NCT07818538

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Aug 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress60%
Aug 2026Oct 2026

Study Start

First participant enrolled

August 27, 2026

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 14, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 26, 2026

Expected
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Last Updated

September 14, 2026

Status Verified

August 1, 2026

Enrollment Period

2 months

First QC Date

September 8, 2026

Last Update Submit

September 8, 2026

Conditions

Keywords

Virtual RealityOccupational TherapyCognitive PerformanceOccupational PerformanceMotivation

Outcome Measures

Primary Outcomes (1)

  • Cognition Assessment Test

    The DLOTCA (Dynamic Loewenstein Cognition Assessment test) will be used.

    8 week

Secondary Outcomes (2)

  • Canadian Occupational Performance Measure (COPM)

    Baseline and at the end of 8 weeks

  • Pediatric Motivation Scale (PMS)

    Baseline and at the end of 8 weeks

Study Arms (2)

Virtual Reality-Supported Cognitive-Focused Occupational Therapy

EXPERIMENTAL

Participants in this group will receive structured occupational therapy sessions incorporating virtual reality-supported cognitive-focused activities, once a week for 8 weeks.

Other: Virtual Reality-Supported Cognitive-Focused Occupational Therapy

Structured Occupational Therapy

ACTIVE COMPARATOR

Participants in this group will receive structured occupational therapy sessions for 40 minutes once a week for 8 weeks.

Other: Structured Occupational Therapy

Interventions

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.

Virtual Reality-Supported Cognitive-Focused Occupational Therapy

Participants will receive structured occupational therapy sessions for 40 minutes once a week for 8 weeks.

Structured Occupational Therapy

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Medipol University

Kadıköy, Istanbul, 34720, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 8, 2026

First Posted

September 14, 2026

Study Start

August 27, 2026

Primary Completion (Estimated)

October 26, 2026

Study Completion (Estimated)

October 30, 2026

Last Updated

September 14, 2026

Record last verified: 2026-08

Locations