- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07386106
Motor Intervention, Motor Skills, and Dual Task in ASD
Examining the Effect of a Motor Intervention Program Applied to Children With Autism Spectrum Disorder on Autism-Related Symptoms, Gross Motor Skills, and Dual Task Performance
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Esenyurt
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Istanbul, Esenyurt, Turkey (Türkiye), 34320
- Istanbul Aydin University
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Standard Education (No Motor Support)
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.
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|
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Experimental: Motor Support Program
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Motor Skills as Measured by the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition - Short Form (BOT-2 SF)"
Time Frame: Evaluations were conducted at three time points: at baseline (pretest), at the end of the 12-week intervention (posttest).
|
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.
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Evaluations were conducted at three time points: at baseline (pretest), at the end of the 12-week intervention (posttest).
|
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Motor-Cognitive Skill Assessment Procedure
Time Frame: Evaluations were conducted at three time points: at baseline (pretest), at the end of the 12-week intervention (posttest).
|
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.
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Evaluations were conducted at three time points: at baseline (pretest), at the end of the 12-week intervention (posttest).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adapted Autism Behavior Checklist (A-ABC):
Time Frame: Evaluations were conducted at three time points: at baseline (pretest), at the end of the 12-week intervention (posttest).
|
The Adapted Autism Behavior Checklist (A-ABC) is an assessment tool designed to determine the severity of autism spectrum disorder in children based on the level of support they require, in accordance with DSM-5 criteria. The scale was originally developed by Krug, Arick, and Almond in 1980 and was subsequently updated in 1993 and 2008. Total scores obtained from the scale range from 0 to 159, with scores of 68 and above indicating a "high likelihood of autistic disorder" (Eaves & Williams, 2006). Some items of the scale can be administered to all children, including nonverbal children, whereas additional items are evaluated for verbal children. Based on the scores obtained, the level of impairment associated with autism spectrum disorder and the degree of support required by the child can be determined. |
Evaluations were conducted at three time points: at baseline (pretest), at the end of the 12-week intervention (posttest).
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- Bruininks RH, & Oseretsky, B. D., 2010, Bruininks-Oseretsky Motor Yeterlilik Testi, İkinci Baskı, Kısa Form. Bloomington: Psychcorp.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IAU-GOKAEK
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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