- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07803172
Artificial Intelligence-Supported Digital Game and Exercise Applications in Children With Autism and Typically Developing Children
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Emine Busra Yılmaz, Ph. D.
- Telefonní číslo: 905544819866
- E-mail: eminebusray@gmail.com
Studijní místa
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Burdur
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Burdur, Burdur, Turecko (Türkiye), 15030
- Burdur Mehmet Akif Ersoy University
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Kontakt:
- Emine Yilmaz
- Telefonní číslo: 05544819866
- E-mail: ebyilmaz@mehmetakif.edu.tr
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: 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.
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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.
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Žádný zásah: 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.
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Experimentální: Typically Developing Intervention Group
Typically developing children assigned to the intervention group will participate in the artificial intelligence-supported digital game and exercise program.
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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.
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Žádný zásah: 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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Brain Activity Assessed With Electroencephalography (EEG)
Časové okno: Baseline and immediately after the 10-week intervention
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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.
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Baseline and immediately after the 10-week intervention
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Motor Skill Performance
Časové okno: Baseline and immediately after the 10-week intervention
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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
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Repetitive Behaviors Assessed With the TEDÖ-R-TV
Časové okno: Baseline and immediately after the 10-week intervention
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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.
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Baseline and immediately after the 10-week intervention
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Working Memory Assessed With the Working Memory Scale (ÇBÖ)
Časové okno: Baseline and immediately after the 10-week intervention
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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.
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Baseline and immediately after the 10-week intervention
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 224S961-MAIN
- 224S961 (Jiné číslo grantu/financování: The Scientific and Technological Research Council of Türkiye (TÜBİTAK))
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