- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Istanbul
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Kadıköy, Istanbul, Turquía (Türkiye), 34720
- Istanbul Medipol University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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.
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Comparador activo: Structured Occupational Therapy
Participants in this group will receive structured occupational therapy sessions for 40 minutes once a week for 8 weeks.
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Participants will receive structured occupational therapy sessions for 40 minutes once a week for 8 weeks.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Cognition Assessment Test
Periodo de tiempo: 8 week
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The DLOTCA (Dynamic Loewenstein Cognition Assessment test) will be used.
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8 week
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Canadian Occupational Performance Measure (COPM)
Periodo de tiempo: Baseline and at the end of 8 weeks
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The Canadian Occupational Performance Measure (COPM) will be used to assess occupational performance and satisfaction with performance.
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Baseline and at the end of 8 weeks
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Pediatric Motivation Scale (PMS)
Periodo de tiempo: Baseline and at the end of 8 weeks
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The Pediatric Motivation Scale (PMS) will be used to assess motivation.
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Baseline and at the end of 8 weeks
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- EFSA tez
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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