NCT06838975

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
328

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Jan 2025Jan 2028

Study Start

First participant enrolled

January 16, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 31, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

February 21, 2025

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2027

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2028

Last Updated

February 21, 2025

Status Verified

January 1, 2025

Enrollment Period

2.7 years

First QC Date

January 31, 2025

Last Update Submit

February 20, 2025

Conditions

Acquired Brain InjuriesSpinal Cord InjuryMultiple SclerosisParkinson Disease

Keywords

NeurorehabilitationVirtual RealityCognitive and motor recoverycognitive rehabilitationneurological disorders

Outcome Measures

Primary Outcomes (2)

  • Improvement in Cognitive Function

    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.

    Baseline (T0), Post-Intervention (T1: 8 weeks), and Follow-Up (T2: 3 months post-intervention).

  • Improvement in Motor Function

    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.

    Baseline (T0), Post-Intervention (T1: 8 weeks), and Follow-Up (T2: 3 months post-intervention).

Secondary Outcomes (2)

  • 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)

Study Arms (2)

VR Training Group

EXPERIMENTAL

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.

Device: VR Training

Active Control Group

ACTIVE COMPARATOR

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.

Other: traditional cognitive and motor rehabilitation following standard clinical practices

Interventions

VR TrainingDEVICE

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.

Also known as: Experimental Group
VR Training Group
traditional cognitive and motor rehabilitation following standard clinical practicesOTHER

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.

Active Control Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

IRCCS Centro Neurolesi Bonino Pulejo

Messina, Italy/Me, 98123, Italy

Location

IRCCS Centro Neurolesi Bonino Pulejo

Messina, Italy/Me, 98124, Italy

Location

Related Publications (3)

  • Maggio MG, Maresca G, De Luca R, Stagnitti MC, Porcari B, Ferrera MC, Galletti F, Casella C, Manuli A, Calabro RS. The Growing Use of Virtual Reality in Cognitive Rehabilitation: Fact, Fake or Vision? A Scoping Review. J Natl Med Assoc. 2019 Aug;111(4):457-463. doi: 10.1016/j.jnma.2019.01.003. Epub 2019 Feb 8.

    PMID: 30739728BACKGROUND

  • De Luca R, Russo M, Naro A, Tomasello P, Leonardi S, Santamaria F, Desiree L, Bramanti A, Silvestri G, Bramanti P, Calabro RS. Effects of virtual reality-based training with BTs-Nirvana on functional recovery in stroke patients: preliminary considerations. Int J Neurosci. 2018 Sep;128(9):791-796. doi: 10.1080/00207454.2017.1403915. Epub 2018 Feb 2.

    PMID: 29148855BACKGROUND

  • Maggio MG, Bonanno M, Manuli A, Onesta MP, De Luca R, Quartarone A, Calabro RS. Do Individuals with Spinal Cord Injury Benefit from Semi-Immersive Virtual Reality Cognitive Training? Preliminary Results from an Exploratory Study on an Underestimated Problem. Brain Sci. 2023 Jun 13;13(6):945. doi: 10.3390/brainsci13060945.

    PMID: 37371423BACKGROUND

MeSH Terms

Conditions

Spinal Cord InjuriesMultiple SclerosisParkinson DiseaseNervous System Diseases

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and InjuriesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Maria Grazia Maggio, PhD, PsyD

    IRCCS Centro Neurolesi Bonino Pulejo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, PsyD

Study Record Dates

First Submitted

January 31, 2025

First Posted

February 21, 2025

Study Start

January 16, 2025

Primary Completion (Estimated)

September 29, 2027

Study Completion (Estimated)

January 31, 2028

Last Updated

February 21, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

IPD related to primary and secondary outcome measures will be shared. This includes data on cognitive performance, social cognition, neurophysiological parameters (EEG and MRI biomarkers), gait analysis, and eye movement metrics. Data will be made available to qualified researchers upon reasonable request, following ethical and legal guidelines to ensure participant confidentiality. Access will be provided through a secure platform for a limited period after the study's completion. Specific requests will be evaluated on a case-by-case basis, and approved researchers must agree to terms of use.

Shared Documents
SAP
Time Frame
IPD and supporting documentation, including the Statistical Analysis Plan (SAP), will be available starting 6 months after the study's primary completion date. Access will be provided for 5 years from the initial availability date, ensuring adequate time for secondary analyses while maintaining relevance to ongoing research efforts.
Access Criteria
Requests for access to Individual Participant Data (IPD) and supporting documentation will be evaluated by the study's data-sharing committee. Researchers must submit a proposal detailing their study objectives, statistical analysis plans, and ethical approval. Access will be granted for scientifically valid purposes, following a signed data use agreement. Requests should be directed to: mariagrazia.maggio@irccsme.it.

Locations

IT(2)