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

M

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)

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).

Trial contacts and locations

1

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Central trial contact

Johanna Uusimaa, MD, PhD; Merja Nikula, M.Psych.

Data sourced from clinicaltrials.gov

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