Clinical trial NCT07000422: Effect of Eye Movement Exercise on Gait Spatial and Temporal Parameters in Cerebral Palsy Spastic Diplegic Children
Official title: Effect of Eye Movement Exercise on Gait Spatial and Temporal Parameters in Cerebral Palsy Spastic Diplegic Children
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Cerebral Palsy Spastic Diplegia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-06-02
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

There is lack in research regarding the area improve eye ex. Its effect on motor ability as in gait, most eye movement studies have been focused on balance, and studies relating eye movement training to gait have been insufficient, so this study will be conducted in hope evidence this area.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Step Length
timeFrame: 6 months
measure: Step Width
timeFrame: 6 months
measure: Stride Length
timeFrame: 6 months
measure: Cadence
timeFrame: 6 months
measure: Step Time (s)
timeFrame: 6 months
measure: Stride Time
timeFrame: 6 months
measure: Stance Time Stance Time
timeFrame: 6 months
measure: Swing Time
timeFrame: 6 months
measure: Single Support Time
timeFrame: 6 months
measure: Double Support Time
timeFrame: 6 months
Secondary outcomes:
measure: Ocular motor score (OMS)
timeFrame: 6 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
Study officials:
affiliation: Professor, Cairo university
name: Kamal Elsayed mohamed Shoukry, PhD
role: STUDY_CHAIR
affiliation: Assistant Professor, Cairo university
name: Asmaa Osama Sayed, PhD
role: STUDY_DIRECTOR
References: