Virtual Reality in Rehabilitation of Executive Functions in Children With Attention Deficit Hyperactivity Disorder.

NCT ID: NCT06123741

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-10

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Attention deficit hyperactivity disorder (ADHD) is caused by an abnormality in the development of the central nervous system. Children with attention and executive function difficulties often need long-lasting rehabilitation and there is an increasing need for timely, cost-effective, and feasible rehabilitation interventions, where the training is targeted to support everyday life functional capacity. The use of Virtual Reality (VR) in the rehabilitation of children with attention and executive function deficits offers opportunities to practice skills required in everyday life in environments emulating real-life situations.

The major aim of this research project is to develop a novel effective VR rehabilitation method for children with deficits in attention, activity control and executive functions by using the virtual environment that corresponds to the typical everyday life. In this randomized control study VR glasses are used to present the tasks, and the levels of difficulty are adjusted according to the child's progress.

Researchers expect that; 1) Intensive training improves the attention regulation, activity control skills and executive functions of the children in the intervention group; 2) Training of executive skills with motivating tasks in a virtual environment that is built to meet challenging everyday situations transfers to the child's everyday life, 3) The duration of the training effect does not depend on the success of the VR training itself, but on how well the child adopts new strategies that make everyday life easier and how the parent is able to support the child's positive behaviour in everyday life.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Attention Deficit Hyperactivity Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Parental Guidance+Virtual Reality Game

Group Type EXPERIMENTAL

Parental Guidance

Intervention Type BEHAVIORAL

Parents get guidance for children's positive behaviour support by using parts of Self-Help Program on the MentalHub.fi (in Finnish: Mielenterveystalo.fi) website regarding children's challenging behaviour (in Finnish: Lasten haastavan käytöksen omahoito-ohjelma) .

Virtual Reality Game

Intervention Type BEHAVIORAL

Virtual reality game for rehabilitation of attention, activity control and executive functions by using the virtual environment that corresponds to the typical everyday situations at home.

Parental Guidance

Group Type EXPERIMENTAL

Parental Guidance

Intervention Type BEHAVIORAL

Parents get guidance for children's positive behaviour support by using parts of Self-Help Program on the MentalHub.fi (in Finnish: Mielenterveystalo.fi) website regarding children's challenging behaviour (in Finnish: Lasten haastavan käytöksen omahoito-ohjelma) .

Virtual Reality Game

Group Type EXPERIMENTAL

Virtual Reality Game

Intervention Type BEHAVIORAL

Virtual reality game for rehabilitation of attention, activity control and executive functions by using the virtual environment that corresponds to the typical everyday situations at home.

Control Group

This group implement the rehabilitation plan drawn up in specialized medical care (treatment as usual).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Parental Guidance

Parents get guidance for children's positive behaviour support by using parts of Self-Help Program on the MentalHub.fi (in Finnish: Mielenterveystalo.fi) website regarding children's challenging behaviour (in Finnish: Lasten haastavan käytöksen omahoito-ohjelma) .

Intervention Type BEHAVIORAL

Virtual Reality Game

Virtual reality game for rehabilitation of attention, activity control and executive functions by using the virtual environment that corresponds to the typical everyday situations at home.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Self-Help Program of children's challenging behaviour (Program name in Finnish: Lasten haastavan käytöksen omahoito-ohjelma).

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Diagnosis of ADHD (ICD-10 F90.0) and
* Methylphenidate medication and
* Age 8-12 years and
* Finnish as a native language

Exclusion Criteria

* Sensitivity to flashing light,
* Epilepsy (ICD-10 G40),
* Mental retardation (ICD-10 F70-F79),
* Pervasive developmental disorders (ICD-10 F84),
* Inflammatory diseases of the central nervous system (ICD-10 G00-G09),
* Severe cerebral palsy syndrome (ICD-10 G80, GMFCS 4-5, MACS 3-5),
* Traumatic brain injury ((ICD-10 S06),
* Brain tumour, and
* Multiple pregnancy
Minimum Eligible Age

8 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oulu

OTHER

Sponsor Role collaborator

Aalto University

OTHER

Sponsor Role collaborator

University of Helsinki

OTHER

Sponsor Role collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role collaborator

Merja Nikula

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Merja Nikula

Principal investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Johanna Uusimaa, MD, PhD

Role: STUDY_CHAIR

Oulu University Hospital

Merja Nikula, M.Psych.

Role: PRINCIPAL_INVESTIGATOR

Oulu University Hospital

Mirjami Mäntymaa, MD, PhD

Role: STUDY_DIRECTOR

Oulu University Hospital

Juha Salmitaival, PhD

Role: STUDY_DIRECTOR

University of Oulu, Finland

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Oulu University Hospital

Oulu, , Finland

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Finland

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Merja Nikula, M.Psych.

Role: CONTACT

+3588315 5218

Johanna Uusimaa, MD, PhD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Merja Nikula, M.Psych.

Role: primary

Johanna Uusimaa, MD, PhD

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

206/2021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Procedural Learning in Participants With ADHD
NCT00446537 UNKNOWN EARLY_PHASE1