Skip to main content
OpenTrials
Completed

NCT Number: NCT07555028

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

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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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

  1. 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.

Sponsors and collaborators

Lead sponsor

Horus University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 28, 2026
Registry last updated
Apr 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.