NCT07017140: REVINE

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

Not yet recruiting NA Last updated 12 June 2025

What this trial tests

NA trial testing Immersive Functional Virtual Reality Intervention using a Head-Mounted Display System for Spatial Neglect Rehabilitation in Acquired Brain Injury Including Stroke in 30 participants. Not yet recruiting.

Timeline

1 October 2025

Primary endpoint
1 March 2028

1 February 2029

Quick facts

Lead sponsor	University of Vic - Central University of Catalonia
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	30
Start date	1 October 2025
Primary completion	1 March 2028
Estimated completion	1 February 2029
Sites	2 locations across Spain

Drugs / interventions tested

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

Conditions studied

• Acquired Brain Injury Including Stroke — all drugs for Acquired Brain Injury Including Stroke →
• Unilateral Spatial Neglect (USN) — all drugs for Unilateral Spatial Neglect (USN) →
• Stroke — all drugs for Stroke →
• Traumatic Brain Injury — all drugs for Traumatic Brain Injury →

Sponsor

University of Vic - Central University of Catalonia

Who can join

18 and older, any sex, with Acquired Brain Injury Including Stroke or Unilateral Spatial Neglect (USN). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.