NCT06996678

Brief Summary

The aim of this study is to investigate the effects of virtual reality (VR) intervention on cognitive skills in children with attention deficit hyperactivity disorder (ADHD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

May 21, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 30, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2025

Completed
Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

1 month

First QC Date

May 21, 2025

Last Update Submit

September 26, 2025

Conditions

Keywords

Attention deficit and hyperactivity disordercognitive functionsmotor skillsVirtual Reality

Outcome Measures

Primary Outcomes (1)

  • Dynamic Occupational Therapy Cognitive Assessment (DOTCA-Ch)

    The Dynamic Occupational Therapy Cognitive Assessment (DOTCA-Ch): It was developed to evaluate the cognitive functions of children between the ages of 6 and 12. It includes 22 subtests in 5 cognitive areas; orientation, spatial perception, praxis, visuomotor construction and thinking operations. There is a structured 5-stage scoring system for each subtest. The purpose of the assessment is to identify the child's strengths and deficiencies in different cognitive areas, to measure learning potential and to identify the child's thinking strategies using dynamic procedures. The practice time is approximately 1½ hours

    1 month

Study Arms (2)

Aspirin (intervention group)

ACTIVE COMPARATOR

The intervention group will receive both occupational therapy and virtual reality.a) Occupational Therapy: The basis of OT intervention consisted of activities requiring increased attention, behavioral regulation, organizational skills, multiple cognitive skills, and motor skills. Virtual Reality: The virtual reality system consists of a camera, television, Eye Toy Play CD and Play Station 2. It is based on the principle of capturing movements represented in a virtual environment (Gatica and Méndez, 2014). In the Eye Toy system, individuals can see themselves on the screen through the camera. In this way, the person constantly interacts with the movements and challenges brought by video games. We can simply call the Eye Toy system a webcam with a motion sensor and microphone. The individual's position in the game is determined on the screen and can perceive the person according to the movements he/she exhibits.

Behavioral: virtual RealityBehavioral: occupational therapy

Plasebo (control group)

ACTIVE COMPARATOR

The control group will receive occupational therapy. Occupational Therapy: The basis of OT intervention consisted of activities requiring increased attention, behavioral regulation, organizational skills, multiple cognitive skills, and motor skills.

Behavioral: occupational therapy

Interventions

virtual RealityBEHAVIORAL

Virtual Reality: The virtual reality system consists of a camera, television, Eye Toy Play CD and Play Station 2. It is based on the principle of capturing movements represented in a virtual environment (Gatica and Méndez, 2014). In the Eye Toy system, individuals can see themselves on the screen through the camera. In this way, the person constantly interacts with the movements and challenges brought by video games. We can simply call the Eye Toy system a webcam with a motion sensor and microphone. The individual's position in the game is determined on the screen and can perceive the person according to the movements he/she exhibits. The main skills required by the games are; target-based movement, visuomotor skills, praxis and thinking process skills.

Aspirin (intervention group)

Occupational Therapy: The basis of OT intervention consisted of activities requiring increased attention, behavioral regulation, organizational skills, multiple cognitive skills, and motor skills

Aspirin (intervention group)Plasebo (control group)

Eligibility Criteria

Age7 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • being between the ages of 7-12, having diagnosed with ADHD by a child psychiatrist in accordance with the DSM-5 diagnostic criteria, having stabilized medications used for ADHD, being open to communication, and being able to understand and follow instructions at a basic level

You may not qualify if:

  • having any neurological, orthopedic or psychiatric diagnosis in addition to ADHD diagnosis, having undergone any surgical intervention in the last 3 months, being inadequate in understanding visual and auditory commands, and having a visual or hearing impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06800, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The therapist who conducted the assessment tests was unaware of the participants' group assignments (interventon or control)
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Two groups with an intervention group and a control group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 21, 2025

First Posted

May 30, 2025

Study Start

July 1, 2025

Primary Completion

August 1, 2025

Study Completion

September 1, 2025

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations