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Clinical Trials/NCT07555028
NCT07555028
Completed
Not Applicable

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

Horus University1 site in 1 country300 target enrollmentStarted: September 1, 2025Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Horus University
Enrollment
300
Locations
1
Primary Endpoint
assessment of development improvement

Overview

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.

Detailed Description

Developmental delays in early childhood involve various conditions where children do not meet age-appropriate milestones, leading to negative outcomes such as decreased academic performance and long-term mental health issues. Research highlights the complex interplay of physical and psychosocial factors in early development, with physical therapy recognized for its role in improving both physical and psychological health. Early detection and intervention are crucial for better developmental outcomes, with recent studies advocating for telerehabilitation and home-based physiotherapy. Prevalence rates of developmental delays in preschoolers range from 5% to over 20%, especially underreported in low- and middle-income countries. This study focuses on the prevalence of developmental delays in preschoolers in Damietta, Egypt, and assesses the effectiveness of customized early physical therapy programs.

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
3 Years to 5 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

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

Exclusion Criteria

  • 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.

Arms & Interventions

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.

Intervention: domain-specific physical therapy interventions (Other)

Outcomes

Primary Outcomes

assessment of development improvement

Time Frame: at baseline and after 6 months

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.

assessment of Developmental progress

Time Frame: at baseline and after 6 months

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

Secondary Outcomes

  • assessment of Parent satisfaction with the therapy program(at baseline and after 6 months)

Investigators

Sponsor
Horus University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mohamed Salah El-Sayed

Principal Investigator

Horus University

Study Sites (1)

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