Unilateral spatial neglect (USN) is a common and highly disabling condition following acquired brain injury (ABI), significantly impairing individuals' ability to perform daily activities and reducing their autonomy. It frequently affects patients who have suffered a stroke or traumatic brain injury, and it is often associated with worse functional outcomes and increased care needs. Despite advances in neurorehabilitation, conventional assessment and treatment tools for USN have shown limitations in sensitivity and ecological validity.
Immersive Functional Virtual Reality (IFVR) is an emerging and promising technology that creates controlled, interactive environments, facilitating both assessment and rehabilitation in a motivating and safe way. The REVINE study explores the feasibility, usability, and preliminary clinical effects of an immersive VR-based intervention tailored to address motor and spatial deficits in adults with ABI and USN.
This is a prospective, non-controlled feasibility study using a single-group interrupted time series design. Participants (N=30) will be recruited from two neurorehabilitation services in Catalonia (Spain): the Neurological Rehabilitation and Brain Injury Unit at Vall d'Hebron University Hospital and the Outpatient Rehabilitation Service at Consorci Hospitalari de Vic. Eligible participants will be adults with ABI in the subacute or chronic phase, presenting USN (as measured by the Catherine Bergego Scale and the Bells Cancellation Test) and mild-to-moderate upper limb impairment.
The intervention consists of 12 supervised individual IFVR sessions (30 minutes/session, 3 times/week for 4 weeks), using the KINESIX system (NeuroGroup XR Inc., Montreal, Canada). A progressive series of gamified tasks will be delivered through immersive VR, targeting spatial exploration and upper limb function, with adjustable difficulty and real-time feedback.
Participants will undergo three pre-intervention and three post-intervention evaluations, spaced one month apart. Clinical outcomes include the degree of USN (measured by the Catherine Bergego Scale, the Bells Cancellation Test, and the KINESIX light-reaching test), usability (System Usability Scale), and satisfaction (User Satisfaction Evaluation Questionnaire). Feasibility outcomes include recruitment and retention rates, adherence to treatment, session completion times, adverse events, and therapist assistance level.
We hypothesize that IFVR will be a viable and well-accepted intervention, with high user satisfaction, minimal adverse effects, and measurable improvements in neglect-related outcomes. This study aims to inform the future design of larger-scale trials and support the integration of IFVR into routine neurorehabilitation settings or home-based telerehabilitation programs.
Age 18 years or older.
Diagnosis of acquired brain injury (stroke or traumatic brain injury) in the subacute phase (>7 days to 6 months) or chronic phase (>6 months).
Presence of unilateral spatial neglect, defined as omission of 6 or more bells on the left hemifield in the Bells Cancellation Test.
Currently receiving care at the Outpatient Rehabilitation Service of the Consorci Hospitalari de Vic or at Vall d'Hebron University Hospital, or listed in the historical patient registry of these centers.
Delirium and/or behavioral disturbances that prevent the participant from following simple instructions.
Severe cognitive impairment, defined as a Mini-Mental State Examination (MMSE) score below 18, that interferes with the use of virtual reality.
Severe visual and/or auditory impairment that prevents the use of immersive VR goggles.
Severe language comprehension difficulties that interfere with the instructions during the intervention.
Single group
Immersive Functional Virtual Reality Intervention using a Head-Mounted Display System for Spatial Neglect Rehabilitation
DeviceParticipants receive 12 sessions (30 minutes each, 3 per week over 4 weeks) of immersive functional virtual reality (IFVR) using the KINESIX system, a CE-certified Class I head-mounted display device. The intervention targets visuospatial attention and upper limb function through progressively challenging, gamified exercises. All sessions are supervised by a physiotherapist or occupational therapist and delivered in a safe, controlled rehabilitation setting. Participants continue receiving usual care.
Feasibility of the immersive virtual reality intervention
Feasibility will be assessed based on: * Recruitment rate: number of participants enrolled versus eligible. * Consent rate: number of participants agreeing to participate after invitation. * Retention rate: percentage completing all planned assessments. * Adherence: number and percentage of VR sessions completed out of 12. * Adverse events: type, severity, and frequency of VR-related events. * Therapist assistance level: rated on a 7-point Likert scale from full dependence to full independence.
System Usability (System Usability Scale - SUS)
Usability of the immersive virtual reality system will be evaluated using the System Usability Scale (SUS), a 10-item questionnaire scored on a 0-100 scale. Scores above 68 indicate acceptable usability.
User Satisfaction (User Satisfaction Evaluation Questionnaire - USEQ)
Participant satisfaction with the intervention will be assessed using the USEQ, a 6-item scale rated on a 7-point Likert scale. Scores range from 1 (low satisfaction) to 7 (high satisfaction).
Change in Unilateral Spatial Neglect (Catherine Bergego Scale)
Spatial neglect will be assessed using the Catherine Bergego Scale (CBS), a 10-item observational scale that evaluates the impact of neglect on daily activities. Each item is scored from 0 (no neglect) to 3 (severe neglect); total scores range from 0 to 30, with higher scores indicating more severe neglect.
Change in Unilateral Spatial Neglect (Bells Cancellation Test)
The Bells Cancellation Test measures visual neglect by asking participants to identify 35 bell figures among distractors on a structured sheet. Omission of 6 or more bells on the left side suggests unilateral spatial neglect. The total number and spatial distribution of omissions will be recorded and compared between time points.
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University of Vic - Central University of Catalonia
Lead sponsor
Hospital Vall d'Hebron
Collaborator
Consorci Hospitalari de Vic (CHV)
Collaborator
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