Neurodevelopmental DisordersNCT07426315
Innovative Methodologies for Neuroplasticity in Developmental Age With the Use of Virtual Reality
A study testing CAREN therapy and Conventional interventions in people with Neurodevelopmental Disorders, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Neurodevelopmental Disorders
- What is being tested?
- CAREN therapy and Conventional interventions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteItaly
- Study dates
- 14 Aug 2025to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Neurolesi Bonino Pulejo
Messina, Messina, 98124
About this study
Official title: M.I.N.E.R.V.A., Metodologie Innovative Per la Neuroplasticità in Età Evolutiva Con l'Uso Della Realtà Virtuale a Scopo Abilitativo
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.
Read the 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
- Being tested
- CAREN therapy, Conventional interventions
- Medical subject headings
- Neurodevelopmental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAREN therapyBehavioural
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.
Conventional interventionsBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Conventional interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
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.
Measured: Up to 7 months
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.
Measured: Up to 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start14 Aug 2025
- Primary completionJan 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 108 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Centro Neurolesi Bonino Pulejo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426315
- Sponsor's protocol ID
- MINERVA_25
- Status last verified
- Feb 2026
- First submitted
- 21 Nov 2025
- Last updated
- 23 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 31858331
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- M.I.N.E.R.V.A., Metodologie Innovative Per la Neuroplasticità in Età Evolutiva Con l'Uso Della Realtà Virtuale a Scopo Abilitativo
- ClinicalTrials.gov ID
- NCT07426315
- Acronym / sponsor ID
- MINERVA_25
- Conditions
- Neurodevelopmental Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 108 participants (estimated)
- Lead sponsor
- IRCCS Centro Neurolesi Bonino PulejoUniversity, hospital or other
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Behavioral: CAREN therapy, Behavioral: Conventional interventionsThe 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. |
| Conventional interventions | Active comparator | Behavioral: Conventional interventionsArm 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. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Children and adolescents aged 8 to 18 years
- Diagnosis of one of the following neurodevelopmental disorders:
- 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
Key exclusion criteria (10 listed)
- 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:
- Severe motor impairments that prevent interaction with the virtual reality platform
- Uncontrolled medical conditions (e.g., severe cardiovascular, respiratory, or endocrine diseases)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAREN therapyThe 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. | Behavioural | Experimental Group |
| 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. | Behavioural | Conventional interventions, Experimental Group |
Primary outcome
Visual Attention and Memory Assessed by the Leiter International Performance Scale - Third Edition (Leiter-3)
Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)
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)
Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)
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)
Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)
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
Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)
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.
Attention and Memory Assessed by the NEPSY-Second Edition (NEPSY-II)
Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)
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.
Executive Function Assessed by the Tower of London Test
Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)
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.
Executive Function Assessed by the Behavior Rating Inventory of Executive Function - Second Edition (BRIEF-2)
Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)
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.
Behavioral and Attention Symptoms Assessed by the Conners' Rating Scales - Third Edition (Conners 3)
Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)
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.
Behavioral and Emotional Problems Assessed by the Child Behavior Checklist (CBCL) - Parent Version
Time frame: Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)
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.
Motor Competence Assessed by the Movement Assessment Battery for Children - Second Edition (Movement ABC-2)
Time frame: T0 (Baseline), T1 (1 month), T2 (3 months), T3 (Follow-up at 3 months)
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.
2 secondary outcomes
System Usability Assessed by the System Usability Scale (SUS)
Time frame: Up to 7 months
Behavioral Safety Assessed by the Behavioral Safety Event Rating Scale (B-SERS)
Time frame: Up to 7 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Results publication: PubMed 31858331Calabro 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAREN therapy and Conventional interventions in people with Neurodevelopmental Disorders, run by IRCCS Centro Neurolesi Bonino Pulejo at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesca Cucinotta (09060128256, francesca.cucinotta@irccsme.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Attention and Memory Assessed by the Leiter International Performance Scale - Third Edition (Leiter-3) (time frame: Baseline (T0), 1 month (T1), 3 months (T2), 3-month follow-up (T3)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07426315, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.