Virtual Reality in Rehabilitation of Executive Functions in Children With Attention Deficit Hyperactivity Disorder. (VREALFUN-ADHD)

Merja Nikula

Status: Enrolling

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Behavioral: Parental Guidance; Behavioral: Virtual Reality Game

Study type: Interventional

Funder types: Other

Identifiers

NCT06123741

206/2021

Details and patient eligibility

About

Attention deficit hyperactivity disorder (ADHD) is caused by an abnormality in the development of the central nervous system. Children with attention and executive function difficulties often need long-lasting rehabilitation and there is an increasing need for timely, cost-effective, and feasible rehabilitation interventions, where the training is targeted to support everyday 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 major 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 the virtual environment that corresponds to the 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.

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.

Enrollment: 88 estimated patients

Sex: All

Ages: 8 to 12 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of ADHD (ICD-10 F90.0) and
• Methylphenidate medication 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),
• Traumatic brain injury ((ICD-10 S06),
• Brain tumour, and
• Multiple pregnancy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 4 patient groups

Parental Guidance+Virtual Reality Game

Experimental group

Treatment:

Behavioral: Virtual Reality Game

Behavioral: Parental Guidance

Parental Guidance

Experimental group

Treatment:

Behavioral: Parental Guidance

Virtual Reality Game

Experimental group

Treatment:

Behavioral: Virtual Reality Game

Control Group

No Intervention group

Description:

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