Cerebral Palsy Spastic DiplegiaNCT07000422
Effect of Eye Movement Exercise on Gait Spatial and Temporal Parameters in Cerebral Palsy Spastic Diplegic Children
A study testing Selected gait training program and Eye movement exercise in people with Cerebral Palsy Spastic Diplegia, run by Cairo University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 years
- Conditions the study is for
- Cerebral Palsy Spastic Diplegia
- What is being tested?
- Selected gait training program and Eye movement exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2025to 7 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Asmaa Osama Sayed, PhD contact
Egypt1 site
Cairo University
Giza
Salma Mohammed Hamza Rezq, B.Sc, +20 106 518 4515, dr.salmaa90@gmail.com
About this study
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.
Read the 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
- Being tested
- Selected gait training program, Eye movement exercise
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Selected gait training programOther
All children in both groups will receive selected gait training (treadmill) sessions for five times per week over 6 successive months.
Eye movement exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Selected gait training program | Active comparator | They will receive selected gait training (treadmill) sessions for five times per week over 6 successive months. Receives: Other: Selected gait training program |
| 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. Receives: Other: Selected gait training program; Other: Eye movement exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step Length
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.
Measured: 6 months
Step Width
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.
Measured: 6 months
Stride Length
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.
Measured: 6 months
Cadence
Using the foot print, the number of steps per minute will be measured before and after treatment for all participants in both groups.
Measured: 6 months
Step Time (s)
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.
Measured: 6 months
Stride Time
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.
Measured: 6 months
Stance Time Stance Time
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.
Measured: 6 months
Swing Time
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.
Measured: 6 months
Single Support Time
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.
Measured: 6 months
Double Support Time
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.
Measured: 6 months
Secondary outcomes (1)
Ocular motor score (OMS)
It will be assessed for all participants in both group before and after treatment. It is a new clinical test protocol for evaluating ocular motor functions in children and young adults. OMS is a set of 15 important and relevant non-invasive ocular motor function parameters derived from clinical practice. The subtests are scored as 0 (normal) 0.3 or 0.5 (subnormal) and 1 (pathological).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2025
- Study start30 May 2025 (estimated)
- Primary completion30 Nov 2025 (estimated)
- Study completion7 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebral Palsy Spastic DiplegiaStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Salma Mohammed Hamza Rizq, Cairo University
- Investigators
- Kamal Elsayed mohamed Shoukry, PhD, Study chair, Professor, Cairo universityAsmaa Osama Sayed, PhD, Study director, Assistant Professor, Cairo university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07000422
- Sponsor's protocol ID
- P.T.REC/012/004463
- Status last verified
- May 2025
- First submitted
- 24 May 2025
- Last updated
- 2 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Eye Movement Exercise on Gait Spatial and Temporal Parameters in Cerebral Palsy Spastic Diplegic Children
- ClinicalTrials.gov ID
- NCT07000422
- Acronym / sponsor ID
- P.T.REC/012/004463
- Conditions
- Cerebral Palsy Spastic Diplegia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 30 May 2025 (estimated)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 7 Dec 2025 (estimated)
- First posted
- 2 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Selected gait training program | Active comparator | Other: Selected gait training programThey will receive selected gait training (treadmill) sessions for five times per week over 6 successive months. |
| Selected gait training program + Eye movement exercise | Experimental | Other: Selected gait training program, Other: Eye movement exerciseThey will receive selected gait training (treadmill) sessions plus eye movement exercise for five times per week over 6 successive months. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Selected gait training programAll children in both groups will receive selected gait training (treadmill) sessions for five times per week over 6 successive months. | Other | Selected gait training program, Selected gait training program + Eye movement exercise |
| Eye movement exerciseAll 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. | Other | Selected gait training program + Eye movement exercise |
Primary outcome
Step Length
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
1 secondary outcome
Ocular motor score (OMS)
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Asmaa Osama Sayed, PhD contact
Kamal Elsayed mohamed Shoukry, PhD study chair
Professor, Cairo university
Asmaa Osama Sayed, PhD study director
Assistant Professor, Cairo university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Selected gait training program and Eye movement exercise in people with Cerebral Palsy Spastic Diplegia, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Salma Mohammed Hamza Rezq, B.Sc (+20 106 518 4515, dr.salmaa90@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Step Length (time frame: 6 months). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2025.