NCT07803172

Brief 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. 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Sep 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Sep 2026Jan 2027

First Submitted

Initial submission to the registry

August 31, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

September 30, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2027

Last Updated

September 15, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

August 31, 2026

Last Update Submit

September 10, 2026

Conditions

Keywords

Artificial IntelligenceDigital GamesElectroencephalography

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    Baseline and immediately after the 10-week intervention

Study Arms (4)

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.

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.

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.

Interventions

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.

ASD Intervention GroupTypically Developing Intervention Group

Eligibility Criteria

Age6 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Burdur Mehmet Akif Ersoy University

Burdur, Burdur, 15030, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Central Study Contacts

Emine Busra Yılmaz, Ph. D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants with autism spectrum disorder and typically developing participants will be assigned to intervention or control groups and followed in parallel.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2026

First Posted

September 3, 2026

Study Start

September 30, 2026

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

January 30, 2027

Last Updated

September 15, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.

Locations