Children With Autism Spectrum DisorderNCT07273240
The Effects of Physical Activity Program on Psychomotor and Psycho-Social Characteristics of Autistic Children
A study testing Physical Activity in people with Children With Autism Spectrum Disorder, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to examine the effect of Physical Activity Program (PAP) on psychomotor and psychosocial characteristics of autistic children. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Children With Autism Spectrum Disorder
- What is being tested?
- Physical Activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Feb 2022to 6 Jun 2023
- Phase
- Interventional
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Family withdrawal from the study
- Failure to participate in pre-tests or post-tests
- Absence from the program for more than two weeks
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmit Special Education Practice School, Derince Special Education Practice School, Golcuk Ozdebir Special Education Practice Center, Kartepe Special Education Practice School, Izmit, Kocaeli 41500
İzmit, Kocaeli, 41500
About this study
The aim of this study was to examine the effect of Physical Activity Program (PAP) on psychomotor and psychosocial characteristics of autistic children.
Read the 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.
- Conditions
- Children With Autism Spectrum Disorder
- Being tested
- Physical Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical ActivityOther
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.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Physical Activity Program Receives: Other: Physical Activity |
| control group | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of physical activity on psychomotor characteristics
Outcome Name: Change in gross motor skills Description: Measured using the Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), total and subscale scores.
Measured: 10-week physical activity program
Secondary outcomes (1)
The effect of physical activity on psychomotor characteristics
Outcome Name: Change in gross motor skills Description: Measured using total and subscale scores using the Eurofit Test Battery.
Measured: 10-week physical activity program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start14 Feb 2022
- Primary completion15 May 2022
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children With Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Istanbul University - CerrahpasaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ebru Ayaz, Istanbul University - Cerrahpasa
- Investigators
- Dilara F Özer, Prof. Dr., Study director, İstanbul Bilgi UniversityGülsüm H Özcan, Dr., Study chair, İstanbul University Cerrahpaşa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273240
- Sponsor's protocol ID
- 06.05.2022-376308
- Other IDs
- 06.05.2022-376308
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPDs that form the basis of a publication's results
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Physical Activity Program on Psychomotor and Psycho-Social Characteristics of Autistic Children
- ClinicalTrials.gov ID
- NCT07273240
- Acronym / sponsor ID
- 06.05.2022-376308
- Conditions
- Children With Autism Spectrum Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 9 Dec 2025 (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.
The aim of this study was to examine the effect of Physical Activity Program (PAP) on psychomotor and psychosocial characteristics of autistic children.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Other: Physical ActivityPhysical Activity Program |
| control group | No intervention | –No intervention |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Family withdrawal from the study
- Failure to participate in pre-tests or post-tests
- Absence from the program for more than two weeks
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 |
|---|---|---|
| Physical ActivityPAP 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. | Other | experimental group |
Primary outcome
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.
1 secondary outcome
The effect of physical activity on psychomotor characteristics
Time frame: 10-week physical activity program
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 9 Dec 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All IPDs that form the basis of a publication's results
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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.
Dilara F Özer, Prof. Dr. study director
İstanbul Bilgi University
Gülsüm H Özcan, Dr. study chair
İstanbul University Cerrahpaşa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Activity in people with Children With Autism Spectrum Disorder, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
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 7 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 9 Dec 2025. 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 Turkey (Türkiye). 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?
The effect of physical activity on psychomotor characteristics (time frame: 10-week physical activity program). 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 9 Dec 2025.