- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07555028
Prevalence of Developmental Delays in Preschool Children and the Role of Early Physical Therapy
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Damietta, Egypt
- Alazhar University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mohamed-00012367
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Child Development
-
SangathUNICEFCompletedChild Development | Child Nutrition and Early Child DevelopmentIndia
-
Yale UniversityRobinhood Foundation; Adelphi University; Docs for TotsCompletedSocial Skills | Child Behavior | Child Development | Infant DevelopmentUnited States
-
International Care Ministries, PhilippinesCompassion International, United States of AmericaNot yet recruitingChild Development | Child Nutrition, Child Neurobehavioral Development | Academic Attainment | Household and Family | Financial Wellbeing
-
University of Southern CaliforniaSafe Water and AIDS Project; Early Childhood Development Network for Kenya...Active, not recruitingChild Behavior | Child Development | Language, ChildKenya
-
Windward Islands Research and Education FoundationGrand Challenges Canada; St. George's University; GRENCASECompletedDevelopment, Child | Behavior, Child | Neurocognition, ChildGrenada
-
London School of Hygiene and Tropical MedicineInternational Centre for Diarrhoeal Disease Research, Bangladesh; University... and other collaboratorsActive, not recruitingChild Development | Child Development DisorderBangladesh, Tanzania, Nepal
-
Children's Hospital of PhiladelphiaNational Institute on Minority Health and Health Disparities (NIMHD)CompletedDevelopment Delay | Development, ChildUnited States
-
University of WashingtonRecruitingChild Behavior | Child DevelopmentUnited States
-
The Hospital for Sick ChildrenAga Khan University; March of DimesCompletedChild Development | Child Mortality | Child Morbidity | Child BehaviourPakistan
-
Universidade Federal de PernambucoCoordination for the Improvement of Higher Education PersonnelNot yet recruitingChild Development | Music Education | Early Child Development | Adaptive Behavior | Preschool EducationBrazil
Clinical Trials on domain-specific physical therapy interventions
-
Indiana UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsRecruiting
-
Hospital Durand, ArgentinaCompletedFrozen Shoulder | Capsulitis, Adhesive | Capsulitis of ShoulderArgentina
-
Michael SofisDartmouth CollegeRecruitingTobacco Use | Marijuana Use | Alcohol Use, Unspecified | Marijuana DependenceUnited States
-
Hunter College of City University of New YorkMultiple Sclerosis FoundationRecruiting
-
Riphah International UniversityRecruitingKnee Osteoarthritis (Knee OA)Pakistan
-
Reynolds Army Community HospitalTemple University; Brooke Army Medical CenterUnknownPhysical Therapy Direct Access | Physical Therapy Primary CareUnited States
-
Third Affiliated Hospital, Sun Yat-Sen UniversityRecruitingDevelop a CT-based Tumor Budding Predictive Model for Bladder Cancer Using Deep Learning AlgorithmsChina
-
Boston Scientific CorporationGuidant CorporationCompletedHeart Failure | Arrhythmias, CardiacJapan
-
Heinrich-Heine University, DuesseldorfCompleted