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Active, not recruiting Not applicable

Virtual Reality Rehabilitation for Cognitive, Emotional, and Motor Recovery in Neurological Disorders

NCT06838975 · tracked via the Priya Life Science Italy tracker
Phase
Not applicable
Started
2025-01-16
Last updated
2025-02-21

Condition(s) studied

Acquired Brain InjuriesSpinal Cord InjuryMultiple SclerosisParkinson Disease

Investigational drug(s) / intervention(s)

VR Trainingtraditional cognitive and motor rehabilitation following standard clinical practices

VR 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.

traditional 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.

Study 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).

Eligibility

Sex
ALL
Min age
18 Years
Max age
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

Primary outcome measure(s)

  • 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.

Trial sites (2)

FacilityCityRegionStatus
IRCCS Centro Neurolesi Bonino Pulejo Messina Italy/Me
IRCCS Centro Neurolesi Bonino Pulejo Messina Italy/Me
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06838975 on ClinicalTrials.gov ↗ ← All trials in Italy