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Virtuele realiteit bij het herstel van executieve functies bij kinderen met aandachtstekortstoornis met hyperactiviteit. (VREALFUN-ADHD)

2 november 2026 bijgewerkt door: Merja Nikula

Virtuele realiteit bij het herstel van executieve functies bij kinderen (VREALFUN)

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

88

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

  • Finland
      • Oulu, Finland, 90029
        • Werving
        • Oulu University Hospital
        • Contact:
        • Contact:
        • Hoofdonderzoeker:
          • Merja Nikula, M.Psych.
        • Onderonderzoeker:
          • Johanna Uusimaa, MD, PhD
        • Onderonderzoeker:
          • Mirjami Mäntymaa, MD, PhD

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

8 jaar tot 12 jaar (Kind)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Ouderlijk toezicht + Virtual Reality-spel
Gedragsmatig: 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) .

Andere namen:
  • Zelfhulpprogramma voor uitdagend gedrag van kinderen (programmanaam in het Fins: Lasten haastavan käytöksen omahoito-ohjelma).
Gedragsmatig: 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.
Experimenteel: Ouderlijke begeleiding
Gedragsmatig: 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) .

Andere namen:
  • Zelfhulpprogramma voor uitdagend gedrag van kinderen (programmanaam in het Fins: Lasten haastavan käytöksen omahoito-ohjelma).
Experimenteel: Virtual Reality-spel
Gedragsmatig: 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.
Geen tussenkomst: Control Group

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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Epeli (Executive Performance in Everyday LIving) task
Tijdsspanne: Baseline, 4-6 weeks, 6 months and 12 months.

A virtual reality task for attention, executive function, and prospective memory. Change in total score, task efficacy, navigation efficacy, controller motion, and total action.
Baseline, 4-6 weeks, 6 months and 12 months.
ADHD-rating scale IV (ADHD-RS) (parent report)
Tijdsspanne: Baseline, 4-6 weeks, 6 months and 12 months.

The ADHD-RS (parent report) is an assessment of a child's ADHD symptoms with 18 items based on the child's behaviour over the past 6 months. 4-point Likert scale. The total score ranges 0-54, scores in inattention subscale and hyperactivity/impulsivity subscale range 0-27. Change in the total score, inattention subscale score, and hyperactivity/impulsivity subscale score on a parent-rated ADHD-RS. A lower score means a better outcome.
Baseline, 4-6 weeks, 6 months and 12 months.
Epeli Questionnaire (parent report)
Tijdsspanne: Baseline, 4-6 weeks, 6 months and 12 months.

An assessment of a child's functional ability and the amount of positive feedback given by the parent to the child over the past 4 weeks. 5-point Likert scale. 2 subscales: Functional ability subscale where score ranges 4-20, and Positive feedback subscale where score ranges 4-20. Change in Functional ability subscale score and Positive feedback subscale score on parent-rated Epeli- questionnaire. A higher score means a better outcome.
Baseline, 4-6 weeks, 6 months and 12 months.
Epeli Questionnaire (child report)
Tijdsspanne: Baseline, 4-6 weeks, 6 months and 12 months.

An assessment of a child's functional ability and the amount of positive feedback given by the parent to the child over the past 4 weeks. 5-point Likert scale. 2 subscales: Functional ability subscale where score ranges 4-20, and Positive feedback subscale where score ranges 4-20. Change in Functional ability subscale score and Positive feedback subscale score on child-rated Epeli- questionnaire. A higher score means a better outcome.
Baseline, 4-6 weeks, 6 months and 12 months.

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Behavior Rating Inventory of Executive Function (BRIEF-2) (parent form)
Tijdsspanne: Baseline, 4-6 weeks, 6 months and 12 months.

A measure of executive functions of children and adolescents in natural settings containing 63 items rated by the parent. 3-point Likert scale. Change in Global Executive Composite score, Behavior regulation score, Emotion regulation score, and Cognitive regulation score on parent-rated BRIEF-2. In case the data in the Behavior regulation, Emotion regulation, and Cognitive regulation subscales are not too strongly correlated (r<0.7) and there will be a significant effect of the intervention on the BRIEF-2 Global Executive Composite score, we will use the subscales to conduct a post hoc analysis examining which domains of executive functions are affected. A higher score means a worse outcome.
Baseline, 4-6 weeks, 6 months and 12 months.
Behavior Rating Inventory of Executive Function (BRIEF-2) (teacher form)
Tijdsspanne: Baseline, 4-6 weeks, 6 months and 12 months.

A measure of executive functions of children and adolescents in natural settings containing 63 items rated by the teacher. 3-point Likert scale. Change in Global Executive Composite score, Behavior regulation score, Emotion regulation score, and Cognitive regulation score on teacher-rated BRIEF-2. In case the data in the Behavior regulation, Emotion regulation, and Cognitive regulation subscales are not too strongly correlated (r<0.7) and there will be a significant effect of the intervention on the BRIEF-2 Global Executive Composite score, we will use the subscales to conduct a post hoc analysis examining which domains of executive functions are affected. A higher score means a worse outcome.
Baseline, 4-6 weeks, 6 months and 12 months.
Concentration questionnaire (in Finnish: Keskittymiskysely)
Tijdsspanne: Baseline, 4-6 weeks, 6 months and 12 months.

An assessment of attention and executive function difficulties in school-aged children with 55 items. 3-point Likert Scale, Total score range 0-110. Change in Total score, Distractibility score (range 0-8), sum of Impulsivity and Motor hyperactivity subscales scores (range 0-32), sum of Directing, Sustaining and Shifting Attention subscales scores (range 0-30), and sum of Initiative, Planning, Execution and Evaluation of Action subscales scores (range 0-40) on teacher-rated Concentration questionnaire. In case the data in the Distractibility subscale, Impulsivity and Motor hyperactivity subscales, Attention subscales and Executive subscales are not too strongly correlated (r<0.7) and there will be a significant effect of the intervention on Concentration questionnaire Total score, we will use the subscales to conduct a post hoc analysis examining which domains of executive functions are affected. A higher score implies a worse outcome.
Baseline, 4-6 weeks, 6 months and 12 months.
Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents Revised Version ( KINDL-R) (parent version)
Tijdsspanne: Baseline, 4-6 weeks, 6 months and 12 months.

An assessment of Health-Related Quality of Life in children and adolescents with 24 items. 5-point Likert scale. Change in Total score on parent-rated questionnaire. A higher score means a better outcome.
Baseline, 4-6 weeks, 6 months and 12 months.
Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents Revised Version (KINDL-R) (self-report version)
Tijdsspanne: Baseline, 4-6 weeks, 6 months and 12 months.

An assessment of Health-Related Quality of Life in children and adolescents with 24 items. 5-point Likert scale. Change in Total score on child-rated questionnaire. A higher score means a better outcome.
Baseline, 4-6 weeks, 6 months and 12 months.
N-back test
Tijdsspanne: Baseline, 4-6 weeks, 6 months and 12 months.

A test for a working memory. Change in 2-back and 1-back hitrate and reaction time.
Baseline, 4-6 weeks, 6 months and 12 months.
The Conners Continuous Performance Test 3rd Edition (Conners CPT3)
Tijdsspanne: Baseline, 4-6 weeks, 6 months and 12 months.

A computerized attention task validated in individuals aged 8 years and older. Change in scores on Conners Continuous Performance Test (CPT-3).
Baseline, 4-6 weeks, 6 months and 12 months.

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Merja Nikula

Medewerkers

Helsinki University Central Hospital
University of Helsinki
University of Oulu
Aalto University

Onderzoekers

  • Studie stoel: Johanna Uusimaa, MD, PhD, Oulu University Hospital
  • Hoofdonderzoeker: Merja Nikula, M.Psych., Oulu University Hospital
  • Studie directeur: Mirjami Mäntymaa, MD, PhD, Oulu University Hospital
  • Studie directeur: Juha Salmitaival, PhD, University of Oulu, Finland

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

10 januari 2024

Primaire voltooiing (Geschat)

31 december 2027

Studie voltooiing (Geschat)

31 december 2028

Studieregistratiedata

Eerst ingediend

28 september 2023

Eerst ingediend dat voldeed aan de QC-criteria

7 november 2023

Eerst geplaatst (Werkelijk)

9 november 2023

Updates van studierecords

Laatste update geplaatst (Werkelijk)

3 november 2026

Laatste update ingediend die voldeed aan QC-criteria

2 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 206/2021

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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