 12 weeks)
  • Assessment of change of balance(at baseline and after 12 weeks)

研究者

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

Ahmed Abdelsamed Mahmoud Mohamed

principal investigator

Cairo University

研究点 (1)

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