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ACTIVE NOT RECRUITING
NCT06838975
NA

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

Sponsor: IRCCS Centro Neurolesi Bonino Pulejo

View on ClinicalTrials.gov

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).

Official title: Effectiveness of Virtual Reality Rehabilitation to Improve Cognitive, Emotional, Relational, and Motor Domains in Patients With Neurological and Neurodegenerative Disorders

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

328

Start Date

2025-01-16

Completion Date

2028-01-31

Last Updated

2025-02-21

Healthy Volunteers

No

Interventions

DEVICE

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.

OTHER

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.

Locations (2)

IRCCS Centro Neurolesi Bonino Pulejo

Messina, Italy/Me, Italy

IRCCS Centro Neurolesi Bonino Pulejo

Messina, Italy/Me, Italy