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.
Children and adolescents aged 8 to 18 years
Attention Deficit Hyperactivity Disorder (ADHD)
Autism Spectrum Disorder (ASD)
Cerebral Palsy (CP)
Children and adolescents younger than 8 or older than 18 years
Severe cognitive impairments or intellectual disabilities that prevent participation in the rehabilitation program
Major psychiatric disorders (e.g., severe depression, schizophrenia)
Neurological disorders not included in the study (e.g., epilepsy)
Crossover
CAREN therapy
BehavioralThe 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.
Conventional interventions
Behavioral\- 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.
Visual Attention and Memory Assessed by the Leiter International Performance Scale - Third Edition (Leiter-3)
The primary outcome will be assessed using the Attention and Memory subtests of the Leiter International Performance Scale - Third Edition (Leiter-3), a standardized nonverbal cognitive assessment tool commonly used in children and adolescents. These subtests evaluate sustained attention, selective attention, visual working memory, immediate memory recall, and delayed memory recall. Higher raw and standardized scores indicate better cognitive performance in the assessed domains.
Gross Motor Function Assessed by the Gross Motor Function Measure-66 (GMFM-66)
Gross motor function will be assessed using the Gross Motor Function Measure-66 (GMFM-66), a standardized observational assessment tool designed to evaluate changes in gross motor abilities in children with motor disabilities. The GMFM-66 provides an interval-level total score derived from 66 items covering key domains of gross motor function, including lying and rolling, sitting, crawling and kneeling, standing, walking, running, and jumping. Higher scores indicate better gross motor function.
Muscle Spasticity Assessed by the Modified Ashworth Scale (MAS)
Muscle spasticity will be assessed using the Modified Ashworth Scale (MAS), a standardized clinical rating scale used to measure resistance to passive soft-tissue stretching as an indicator of muscle spasticity. The MAS is scored on a 5-point ordinal scale ranging from 0 to 4, where 0 indicates no increase in muscle tone and 4 indicates affected parts rigid in flexion or extension. Higher scores indicate greater muscle spasticity, reflecting a worse outcome.
Balance Assessed by the Tinetti Assessment Tool - Balance Subscale
Balance will be assessed using the Balance Subscale of the Tinetti Assessment Tool, a standardized clinical scale designed to evaluate postural stability as part of functional mobility and fall risk assessment. The Balance Subscale is scored on a range from 0 to 16, with higher scores indicating better balance and a lower risk of falls. Lower scores indicate reduced mobility and higher fall risk.
System Usability Assessed by the System Usability Scale (SUS)
System usability will be assessed using the System Usability Scale (SUS), a standardized 10-item questionnaire designed to measure users' perceived usability of a system or device. The SUS provides a total score ranging from 0 to 100, calculated according to the standard scoring method. Higher scores indicate better perceived usability, with scores above 68 generally considered above average usability.
Behavioral Safety Assessed by the Behavioral Safety Event Rating Scale (B-SERS)
Behavioral safety will be assessed using the Behavioral Safety Event Rating Scale (B-SERS), based on a behavioral risk assessment framework. The B-SERS evaluates the frequency and severity of safety-related behavioral events, such as behaviors that may pose a risk to oneself, others, or the environment. The scale includes 5 items, each scored from 0 to 4 (0 = no event; 1 = mild; 2 = moderate; 3 = marked; 4 = severe). The total score ranges from 0 to 20, with higher scores indicating worse safety outcomes.
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