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

10 settembre 2026 aggiornato da: Burdur Mehmet Akif Ersoy University

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?

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

60

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

Sì

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: ASD Intervention Group
Children with autism spectrum disorder assigned to the intervention group will participate in the artificial intelligence-supported digital game and exercise program.
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.
Nessun intervento: ASD Control Group
Children with autism spectrum disorder assigned to the control group will not participate in the artificial intelligence-supported digital game and exercise intervention.
Sperimentale: Typically Developing Intervention Group
Typically developing children assigned to the intervention group will participate in the artificial intelligence-supported digital game and exercise program.
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.
Nessun intervento: Typically Developing Control Group
Typically developing children assigned to the control group will not participate in the artificial intelligence-supported digital game and exercise intervention.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Brain Activity Assessed With Electroencephalography (EEG)
Lasso di tempo: 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.
Baseline and immediately after the 10-week intervention
Motor Skill Performance
Lasso di tempo: 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.

Baseline and immediately after the 10-week intervention
Repetitive Behaviors Assessed With the TEDÖ-R-TV
Lasso di tempo: 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.
Baseline and immediately after the 10-week intervention
Working Memory Assessed With the Working Memory Scale (ÇBÖ)
Lasso di tempo: 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.
Baseline and immediately after the 10-week intervention

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

30 settembre 2026

Completamento primario (Stimato)

30 dicembre 2026

Completamento dello studio (Stimato)

30 gennaio 2027

Date di iscrizione allo studio

Primo inviato

31 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

31 agosto 2026

Primo Inserito (Effettivo)

3 settembre 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

15 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

10 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 224S961-MAIN
  • 224S961 (Altro numero di sovvenzione/finanziamento: The Scientific and Technological Research Council of Türkiye (TÜBİTAK))

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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