Autism Spectrum DisorderCOGNITIVE PERFNCT07818538
OCCUPATIONAL THERAPY INTERVENTIONS ON COGNITIVE PERFORMANCE IN CHILDREN WITH AUTISM SPECTRUM DISORDER
A study testing Virtual Reality-Supported Cognitive-Focused Occupational Therapy and Structured Occupational Therapy in people with Autism Spectrum Disorder, run by Biruni University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Virtual Reality-Supported Cognitive-Focused Occupational Therapy and Structured Occupational Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Aug 2026to 30 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Medipol University
Kadıköy, Istanbul, 34720
About this study
Official title: 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.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Virtual Reality-Supported Cognitive-Focused Occupational Therapy, Structured Occupational Therapy
- Keywords
- Virtual Reality, Occupational Therapy, Cognitive Performance, Occupational Performance, Motivation
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality-Supported Cognitive-Focused Occupational TherapyOther
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.
Structured Occupational TherapyOther
Participants will receive structured occupational therapy sessions for 40 minutes once a week for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Structured Occupational Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition Assessment Test
The DLOTCA (Dynamic Loewenstein Cognition Assessment test) will be used.
Measured: 8 week
Secondary outcomes (2)
Canadian Occupational Performance Measure (COPM)
The Canadian Occupational Performance Measure (COPM) will be used to assess occupational performance and satisfaction with performance.
Measured: Baseline and at the end of 8 weeks
Pediatric Motivation Scale (PMS)
The Pediatric Motivation Scale (PMS) will be used to assess motivation.
Measured: Baseline and at the end of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study start27 Aug 2026
- Primary completion26 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled study
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07818538
- Sponsor's protocol ID
- EFSA tez
- Acronym
- COGNITIVE PERF
- Status last verified
- Aug 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF VIRTUAL REALITY-SUPPORTED OCCUPATIONAL THERAPY INTERVENTIONS ON COGNITIVE PERFORMANCE IN CHILDREN WITH AUTISM SPECTRUM DISORDER
- ClinicalTrials.gov ID
- NCT07818538
- Acronym / sponsor ID
- COGNITIVE PERF / EFSA tez
- Conditions
- Autism Spectrum Disorder
- Keywords
- Virtual Reality, Occupational Therapy, Cognitive Performance, Occupational Performance, Motivation
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 27 Aug 2026 (actual)
- Primary completion
- 26 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality-Supported Cognitive-Focused Occupational Therapy | Experimental | Other: Virtual Reality-Supported Cognitive-Focused Occupational TherapyParticipants 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 | Active comparator | Other: Structured Occupational TherapyParticipants in this group will receive structured occupational therapy sessions for 40 minutes once a week for 8 weeks. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality-Supported Cognitive-Focused Occupational TherapyStructured 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. | Other | Virtual Reality-Supported Cognitive-Focused Occupational Therapy |
| Structured Occupational TherapyParticipants will receive structured occupational therapy sessions for 40 minutes once a week for 8 weeks. | Other | Structured Occupational Therapy |
Primary outcome
Cognition Assessment Test
Time frame: 8 week
The DLOTCA (Dynamic Loewenstein Cognition Assessment test) will be used.
2 secondary outcomes
Canadian Occupational Performance Measure (COPM)
Time frame: Baseline and at the end of 8 weeks
Pediatric Motivation Scale (PMS)
Time frame: Baseline and at the end of 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Autism Spectrum Disorder
Not yet recruiting
"Family Resilience And Mind-body Enhancement" (FRAME): A Randomised Controlled Trial
Autism
Recruiting
Trial of Center-Based vs. In-Home Pivotal Response Treatment (PRT) in Autism
Autism, Autism Spectrum Disorder
Recruiting
Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism
Autism Spectrum Disorder, Autism
RecruitingPhase 2
A Study of Esomeprazole in Children With Autism
Autism, Autism Spectrum Disorder
Recruiting
Transcranial Magnetic Stimulation for Restricted and Repetitive Behavior in ASD
Autism Spectrum Disorder, Autism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality-Supported Cognitive-Focused Occupational Therapy and Structured Occupational Therapy in people with Autism Spectrum Disorder, run by Biruni University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition Assessment Test (time frame: 8 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.