NCT07426315

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 108 (estimated)
• Sponsor: IRCCS Centro Neurolesi Bonino Pulejo · Academic / Other
• Sex: All
• Age: 8 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This protocol was created to evaluate the effects of rehabilitation with IVR in subjects with neurodevelopmental disorders that profoundly impact their quality of life and that of their families: Cerebral Palsy (CP), Attention-Deficit/Hyperactivity Disorder (ADHD), Autism Spectrum Disorder (ASD). In the literature we find many studies and guidelines concerning the neuropsychological interventions envisaged for the pathologies that affect our protocol. However, rehabilitation interventions in the developmental age often focus on a single clinical aspect, aiming to implement some deficient skills and losing sight of the global vision of the patient and his needs. Furthermore, conventional rehabilitation methods do not always appear motivating for the minor, who is often forced to perform the tasks required in a non-participatory and active way. In recent decades, scientific research has instead highlighted the effectiveness of therapeutic interventions with innovative technologies, demonstrating how these tools can make the rehabilitation process more engaging and stimulating, both for adults and minors. In particular, the use of Immersive Virtual Reality (IVR) is configured as a promising frontier in neuropsychological rehabilitation, with the potential to significantly improve patients' quality of life and optimize clinical outcomes compared to traditional methods.

Conditions

• Neurodevelopmental Disorders

Interventions

Type	Name	Description
BEHAVIORAL	CAREN 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.
BEHAVIORAL	Conventional 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.

Timeline

• Start date: 2025-08-14
• Primary completion: 2028-01-01
• Completion: 2028-08-01
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

1 site across 1 country: Italy