NCT06127459 Virtual Reality in Rehabilitation of Executive Functions in Children With Mild or Moderate Traumatic Brain Injury
| NCT ID | NCT06127459 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Merja Nikula |
| Condition | Traumatic Brain Injury |
| Study Type | INTERVENTIONAL |
| Enrollment | 44 participants |
| Start Date | 2024-01-19 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 44 participants in total. It began in 2024-01-19 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Contact & Investigator
Johanna Uusimaa, MD, PhD
STUDY CHAIR
Oulu University Hospital
Frequently Asked Questions
Who can join the NCT06127459 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 12 Years, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06127459 currently recruiting?
Yes, NCT06127459 is actively recruiting participants. Contact the research team at merja.nikula@pohde.fi for enrollment information.
Where is the NCT06127459 trial being conducted?
This trial is being conducted at Oulu, Finland.
Who is sponsoring the NCT06127459 clinical trial?
NCT06127459 is sponsored by Merja Nikula. The principal investigator is Johanna Uusimaa, MD, PhD at Oulu University Hospital. The trial plans to enroll 44 participants.