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Autism Spectrum DisorderNCT07321561

Effect of a Motor Support Program in Children With Autism

A study testing Motor Support Program in people with Autism Spectrum Disorder, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 4 to 6 years
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
Motor Support Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
43 participants
Where
1 siteTurkey (Türkiye)
Study dates
5 Jan 2024to 5 Jun 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 6 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Istanbul Aydin University

    Istanbul, Istanbul, 34320

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Motor Support Program
Keywords
Autism Spectrum Disorder, Motor Skil, Sensory motor skill, Motor Support Program
Medical subject headings
Autism Spectrum Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motor Support ProgramOther

    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

Study groups in NCT07321561
Study groupRoleWhat they receive
Motor Support ProgramExperimentalThe 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.
Receives: Other: Motor Support Program
Standard Education (No Motor Support)No interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. Sensory profile questionnaire to assess sensory motor skills

    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.

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

  3. The Gilliam Autism Rating Scale-2 (GADRS) for the assessment of autism-related symptoms.

    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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2026
  2. Study start5 Jan 2024
  3. Primary completion10 May 2024
  4. Study completion5 Jun 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
A total of 28 children with ASD participated in the study, 14 students in the experimental group and 14 in the control group. In addition to the special education sessions, the participants in the experimental group received a motor support program for 40 minutes 2 days a week for 12 weeks. In the study, the Gilliam Autistic Disorder Rating Scale-2-TV, the Bruininks-Oseretsky Motor Competence 2 Test Short Form (BOT-2) for the assessment of gross motor skills, and the caregiver sensory profile questionnaire for the assessment of sensory-motor skills were used.
Masking
None (open label)
Enrolment
43 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07321561
Sponsor's protocol ID
IUC-SBBEK-2024-143
Status last verified
Jan 2026
First submitted
19 Dec 2025
Last updated
7 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bruininks RH, & Oseretsky, B. D., 2010, Bruininks-Oseretsky Test Of Motor Proficiency, Second Edition, Brief Form. Bloomington: Psychcorp.

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing Motor Support Program in people with Autism Spectrum Disorder, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07321561, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.

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