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

NCT ID: NCT07000422

Last Updated: 2025-06-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-30
• Study Completion Date: 2025-12-07

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.

Conditions

Cerebral Palsy Spastic Diplegia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Selected gait training program

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

Group Type: ACTIVE_COMPARATOR

Selected gait training program

Intervention Type: OTHER

All children in both groups will receive selected gait training (treadmill) sessions for five times per week over 6 successive months.

Selected gait training program + Eye movement exercise

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

Group Type: EXPERIMENTAL

Selected gait training program

Intervention Type: OTHER

All children in both groups will receive selected gait training (treadmill) sessions for five times per week over 6 successive months.

Eye movement exercise

Intervention Type: OTHER

All children in the experimental group will receive eye training exercises for five times per week over 6 successive months. The exercises include tasks to improve visual focus and tracking. Children search for a specific card among 20 while covering one eye, repeated 10 times. They follow a pencil moving vertically, horizontally, in circles, and in a figure 8, maintaining a 1m distance. Exercises include shifting gaze between two pencils, recognizing letters on a shaking card, and tracking a pencil from 5cm to 50cm. Tasks are done with each eye covered separately. Another task involves walking while focusing on a fixed target 1m away at eye level for 5 minutes.

Interventions

Selected gait training program

All children in both groups will receive selected gait training (treadmill) sessions for five times per week over 6 successive months.

Intervention Type: OTHER

Eye movement exercise

All children in the experimental group will receive eye training exercises for five times per week over 6 successive months. The exercises include tasks to improve visual focus and tracking. Children search for a specific card among 20 while covering one eye, repeated 10 times. They follow a pencil moving vertically, horizontally, in circles, and in a figure 8, maintaining a 1m distance. Exercises include shifting gaze between two pencils, recognizing letters on a shaking card, and tracking a pencil from 5cm to 50cm. Tasks are done with each eye covered separately. Another task involves walking while focusing on a fixed target 1m away at eye level for 5 minutes.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Salma Mohammed Hamza Rizq

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kamal Elsayed mohamed Shoukry, PhD

Role: STUDY_CHAIR

Professor, Cairo university

Asmaa Osama Sayed, PhD

Role: STUDY_DIRECTOR

Assistant Professor, Cairo university

Locations

Cairo University

Giza, , Egypt

Countries

Egypt

Central Contacts

Salma Mohammed Hamza Rezq, B.Sc

Role: CONTACT

dr.salmaa90@gmail.com

+20 106 518 4515

Asmaa Osama Sayed, PhD

Role: CONTACT

Facility Contacts

Salma Mohammed Hamza Rezq, B.Sc

Role: primary

dr.salmaa90@gmail.com

+20 106 518 4515

Other Identifiers

P.T.REC/012/004463

Identifier Type: -

Identifier Source: org_study_id