Autism Spectrum DisorderNCT07386106
Motor Intervention, Motor Skills, and Dual Task in ASD
A study testing Motor Support Program in people with Autism Spectrum Disorder, run by Istanbul Aydın University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 6 yearsHealthy volunteers can take part
- 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
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Apr 2025to 15 Sep 2025
- 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
- Healthy volunteers accepted
- 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, Esenyurt, 34320
About this study
Official title: 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.
Read more
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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Motor Support Program
- Keywords
- Autism spectrum disorder, Motor intervention, Dual-task performance, Gross motor skills, Motor skills
- 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 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
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.
Measured: 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):
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.
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.
- First posted4 Feb 2026
- Study start5 Apr 2025
- Primary completion30 Aug 2025
- Study completion15 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 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.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Aydın University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Gökçe Oktay, Istanbul Aydın University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07386106
- Sponsor's protocol ID
- IAU-GOKAEK
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bruininks RH, & Oseretsky, B. D., 2010, Bruininks-Oseretsky Motor Yeterlilik Testi, İkinci Baskı, Kısa Form. Bloomington: Psychcorp.
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07386106
- Acronym / sponsor ID
- IAU-GOKAEK
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism spectrum disorder, Motor intervention, Dual-task performance, Gross motor skills, Motor skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Istanbul Aydın UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 5 Apr 2025 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 4 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Motor Support Program | Experimental | Other: Motor Support ProgramThe 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. |
| 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. |
Who may qualify
- Ages
- 4 to 6 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motor Support ProgramThe 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. | Other | Motor Support Program |
Primary outcome
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.
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.
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- BackgroundBruininks RH, & Oseretsky, B. D., 2010, Bruininks-Oseretsky Motor Yeterlilik Testi, İkinci Baskı, Kısa Form. Bloomington: Psychcorp.
- Individual participant dataSharing planned: No
Related trials for Autism Spectrum Disorder
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Sensory-integration Therapy Verses Augumented Reality-based Training in ASD
Autism Spectrum Disorder
Recruiting
Cumulative and Booster Effects of Multisession Prefrontal tDCS in ASD Adolescents
Transcranial Direct Current Stimulation, Autistic Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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 4 Feb 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 2 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 NCT07386106, which also lists 1 linked publication.
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 4 Feb 2026.