An interventional study of Immersive Functional Virtual Reality Intervention using a Head-Mounted Display System for Spatial Neglect Rehabilitation in Acquired Brain Injury Including Stroke, Unilateral Spatial Neglect (USN) and Stroke, sponsored by University of Vic - Central University of Catalonia. Not yet recruiting at 2 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by University of Vic - Central University of Catalonia · Not applicable, Interventional, and Treatment
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.
Background and Rationale
Acquired brain injury (ABI), including stroke and traumatic brain injury, is a leading cause of long-term disability worldwide. One of its most disabling consequences is unilateral spatial neglect (USN), a complex perceptual-attentional syndrome characterized by an impaired ability to attend, respond, or orient to stimuli presented on the side opposite the brain lesion. USN significantly affects functional independence and daily living activities such as grooming, eating, dressing, or mobility, and it is associated with a poorer rehabilitation prognosis and prolonged dependence on caregivers.
Despite the high prevalence and impact of USN, conventional assessment tools (e.g., cancellation tasks, line bisection) often lack sensitivity to detect subtle deficits and do not reflect real-life performance. Furthermore, traditional rehabilitation approaches may be insufficient to address the multifaceted nature of USN, especially its extrapersonal and representational aspects.
Virtual reality (VR) technologies provide controlled, interactive environments that simulate real-life situations, enabling both the assessment and treatment of cognitive and motor impairments. Immersive Functional Virtual Reality (IFVR), in particular, can engage users in multisensory, gamified tasks that promote neuroplasticity while ensuring ecological validity. Previous evidence supports the use of VR-especially semi-immersive systems-for USN rehabilitation, though immersive systems remain underexplored in clinical trials and feasibility studies.
Study Objectives
The REVINE project aims to evaluate the feasibility, usability, and preliminary clinical effects of an IFVR intervention in adults with ABI and USN.
The general objectives of the REVINE project are:
The specific objectives are:
Study Design
This is a prospective, single-arm feasibility study employing a single interrupted time series design. A total of 30 participants will be recruited using a non-probabilistic convenience sampling method. Each participant will undergo three pre-intervention evaluations (T1, T2, T3) and three post-intervention evaluations (T4, T5, T6), each spaced one month apart. The intervention will consist of 12 individual, supervised IFVR sessions over four weeks (three sessions per week, 30 minutes per session).
Setting and Participants
The study will take place at two specialized rehabilitation centers in Catalonia, Spain:
Eligible participants must meet the following criteria:
Exclusion criteria include severe cognitive, visual, or auditory deficits, language comprehension difficulties, hypersensitivity or intolerance to VR headsets, photosensitive epilepsy, or active behavioral disturbances.
Intervention
The IFVR intervention will be delivered using the KINESIX system (NeuroGroup XR Inc.), consisting of a VR headset with integrated software, a therapist tablet interface, and a web-based monitoring platform. The intervention includes 12 exercises grouped into three modules: practice, activities, and participation. Tasks will focus on visuospatial exploration, reaching, grasping, and manipulating virtual objects, particularly in the contralesional space.
Exercises are designed with five increasing difficulty levels to support motor learning and maintain user engagement. Playlists of exercises will progress in difficulty as the participant advances through sessions. Sessions will take place in a safe space under the supervision of a physiotherapist or occupational therapist.
Outcome Measures
Feasibility Outcomes:
Usability and Satisfaction:
Clinical Outcomes:
Safety Considerations
Initial familiarization with the VR headset will ensure gradual exposure to immersive environments. Any adverse events (e.g., dizziness, nausea) will be documented and managed using a pre-defined protocol. Sessions may be interrupted or modified based on participant tolerance. All devices will be disinfected between uses.
Timeline
The study will span 24 months, starting in December 2024. Recruitment will begin in March 2025, following ethics approval, and continue for approximately 12 months. Post-intervention follow-up will conclude by late 2026. Data analysis is planned for November 2026 to January 2027.
Significance and Innovation
This study will provide essential insights into the practical implementation of immersive VR technologies in neurorehabilitation settings. By focusing on feasibility and user experience, the REVINE project seeks to bridge the gap between experimental innovation and clinical application. The findings will inform the design of future randomized controlled trials and the potential integration of IFVR into conventional and remote rehabilitation programs.
7,286 studies on the registry are indexed under Stroke; 2,013 are open to participants now.
This study's planned enrollment of 30 is below the median of 50 across 5,366 interventional studies indexed under Stroke.
Browse Stroke studies →University of Vic - Central University of Catalonia is the lead sponsor of 36 studies on the registry; 11 are open to participants now.
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Exclusion Criteria:
Participants will receive 12 individual IFVR sessions (30 minutes each, 3 sessions per week for 4 weeks) using the KINESIX system. The intervention targets visuospatial attention and upper limb function through progressive, gamified exercises in a controlled virtual environment. Sessions are supervised by a physiotherapist or occupational therapist. In addition to the VR intervention, participants continue their usual care rehabilitation as prescribed at their center.
Device: Immersive Functional Virtual Reality Intervention using a Head-Mounted Display System for Spatial Neglect Rehabilitation
Participants 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.
Time frame: From enrollment to T6 (final follow-up, 5 months after baseline)
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.
Time frame: At T4 (first post-intervention evaluation, 3 months after baseline)
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).
Time frame: At T4 (first post-intervention evaluation, 3 months after baseline)
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.
Time frame: From T1 (baseline) to T6 (first post-intervention evaluation, 5 months after baseline)
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.
Time frame: From T1 (baseline) to T6 (first post-intervention evaluation, 5 months after baseline)
Change in Spatial Reach (KINESIX Light Reach Test)
Spatial reach and exploration will be measured using the KINESIX Light Reach Test, a VR-based assessment involving activation of LED lights on a horizontal surface. The number and location of lights reached will be recorded to evaluate performance in peripersonal and extrapersonal space.
Time frame: From T1 (baseline) to T6 (first post-intervention evaluation, 5 months after baseline)
Plan to share: No — Individual participant data (IPD) will not be shared due to the exploratory nature of this feasibility study and the limited sample size. Additionally, the study involves sensitive health data from individuals with acquired brain injury, and the data use has been approved only for internal analysis within the research team under strict confidentiality agreements. No extended consent for data sharing beyond the current project scope has been obtained.
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University of Vic - Central University of Catalonia