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

NCT ID: NCT06127459

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-19
• Study Completion Date: 2026-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Parental Guidance+Virtual Reality Game

Group Type: EXPERIMENTAL

Parental Guidance

Intervention Type: 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).

Virtual Reality Game

Intervention Type: 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.

Control Group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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).

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

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

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

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Oulu

OTHER

Sponsor Role: collaborator

Aalto University

OTHER

Sponsor Role: collaborator

University of Helsinki

OTHER

Sponsor Role: collaborator

Helsinki University Central Hospital

OTHER

Sponsor Role: collaborator

Merja Nikula

OTHER

Sponsor Role: lead

Responsible Party

Merja Nikula

Principal investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Johanna Uusimaa, MD, PhD

Role: STUDY_CHAIR

Oulu University Hospital

Merja Nikula, M.Psych.

Role: PRINCIPAL_INVESTIGATOR

Oulu University Hospital

Mirjami Mäntymaa, MD, PhD

Role: STUDY_DIRECTOR

Oulu University Hospital

Juha Salmitaival, PhD

Role: STUDY_DIRECTOR

Aalto University, Finland

Elias Ollikainen, B.M.

Role: PRINCIPAL_INVESTIGATOR

University of Oulu, Finland

Locations

Oulu University Hospital

Oulu, , Finland

Site Status: RECRUITING

Countries

Finland

Central Contacts

Merja Nikula, M.Psych.

Role: CONTACT

merja.nikula@pohde.fi

+358505794427

Johanna Uusimaa, MD, PhD

Role: CONTACT

johanna.uusimaa@pohde.fi

Facility Contacts

Merja Nikula, M.Psych.

Role: primary

merja.nikula@pohde.fi

+358505794427

Johanna Uusimaa, MD, PhD

Role: backup

johanna.uusimaa@pohde.fi

Other Identifiers

206/ 2021

Identifier Type: -

Identifier Source: org_study_id