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

NCT07017140 | Not Yet Recruiting

• 1 other identifier: 25/009
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Acquired Brain Injury Including Stroke; Unilateral Spatial Neglect (USN); Stroke; Traumatic Brain Injury

Keywords

acquired brain injury; unilateral spatial neglect; stroke; traumatic brain injury; cognitive and motor rehabilitation; virtual reality-based therapy; virtual reality

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to T6 (final follow-up, 5 months after baseline)

Secondary Outcomes (5)

• System Usability (System Usability Scale - SUS)

  At T4 (first post-intervention evaluation, 3 months after baseline)

• User Satisfaction (User Satisfaction Evaluation Questionnaire - USEQ)

  At T4 (first post-intervention evaluation, 3 months after baseline)

• Change in Unilateral Spatial Neglect (Catherine Bergego Scale)

  From T1 (baseline) to T6 (first post-intervention evaluation, 5 months after baseline)

• Change in Unilateral Spatial Neglect (Bells Cancellation Test)

  From T1 (baseline) to T6 (first post-intervention evaluation, 5 months after baseline)

• Change in Spatial Reach (KINESIX Light Reach Test)

  From T1 (baseline) to T6 (first post-intervention evaluation, 5 months after baseline)

Study Arms (1)

Arm 1 - Immersive Functional Virtual Reality

EXPERIMENTAL

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

Interventions

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

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.

Arm 1 - Immersive Functional Virtual Reality

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Presence of mild to moderate upper limb impairment, defined as a score \>29 on the Fugl-Meyer Upper-Extremity scale.
• Medically stable and eligible to begin a rehabilitation program.
• Willing to participate in the study and able to provide signed informed consent.

You may not qualify if:

• 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.
• Hypersensitivity that prevents the placement of the VR headset.
• Headache or dizziness induced by the use of VR goggles.
• History of photosensitive epilepsy.

Sponsors & Collaborators

• University of Vic - Central University of Catalonia: lead
• Hospital Vall d'Hebron: collaborator
• Consorci Hospitalari de Vic (CHV): collaborator

Study Sites (2)

Hospital Vall d'Hebron

Barcelona, Spain, 08035, Spain

Location

Consorci Hospitalari de Vic

Vic, Spain, 08500, Spain

Location

Related Publications (5)

• Hategeka C, Ruton H, Karamouzian M, Lynd LD, Law MR. Use of interrupted time series methods in the evaluation of health system quality improvement interventions: a methodological systematic review. BMJ Glob Health. 2020 Oct;5(10):e003567. doi: 10.1136/bmjgh-2020-003567.

  PMID: 33055094 BACKGROUND

• Gammeri R, Iacono C, Ricci R, Salatino A. Unilateral Spatial Neglect After Stroke: Current Insights. Neuropsychiatr Dis Treat. 2020 Jan 10;16:131-152. doi: 10.2147/NDT.S171461. eCollection 2020.

  PMID: 32021206 BACKGROUND

• Corbetta M, Kincade MJ, Lewis C, Snyder AZ, Sapir A. Neural basis and recovery of spatial attention deficits in spatial neglect. Nat Neurosci. 2005 Nov;8(11):1603-10. doi: 10.1038/nn1574. Epub 2005 Oct 23.

  PMID: 16234807 BACKGROUND

• Cavedoni S, Cipresso P, Mancuso V, Bruni F, Pedroli E. Virtual reality for the assessment and rehabilitation of neglect: where are we now? A 6-year review update. Virtual Real. 2022;26(4):1663-1704. doi: 10.1007/s10055-022-00648-0. Epub 2022 May 30.

  PMID: 35669614 BACKGROUND

• Bernhardt J, Hayward KS, Kwakkel G, Ward NS, Wolf SL, Borschmann K, Krakauer JW, Boyd LA, Carmichael ST, Corbett D, Cramer SC. Agreed Definitions and a Shared Vision for New Standards in Stroke Recovery Research: The Stroke Recovery and Rehabilitation Roundtable Taskforce. Neurorehabil Neural Repair. 2017 Sep;31(9):793-799. doi: 10.1177/1545968317732668.

  PMID: 28934920 BACKGROUND

MeSH Terms

Conditions

Stroke; Brain Injuries, Traumatic; Brain Injuries

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Dr. Jose Antonio Merchan-Baeza, PhD

  University of Vic - Central University of Catalonia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Jose Antonio Merchan-Baeza, PhD

CONTACT

34 938 886 12 22; josan.merchan@uvic.cat

Dr. Marc Terradas-Monllor, PhD

CONTACT

34 93 881 60 25; marc.terradas@uvic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Josan Merchan-Baeza

Model Details: This is a prospective, single-arm feasibility study using a single-group interrupted time series design. All participants receive the same intervention: 12 sessions of immersive functional virtual reality (IFVR) over 4 weeks. Pre- and post-intervention outcomes are assessed at three time points each, spaced one month apart.

Study Record Dates

• First Submitted: June 3, 2025
• First Posted: June 12, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)