Acquired Brain Injuries, Multiple Sclerosis, Parkinson Disease, Spinal Cord Injury
Conditions
Keywords
Neurorehabilitation, Virtual Reality, Cognitive and motor recovery, cognitive rehabilitation, neurological disorders
Brief summary
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).
Detailed description
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. Secondary Objectives: Identify behavioral and neurophysiological biomarkers predictive of rehabilitation outcomes. Compare the effectiveness of different VR devices for rehabilitation. Evaluate the impact of VR telerehabilitation on recovery and continuity of care. Explore the synergistic effects of VR combined with NIBS. Methods: Study Site: IRCCS Centro Neurolesi Bonino Pulejo. Duration: 3 years. Participants: 328 individuals with neurological disorders (18-75 years old). Design: Participants will be randomized into two groups: VR Training Group: Engages in immersive VR-based rehabilitation. Active Control Group: Receives conventional therapy. Sessions: 20 sessions over 8 weeks (3 times per week). Assessments at 3 time points: T0 (Baseline): Neurological, neuropsychological, motor, and neurophysiological evaluations. T1 (Post-intervention): Repeat assessments to measure immediate effects. T2 (Follow-up at 3 months): Evaluate the maintenance of improvements. Assessments & Outcome Measures: Cognitive Function: MoCA, MMSE, ACE-R, Rao's Battery. Motor Function: Functional Independence Measure (FIM), TUG, Tinetti Scale, Berg Balance Scale. Neurophysiological Changes: EEG, fNIRS, MRI, eye-tracking, motion analysis, sEMG. Emotional & Social Function: Short Empathy Quotient (EQ-short), Faux Pas Test, Hamilton Depression Scale. Usability & Acceptance: System Usability Scale (SUS). Expected Impact: This study aims to advance personalized rehabilitation strategies, improve accessibility to innovative therapies (e.g., telerehabilitation), and optimize the use of VR-based interventions in clinical practice.
Interventions
DEVICEVR Training
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.
OTHERtraditional cognitive and motor rehabilitation following standard clinical practices
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.
Sponsors
IRCCS Centro Neurolesi Bonino Pulejo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
This study follows a randomized controlled trial (RCT) design with a parallel assignment model, where participants are randomly allocated to either a VR-based rehabilitation group or a traditional rehabilitation control group. The intervention consists of 20 sessions over 8 weeks, with follow-up assessments at post-intervention (T1) and 3 months (T2). Blinded evaluators will conduct neurological, cognitive, motor, and neurophysiological assessments (EEG, MRI, fNIRS, motion analysis) at each time point. This model allows for a rigorous comparison of VR rehabilitation with conventional therapy, examining its effects on functional recovery, neurophysiological changes, and treatment adherence.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Cognitive Function | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurophysiological Changes Associated with Rehabilitation | Baseline (T0), Post-Intervention (T1: 8 weeks), and Follow-Up (T2: 3 months post-intervention). | Change in neurophysiological markers from baseline (T0) to post-intervention (T1) and follow-up (T2), assessed through EEG. Significant changes will be identified based on increased functional connectivity and structural adaptations indicative of neuroplasticity. |
| Effectiveness of Telerehabilitation | Baseline (T0), Post-Intervention (T1: 8 weeks), and Follow-Up (T2: 3 months post-intervention) | Comparison of functional improvements between participants receiving VR-based rehabilitation in clinical settings versus those undergoing a telerehabilitation protocol. Changes in motor and cognitive function will be assessed from baseline (T0) to post-intervention (T1) and follow-up (T2) using MoCA. Accessibility, adherence, and patient-reported outcomes will also be analyzed to evaluate the feasibility and effectiveness of remote VR-based rehabilitation. |
Countries
Italy
Outcome results
None listed