- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07818538
OCCUPATIONAL THERAPY INTERVENTIONS ON COGNITIVE PERFORMANCE IN CHILDREN WITH AUTISM SPECTRUM DISORDER (COGNITIVE PERF)
THE EFFECT OF VIRTUAL REALITY-SUPPORTED OCCUPATIONAL THERAPY INTERVENTIONS ON COGNITIVE PERFORMANCE IN CHILDREN WITH AUTISM SPECTRUM DISORDER
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder characterized by deficits in social communication and interaction, as well as restricted and repetitive patterns of behavior. Children with ASD may experience difficulties in attention, working memory, planning, cognitive flexibility, problem-solving, and executive functions. The aim of this study is to investigate the effects of virtual reality-supported cognitive-focused occupational therapy on cognitive performance, occupational performance, and motivation in children with ASD.
A total of 32 children with ASD aged 6-12 years will be assigned to either the intervention group (n=16) or the control group (n=16). The intervention group will receive virtual reality-supported cognitive-focused occupational therapy for 40 minutes once a week for 8 weeks, while the control group will receive structured occupational therapy sessions with the same frequency and duration. Cognitive performance, occupational performance, and motivation will be assessed using the Dynamic Loewenstein Occupational Therapy Cognitive Assessment (DLOTCA), the Canadian Occupational Performance Measure (COPM), and the Pediatric Motivation Scale (PMS), respectively.
Aperçu de l'étude
Statut
Les conditions
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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-
Istanbul
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Kadıköy, Istanbul, Turquie (Türkiye), 34720
- Istanbul Medipol University
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
La description
Inclusion Criteria:
Aged between 6 and 12 years. Diagnosed with Autism Spectrum Disorder (ASD) Level 1 according to DSM-5 diagnostic criteria.
Able to stand and ambulate independently. Able to follow basic instructions and interact within a virtual environment. Voluntary participation of the child and/or legal guardian in the study and provision of written informed consent.
Exclusion Criteria:
History of epilepsy. Presence of vestibular system disorders or complaints of vertigo. Presence of severe cardiovascular disorders. Inability to use the virtual reality application due to severe visual impairment.
Diagnosis of a severe neurological or psychiatric disorder other than Autism Spectrum Disorder.
Having a condition that may require medical treatment or a different intervention during the study period.
Inability to understand the virtual reality experience or appropriately follow instructions.
Demonstrating difficulties in cooperation at a level that prevents the implementation of the SmartPose system.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Virtual Reality-Supported Cognitive-Focused Occupational Therapy
Participants in this group will receive structured occupational therapy sessions incorporating virtual reality-supported cognitive-focused activities, once a week for 8 weeks.
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Structured occupational therapy sessions incorporating virtual reality-supported cognitive-focused activities will be administered once a week for 8 weeks.
The intervention will target cognitive skills, occupational performance, and motivation in children with Autism Spectrum Disorder.
|
|
Comparateur actif: Structured Occupational Therapy
Participants in this group will receive structured occupational therapy sessions for 40 minutes once a week for 8 weeks.
|
Participants will receive structured occupational therapy sessions for 40 minutes once a week for 8 weeks.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Cognition Assessment Test
Délai: 8 week
|
The DLOTCA (Dynamic Loewenstein Cognition Assessment test) will be used.
|
8 week
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Canadian Occupational Performance Measure (COPM)
Délai: Baseline and at the end of 8 weeks
|
The Canadian Occupational Performance Measure (COPM) will be used to assess occupational performance and satisfaction with performance.
|
Baseline and at the end of 8 weeks
|
|
Pediatric Motivation Scale (PMS)
Délai: Baseline and at the end of 8 weeks
|
The Pediatric Motivation Scale (PMS) will be used to assess motivation.
|
Baseline and at the end of 8 weeks
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- EFSA tez
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
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