RecruitingNot ApplicableNCT07426315

Innovative Methodologies for Neuroplasticity in Developmental Age With the Use of Virtual Reality

M.I.N.E.R.V.A., Metodologie Innovative Per la Neuroplasticità in Età Evolutiva Con l'Uso Della Realtà Virtuale a Scopo Abilitativo


Sponsor

IRCCS Centro Neurolesi Bonino Pulejo

Enrollment

108 participants

Start Date

Aug 14, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Neurodevelopmental disorders, such as Cerebral Palsy (CP), Attention-Deficit/Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD), are complex conditions that affect various aspects of children's development. Despite advancements in treatments, conventional rehabilitative interventions tend to focus on specific aspects, often overlooking the holistic needs of the patient. Many of these interventions fail to engage children, who may feel uninvolved or demotivated. Innovative technologies, such as immersive virtual reality (IVR), offer a promising alternative to make rehabilitation more engaging and comprehensive. This study aims to evaluate the effects of IVR-based rehabilitation on children and adolescents with neurodevelopmental disorders, focusing on improvements in cognitive, motor, and social functions. We hypothesize that IVR will enhance social interaction, attention, motor skills, and overall quality of life. The study will include children and adolescents aged 8 to 18 years, diagnosed with ADHD, ASD, and cerebral palsy. The CAR-EN platform, which provides a highly customizable therapeutic environment, will be used. Assessments will measure cognitive, motor, and social skills before and after the intervention. We expect immersive virtual reality to lead to significant improvements in the participants' cognitive, motor, and social abilities. These findings could potentially contribute to a shift in therapeutic guidelines, offering more effective treatments for children with neurodevelopmental disorders.


Eligibility

Min Age: 8 YearsMax Age: 18 Years

Inclusion Criteria8

  • Children and adolescents aged 8 to 18 years
  • Diagnosis of one of the following neurodevelopmental disorders:
  • Attention Deficit Hyperactivity Disorder (ADHD)
  • Autism Spectrum Disorder (ASD)
  • Cerebral Palsy (CP)
  • Ability to understand and comply with instructions for the intervention
  • Adequate cognitive, motor, and social skills to participate in the rehabilitation program
  • Informed consent obtained from a parent or legal guardian

Exclusion Criteria10

  • Children and adolescents younger than 8 or older than 18 years
  • Severe cognitive impairments or intellectual disabilities that prevent participation in the rehabilitation program
  • Diagnosis of conditions not related to the target neurodevelopmental disorders, such as:
  • Major psychiatric disorders (e.g., severe depression, schizophrenia)
  • Neurological disorders not included in the study (e.g., epilepsy)
  • Severe motor impairments that prevent interaction with the virtual reality platform
  • Uncontrolled medical conditions (e.g., severe cardiovascular, respiratory, or endocrine diseases)
  • Lack of informed consent from a parent or legal guardian
  • Participation in another intervention or study that may interfere with the rehabilitation program
  • Behavioral issues or extreme anxiety that make it impossible to follow instructions or interact with the virtual reality system

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Interventions

BEHAVIORALCAREN therapy

The experimental intervention uses the CAREN immersive virtual reality system, which integrates visual, auditory and tactile sensory stimuli, to stimulate cognitive, motor and social skills through interactive exercises. The system monitors progress in real time and reduces the stress associated with traditional therapies, offering an innovative and engaging therapy experience.

BEHAVIORALConventional interventions

\- Neuropsychomotricity for children with cerebral palsy, with the objectives of motor improvement, balance and coordination. - Cognitive-behavioral training for ADHD, focusing on attentional skills, planning and emotional self-regulation. - Cognitive-behavioral training for ASD, focusing on cognitive flexibility, impulse control and motor coordination.


Locations(1)

IRCCS Neurolesi Bonino Pulejo

Messina, Messina, Italy

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NCT07426315


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