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

NCT07426315 | Recruiting

• 1 other identifier: MINERVA_25
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neurodevelopmental Disorders

Outcome Measures

Primary Outcomes (10)

• 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.

  Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)

• 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.

  Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)

• 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.

  Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)

• 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.

  Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)

• Attention and Memory Assessed by the NEPSY-Second Edition (NEPSY-II)

  The outcome will be assessed using the Attention and Memory domain of the NEPSY-Second Edition (NEPSY-II), a standardized developmental neuropsychological assessment battery designed to evaluate cognitive functioning in children. The Attention and Memory domain includes subtests assessing sustained attention, selective attention, auditory and visual attention, immediate and delayed memory, and working memory. Scores are reported as age-normed scaled scores derived from standardized test performance. Higher scores indicate better attention and memory functioning.

  Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)

• Executive Function Assessed by the Tower of London Test

  Executive functioning will be assessed using the Tower of London Test, a standardized neuropsychological assessment designed to evaluate executive functions, particularly planning ability, problem-solving, and working memory. Outcome parameters include the total number of correct solutions, number of moves, and task completion time. Higher performance scores indicate better executive functioning, whereas a greater number of errors or longer completion times indicate poorer performance.

  Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)

• Executive Function Assessed by the Behavior Rating Inventory of Executive Function - Second Edition (BRIEF-2)

  Executive functioning will be assessed using the Behavior Rating Inventory of Executive Function - Second Edition (BRIEF-2), a standardized caregiver-report questionnaire designed to evaluate everyday executive function behaviors in children and adolescents aged 5 to 18 years. The BRIEF-2 yields three index scores-Behavior Regulation Index, Emotion Regulation Index, and Cognitive Regulation Index-as well as a Global Executive Composite (GEC) score, derived from nine clinical scales. All outcomes are reported as age-normed T-scores. Higher T-scores indicate greater executive function difficulties, reflecting worse outcomes.

  Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)

• Behavioral and Attention Symptoms Assessed by the Conners' Rating Scales - Third Edition (Conners 3)

  Behavioral, emotional, and attention-related symptoms will be assessed using the Conners' Rating Scales - Third Edition (Conners 3), a standardized caregiver- and teacher-report questionnaire designed to evaluate behavioral and attentional difficulties in children and adolescents. The Conners 3 provides T-scores across multiple clinical scales, including Inattention, Hyperactivity/Impulsivity, Executive Functioning, Learning Problems, Aggression, and Peer Relations, based on age- and sex-normed data. Higher T-scores indicate greater severity of behavioral and attention-related symptoms, reflecting worse outcomes.

  Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)

• Behavioral and Emotional Problems Assessed by the Child Behavior Checklist (CBCL) - Parent Version

  This outcome will be assessed using the Child Behavior Checklist (CBCL), a standardized caregiver-report questionnaire designed to evaluate emotional and behavioral problems in children and adolescents. The CBCL provides syndrome scale scores (e.g., Anxious/Depressed, Withdrawn/Depressed, Somatic Complaints, Social Problems, Thought Problems, Attention Problems, Rule-Breaking Behavior, Aggressive Behavior) and broad-band composite scores (Internalizing, Externalizing, and Total Problems). Scores are reported as T-scores, derived from age- and gender-normed data. Higher T-scores indicate greater behavioral or emotional difficulties, representing a worse outcome.

  Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)

• Motor Competence Assessed by the Movement Assessment Battery for Children - Second Edition (Movement ABC-2)

  Motor competence in children and adolescents will be assessed using the Movement Assessment Battery for Children - Second Edition (Movement ABC-2), a standardized test. The Movement ABC-2 evaluates three motor domains: Manual Dexterity, Aiming and Catching, and Balance (static and dynamic). The assessment provides age-standardized scores, a Total Motor Score, and percentile rankings. Higher scores indicate better motor performance, whereas lower scores reflect greater motor coordination difficulties, representing a worse outcome.

  T0 (Baseline), T1 (1 month), T2 (3 months), T3 (Follow-up at 3 months)

Secondary Outcomes (2)

• System Usability Assessed by the System Usability Scale (SUS)

  Up to 7 months

• Behavioral Safety Assessed by the Behavioral Safety Event Rating Scale (B-SERS)

  Up to 7 months

Study Arms (2)

Experimental Group

EXPERIMENTAL

The treatment group consists of n. 36 children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD), n. 36 with Autism Spectrum Disorder (ASD) and n. 36 with Cerebral Palsy (CP). The intervention was tailored to individual needs and aimed at evaluating the efficacy of motor and cognitive treatment in an immersive virtual reality environment, in support of conventional therapy.

Behavioral: CAREN therapy; Behavioral: Conventional interventions

Conventional interventions

ACTIVE COMPARATOR

Arm Description: The treatment group consists of n. 36 children diagnosed with Attention Deficit Hyperactivity Disorder (ADHD), n. 36 with Autism Spectrum Disorder (ASD) and n. 36 with Cerebral Palsy (CP). The intervention was tailored to individual needs and aimed at evaluating the efficacy of motor and cognitive treatment in conventional therapy.

Behavioral: Conventional interventions

Interventions

CAREN therapy BEHAVIORAL

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.

Experimental Group

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.

Conventional interventions; Experimental Group

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IRCCS Centro Neurolesi Bonino Pulejo: lead

Study Sites (1)

IRCCS Neurolesi Bonino Pulejo

Messina, Messina, 98124, Italy

RECRUITING

Related Publications (1)

• Calabro RS, Naro A, Cimino V, Buda A, Paladina G, Di Lorenzo G, Manuli A, Milardi D, Bramanti P, Bramanti A. Improving motor performance in Parkinson's disease: a preliminary study on the promising use of the computer assisted virtual reality environment (CAREN). Neurol Sci. 2020 Apr;41(4):933-941. doi: 10.1007/s10072-019-04194-7. Epub 2019 Dec 19.

  PMID: 31858331 RESULT

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Central Study Contacts

Francesca Cucinotta

CONTACT

09060128256; francesca.cucinotta@irccsme.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a within-subject trial. A group of 36 children (8-18 years) will be selected for each pathology. The protocol includes 6 phases: Phase 1: Patient enrollment, physical examination, and baseline neuropsychological assessment. Phase 2: initial assessment (T0) and start of conventional rehabilitation management for 3 months. Phase 3: textological re-evaluation at the end of the 3 months of conventional therapy (T1). Phase 4: one month wash-out followed by psychodiagnostic re-evaluation (T2) Phase 5: conventional rehabilitation therapy will be resumed with the same frequency and therapeutic objectives as the first cycle with therapeutic integration with IRV sessions for a standardized period of 12 sessions, lasting 45 minutes each, on a weekly basis. Phase 6: Patients will undergo neuropsychological reassessment at the end of treatment (T3); The data will be processed and subsequently published in scie

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: February 23, 2026
• Study Start: August 14, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

IT (1)