- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07273240
The Effects of Physical Activity Program on Psychomotor and Psycho-Social Characteristics of Autistic Children
December 6, 2025 updated by: Ebru Ayaz, Istanbul University - Cerrahpasa
The aim of this study was to examine the effect of Physical Activity Program (PAP) on psychomotor and psychosocial characteristics of autistic children.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The research group consisted of a total of 40 participants, 20 in the control group (CG) and 20 in the experimental group (EG), aged between 8-12 years.
EG participated in the PAP for 60 minutes a day, 3 days a week for 10 weeks.
Gilliam Autistic Disorder Rating Scale-2, Bruininks-Oseretsky motor competence test-2 short form (BOT-2 SF), Eurofit Test Battery, Pediatric Quality of Life Form and Social Skills Rating System Parent Form were used in the study.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
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
-
-
Kocaeli
-
İzmit, Kocaeli, Turkey (Türkiye), 41500
- Izmit Special Education Practice School, Derince Special Education Practice School, Golcuk Ozdebir Special Education Practice Center, Kartepe Special Education Practice School, Izmit, Kocaeli 41500
-
-
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
Yes
Description
Inclusion Criteria:
- Recognized ASD
- Between 8 and 12 years of age
- Attending a special education school
- No impairment of vision, hearing, or acceleration
- No health problems that would prevent economic activity
- Not participating in any sports
- Updated procedures by the parent.
Exclusion Criteria:
- Family withdrawal from the study
- Failure to participate in pre-tests or post-tests
- Absence from the program for more than two weeks
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
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: control group
No intervention
|
|
|
Experimental: experimental group
Physical Activity Program
|
PAP was prepared for psychomotor (motor skills and physical fitness) and psychosocial (social skills and daily living skills) development areas based on the pre-test items of the data collection tools.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The effect of physical activity on psychomotor characteristics
Time Frame: 10-week physical activity program
|
Outcome Name: Change in gross motor skills Description: Measured using the Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), total and subscale scores.
|
10-week physical activity program
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The effect of physical activity on psychomotor characteristics
Time Frame: 10-week physical activity program
|
Outcome Name: Change in gross motor skills Description: Measured using total and subscale scores using the Eurofit Test Battery.
|
10-week physical activity program
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The effect of physical activity on psychososyal characteristics
Time Frame: 10-week physical activity program
|
Outcome Name: Change in psychosocial skills Description: Psychosocial characteristics were measured using the Gilliam Autism Disorder Rating Scale-2.
|
10-week physical activity program
|
|
The effect of physical activity on psychosocial characteristics
Time Frame: 10-week physical activity program
|
Outcome Name: Change in gross psychosocial skills Description: Psychosocial characteristics were measured using the Pediatric Quality of Life Form.
|
10-week physical activity program
|
|
The effect of physical activity on psychosocial characteristics
Time Frame: 10-week physical activity program
|
Outcome Name: Change in gross psychosocial skills Description: Psychosocial characteristics were measured using the Social Skills Rating System Parent Form
|
10-week physical activity program
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Dilara F Özer, Prof. Dr., Istanbul Bilgi University
- Study Chair: Gülsüm H Özcan, Dr., Istanbul University Cerrahpasa
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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)
February 14, 2022
Primary Completion (Actual)
May 15, 2022
Study Completion (Actual)
June 6, 2023
Study Registration Dates
First Submitted
November 16, 2025
First Submitted That Met QC Criteria
December 6, 2025
First Posted (Estimated)
December 9, 2025
Study Record Updates
Last Update Posted (Estimated)
December 9, 2025
Last Update Submitted That Met QC Criteria
December 6, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06.05.2022-376308 (Other Identifier: Istanbul University-Cerrahpaşa)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All IPDs that form the basis of a publication's results
IPD Sharing Time Frame
Individual participant data and supporting documentation will be made available 6 months after the main results are published and will remain available for 5 years.
IPD Sharing Access Criteria
Individual participant data and supporting documentation will be made available to qualified researchers upon reasonable request.
Access will be granted for scientific research proposals that have received ethics committee approval, and researchers will be required to sign an access agreement outlining data use and confidentiality terms.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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