- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Istanbul
-
Kadıköy, Istanbul, Turkey (Türkiye), 34720
- Istanbul Medipol University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
|
Active Comparator: 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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cognition Assessment Test
Time Frame: 8 week
|
The DLOTCA (Dynamic Loewenstein Cognition Assessment test) will be used.
|
8 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Canadian Occupational Performance Measure (COPM)
Time Frame: 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)
Time Frame: 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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- EFSA tez
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.