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临床试验/NCT07686809
NCT07686809招募中不适用

Effect of Lower Extremity Modified Constraint-induced Movement Therapy on Locomotion in Children With Hemiplegia

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
assessment of spatial gait parameters

研究概览

简要总结

  • To determine the effect of modified constraint-induced movement therapy on spatial and temporal gait parameters in children with hemiplegia.
  • To determine the effect of modified constraint-induced movement therapy on functional mobility in children with hemiplegia.

详细描述

Children with spastic hemiplegic cerebral palsy experience longer gait cycles, slower walking speeds, and longer support phases compared to healthy children, with substantial joint angle differences noted during ground contact and stride buffering. Although most can achieve independent walking, they often exhibit poor motor coordination, resulting in short strides and high stride frequencies for speed maintenance. Modified constraint-induced movement therapy has been employed to enhance lower-extremity function, but its effectiveness on key ambulation aspects like gait speed and balance remains unclear. The reliance on the unaffected limb further impacts locomotive behavior, leading to stiff knee gait and reduced functional mobility. This study aims to explore the therapy's effects on locomotion in hemiplegic 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
6 Years 至 8 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The age of the selected children will range from 6 to 8 years old.
  • Degree of spasticity will range from 1+ to 2 according to the modified Ashworth scale.
  • The level of motor function of the children will be levels I-II according to the Gross Motor Function Classification System.
  • Participants will present a score between 41 to 56 points on the pediatric balance scale.
  • They will be able to follow instructions and understand commands.

排除标准

  • Bone and tendon lengthening surgeries within the last 6 months.
  • Lung and heart diseases and disorders.
  • Vision or hearing problems.
  • Children with fixed deformities in the lower extremity.
  • Children with epilepsy.
  • Recent intramuscular Botulinum toxin injection.

结局指标

主要结局

assessment of spatial gait parameters

时间窗: At baseline and after Four weeks

Kinovea is a free 2D motion analysis software that facilitates inexpensive, sensor-free video-based motion assessments suitable for clinical practice. Its reliability has been established for measuring cervical range of motion (ROM) in both sagittal and frontal planes, dominant wrist joint ROM, shoulder ROM, and ankle joint ROM during walking. Additionally, it effectively measures spatial gait parameters, including stride length, step length, and hip, knee, and ankle angles at initial contact and mid-swing stages of the gait cycle. Required tools for its use include a walking area, digital camera, adhesive skin marks, and a tripod.

次要结局

  • assessment of Temporal gait parameters(At baseline and after four weeks)
  • assessment of the functional mobility(At baseline and after four weeks)

研究者

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

Mohamed Ali Elsayed Taha

Principal investigator

Cairo University

研究点 (1)

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