Virtual Reality in Rehabilitation of Executive Functions in Children (VREALFUN)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Attention Deficit Hyperactivity Disorder
- Sponsor
- Merja Nikula
- Enrollment
- 88
- Locations
- 1
- Primary Endpoint
- Epeli (Executive Performance in Everyday LIving) task
- Status
- Recruiting
- Last Updated
- 7 months ago
Overview
Brief Summary
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.
Investigators
Merja Nikula
Principal investigator
Oulu University Hospital
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
Outcomes
Primary Outcomes
Epeli (Executive Performance in Everyday LIving) task
Time Frame: 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.
Epeli Questionnaire (child report)
Time Frame: 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.
ADHD-rating scale IV (ADHD-RS) (parent report)
Time Frame: 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.
Epeli Questionnaire (parent report)
Time Frame: 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.
Secondary Outcomes
- Behavior Rating Inventory of Executive Function (BRIEF-2) (parent form)(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)(Baseline, 4-6 weeks, 6 months and 12 months.)
- Behavior Rating Inventory of Executive Function (BRIEF-2) (teacher form)(Baseline, 4-6 weeks, 6 months and 12 months.)
- N-back test(Baseline, 4-6 weeks, 6 months and 12 months.)
- Concentration questionnaire (in Finnish: Keskittymiskysely)(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)(Baseline, 4-6 weeks, 6 months and 12 months.)
- The Conners Continuous Performance Test 3rd Edition (Conners CPT3)(Baseline, 4-6 weeks, 6 months and 12 months.)