- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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.
Studieoversikt
Status
Forhold
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Istanbul
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Kadıköy, Istanbul, Tyrkia (Türkiye), 34720
- Istanbul Medipol University
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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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Aktiv komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Cognition Assessment Test
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Canadian Occupational Performance Measure (COPM)
Tidsramme: 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)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
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