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临床试验/NCT07289347
NCT07289347进行中(未招募)不适用

Effect of a Light Stimulated Footsteps Pathway on Kinematics of Gait in Spastic Diplegic Children

Amira saad mohamed1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年9月20日最近更新:
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
30
试验地点
1
主要终点
step length

研究概览

简要总结

PURPOSE: The purpose of this study will be investigation of the effect oflight stimulated footsteps pathway on kinematics of gait in spastic diplegic children BACKGROUND: The goal of most therapy procedures for children with spastic cerebral palsy is to increase their walking abilities. Locomotor training usinglight stimulated footsteps pathwayhas been recommended for the rehabilitation of children with cerebral palsy in an effort to improve walking independence and gait speed.

HYPOTHESES: Walking on light stimulated footsteps pathway may not affect kinematics of gait in spastic diplegic children RESEARCH QUESTION: Does walking on light stimulated footsteps pathway have any effect onkinematics of gait in spastic diplegic 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 (Outcomes Assessor)

入排标准

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

入选标准

  • Age will range between5 and 8 years old.
  • They had Grade 1 and 1+ hypertonia according to Modified Ashworth Scale (Bohannon and Smith, 1987)
  • Motor Classification System, they were at level I and II (GMFCS)
  • They will capable of following commands and comprehend them.
  • They will exhibit defective gait kinematics, which can be determined through gait kinematics evaluation.
  • All patients who will be enrolled to the study will have their informed consent.

排除标准

  • Epilepsy history.
  • Taking any anti spastic drugs.
  • Both lower limbs had permanent deformity.
  • Surgical intervention history.
  • Have visual or auditory defects.
  • Chest infections or unstable cardiac status.
  • Infective skin conditions.
  • Markedly high or low blood pressure.
  • Individuals with cardiopulmonary conditions.
  • Individuals with any pelvic disease.
  • Individuals undergoing radiation therapy or chemotherapy.
  • Hepatic or pancreatic diseases.

研究组 & 干预措施

Control Group (A)

Active Comparator

This group of fifteen children received a regular traditional therapeutic exercise program three times per week for three month based on the Pragmatic approach .

干预措施: therapeutic exercise (Other)

Study Group (B)

Experimental

The fifteen children in this group got the same therapeutic exercise program as the control group, as well as 30 minutes of gait training on light stimulated footsteps pathway three times per week for three month.

干预措施: therapeutic exercise (Other)

Study Group (B)

Experimental

The fifteen children in this group got the same therapeutic exercise program as the control group, as well as 30 minutes of gait training on light stimulated footsteps pathway three times per week for three month.

干预措施: gait training on light stimulated footsteps pathway (Other)

结局指标

主要结局

step length

时间窗: At baseline and re assessed following 3 months

kinovea software used to evaluate step length The unit of measurement for Step Length is centimeter (cm)

step width

时间窗: At baseline and re assessed following 3 months

kinovea software used to evaluate step width The unit of measurement for Step width is centimeter (cm)

spasticity

时间窗: At baseline and re assessed following 3 months

The Modified Ashworth Scale (MAS) used for evaluation MAS assigns a grade of spasticity from a 0-4 ordinal scale. The grade is assigned by moving a joint/muscle through a high velocity quick stretch.

gross motor function

时间窗: At baseline and re assessed following 3 months

The Gross Motor Function Measure (GMFM) is a standardized tool used to assess changes in gross motor function in children, particularly those with cerebral palsy. The GMFM uses a four-point ordinal scale for scoring each item, where: 0: Does not initiate 1. Initiates (but does not complete) 2. Partially completes 3. Completes the task fully Scores can be summed to calculate raw and percent scores for each dimension and a total GMFM score.

次要结局

未报告次要终点

研究者

发起方
Amira saad mohamed
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Amira saad mohamed

lecturer of physical therapy

Cairo University

研究点 (1)

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