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NCT Number: NCT07803172

Artificial Intelligence-Supported Digital Game and Exercise Applications in Children With Autism and Typically Developing Children

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.

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Key information

Conditions

Autism Disorder Autism Spectrum Disorder Autistic Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Movement-Based Digital Game Intervention

Behavioral

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.

Primary outcomes

  1. Motor Skill Performance

    Time frame: Baseline and immediately after the 10-week intervention

    Motor skill performance will be assessed using the Bruininks-Oseretsky Test of Motor Proficiency, Second Edition, Short Form (BOT-2 SF). The assessment provides a total motor proficiency score based on tasks evaluating different aspects of motor performance. Higher scores indicate better motor performance.

  2. Repetitive Behaviors Assessed With the TEDÖ-R-TV

    Time frame: Baseline and immediately after the 10-week intervention

    Repetitive behaviors will be assessed using the Turkish Version of the Repetitive Behavior Scale-Revised (TEDÖ-R-TV). The total score obtained from the scale will be used to evaluate change in repetitive behaviors from pre-intervention to post-intervention.

  3. 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 scale assesses four domains: verbal short-term memory, visual short-term memory, verbal working memory, and visual working memory, through nine subscales. Pre-intervention and post-intervention scores will be compared to evaluate changes in working memory performance.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emine Busra Yılmaz, Ph. D.

CONTACT

[email protected]

905544819866

Sponsors and collaborators

Lead sponsor

Burdur Mehmet Akif Ersoy University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 3, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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