Immersive Functional Virtual Reality in People With Acquired Brain Injury and Unilateral Spatial Neglect

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Vic - Central University of Catalonia

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Immersive Functional Virtual Reality Intervention using a Head-Mounted Display System for Spatial Neglect Rehabilitation

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

University of Vic - Central University of Catalonia

Lead sponsor

Hospital Vall d'Hebron

Collaborator

Consorci Hospitalari de Vic (CHV)

Collaborator