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临床试验/NCT07000422
NCT07000422尚未招募不适用

Effect of Eye Movement Exercise on Gait Spatial and Temporal Parameters in Cerebral Palsy Spastic Diplegic Children

Cairo University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年5月30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
30
试验地点
1
主要终点
Step Length

研究概览

简要总结

The purpose of this study is to determine if there is an effect of eye movement training exercises on gait kinetic variables in cerebral palsy spastic diplegic children.

详细描述

Cerebral palsy is often accompanied by a dysfunction of the visual system consisting of an anterior part both eyes and the optic nerves up to the optic chiasm and a posterior part--the optic tracts, the lateral geniculate nuclei, the optic radiations and the occipital cortex. among children with cerebral palsy, 49.6% had ophthalmological disorders. The eye movement disorders are most common showing functional abnormalities such as gaze, saccade, and smooth pursuit in addition to strabismus and abnormal eye movements. In other words, the aspects of cerebral palsy are based not only on motor dysfunction characteristics and local anatomy but also on neuro-ophthalmology.

The visual perception system has a great influence on postural control and motor development by engaging in spatial association, identifying object characteristics, and distinguishing objects and their backgrounds, and eye movement function to place the image of nearby objects in the center also acts as an important factor in postural control and motor development. Eye movement control is the most basic type of visual perception, and lack of eye movement control often occurs in patients suffering from central nervous system diseases.

In order to achieve balance during normal gait, diverse brain regions, such as the cerebral cortex, cerebellum, and brain stem are involved. There are three crucial functional factors: the supporting action of the musculoskeletal system, the coordination of functional eye movement, and the integration of sensory function with action.

Eye movement training, in which movement patterns are adjusted through visual feedback, has been studied recently. Visual field and visual accuracy affect balance and movement ability, and in particular, patients with problems in the visual system often develop problems with balance ability.

The vestibular system contributes to postural stability and visual stabilization through the vestibulo-spinal reflex (VSR) and the vestibulo-ocular reflex (VOR). The vestibulo-ocular reflex is a reflex eye movement that stabilizes images on the retina during head movement. A rotation of the head is detected, which triggers an inhibitory signal to the extraocular muscles on one side and an excitatory signal to the muscles on the other side. The result is a compensatory movement of the eyes. the vestibulo-ocular reflex does not depend on visual input and works even in total darkness or when the eyes are closed.

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 6 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Their age range 4-6 years old.
  • •They are Classified on levels I and II of the Gross Motor Function Classification System (GMFCS).
  • •The degree of spasticity will range from grade 1 or 1+ according to Modified Ashworth Scale.
  • •They able to walk without the assistance of another individual.
  • •Children with spastic diplegia gait pattern of Crouch gait.
  • •Intact vision and clear eye investigations.
  • •They Able to follow the verbal command.

排除标准

  • •Orthopedic deformities, a history of surgery.
  • •A history of eye surgery, squint or optic neuropathy.
  • •Diagnosis of epilepsy or having experienced convulsive crises (whether treated with medication or not).

研究组 & 干预措施

Selected gait training program

Active Comparator

They will receive selected gait training (treadmill) sessions for five times per week over 6 successive months.

干预措施: Selected gait training program (Other)

Selected gait training program + Eye movement exercise

Experimental

They will receive selected gait training (treadmill) sessions plus eye movement exercise for five times per week over 6 successive months.

干预措施: Selected gait training program (Other)

Selected gait training program + Eye movement exercise

Experimental

They will receive selected gait training (treadmill) sessions plus eye movement exercise for five times per week over 6 successive months.

干预措施: Eye movement exercise (Other)

结局指标

主要结局

Step Length

时间窗: 6 months

Using the foot print, the distance from the heel of one foot-strike to the heel of the opposite foot-strike will be measured in centimeters before and after treatment for all participants in both groups.

Step Width

时间窗: 6 months

Using the foot print, the distance between the centers of the feet during the double limb support portion of the gait cycle will be measured in centimeters before and after treatment for all participants in both groups.

Stride Length

时间窗: 6 months

Using the foot print, the distance between heels of two consecutive foot-strikes of the same foot (distance of a whole gait cycle) will be measured in centimeters before and after treatment for all participants in both groups.

Cadence

时间窗: 6 months

Using the foot print, the number of steps per minute will be measured before and after treatment for all participants in both groups.

Step Time (s)

时间窗: 6 months

Using the foot print, the time elapsed from initial contact of one foot to initial contact of the opposite foot will be calculated in seconds before and after treatment for all participants in both groups.

Stride Time

时间窗: 6 months

Using the foot print, the time of one whole gait cycle (right foot hitting the ground, left foot hitting the ground, then right foot hitting the ground again) will be calculated in seconds before and after treatment for all participants in both groups.

Stance Time Stance Time

时间窗: 6 months

Using the foot print, the time from heel strike to toe off on the same foot will be calculated in seconds before and after treatment for all participants in both groups.

Swing Time

时间窗: 6 months

Using the foot print, the time from toe off to heel strike on the same foot will be calculated in seconds before and after treatment for all participants in both groups.

Single Support Time

时间窗: 6 months

Using the foot print, the time in one gait cycle in which only one foot is on the ground will be calculated in seconds before and after treatment for all participants in both groups.

Double Support Time

时间窗: 6 months

Using the foot print, the time in one gait cycle in which both feet are on the ground will be calculated in seconds before and after treatment for all participants in both groups.

次要结局

  • Ocular motor score (OMS)(6 months)

研究者

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

Salma Mohammed Hamza Rizq

Principal Investigator

Cairo University

研究点 (1)

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