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

April 21, 2026 updated by: Mohamed Salah El-Sayed, Horus University
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.

Study Overview

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 Type

Observational

Enrollment (Actual)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Damietta, Egypt
        • Alazhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
at baseline and after 6 months
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
at baseline and after 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
assessment of Parent satisfaction with the therapy program
Time Frame: at baseline and after 6 months
Parent satisfaction with the therapy program was evaluated using a structured questionnaire developed for the study. The questionnaire was administered to caregivers at the end of the intervention period in a quiet setting, with clear instructions provided to ensure accurate responses. It included multiple items assessing satisfaction with different aspects of the program, such as perceived effectiveness, ease of implementation, therapist-parent communication, and overall experience. Responses were recorded using a Likert scale ranging from "very dissatisfied" to "very satisfied." The collected data were reviewed for completeness, and total satisfaction scores were calculated and analyzed to determine the overall level of parent satisfaction with the therapy program.
at baseline and after 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2025

Primary Completion (Actual)

February 1, 2026

Study Completion (Actual)

March 1, 2026

Study Registration Dates

First Submitted

April 21, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 28, 2026

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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