- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07321561
Effect of a Motor Support Program in Children With Autism
January 6, 2026 updated by: Gökçe Oktay, Istanbul Aydın University
The Effect of Motor Support Program Applıed to Chıldren wıth Autısm Spectrum Dısorder on Gross Motor and Sensory Motor
This study examined a motor support program applied for 40 minutes, two days per week, over a period of 12 weeks in children aged 4-6 years diagnosed with autism spectrum disorder.
A total of 28 children with autism spectrum disorder participated in the study, including 14 children in the experimental group and 14 children in the control group.
In addition to their regular special education sessions, participants in the experimental group received the motor support program for 40 minutes, two days per week, for 12 weeks.
Data collection instruments included the Gilliam Autistic Disorder Rating Scale-Second Edition, Turkish Version (GARS-2-TV), the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition, Short Form (BOT-2) for the assessment of gross motor skills, and the caregiver-completed Sensory Profile Questionnaire for the assessment of sensory-motor skills.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study is a quasi-experimental research design including pretest-posttest experimental and control groups, and one of the previously determined groups was randomly assigned as the experimental group and the other as the control group.
The study was conducted with a total of 28 children, including 14 children in the control group (CG) and 14 children in the experimental group (EG), aged between 4 and 6 years, diagnosed with autism spectrum disorder, who were continuing their education in special education and rehabilitation centers located in the Bayrampaşa and Esenyurt districts of Istanbul.
The number of participants was determined using G*Power analysis, with a statistical power of 0.80, an effect size of 0.05, and a margin of error of 0.05.
The inclusion criteria were defined as being between the ages of 4 and 6 years, having a diagnosis of autism spectrum disorder, having no additional intellectual disability, and having no health condition that would prevent participation in physical activity.
Data collection instruments included the Gilliam Autistic Disorder Rating Scale-Second Edition, Turkish Version (GARS-2-TV), the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition, Short Form (BOT-2) for the assessment of gross motor skills, and the caregiver-completed Sensory Profile Questionnaire for the assessment of sensory-motor skills.
The BOT-2 Short Form was administered in approximately 20-25 minutes per child.
The GARS-2-TV, administered through interviews with caregivers, was completed in approximately 25-30 minutes per child.
The Sensory Profile Questionnaire was completed by caregivers in approximately 30-35 minutes per child.
As the GARS-2-TV requires certification for administration, the required training and certification were obtained by the evaluator.The motor support program (MSP) consisted of activities prepared in accordance with test protocols to support children's gross motor skills (e.g., throwing, jumping, catching, running) and sensory-motor skills (e.g., sensory modulation, sensory processing, and movement-related sensory input).
The MSP was implemented for 60 minutes per session, two days per week, over a period of 12 weeks at the special education centers attended by the participants.
A structured program was applied during the first 10 weeks, and during the final 2 weeks, a "choose-your-activity" approach was implemented, in which children selected activities from those applied during the previous weeks.
Within each session, at least three different game-based activity formats targeting gross motor and sensory-motor skills were implemented.
In subsequent weeks, different game formats were included to address multiple developmental domains.
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Istanbul
-
Istanbul, Istanbul, Turkey (Türkiye), 34320
- Istanbul Aydin University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
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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|
|
Experimental: Motor Support Program
The motor support program (MSP) consists of activities prepared by the researchers by taking into account the test protocols used to achieve desired changes in children's gross motor (throwing, jumping, catching, running, etc.), sensory-motor (sensory modulation, sensory processing, sensory inputs related to movement) skill levels and developmental areas.
|
The MSP was administered by the first researcher for 60 minutes, 2 days a week for 12 weeks at the special education center where they were studying.
A special program was prepared for the first 10 weeks, and in the last 2 weeks, a choose your activity activity was conducted.
During this activity, children were presented with different options consisting of the activities implemented in the first 8 weeks and were asked to choose and implement them.
Within each lesson plan, at least 3 different game formats were implemented for children's gross motor skills and sensory motor skills.
In the following weeks, different game formats aime
|
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.
|
Evaluations were conducted at three time points: at baseline (pretest), at the end of the 12-week intervention (posttest).
|
|
Sensory profile questionnaire to assess sensory motor skills
Time Frame: Evaluations were conducted at three time points: at baseline (pretest), at the end of the 12-week intervention (posttest).
|
The Sensory Profile Scala was designed by Dunn in 1999 to assess children's sensory processing skills and is administered to children aged 3-10 years.
The scale aims to assess the sensory reactions of children in their daily lives and is completed by the caregiver.
Turkish adaptation, validity and reliability study was conducted by Kayıhan et al.
The Sensory Profile Scale consists of three main sections and their sub-sections: (1) Sensory processing, (2) Sensory modulation, and (3) Behavioral-emotional responses.
The scale, which consists of 125 items in total, is structured to assess the frequency of children's behaviors in response to different sensory stimuli.
The items are scored on a 5-point Likert-type rating system.
In this system, "Always" response is evaluated as 1 point and "Never" response is evaluated as 5 points.As the total score on the scale increases, sensory regulation skills improve.
|
Evaluations were conducted at three time points: at baseline (pretest), at the end of the 12-week intervention (posttest).
|
|
The Gilliam Autism Rating Scale-2 (GADRS) for the assessment of autism-related symptoms.
Time Frame: Evaluations were conducted at three time points: at baseline (pretest), at the end of the 12-week intervention (posttest).
|
This scale was developed by Gilliam (2006) to diagnose children with autism spectrum disorder.
The scale is completed by caregivers.
The scale consists of 3 sub-dimensions."0"
means never observed while '3' means frequently observed.
The scale consists of 42 items.
The highest standard score that can be obtained from this scale is 153, and the lowest score is 55.
A high total score indicates a high probability of ASD.
A low score indicates a low likelihood of ASD.
Since the Gilliam Autistic Disorder Rating Scale-2 is a scale that can be used with a certificate, the necessary training and certificate were obtained by the researcher.
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Evaluations were conducted at three time points: at baseline (pretest), at the end of the 12-week intervention (posttest).
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Kayıhan H, Günel M. K, Bumin G. Adaptation of the Sensory Profile into Turkish for children aged 3-10 years: A validity and reliability study. Turkish Journal of Physiotherapy and Rehabilitation. 2011; 22(2): 44-53.
- Bruininks RH, & Oseretsky, B. D., 2010, Bruininks-Oseretsky Test Of Motor Proficiency, Second Edition, Brief Form. Bloomington: Psychcorp.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 5, 2024
Primary Completion (Actual)
May 10, 2024
Study Completion (Actual)
June 5, 2024
Study Registration Dates
First Submitted
December 19, 2025
First Submitted That Met QC Criteria
January 6, 2026
First Posted (Actual)
January 7, 2026
Study Record Updates
Last Update Posted (Actual)
January 7, 2026
Last Update Submitted That Met QC Criteria
January 6, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IUC-SBBEK-2024-143
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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