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

NCT07000422 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/004463
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Cerebral Palsy Spastic Diplegia

Outcome Measures

Primary Outcomes (10)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  6 months

Secondary Outcomes (1)

• Ocular motor score (OMS)

  6 months

Study Arms (2)

Selected gait training program

ACTIVE COMPARATOR

They 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

EXPERIMENTAL

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

Other: Selected gait training program; Other: Eye movement exercise

Interventions

Selected gait training program 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; Selected gait training program + Eye movement exercise

Eye movement exercise 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.

Selected gait training program + Eye movement exercise

Eligibility Criteria

• Age: 4 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, Egypt

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Kamal Elsayed mohamed Shoukry, PhD

  Professor, Cairo university

  STUDY CHAIR

• Asmaa Osama Sayed, PhD

  Assistant Professor, Cairo university

  STUDY DIRECTOR

Central Study Contacts

Salma Mohammed Hamza Rezq, B.Sc

CONTACT

+20 106 518 4515; dr.salmaa90@gmail.com

Asmaa Osama Sayed, PhD

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 24, 2025
• First Posted: June 2, 2025
• Study Start: May 30, 2025
• Primary Completion: November 30, 2025
• Study Completion: December 7, 2025
• Last Updated: June 2, 2025

Record last verified: 2025-05

Locations

EG (1)