NCT07386106

Brief Summary

This study is designed to understand whether a structured movement (motor) program can help improve movement skills and daily functioning in young children with autism spectrum disorder (ASD). The study will include children aged 4-6 years who have been diagnosed with ASD. Some children will take part in a 12-week motor intervention program in addition to their regular individual education at special education centers. This program will include movement activities twice a week, each session lasting about one hour. Other children will continue with their usual individual education only. Before and after the 12-week period, all children will be assessed using simple and age-appropriate tools to evaluate their motor skills, ability to perform tasks that require both movement and attention at the same time, and autism-related behaviors. These assessments are commonly used in child development and do not involve any invasive procedures. The goal of this study is to determine whether participating in a regular movement program can support motor development, coordination, and daily activity participation in children with ASD. Improving these skills at an early age may help children become more independent in daily life and enhance their overall quality of life. The findings of this study may provide useful information for families, educators, and health care professionals and help improve movement-based practices in special education settings.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 4, 2026

Completed
Last Updated

February 4, 2026

Status Verified

January 1, 2026

Enrollment Period

5 months

First QC Date

January 28, 2026

Last Update Submit

January 28, 2026

Conditions

Keywords

Autism spectrum disorderMotor interventionDual-task performanceGross motor skillsMotor skills

Outcome Measures

Primary Outcomes (2)

  • Change in Motor Skills as Measured by the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition - Short Form (BOT-2 SF)"

    In this study, the short form of the Bruininks-Oseretsky Motor Competence Test-2 (BOT-2 SF), which was developed to assess the motor skill levels of individuals aged 4-21 years, was used. The short form used in the study consists of a total of eight subtests and 12 items. These subtests include fine motor accuracy, fine motor integration, manual agility, two-way coordination, balance, running speed and agility, hand-arm coordination and strength. The maximum score that can be obtained in the test is 50. As the total score increases, the level of motor skills increases.

    Evaluations were conducted at three time points: at baseline (pretest), at the end of the 12-week intervention (posttest).

  • Motor-Cognitive Skill Assessment Procedure

    Motor-cognitive skills were assessed using the Fitlight Trainer system. Four LED lights were positioned in front of each participant at 10 cm intervals, with placement adjusted according to the participant's height. The lights were activated in a random sequence. Participants were asked to count aloud from 1 to 10 while simultaneously turning off the illuminated lights by touching them with their foot. Task completion time was recorded via the mobile application connected to the Fitlight system and used to evaluate motor-cognitive performance.

    Evaluations were conducted at three time points: at baseline (pretest), at the end of the 12-week intervention (posttest).

Secondary Outcomes (1)

  • Adapted Autism Behavior Checklist (A-ABC):

    Evaluations were conducted at three time points: at baseline (pretest), at the end of the 12-week intervention (posttest).

Study Arms (2)

Motor Support Program

EXPERIMENTAL

The motor support program (MSP) consists of activities developed by the researchers based on the assessment protocols and designed to promote improvements in children's gross motor skills (such as throwing, jumping, catching, and running) while simultaneously engaging cognitive processes. The program includes dual-task activities that require children to perform motor tasks together with attention, reaction, and decision-making components.

Other: Motor Support Program

Standard Education (No Motor Support)

NO INTERVENTION

Participants in the control group continued their individual education programs. However, they did not participate in any physiotherapy or motor support programs. Only pre- and post-test measurements were taken.

Interventions

The motor support program (MSP) was implemented by the first researcher at a special education center for 12 weeks, with two sessions per week, each lasting 60 minutes. A structured and planned intervention program was developed for the first 10 weeks, while an "Activity Choice" approach was applied during the final 2 weeks of the intervention. During this phase, children were presented with various activity options derived from the activities implemented during the first 8 weeks and were encouraged to select and perform these activities. Within each session, at least three different game-based formats were used to target children's gross motor skills and dual-task (motor-cognitive) abilities. In the subsequent weeks, the intervention content was diversified by targeting different game formats.

Motor Support Program

Eligibility Criteria

Age4 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Being between 4 and 6 years of age
  • Having no health problems that would prevent participation in the study
  • Having been diagnosed with autism according to the Health Board and Guidance and Research Center (RAM) report
  • Not having previously participated in any motor-supported education programs (e.g., occupational therapy sessions)
  • Having no additional diagnoses related to physical or intellectual disabilities other than autism spectrum disorder

You may not qualify if:

  • The participant's failure to attend the training program for three consecutive sessions
  • The participant's failure to fulfill the assigned responsibilities
  • The participant's voluntary withdrawal from the study at any stage for any reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Aydin University

Istanbul, Esenyurt, 34320, Turkey (Türkiye)

Location

Related Publications (1)

  • Bruininks RH, & Oseretsky, B. D., 2010, Bruininks-Oseretsky Motor Yeterlilik Testi, İkinci Baskı, Kısa Form. Bloomington: Psychcorp.

    BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: This study was designed as a pre-test-post-test controlled experimental trial including 28 children aged 4-6 years diagnosed with autism spectrum disorder (ASD). Participants were assigned to an experimental group (n = 14) and a control group (n = 14), with the sample size determined using G\*Power analysis. Gross motor skills were assessed using the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition - Short Form (BOT-2), autism-related behaviors were evaluated with the Adapted Autism Behavior Checklist, and motor-cognitive performance was measured using a reaction time test. Assessments were conducted before and after the intervention period. The experimental group participated in a 12-week motor intervention program consisting of two 60-minute sessions per week in addition to their regular individual education, while the control group continued with their routine individual education only.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 4, 2026

Study Start

April 5, 2025

Primary Completion

August 30, 2025

Study Completion

September 15, 2025

Last Updated

February 4, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations