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

Not Applicable

Active, not recruiting

• Conditions: Acquired Brain Injuries; Spinal Cord Injury; Multiple Sclerosis; Parkinson Disease

• Registration Number: NCT06838975
• Lead Sponsor: IRCCS Centro Neurolesi Bonino Pulejo

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.

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-16
• Study First Submitted: 2025-01-31
• Study First Submitted QC: 2025-02-20
• Last Update Submitted: 2025-02-20
• Study First Posted: 2025-02-21
• Last Update Posted: 2025-02-21
• Primary Completion: 2027-09-29
• Study Completion: 2028-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 328

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

IRCCS Centro Neurolesi Bonino Pulejo; 🇮🇹 Messina, Italy/Me, Italy