Virtuell virkelighet i rehabilitering av utøvende funksjoner hos barn med oppmerksomhetssvikt og hyperaktivitetsforstyrrelse. (VREALFUN-ADHD)
Virtuell virkelighet i rehabilitering av utøvende funksjoner hos barn (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.
Studieoversikt
Status
Intervensjon / Behandling
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Merja Nikula, M.Psych.
- Telefonnummer: +3588315 5218
- E-post: merja.nikula@pohde.fi
Studer Kontakt Backup
- Navn: Johanna Uusimaa, MD, PhD
- E-post: johanna.uusimaa@pohde.fi
Studiesteder
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Oulu, Finland, 90029
- Rekruttering
- Oulu University Hospital
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Ta kontakt med:
- Johanna Uusimaa, MD, PhD
- E-post: johanna.uusimaa@pohde.fi
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Ta kontakt med:
- Merja Nikula, M.Psych.
- E-post: merja.nikula@pohde.fi
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Hovedetterforsker:
- Merja Nikula, M.Psych.
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Underetterforsker:
- Johanna Uusimaa, MD, PhD
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Underetterforsker:
- Mirjami Mäntymaa, MD, PhD
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: Foreldreveiledning+Virtual Reality Game
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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) .
Andre navn:
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. |
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Eksperimentell: Veiledning fra foreldre
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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) .
Andre navn:
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Eksperimentell: Virtual Reality-spill
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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. |
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Ingen inngripen: Control Group
This group implement the rehabilitation plan drawn up in specialized medical care (treatment as usual). |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Epeli (Executive Performance in Everyday LIving) task
Tidsramme: Baseline, 4-6 weeks, 6 months and 12 months.
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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.
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ADHD-rating scale IV (ADHD-RS) (parent report)
Tidsramme: Baseline, 4-6 weeks, 6 months and 12 months.
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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.
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Epeli Questionnaire (parent report)
Tidsramme: Baseline, 4-6 weeks, 6 months and 12 months.
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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.
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Epeli Questionnaire (child report)
Tidsramme: 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.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Behavior Rating Inventory of Executive Function (BRIEF-2) (parent form)
Tidsramme: Baseline, 4-6 weeks, 6 months and 12 months.
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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.
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Behavior Rating Inventory of Executive Function (BRIEF-2) (teacher form)
Tidsramme: Baseline, 4-6 weeks, 6 months and 12 months.
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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.
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Concentration questionnaire (in Finnish: Keskittymiskysely)
Tidsramme: Baseline, 4-6 weeks, 6 months and 12 months.
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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.
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Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents Revised Version ( KINDL-R) (parent version)
Tidsramme: Baseline, 4-6 weeks, 6 months and 12 months.
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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.
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Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents Revised Version (KINDL-R) (self-report version)
Tidsramme: Baseline, 4-6 weeks, 6 months and 12 months.
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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.
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N-back test
Tidsramme: Baseline, 4-6 weeks, 6 months and 12 months.
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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.
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The Conners Continuous Performance Test 3rd Edition (Conners CPT3)
Tidsramme: Baseline, 4-6 weeks, 6 months and 12 months.
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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.
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Johanna Uusimaa, MD, PhD, Oulu University Hospital
- Hovedetterforsker: Merja Nikula, M.Psych., Oulu University Hospital
- Studieleder: Mirjami Mäntymaa, MD, PhD, Oulu University Hospital
- Studieleder: Juha Salmitaival, PhD, University of Oulu, Finland
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 206/2021
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