[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659192":3},{"organization":4,"outcomesModule":7,"designInfo":46,"detailedDescription":54,"studyPopulation":45,"armGroups":55,"interventions":66,"overallOfficials":45,"centralContacts":74,"locations":80,"responsibleParty":99,"collaborators":45,"id":101,"slug":102,"hasResults":103,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":103,"sex":109,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":45,"studyType":115,"phases":116,"briefSummary":118,"conditions":119,"keywords":123,"overallStatus":83,"whyStopped":45,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"IRCCS Sacro Cuore Don Calabria di Negrar","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":45},[9,13],{"measure":10,"description":11,"timeFrame":12},"Efficacy of preparatory treatment with Intensive Visual Simulation (IVS) for step training with an exoskeleton (EKSO)","Scores on the Berg Balance Scale from baseline to the end of treatment. The scale assesses static and minimal dynamic balance, as well as the risk of falling. The score ranges from 0 to 56.","Baseline to Timepoint 1 (3 weeks after)",{"measure":10,"description":14,"timeFrame":12},"Scores on the Timed Up and Go test from baseline to the end of treatment. The test measures, in seconds, the time it takes a patient to stand up from a chair with armrests, walk 3 meters, turn around, walk back, and sit down again.",[16,20,23,26,29,32,35,38,42],{"measure":17,"description":18,"timeFrame":19},"Revised Nottingham Sensory Assessment Scale Score","Revised Nottingham Sensory Assessment Scale Score for evaluating sensitivity in the paretic hemibody","Baseline to Timepoint 2 (7 weeks after)",{"measure":21,"description":22,"timeFrame":19},"Range of Motion (ROM) Values for the Tibiotarsal and Knee Joints","Range of Motion (ROM) Values for Assessment of the Tibiotarsal and Knee Joints",{"measure":24,"description":25,"timeFrame":19},"Presence\u002Fabsence of tendon retractions","Presence\u002Fabsence of tendon retractions in the knee and tibiotarsal flexor-extensor muscles and the tibiotarsal pronator-supinator muscles",{"measure":27,"description":28,"timeFrame":19},"Ashworth Scale (MAS)","Ashworth Scale (MAS) for Assessing Muscle Tone",{"measure":30,"description":31,"timeFrame":12},"Minimum number of sessions required to achieve independent walking with assistive devices","Evaluation of the minimum number of sessions required to achieve independent walking with assistive devices.",{"measure":33,"description":34,"timeFrame":19},"Percentage of assistance provided by EKSO","Percentage of assistance provided by EKSO as recorded by the machine after 10 minutes, after 20 minutes, and at the end of 30 minutes of robotic training.",{"measure":36,"description":37,"timeFrame":19},"Number of steps taken during a training session with EKSO","Number of steps taken during a single 30-minute training session with EKSO, as recorded by the machine.",{"measure":39,"description":40,"timeFrame":41},"Assessment of the maintenance of skills acquired through preparatory training, with or without Intensive Visual Simulation (IVS), for exoskeleton (EKSO) step training","Values after 7 weeks from the Timed Up and Go Test. The test measures, in seconds, the time it takes a patient to stand up from a chair with armrests, walk 3 meters, turn around, walk back, and sit down again.","Timepoint 2 (7 weeks after baseline)",{"measure":39,"description":43,"timeFrame":44},"Values after 7 weeks from the Berg Balance Scale. The scale assesses static and minimal dynamic balance, as well as the risk of falling. The score ranges from 0 to 56.","At Timepoint 2 (7 weeks after baseline)",null,{"allocation":47,"interventionModel":48,"interventionModelDescription":45,"primaryPurpose":49,"observationalModel":45,"timePerspective":45,"maskingInfo":50},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":51,"maskingDescription":45,"whoMasked":52},"SINGLE",[53],"OUTCOMES_ASSESSOR","Enrolled patients will be randomized to one of the two rehabilitation treatment arms included in the trial.\n\n* Arm A: Rehabilitation treatment with IVS before physiotherapy-based and robotic gait training using an exoskeleton.\n* Arm B: Rehabilitation treatment with physiotherapy-based and robotic step training using an exoskeleton.\n\nTraining will last:\n\n* 15 minutes of IVS (only for Arm A)\n* 30 minutes of EKSO training (which in Arm A will be performed after IVS treatment)\n* 45 minutes of non-robotic motor therapy following robotic treatment.\n\nEach rehabilitation session will last a maximum of approximately 1.5 hours and will be repeated 5 days a week for 3 weeks.\n\nClinical evaluations will be conducted by a physician who is unaware of the rehabilitation treatment the patient has undergone (the patient will be appropriately informed of the need not to disclose the type of rehabilitation received to the evaluating physician).",[56,61],{"label":57,"type":58,"description":45,"interventionNames":59},"Rehabilitation treatment with IVS before step training using an exoskeleton","EXPERIMENTAL",[60],"Device: Rehabilitation treatment with IVS before step training using an exoskeleton",{"label":62,"type":63,"description":45,"interventionNames":64},"Rehabilitation treatment with step training using an exoskeleton","ACTIVE_COMPARATOR",[65],"Device: Rehabilitation treatment with step training using an exoskeleton",[67,71],{"type":68,"name":57,"description":69,"armGroupLabels":70,"otherNames":45},"DEVICE","* 15 minutes of IVS: The physical therapist will show the patient a pre-recorded sequence of movements and activities involving the lower limb. Patient will observe the movements on a screen positioned to cover the paretic limb and will then be ask to repeat them.\n* 30 minutes of EKSO training:The physical therapist will set up the training using a single program defined as \"assistive\" to observe the degree of dependence on the machine throughout the course of treatment and will maintain this setting for all sessions, documenting the percentage changes in the level of assistance required.\n* 45 minutes of non-robotic motor therapy following the robotic treatment. The physical therapist will perform motor treatments involving mobilization, muscle strengthening, and standing with the goal of improving the patient's ability to perform transfers and maintain an upright position independently.\n\nThe rehabilitation treatment session will be repeated 5 days a week for 3 weeks.",[57],{"type":68,"name":62,"description":72,"armGroupLabels":73,"otherNames":45},"* 30 minutes of EKSO training: The physical therapist will set up the training using a single program defined as \"assistive\" to observe the degree of dependence on the machine throughout the course of treatment and will maintain this setting for all sessions, documenting the percentage changes in the level of assistance required.\n* 45 minutes of non-robotic motor therapy following the robotic treatment. The physical therapist will perform motor treatments involving mobilization, muscle strengthening, and standing with the goal of improving the patient's ability to perform transfers and maintain an upright position independently.\n\nThe rehabilitation treatment session will be repeated 5 days a week for 3 weeks.",[62],[75],{"name":76,"role":77,"phone":78,"phoneExt":45,"email":79},"Elvia Malo, Dr.","CONTACT","+39 045.6014877","ricerca.clinica@sacrocuore.it",[81],{"facility":82,"status":83,"city":84,"state":85,"zip":86,"country":85,"countryCode":87,"cosmosGeoPoint":88,"geoPoint":93,"contacts":94},"IRCCS Sacro Cuore Don Calabria Hospital","RECRUITING","Negrar","Italy","37024","IT",{"type":89,"coordinates":90},"Point",[91,92],10.93899,45.52918,{"lat":92,"lon":91},[95],{"name":96,"role":77,"phone":97,"phoneExt":45,"email":98},"Elena Rossato, Dr.ssa","+39 045.6014597","elena.rossato@sacrocuore.it",{"type":100,"investigatorFullName":45,"investigatorTitle":45,"investigatorAffiliation":45,"oldNameTitle":45,"oldOrganization":45},"SPONSOR","100659192","efficacy-of-intensive-visual-simulation-ivs-before-exoskeleton-assisted-step-training-in-patients-with-hemisensory-syndrome-with-brain-injury-of-vascular-etiology-100659192",false,"NCT07860840","Efficacy of Intensive Visual Simulation (IVS) Before Exoskeleton-assisted Step Training in Patients With Hemisensory Syndrome With Brain Injury of Vascular Etiology.","Experimental Pilot Study: Efficacy of Preparatory Treatment With Intensive Visual Simulation (IVS) Prior to Step Training With an Exoskeleton (EKSO) in Patients With Hemisensory Syndrome Resulting From Acquired Brain Injury of Vascular Etiology.","IVS","Inclusion Criteria:\n\n* Male and female patients aged 18 to 80 years (both ends included).\n* Diagnosis of hemiparesis\u002Fplegia with proprioceptive sensory deficit due to a cerebrovascular event within the last 6 months\n* Orientation in the 3 domains (space, time, and person)\n* Cooperation\n* Clinical stability\n* Trunk control while standing\n* Signature of the Informed Consent Form for participation in the study and for the processing of personal data\n\nExclusion Criteria:\n\n* Patients aged \\\u003C 18 years and \\> 80 years\n* Patients who are disoriented in at least one of the three domains (space, time, and person)\n* Non-cooperative patients\n* Patients with global aphasia\n* Patients with severe ideomotor apraxia\n* Patients with cognitive or mental disorders\n* Patients not eligible for EKSO:\n* Severe comorbid conditions: infections, circulatory, cardiac, or pulmonary diseases, pressure ulcers.\n* Severe spasticity (level 4 on the modified Ashworth scale).\n* Spinal instability or unhealed fractures of the limbs or pelvis.\n* Heterotopic ossification.\n* Psychiatric or cognitive conditions that may interfere with the proper use of the device.\n* Pregnant women.\n* Reduced tolerance for standing due to orthostatic hypotension.\n* Range of motion (ROM) limitations that would prevent the patient from achieving a normal bilateral gait pattern or performing normal transitions from a seated to a standing position and vice versa: Bilateral hip flexion less than 110°, knee flexion contracture greater than 12°, or inability to achieve neutral dorsiflexion of 0° with knee flexion up to 12°.\n* Leg length discrepancy greater than 1.27 cm for the upper leg and 1.9 cm for the lower leg.\n* Unresolved deep vein thrombosis.\n* Uncontrolled autonomic dysreflexia.\n* Lower limb prostheses.","ALL","18 Years","80 Years",{"count":113,"type":114},22,"ESTIMATED","INTERVENTIONAL",[117],"NA","Clinical trial involving a medical device, not intended for CE marking, randomized, blinded to evaluate the efficacy of preparatory treatment with Intensive Visual Simulation 4 (IVS) prior to exoskeleton-assisted (EKSO) step training in achieving independent ambulation in hemiparetic patients with impaired proprioceptive sensation. Patients will be randomized into two groups: one group in which patients will undergo IVS treatment before physiotherapy and robotic step training with an exoskeleton; and one group in which patients will undergo only physiotherapy and robotic step training with an exoskeleton.",[120,121,122],"Exoskeleton Device","Sensory Disorder","Brain Injuries, Vascular",[124,125,126,127,122],"EKSO","Intensive Visual Simulation","Exoskeleton device","sensory hemisyndrome","2026-09-30",{"date":130,"type":131},"2026-10-06","ACTUAL",{"date":133,"type":131},"2024-04-21",{"date":135,"type":114},"2027-09-30",{"name":5,"class":6},1]