Immersive Functional Virtual Reality in People With Acquired Brain Injury and Unilateral Spatial Neglect: A Feasibility and Usability Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Feasibility of the immersive virtual reality intervention
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Arm 1 - Immersive Functional Virtual Reality
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.
干预措施: Immersive Functional Virtual Reality Intervention using a Head-Mounted Display System for Spatial Neglect Rehabilitation (Device)
结局指标
主要结局
Feasibility of the immersive virtual reality intervention
时间窗: From enrollment to T6 (final follow-up, 5 months after baseline)
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.
次要结局
- User Satisfaction (User Satisfaction Evaluation Questionnaire - USEQ)(At T4 (first post-intervention evaluation, 3 months after baseline))
- System Usability (System Usability Scale - SUS)(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))
研究者
Josan Merchan
Dr. Josan Merchan-Baeza
University of Vic - Central University of Catalonia