Clinical trial NCT06127459: Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury
Official title: Virtual Reality in Rehabilitation of Executive Functions in Children (VREALFUN)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Traumatic Brain Injury
Keywords: Traumatic Brain Injury
Attention
Executive Function
Virtual Reality
Child
Lead sponsor: Oulu University Hospital
Sponsor class: OTHER
Collaborators: name: University of Oulu
name: Aalto University
name: University of Helsinki
name: Helsinki University Central Hospital
First posted: 2023-11-13
Enrollment: 44
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Traumatic brain injury (TBI) causes lifelong disability. Children with TBI often have difficulties in attention regulation and executive functions affecting their daily living. Need for rehabilitation is often long-lasting and there is an increasing demand for timely, cost-effective, and feasible rehabilitation methods, where the training is targeted to support daily 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 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 a virtual environment that corresponds to 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.

The 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.


Eligibility criteria: Inclusion Criteria:

* Mild to moderate traumatic brain injury (ICD-10: S06.0-S06.6 and S06.8-S06.9 and criteria defined in the Current Care Recommendation, 2021) and
* The challenges of attention and executive function identified in the assessment of a neuropsychologist/experienced psychologist 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),
* Brain tumour, and
* Multiple pregnancy

Primary outcomes:
measure: Epeli (Executive Performance in Everyday LIving) task
timeFrame: Baseline, 4-6 weeks, 6 months and 12 months.
measure: ADHD-rating scale IV (ADHD-RS) (parent report)
timeFrame: Baseline, 4-6 weeks, 6 months and 12 months.
measure: Epeli Questionnaire (parent report)
timeFrame: Baseline, 4-6 weeks, 6 months and 12 months.
measure: Epeli Questionnaire (child report)
timeFrame: Baseline, 4-6 weeks, 6 months and 12 months.
Secondary outcomes:
measure: Behavior Rating Inventory of Executive Function (BRIEF-2) (parent form)
timeFrame: Baseline, 4-6 weeks, 6 months and 12 months.
measure: Behavior Rating Inventory of Executive Function (BRIEF-2) (teacher form)
timeFrame: Baseline, 4-6 weeks, 6 months and 12 months.
measure: Concentration questionnaire (in Finnish: Keskittymiskysely)
timeFrame: Baseline, 4-6 weeks, 6 months and 12 months.
measure: Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents Revised Version ( KINDL-R) (parent version)
timeFrame: Baseline, 4-6 weeks, 6 months and 12 months.
measure: 9. Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents Revised Version (KINDL-R) (self-report version)
timeFrame: Baseline, 4-6 weeks, 6 months and 12 months.
measure: N-back test
timeFrame: Baseline, 4-6 weeks, 6 months and 12 months.
measure: The Conners Continuous Performance Test 3rd Edition (Conners CPT3)
timeFrame: Baseline, 4-6 weeks, 6 months and 12 months.
Other outcomes:
Locations:
city: Oulu
country: Finland
facility: Oulu University Hospital
Study officials:
affiliation: Oulu University Hospital
name: Johanna Uusimaa, MD, PhD
role: STUDY_CHAIR
affiliation: Oulu University Hospital
name: Merja Nikula, M.Psych.
role: PRINCIPAL_INVESTIGATOR
affiliation: Oulu University Hospital
name: Mirjami Mäntymaa, MD, PhD
role: STUDY_DIRECTOR
affiliation: Aalto University, Finland
name: Juha Salmitaival, PhD
role: STUDY_DIRECTOR
affiliation: University of Oulu, Finland
name: Elias Ollikainen, B.M.
role: PRINCIPAL_INVESTIGATOR
References: