NCT07273240

Brief Summary

The aim of this study was to examine the effect of Physical Activity Program (PAP) on psychomotor and psychosocial characteristics of autistic children.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 14, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2023

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 16, 2025

Completed
23 days until next milestone

First Posted

Study publicly available on registry

December 9, 2025

Completed
Last Updated

December 9, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

November 16, 2025

Last Update Submit

December 6, 2025

Conditions

Outcome Measures

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.

    10-week physical activity program

Secondary Outcomes (1)

  • The effect of physical activity on psychomotor characteristics

    10-week physical activity program

Other Outcomes (3)

  • The effect of physical activity on psychososyal characteristics

    10-week physical activity program

  • The effect of physical activity on psychosocial characteristics

    10-week physical activity program

  • The effect of physical activity on psychosocial characteristics

    10-week physical activity program

Study Arms (2)

experimental group

EXPERIMENTAL

Physical Activity Program

Other: Physical Activity

control group

NO INTERVENTION

No intervention

Interventions

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.

experimental group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • Family withdrawal from the study
  • Failure to participate in pre-tests or post-tests
  • Absence from the program for more than two weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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)

Location

Related Links

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Dilara F Özer, Prof. Dr.

    İstanbul Bilgi University

    STUDY DIRECTOR
  • Gülsüm H Özcan, Dr.

    İstanbul University Cerrahpaşa

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Independent Researcher

Study Record Dates

First Submitted

November 16, 2025

First Posted

December 9, 2025

Study Start

February 14, 2022

Primary Completion

May 15, 2022

Study Completion

June 6, 2023

Last Updated

December 9, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will share

All IPDs that form the basis of a publication's results

Shared Documents
STUDY PROTOCOL
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.
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.

Locations