Prevalence of Developmental Delays in Preschool Children and the Role of Early Physical Therapy

NCT07555028 | Completed

• 1 other identifier: Mohamed-00012367
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study was done to determine the prevalence of developmental delays among preschool children in Damietta and to evaluate the effect of early physical therapy intervention on children diagnosed with developmental delays.

Conditions

Developmental Delay; Child Development; Physical Therapy

Outcome Measures

Primary Outcomes (2)

• assessment of development improvement

  Assessment of developmental outcomes was conducted using the Denver II Developmental Screening Test. Each child was evaluated individually in a quiet, well-lit environment to minimize distractions and ensure optimal performance. The test was administered according to standardized guidelines, covering four developmental domains: personal-social, fine motor-adaptive, language, and gross motor skills. Age-appropriate items were selected based on the child's chronological age line, and each item was scored as "pass," "fail," "refusal," or "no opportunity" based on the child's performance. The assessment was carried out by a trained examiner to maintain consistency and reliability. Pre- and post-intervention scores were recorded and compared to determine improvement in developmental domain outcomes.

  at baseline and after 6 months

• assessment of Developmental progress

  Developmental progress was assessed using the Ages and Stages Questionnaire, Third Edition (ASQ-3), a parent-completed screening instrument. Caregivers were provided with the age-appropriate questionnaire and given clear instructions on how to complete it based on their child's typical behavior. The ASQ-3 evaluates five developmental domains: communication, gross motor, fine motor, problem-solving, and personal-social skills. Each item was rated by the parent as "yes," "sometimes," or "not yet," and corresponding scores were calculated for each domain. The completed questionnaires were reviewed by the researcher to ensure accuracy and completeness. Pre- and post-intervention scores were compared to determine changes in developmental performance

  at baseline and after 6 months

Secondary Outcomes (1)

• assessment of Parent satisfaction with the therapy program

  at baseline and after 6 months

Study Arms (1)

preschool children from urban and rural areas

Children aged 3 to 5 years attending public and private kindergartens in Damietta were included. Stratified random sampling was used to ensure representation from urban and rural areas.

Other: domain-specific physical therapy interventions

Interventions

domain-specific physical therapy interventions OTHER

Motor Delay: Gross and fine motor stimulation, balance training, coordination activities. Language Delay: Speech exercises, articulation therapy, and parent-guided interaction tasks. Social/Emotional Delay: Group play, role-playing exercises, and emotion recognition tasks. Therapy was conducted twice weekly for 6 months by licensed pediatric physical therapists. Progress was monitored monthly and documented in structured logs reviewed by the clinical supervisor.

preschool children from urban and rural areas

Eligibility Criteria

• Age: 3 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children aged 3 to 5 years attending public and private kindergartens in Damietta were included. Stratified random sampling was used to ensure representation from urban and rural areas.

You may qualify if:

• Children aged 3 to 5 years.
• Enrolled in kindergarten in Damietta.
• Informed parental consent obtained.

You may not qualify if:

• Children with diagnosed neurological disorders (e.g., cerebral palsy).
• Children with severe sensory impairments (e.g., blindness, deafness).
• Children on active pharmacological treatments for developmental disorders.

Sponsors & Collaborators

• Horus University: lead

Study Sites (1)

Alazhar University

Damietta, Egypt

Location

MeSH Terms

Conditions

Learning Disabilities

Condition Hierarchy (Ancestors)

Communication Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 21, 2026
• First Posted: April 28, 2026
• Study Start: September 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

EG (1)