Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury

NCT06127459 | Recruiting

• 1 other identifier: 206/ 2021
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury; Attention; Executive Function; Virtual Reality; Child

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (7)

• Behavior Rating Inventory of Executive Function (BRIEF-2) (parent form)

  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.

• 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) (parent version)

  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)

  Baseline, 4-6 weeks, 6 months and 12 months.

Study Arms (2)

Parental Guidance+Virtual Reality Game

EXPERIMENTAL

Behavioral: Parental Guidance; Behavioral: Virtual Reality Game

Control Group

NO INTERVENTION

This group implement the rehabilitation plan drawn up in specialized medical care (treatment as usual).

Interventions

Parental Guidance BEHAVIORAL

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).

Also known as: Self-Help Program of children's challenging behaviour ( Program name in Finnish: Lasten haastavan käytöksen omahoito-ohjelma).

Parental Guidance+Virtual Reality Game

Virtual Reality Game BEHAVIORAL

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.

Parental Guidance+Virtual Reality Game

Eligibility Criteria

• Age: 8 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merja Nikula: lead
• University of Oulu: collaborator
• Aalto University: collaborator
• University of Helsinki: collaborator
• Helsinki University Central Hospital: collaborator

Study Sites (1)

Oulu University Hospital

Oulu, 90029, Finland

RECRUITING

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Johanna Uusimaa, MD, PhD

  Oulu University Hospital

  STUDY CHAIR

• Merja Nikula, M.Psych.

  Oulu University Hospital

  PRINCIPAL INVESTIGATOR

• Mirjami Mäntymaa, MD, PhD

  Oulu University Hospital

  STUDY DIRECTOR

• Juha Salmitaival, PhD

  Aalto University, Finland

  STUDY DIRECTOR

• Elias Ollikainen, B.M.

  University of Oulu, Finland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Merja Nikula, M.Psych.

CONTACT

+358505794427; merja.nikula@pohde.fi

Johanna Uusimaa, MD, PhD

CONTACT

johanna.uusimaa@pohde.fi

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: September 28, 2023
• First Posted: November 13, 2023
• Study Start: January 19, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 26, 2025

Record last verified: 2025-02

Locations

FI (1)