Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury (VREALFUN-TBI)

Virtual Reality in Rehabilitation of Executive Functions in Children (VREALFUN)

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.

Study Overview

• Status: Recruiting
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Behavioral: Virtual Reality Game; Behavioral: Parental Guidance

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Merja Nikula, M.Psych.; Phone Number: +3588315 5218; Email: merja.nikula@pohde.fi
• Study Contact Backup: Name: Johanna Uusimaa, MD, PhD; Email: johanna.uusimaa@pohde.fi

Study Locations

• Finland
  • Oulu, Finland, 90029
    • Recruiting
    • Oulu University Hospital
    • Contact: Johanna Uusimaa, MD, PhD; Email: johanna.uusimaa@pohde.fi
    • Contact: Merja Nikula, M.Psych.; Email: merja.nikula@pohde.fi
    • Principal Investigator: Merja Nikula, M.Psych.
    • Sub-Investigator: Johanna Uusimaa, MD, PhD
    • Sub-Investigator: Mirjami Mäntymaa, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parental Guidance+Virtual Reality Game	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.; 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).; Other Names: Self-Help Program of children's challenging behaviour ( Program name in Finnish: Lasten haastavan käytöksen omahoito-ohjelma).
No Intervention: Control Group; This group implement the rehabilitation plan drawn up in specialized medical care (treatment as usual).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epeli (Executive Performance in Everyday LIving) task	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)	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)	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)	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.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Behavior Rating Inventory of Executive Function (BRIEF-2) (parent form)	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)	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)	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)	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.
N-back test	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)	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.
9. Questionnaire for Measuring Health-Related Quality of Life in Children and Adolescents Revised Version (KINDL-R) (self-report version)	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.

Collaborators and Investigators

• Sponsor: Merja Nikula
• Collaborators: Helsinki University Central Hospital; University of Helsinki; University of Oulu; Aalto University
• Investigators: Study Chair: Johanna Uusimaa, MD, PhD, Oulu University Hospital; Principal Investigator: Merja Nikula, M.Psych., Oulu University Hospital; Study Director: Mirjami Mäntymaa, MD, PhD, Oulu University Hospital; Study Director: Juha Salmitaival, PhD, Aalto University, Finland

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Actual): November 13, 2023

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 19, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Child; Attention; Virtual Reality; Executive Function; Traumatic Brain Injury
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 206/ 2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No