Virtual Reality in Rehabilitation of Executive Functions in Children With Attention Deficit Hyperactivity Disorder.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Parental Guidance, Virtual Reality Game.
- Who it may be relevant to
- Registry conditions: Attention Deficit Hyperactivity Disorder. Basic parameters: 8 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Finland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Virtual Reality in Rehabilitation of Executive Functions in Children (VREALFUN)
Overview
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.
Interventions
- Behavioral 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) . - 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.
Primary outcome measures
- Epeli (Executive Performance in Everyday LIving) task [Time frame: Baseline, 4-6 weeks, 6 months and 12 months.]
- ADHD-rating scale IV (ADHD-RS) (parent report) [Time frame: Baseline, 4-6 weeks, 6 months and 12 months.]
- Epeli Questionnaire (parent report) [Time frame: Baseline, 4-6 weeks, 6 months and 12 months.]
- Epeli Questionnaire (child report) [Time frame: Baseline, 4-6 weeks, 6 months and 12 months.]
Secondary outcome measures (7)
- Behavior Rating Inventory of Executive Function (BRIEF-2) (parent form) [Time frame: Baseline, 4-6 weeks, 6 months and 12 months.]
- Behavior Rating Inventory of Executive Function (BRIEF-2) (teacher form) [Time frame: Baseline, 4-6 weeks, 6 months and 12 months.]
- Concentration questionnaire (in Finnish: Keskittymiskysely) [Time frame: 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) [Time frame: 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) [Time frame: Baseline, 4-6 weeks, 6 months and 12 months.]
- N-back test [Time frame: Baseline, 4-6 weeks, 6 months and 12 months.]
- The Conners Continuous Performance Test 3rd Edition (Conners CPT3) [Time frame: Baseline, 4-6 weeks, 6 months and 12 months.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Finland · 1 center
- Oulu University Hospital — Oulu
Identifiers
NCT: NCT06123741 · 206/2021