M.I.N.E.R.V.A., Metodologie Innovative Per la Neuroplasticità in Età Evolutiva Con l'Uso Della Realtà Virtuale a Scopo Abilitativo
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Visual Attention and Memory Assessed by the Leiter International Performance Scale - Third Edition (Leiter-3)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 8 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Experimental Group
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.
干预措施: CAREN therapy (Behavioral)
Experimental Group
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.
干预措施: Conventional interventions (Behavioral)
Conventional interventions
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.
干预措施: Conventional interventions (Behavioral)
结局指标
主要结局
Visual Attention and Memory Assessed by the Leiter International Performance Scale - Third Edition (Leiter-3)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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)
时间窗: 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.
次要结局
- 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)