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CompletedNCT07273240Updated Dec 9, 2025

The Effects of Physical Activity Program on Psychomotor and Psycho-Social Characteristics of Autistic Children

An interventional study of Physical Activity in Children With Autism Spectrum Disorder, sponsored by Istanbul University - Cerrahpasa. Completed at 1 site in Turkey (Türkiye). Open to participants aged 8 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-09.

Sponsored by Istanbul University - Cerrahpasa · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 3 years 9 months after the study started (first participant enrolled Feb 2022, registered Nov 2025).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
8 Years to 12 Years
Sex
All
01

Study 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 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.

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Conditions studied

  • Children With Autism Spectrum Disorder
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In context

Lead sponsor

Istanbul University - Cerrahpasa is the lead sponsor of 680 studies on the registry; 208 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
8 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    experimental group

    Physical Activity Program

    Other: Physical Activity

  • No intervention
    control group

    No intervention

Interventions

  • OtherPhysical Activity

    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.

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 10-week physical activity program

Other outcomes

  1. The effect of physical activity on psychososyal characteristics

    Outcome Name: Change in psychosocial skills Description: Psychosocial characteristics were measured using the Gilliam Autism Disorder Rating Scale-2.

    Time frame: 10-week physical activity program

  2. The effect of physical activity on psychosocial characteristics

    Outcome Name: Change in gross psychosocial skills Description: Psychosocial characteristics were measured using the Pediatric Quality of Life Form.

    Time frame: 10-week physical activity program

  3. The effect of physical activity on psychosocial characteristics

    Outcome Name: Change in gross psychosocial skills Description: Psychosocial characteristics were measured using the Social Skills Rating System Parent Form

    Time frame: 10-week physical activity program

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Study locations

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, Turkey (Türkiye)
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References and documents

Related links

Study documents

  • Study protocol · Apr 3, 2022
  • Statistical analysis plan · Apr 10, 2022
  • Informed consent form · Apr 3, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — All IPDs that form the basis of a publication's results

Supporting information: Study protocol

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 9, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07273240
Lead sponsor
Istanbul University - Cerrahpasa
Responsible party
Ebru Ayaz (Independent Researcher, Istanbul University - Cerrahpasa) — Principal investigator
First posted
Dec 9, 2025
Start date
Feb 14, 2022
Primary completion
May 15, 2022
Completion
Jun 6, 2023
Last update
Dec 9, 2025

Study contacts

Dilara F Özer, Prof. Dr.
study director · İstanbul Bilgi University
Gülsüm H Özcan, Dr.
study chair · İstanbul University Cerrahpaşa

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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