Developmental DelayNCT07555028
Prevalence of Developmental Delays in Preschool Children and the Role of Early Physical Therapy
An observational study of Developmental Delay and Child Development, run by Horus University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 5 years
- Conditions the study is for
- Developmental Delay, Child Development, Physical Therapy
- What is being tested?
- domain-specific physical therapy interventions
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2025to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 5 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- Children aged 3 to 5 years.
- Enrolled in kindergarten in Damietta.
- Informed parental consent obtained.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Developmental Delay, Child Development, Physical Therapy
- Being tested
- domain-specific physical therapy interventions
- Medical subject headings
- Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
domain-specific physical therapy interventionsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: domain-specific physical therapy interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: at baseline and after 6 months
Secondary outcomes (1)
assessment of Parent satisfaction with the therapy program
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.
Measured: at baseline and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start1 Sep 2025
- Primary completion1 Feb 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Developmental DelayStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Horus University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Salah El-Sayed, Horus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555028
- Sponsor's protocol ID
- Mohamed-00012367
- Status last verified
- Apr 2026
- First submitted
- 21 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Developmental Delays in Preschool Children and the Role of Early Physical Therapy
- ClinicalTrials.gov ID
- NCT07555028
- Acronym / sponsor ID
- Mohamed-00012367
- Conditions
- Developmental Delay, Child Development, Physical Therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Horus UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| preschool children from urban and rural areas | – | Other: domain-specific physical therapy interventionsChildren 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. |
Who may qualify
- Ages
- 3 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (3 listed)
- Children aged 3 to 5 years.
- Enrolled in kindergarten in Damietta.
- Informed parental consent obtained.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| domain-specific physical therapy interventionsMotor 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. | Other | preschool children from urban and rural areas |
Primary outcome
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
1 secondary outcome
assessment of Parent satisfaction with the therapy program
Time frame: at baseline and after 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
Related trials for Developmental Delay
RecruitingObservational study
Role of Genetic Factors in the Development of Lung Disease
Cystic Fibrosis, Pulmonary Fibrosis
Recruiting
A Center Based Early Intervention Program For Preschoolers With Developmental Disorders
Development Disorder, Child, Developmental Disability
RecruitingEarly Phase 1
Aprepitant for the Treatment of CLIFAHDD
CLIFAHDD, Congenital Contractures of the Limbs and Face, Hypotonia, and Developmental Delay
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
RecruitingObservational study
Inherited Reproductive Disorders
Genetic Disorder, Infertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Developmental Delay and Child Development, run by Horus University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assessment of development improvement (time frame: at baseline and after 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.