protocolSection identificationModule nctId: NCT06341777, orgStudyIdInfo id: 25M621, briefTitle: Multisensory Telerehabilitation for Visual Field Defects, acronym: MUST, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-01-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-04-02, lastUpdatePostDateStruct date: 2024-04-02, sponsorCollaboratorsModule leadSponsor name: Istituto Auxologico Italiano, class: OTHER, collaborators name: IRCCS Fondazione Stella Maris, collaborators name: Azienda Ospedaliero, Universitaria Meyer, descriptionModule briefSummary: Brain injuries may cause the loss of the ability to see portions of the visual field, the so-called visual field defects (VFDs). VFDs significantly impact the survivors' functional recovery and quality of life, with the majority of patients displaying no spontaneous recovery or being left with residual deficits. Among the available therapies for VFDs, the compensatory scanning training is considered the most promising. Yet, current evidence is insufficient to recommend it in clinical practice, and the scientific community has stressed the need of more high-quality research. The present randomized clinical trial in patients with chronic VFDs caused by brain lesions aims at verifying the feasibility and efficacy of a novel telerehabilitation using a multisensory scanning therapy, by measuring its effects on visual functions and daily activities, and by looking for neural indicators of the therapy-induced improvements., conditionsModule conditions: Visual Field Defect Following Cerebrovascular Accident, conditions: Hemianopia, conditions: Brain Injuries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 72, type: ACTUAL, armsInterventionsModule interventions name: Audio-visual training (AVT) telerehabilitation, outcomesModule primaryOutcomes measure: Change from baseline in Accuracy on the EF Task, primaryOutcomes measure: Change from baseline in Response Times (RTs) on the EF Task, primaryOutcomes measure: Change from baseline in Accuracy on the Triangle Task, primaryOutcomes measure: Change from baseline in RTs on the Triangle Task, primaryOutcomes measure: Change from baseline in RTs on the Numbers Task, primaryOutcomes measure: Change from baseline in omissions on the Bell Test (only children), primaryOutcomes measure: Change from baseline in RTs on the Bell Test (only children), primaryOutcomes measure: Change from baseline in Accuracy on the Small Faces Test (only children), primaryOutcomes measure: Change from baseline in RTs on the Small Faces Test (only children), secondaryOutcomes measure: Change from baseline in Daily Living Dependent on Vision Questionnaire (total score), secondaryOutcomes measure: Change from baseline in the Reading test (reading time), secondaryOutcomes measure: Change from baseline in the Hamilton Anxiety Scale (total score; only adults), secondaryOutcomes measure: Change from baseline in the Beck's Depression Inventory (BDI; total score; only adults), secondaryOutcomes measure: Change from baseline in the Multidimensional Anxiety Scale for Children (MASC; total score; only children), secondaryOutcomes measure: Change from baseline in the Children Depression Inventory (CDI; total score; only children), secondaryOutcomes measure: Change from baseline in the visual field size (only adults), secondaryOutcomes measure: Change from baseline in the amplitude of Visual Evoked Potentials (VEPs), secondaryOutcomes measure: Change from baseline in the latency of Visual Evoked Potentials (VEPs), secondaryOutcomes measure: Change from baseline in the connectivity of the Inferior Longitudinal Fasciculus, secondaryOutcomes measure: Change from baseline in the connectivity of the Superior Longitudinal Fasciculus, secondaryOutcomes measure: Change from baseline in the connectivity of the Inferior Fronto Occipital Fasciculus, secondaryOutcomes measure: Change from baseline in the connectivity of the Optic Radiations, secondaryOutcomes measure: Change from baseline in the connectivity of the Optic Tracts, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 70 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Istituto Auxologico Italiano IRCCS, city: Milan, state: Lombardia, zip: 20122, country: Italy, geoPoint lat: 45.46427, lon: 9.18951, hasResults: False