Autism DisorderNCT07803172
Artificial Intelligence-Supported Digital Game and Exercise Applications in Children With Autism and Typically Developing Children
A study testing Movement-Based Digital Game Intervention in people with Autism Disorder, run by Burdur Mehmet Akif Ersoy University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this study is to learn how artificial intelligence-supported digital games and exercise activities affect children with autism spectrum disorder and typically developing children aged 6 to 10 years. Read more about this study
- Who is it for?
- Ages 6 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Disorder
- What is being tested?
- Movement-Based Digital Game Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Sep 2026to 30 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6-10 years.
- Written informed consent from a parent or legal guardian.
- Ability to understand and follow simple verbal instructions.
- Ability to stand independently and perform basic locomotor movements.
- For participants in the ASD groups: a physician-confirmed diagnosis of autism -spectrum disorder (ASD) with mild to moderate severity.
- For typically developing participants: typical development without a diagnosis of ASD or another neurodevelopmental disorder.
- For typically developing participants: no known neurological, orthopedic, or cardiovascular condition that would interfere with participation in the study activities.
Who cannot join
- Orthopedic surgery within the previous 6 months.
- Presence of a neurological, orthopedic, or cardiovascular condition that may limit participation in movement-based activities.
- An acute health condition that prevents participation in physical activity.
- For typically developing participants: presence of a diagnosed neurodevelopmental disorder.
- Inability to complete the planned assessments or participate safely in the study activities.
- For participants assigned to an intervention group: expected attendance of less than 80% of the planned intervention sessions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Burdur Mehmet Akif Ersoy University
Burdur, Burdur, 15030
Emine Yilmaz, 05544819866, ebyilmaz@mehmetakif.edu.tr
About this study
Official title: Examining the Effects of Artificial Intelligence-Supported Digital Game and Exercise Applications on Children With Autism and Typically Developing Children With a Holistic Approach
The goal of this study is to learn how artificial intelligence-supported digital games and exercise activities affect children with autism spectrum disorder and typically developing children aged 6 to 10 years. The main questions it aims to answer are:
Do the digital game and exercise activities improve children's motor skills? Do the activities affect repetitive behaviors, working memory, and brain activity?
Read more
Researchers will compare children who take part in the digital game and exercise activities with children who do not take part in these activities.
Participants will complete assessments before and after the study. Children in the intervention group will take part in artificial intelligence-supported digital game and exercise activities. Researchers will assess children's motor skills, working memory, behaviors, and brain activity.
Read the detailed description
This study will examine the effects of artificial intelligence-supported digital game and exercise applications on children with autism spectrum disorder and typically developing children using a holistic approach. The study will include 60 children aged 6 to 10 years, including 30 children with autism spectrum disorder and 30 typically developing children.
Participants will be assigned to intervention and control groups. The intervention group will include 15 children with autism spectrum disorder and 15 typically developing children. The control group will include 15 children with autism spectrum disorder and 15 typically developing children. Children in the intervention group will participate in artificial intelligence-supported digital game and exercise activities, while children in the control group will not receive this intervention.
The study will examine changes in motor skills, repetitive behaviors, working memory, and brain activity. Quantitative assessments will include standardized measures and electroencephalography (EEG). Qualitative information will also be collected from parents to provide a broader understanding of children's experiences and development.
- Conditions
- Autism Disorder
- Being tested
- Movement-Based Digital Game Intervention
- Keywords
- Artificial Intelligence, Digital Games, Electroencephalography
- Medical subject headings
- Autistic Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Movement-Based Digital Game InterventionBehavioural
The intervention consists of a 10-week movement-based digital game program specifically developed for children aged 6-10 years. Participants in the intervention groups will attend two sessions per week, with each session lasting approximately 60 minutes. Sessions include warm-up, movement-based digital game activities, and cool-down. The digital games are delivered using an interactive projection system and require children to perform active body movements in response to visual and game-based tasks. Activities progressively target balance, coordination, locomotor skills, object control, hand-eye coordination, bilateral coordination, rhythm, reaching, jumping, changing direction, body awareness, and target-directed movements. Game difficulty and movement demands are progressively adjusted throughout the intervention period.
| Study group | Role | What they receive |
|---|---|---|
| ASD Intervention Group | Experimental | Children with autism spectrum disorder assigned to the intervention group will participate in the artificial intelligence-supported digital game and exercise program. Receives: Behavioral: Movement-Based Digital Game Intervention |
| ASD Control Group | No intervention | Children with autism spectrum disorder assigned to the control group will not participate in the artificial intelligence-supported digital game and exercise intervention. |
| Typically Developing Intervention Group | Experimental | Typically developing children assigned to the intervention group will participate in the artificial intelligence-supported digital game and exercise program. Receives: Behavioral: Movement-Based Digital Game Intervention |
| Typically Developing Control Group | No intervention | Typically developing children assigned to the control group will not participate in the artificial intelligence-supported digital game and exercise intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor Skill Performance
Motor proficiency in the 30 children with autism spectrum disorder and 30 typically developing children will be assessed using the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition, Short Form (BOT-2 SF).
The BOT-2 SF consists of 12 items representing eight motor skill areas: Fine Motor Precision, Fine Motor Integration, Manual Dexterity, Bilateral Coordination, Balance, Running Speed and Agility, Upper-Limb Coordination, and Strength. Raw performance scores for individual items are converted to point scores according to the BOT-2 scoring procedures and summed to obtain a Total Point Score.
The BOT-2 SF Total Point Score ranges from 0 to 88. Higher scores indicate better overall motor proficiency, whereas lower scores indicate poorer motor proficiency.
Measured: Baseline and immediately after the 10-week intervention
Repetitive Behaviors Assessed With the TEDÖ-R-TV
Repetitive behaviors in the 30 children with autism spectrum disorder will be assessed using the Repetitive Behavior Scale-Revised-Turkish Version (RBS-R-TV). The scale consists of 43 items covering six domains of repetitive behavior: Stereotyped Behavior, Self-Injurious Behavior, Compulsive Behavior, Ritualistic Behavior, Sameness Behavior, and Restricted Behavior. Each item is rated on a 4-point scale from 0 to 3. The total score ranges from 0 to 129. Higher scores indicate greater severity of repetitive behaviors and, therefore, a worse outcome, whereas lower scores indicate less severe repetitive behaviors.
Measured: Baseline and immediately after the 10-week intervention
Working Memory Assessed With the Working Memory Scale (ÇBÖ)
Working memory will be assessed using the Working Memory Scale (ÇBÖ) developed by Ergül, Özgür-Yılmaz, and Demir. The Working Memory Scale for Children Aged 5-10 Years will be used to assess working memory performance in children with autism spectrum disorder and typically developing children. The scale consists of nine subtests grouped into four dimensions: Verbal Short-Term Memory (Digit Recall, Word Recall, and Nonword Recall), Visual Short-Term Memory (Pattern Matrix and Block Recall), Verbal Working Memory (Backward Digit Recall and First-Word Recall), and Visual Working Memory (Odd-One-Out and Spatial Discrimination). Each item includes two trials, and one point is awarded for each sequence correctly recalled or identified in the required order. The total raw score ranges from 0 to 86, with higher scores indicating better working memory performance.
Measured: Baseline and immediately after the 10-week intervention
Brain Activity Assessed With Electroencephalography (EEG)
Brain activity will be assessed using electroencephalography (EEG) before and after the intervention. EEG recordings will be used to evaluate changes in brain activity associated with the artificial intelligence-supported digital game and exercise intervention.
Measured: Baseline and immediately after the 10-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2026
- Study start30 Sep 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants with autism spectrum disorder and typically developing participants will be assigned to intervention or control groups and followed in parallel.
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burdur Mehmet Akif Ersoy University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07803172
- Sponsor's protocol ID
- 224S961-MAIN
- Other IDs
- 224S961
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared due to participant privacy and confidentiality considerations. The study involves children, including children with autism spectrum disorder, and the informed consent process does not include provisions for sharing individual-level data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining the Effects of Artificial Intelligence-Supported Digital Game and Exercise Applications on Children With Autism and Typically Developing Children With a Holistic Approach
- ClinicalTrials.gov ID
- NCT07803172
- Acronym / sponsor ID
- 224S961-MAIN
- Conditions
- Autism Disorder
- Keywords
- Artificial Intelligence, Digital Games, Electroencephalography
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Burdur Mehmet Akif Ersoy UniversityUniversity, hospital or other
- Study start
- 30 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Jan 2027 (estimated)
- First posted
- 3 Sep 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.
The goal of this study is to learn how artificial intelligence-supported digital games and exercise activities affect children with autism spectrum disorder and typically developing children aged 6 to 10 years. The main questions it aims to answer are:
Do the digital game and exercise activities improve children's motor skills? Do the activities affect repetitive behaviors, working memory, and brain activity?
Researchers will compare children who take part in the digital game and exercise activities with children who do not take part in these activities.
Participants will complete assessments before and after the study. Children in the intervention group will take part in artificial intelligence-supported digital game and exercise activities. Researchers will assess children's motor skills, working memory, behaviors, and brain activity.
Detailed description
This study will examine the effects of artificial intelligence-supported digital game and exercise applications on children with autism spectrum disorder and typically developing children using a holistic approach. The study will include 60 children aged 6 to 10 years, including 30 children with autism spectrum disorder and 30 typically developing children.
Participants will be assigned to intervention and control groups. The intervention group will include 15 children with autism spectrum disorder and 15 typically developing children. The control group will include 15 children with autism spectrum disorder and 15 typically developing children. Children in the intervention group will participate in artificial intelligence-supported digital game and exercise activities, while children in the control group will not receive this intervention.
The study will examine changes in motor skills, repetitive behaviors, working memory, and brain activity. Quantitative assessments will include standardized measures and electroencephalography (EEG). Qualitative information will also be collected from parents to provide a broader understanding of children's experiences and development.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Participants with autism spectrum disorder and typically developing participants will be assigned to intervention or control groups and followed in parallel.
| Arm | Type | Receives |
|---|---|---|
| ASD Intervention Group | Experimental | Behavioral: Movement-Based Digital Game InterventionChildren with autism spectrum disorder assigned to the intervention group will participate in the artificial intelligence-supported digital game and exercise program. |
| ASD Control Group | No intervention | –Children with autism spectrum disorder assigned to the control group will not participate in the artificial intelligence-supported digital game and exercise intervention. |
| Typically Developing Intervention Group | Experimental | Behavioral: Movement-Based Digital Game InterventionTypically developing children assigned to the intervention group will participate in the artificial intelligence-supported digital game and exercise program. |
| Typically Developing Control Group | No intervention | –Typically developing children assigned to the control group will not participate in the artificial intelligence-supported digital game and exercise intervention. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Children aged 6-10 years.
- Written informed consent from a parent or legal guardian.
- Ability to understand and follow simple verbal instructions.
- Ability to stand independently and perform basic locomotor movements.
- For participants in the ASD groups: a physician-confirmed diagnosis of autism -spectrum disorder (ASD) with mild to moderate severity.
Key exclusion criteria (6 listed)
- Orthopedic surgery within the previous 6 months.
- Presence of a neurological, orthopedic, or cardiovascular condition that may limit participation in movement-based activities.
- An acute health condition that prevents participation in physical activity.
- For typically developing participants: presence of a diagnosed neurodevelopmental disorder.
- Inability to complete the planned assessments or participate safely in the study activities.
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 |
|---|---|---|
| Movement-Based Digital Game InterventionThe intervention consists of a 10-week movement-based digital game program specifically developed for children aged 6-10 years. Participants in the intervention groups will attend two sessions per week, with each session lasting approximately 60 minutes. Sessions include warm-up, movement-based digital game activities, and cool-down. The digital games are delivered using an interactive projection system and require children to perform active body movements in response to visual and game-based tasks. Activities progressively target balance, coordination, locomotor skills, object control, hand-eye coordination, bilateral coordination, rhythm, reaching, jumping, changing direction, body awareness, and target-directed movements. Game difficulty and movement demands are progressively adjusted throughout the intervention period. | Behavioural | ASD Intervention Group, Typically Developing Intervention Group |
Primary outcome
Motor Skill Performance
Time frame: Baseline and immediately after the 10-week intervention
Motor proficiency in the 30 children with autism spectrum disorder and 30 typically developing children will be assessed using the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition, Short Form (BOT-2 SF). The BOT-2 SF consists of 12 items representing eight motor skill areas: Fine Motor Precision, Fine Motor Integration, Manual Dexterity, Bilateral Coordination, Balance, Running Speed and Agility, Upper-Limb Coordination, and Strength. Raw performance scores for individual items are converted to point scores according to the BOT-2 scoring procedures and summed to obtain a Total Point Score. The BOT-2 SF Total Point Score ranges from 0 to 88. Higher scores indicate better overall motor proficiency, whereas lower scores indicate poorer motor proficiency.
Repetitive Behaviors Assessed With the TEDÖ-R-TV
Time frame: Baseline and immediately after the 10-week intervention
Repetitive behaviors in the 30 children with autism spectrum disorder will be assessed using the Repetitive Behavior Scale-Revised-Turkish Version (RBS-R-TV). The scale consists of 43 items covering six domains of repetitive behavior: Stereotyped Behavior, Self-Injurious Behavior, Compulsive Behavior, Ritualistic Behavior, Sameness Behavior, and Restricted Behavior. Each item is rated on a 4-point scale from 0 to 3. The total score ranges from 0 to 129. Higher scores indicate greater severity of repetitive behaviors and, therefore, a worse outcome, whereas lower scores indicate less severe repetitive behaviors.
Working Memory Assessed With the Working Memory Scale (ÇBÖ)
Time frame: Baseline and immediately after the 10-week intervention
Working memory will be assessed using the Working Memory Scale (ÇBÖ) developed by Ergül, Özgür-Yılmaz, and Demir. The Working Memory Scale for Children Aged 5-10 Years will be used to assess working memory performance in children with autism spectrum disorder and typically developing children. The scale consists of nine subtests grouped into four dimensions: Verbal Short-Term Memory (Digit Recall, Word Recall, and Nonword Recall), Visual Short-Term Memory (Pattern Matrix and Block Recall), Verbal Working Memory (Backward Digit Recall and First-Word Recall), and Visual Working Memory (Odd-One-Out and Spatial Discrimination). Each item includes two trials, and one point is awarded for each sequence correctly recalled or identified in the required order. The total raw score ranges from 0 to 86, with higher scores indicating better working memory performance.
Brain Activity Assessed With Electroencephalography (EEG)
Time frame: Baseline and immediately after the 10-week intervention
Brain activity will be assessed using electroencephalography (EEG) before and after the intervention. EEG recordings will be used to evaluate changes in brain activity associated with the artificial intelligence-supported digital game and exercise intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared due to participant privacy and confidentiality considerations. The study involves children, including children with autism spectrum disorder, and the informed consent process does not include provisions for sharing individual-level data with other researchers.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Movement-Based Digital Game Intervention in people with Autism Disorder, run by Burdur Mehmet Akif Ersoy 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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 15 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emine Busra Yılmaz, Ph. D. (905544819866, eminebusray@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Motor Skill Performance (time frame: Baseline and immediately after the 10-week intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2026.