VREALFUN-ADHDNCT06123741

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

StatusRecruiting

PhaseNot applicable

SponsorMerja Nikula

Primary completionDec 31, 2027 (estimated)

At risk: Primary completion moved 2 years later.

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Record History

All 5 versions: 4 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

Notable Nov 2, 2026 Primary completion pushed from Dec 31, 2025 to Dec 31, 2027
- Study completion pushed from Dec 31, 2025 to Dec 31, 2028
- Eligibility criteria expanded, about 13 words
- Secondary endpoints: details revised at 7 of 7 entries
Minor Jan 10, 2024 Start date changed from estimate of Dec 12, 2023 to Jan 10, 2024v3
Notable Dec 12, 2023 Trial status: Not Yet Recruiting to Recruiting
- Start date: Nov 15, 2023 to Dec 12, 2023
- Site details revised
v2
Nov 7, 2023 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

Epeli (Executive Performance in Everyday LIving) task

Timeframe: Baseline, 4-6 weeks, 6 months and 12 months.

ADHD-rating scale IV (ADHD-RS) (parent report)

Timeframe: Baseline, 4-6 weeks, 6 months and 12 months.

Epeli Questionnaire (parent report)

Timeframe: Baseline, 4-6 weeks, 6 months and 12 months.

Epeli Questionnaire (child report)

Timeframe: Baseline, 4-6 weeks, 6 months and 12 months.

Secondary (7)

Behavior Rating Inventory of Executive Function (BRIEF-2) (parent form)

Behavior Rating Inventory of Executive Function (BRIEF-2) (teacher form)

Concentration questionnaire (in Finnish: Keskittymiskysely)

Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents Revised Version ( KINDL-R) (parent version)

Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents Revised Version (KINDL-R) (self-report version)

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N-back test

The Conners Continuous Performance Test 3rd Edition (Conners CPT3)

Arms and interventions

Parental Guidance+Virtual Reality GameExperimental

Parental GuidanceExperimental

Virtual Reality GameExperimental

Control GroupNo intervention

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

Behavioral: Parental Guidance, Virtual Reality Game

Sites

1 site in 1 country

Oulu University HospitalOulu, Finland

About this trial

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.

Trial details

Enrollment: 88 participants (estimated)
Started: Jan 10, 2024
Study completion: Dec 31, 2028 (estimated)
Eligibility: 8 to 12, all sexes, no healthy volunteers
Design: Interventional, randomized, open label, treatment
Conditions: Attention Deficit Disorder with Hyperactivity, Attention Deficit Hyperactivity Disorder
Collaborators: University of Oulu, Aalto University, University of Helsinki, Helsinki University Central Hospital
Official title: Virtual Reality in Rehabilitation of Executive Functions in Children (VREALFUN)
First posted: Nov 9, 2023
Registry updated: Nov 3, 2026
Last verified: Nov 2026

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