protocolSection identificationModule nctId: NCT06264713, orgStudyIdInfo id: CE/2023_041, briefTitle: Immersive Virtual REality for Treatment of Unilateral Spatial NEglect Via Eye-tracking Biofeedback, acronym: IRENE, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2025-11-01, completionDateStruct date: 2025-12-01, studyFirstPostDateStruct date: 2024-02-20, lastUpdatePostDateStruct date: 2024-02-22, sponsorCollaboratorsModule leadSponsor name: I.R.C.C.S. Fondazione Santa Lucia, class: OTHER, descriptionModule briefSummary: The purpose of this study is to evaluate the effects of a treatment using virtual reality on the recovery of unilateral spatial neglect. The investigators hypothesize that the experimental group underwent to a protocol of active exercises within the virtual environment will show an improvement in the exploratory functions of the left hemispace, investigated with specific scales and clinical tests., conditionsModule conditions: Neglect, Hemispatial, conditions: Stroke, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomised Clinical Trial, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: Double blind randomisation. The patients and their families/caregivers are blinded with respect to the group allocation. The assessors are not informed about the group allocation for the entire period of the study., whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Immersive Virtual Reality, interventions name: Sham Immersive Virtual Reality, outcomesModule primaryOutcomes measure: Changes in the Behavioural Inattention Test, secondaryOutcomes measure: Changes in the Copying drawings with or without programming elements, secondaryOutcomes measure: Changes in the Barrage Test, secondaryOutcomes measure: Changes in the Wundt Justrow area illusion test, secondaryOutcomes measure: Changes in the Kessler Foundation Neglect Assessment Process, secondaryOutcomes measure: Changes in the Stroke Specific Quality of Life Scale, secondaryOutcomes measure: Changes in the Fugl-Meyer Assessment scale, secondaryOutcomes measure: Changes in reaction time e time of fixation, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: IRCCS Santa Lucia Foundation, status: RECRUITING, city: Rome, state: Lazio, zip: 00142, country: Italy, contacts name: Valeria Verna, MSc, role: CONTACT, phone: 0651501907, contacts name: Valeria Verna, MSc, role: PRINCIPAL_INVESTIGATOR, contacts name: Marco Tramontano, PhD, role: SUB_INVESTIGATOR, contacts name: Alex Martino Cinnera, PhD, role: SUB_INVESTIGATOR, contacts name: Viviana Betti, PhD, role: SUB_INVESTIGATOR, contacts name: Matteo Marucci, PhD, role: SUB_INVESTIGATOR, contacts name: Luisa Magnotti, BSc, role: SUB_INVESTIGATOR, contacts name: Alessandro Matano, MSc, role: SUB_INVESTIGATOR, contacts name: Aurora Tavernese, MSc, role: SUB_INVESTIGATOR, contacts name: Paolucci Stefano, MD, role: SUB_INVESTIGATOR, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False