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NCT07017140Toborzás még nem indult

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

Immersive Functional Virtual Reality in People With Acquired Brain Injury and Unilateral Spatial Neglect: A Feasibility and Usability Study

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. jún. 12. · Több mint 12 hónapja nem frissült - kérdezd meg a helyszínt, nyitott-e még

Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Toborzás még nem indult
Vizsgálattípus
Beavatkozással járó
Résztvevők száma
30 (tervezett)
Első benyújtás
2025. jún. 3.
Kezdés
2025. okt. 1.
Elsődleges befejezés
2028. márc. 1.
Fő szponzor
University of Vic - Central University of Catalonia
NCT-szám
NCT07017140

Mit vállalsz

  • Vizsgálat típusa: Beavatkozással járó
  • Tervezett résztvevők: 30
  • 2025. okt. 1. és az elsődleges befejezés (2028. márc. 1.) között
  • 2 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Más betegség

  • 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.
  • Hypersensitivity that prevents the placement of the VR headset.
  • History of photosensitive epilepsy.

Egyéb

  • Delirium and/or behavioral disturbances that prevent the participant from following simple instructions.
  • Severe language comprehension difficulties that interfere with the instructions during the intervention.
  • Headache or dizziness induced by the use of VR goggles.

Kiket keres a vizsgálat

  • 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.

Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (2)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Hospital Vall d'Hebron
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BarcelonaSpanyolországIsmeretlen állapot
Consorci Hospitalari de Vic
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VicSpanyolországIsmeretlen állapot

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