Effectiveness of Virtual Reality Rehabilitation to Improve Cognitive, Emotional, Relational, and Motor Domains in Patients With Neurological and Neurodegenerative Disorders
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 328
- 试验地点
- 2
- 主要终点
- Improvement in Cognitive Function
研究概览
简要总结
This randomized controlled trial (RCT) evaluates the effectiveness of virtual reality (VR) rehabilitation in improving cognitive, emotional, social, and motor functions in patients with neurological disorders (ABI, SCI, MS, PD). It investigates whether VR improves motor and cognitive functions more than traditional therapy, identifies neurophysiological changes (EEG, fNIRS, MRI), and assesses the integration of VR with NIBS or telerehabilitation. Conducted over three years at IRCCS Centro Neurolesi Bonino Pulejo, participants are randomly assigned to either a VR training group or an active control group receiving traditional rehabilitation. Procedures include baseline assessments (T0), 20 rehabilitation sessions over 8 weeks, post-intervention evaluations (T1), and a 3-month follow-up (T2). Primary outcomes measure motor and cognitive function (MoCA, MMSE, FIM, TUG, Berg Balance Scale), neurophysiological changes (EEG, MRI, fNIRS, motion analysis), and emotional/social function (Empathy Quotient, Hamilton Depression Scale).
详细描述
This randomized controlled trial (RCT) aims to evaluate the effectiveness of virtual reality (VR) rehabilitation in improving cognitive, emotional, social, and motor functions in patients with neurological and neurodegenerative disorders (Acquired Brain Injuries, Spinal Cord Injuries, Multiple Sclerosis, and Parkinson's Disease). The study also explores neurophysiological changes and the potential benefits of combining VR with non-invasive brain stimulation (NIBS) and telerehabilitation.
Objectives:
Primary Objectives:
Assess the effectiveness of VR-based rehabilitation in enhancing cognitive and motor functions.
Identify neurophysiological changes (EEG, fNIRS, MRI) associated with functional recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
This study uses a single-blind design, where outcome assessors are masked to group assignments to reduce bias. Participants and therapists delivering the intervention are aware of the assignment due to the nature of the rehabilitation protocols, but the neuropsychological, motor, and neurophysiological evaluations (EEG, MRI, motion analysis) will be conducted by blinded assessors who do not know whether the participant belongs to the VR Training Group or the Active Control Group.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18 to 75 years
- •Diagnosis:
- •Parkinson's Disease (PD) (MDS Clinical Diagnostic Criteria) Multiple Sclerosis (MS) (McDonald Criteria) Spinal Cord Injury (SCI) (ASIA Impairment Scale) Acquired Brain Injury (ABI) (WHO Criteria for Stroke)
- •Education: Minimum of 5 years of formal education
- •Cognitive and physical ability to engage in rehabilitation
排除标准
- •Major psychiatric disorders (e.g., psychosis, severe depression, anxiety disorders)
- •Severe medical conditions that impair participation
- •Sensory or motor impairments preventing VR interaction
- •Contraindications for MRI (e.g., pacemakers, incompatible implants)
- •Pregnancy
研究组 & 干预措施
VR Training Group
Participants in the VR Training Group will undergo a virtual reality-based rehabilitation program designed to improve cognitive, emotional, social, and motor functions. The intervention consists of 20 sessions over 8 weeks (3 sessions per week), using immersive and non-immersive VR systems tailored to individual needs. The program integrates interactive exercises, real-time feedback, and task-oriented training to enhance motor function, cognitive abilities, and patient engagement. Neurophysiological changes will be monitored through EEG, MRI, and motion analysis to assess brain plasticity and functional improvements.
干预措施: VR Training (Device)
Active Control Group
Participants in the Active Control Group will receive traditional cognitive and motor rehabilitation following standard clinical practices. The intervention consists of 20 sessions over 8 weeks (3 sessions per week), focusing on conventional physical therapy, cognitive training, and task-oriented exercises to enhance motor function and cognitive abilities. This group serves as a comparison to evaluate the effectiveness of VR-based rehabilitation. Neurophysiological changes will be monitored using EEG, MRI, and motion analysis to assess functional improvements.
干预措施: traditional cognitive and motor rehabilitation following standard clinical practices (Other)
结局指标
主要结局
Improvement in Cognitive Function
时间窗: Baseline (T0), Post-Intervention (T1: 8 weeks), and Follow-Up (T2: 3 months post-intervention).
Change in cognitive function from baseline (T0) to post-intervention (T1) and follow-up at 3 months (T2), assessed through standardized neuropsychological tests (Montreal Cognitive Assessment - MOCA). A clinically significant improvement is defined as a measurable increase in at least two subscales of the respective cognitive tests.
Improvement in Motor Function
时间窗: Baseline (T0), Post-Intervention (T1: 8 weeks), and Follow-Up (T2: 3 months post-intervention).
Change in motor function from baseline (T0) to post-intervention (T1) and follow-up at 3 months (T2), assessed through standardized clinical tests, including the Berg Balance Scale. A clinically significant improvement is defined as a measurable increase in functional mobility and balance scores.
次要结局
- Neurophysiological Changes Associated with Rehabilitation(Baseline (T0), Post-Intervention (T1: 8 weeks), and Follow-Up (T2: 3 months post-intervention).)
- Effectiveness of Telerehabilitation(Baseline (T0), Post-Intervention (T1: 8 weeks), and Follow-Up (T2: 3 months post-intervention))
研究者
Maria Grazia Maggio
PhD, PsyD
IRCCS Centro Neurolesi Bonino Pulejo