[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100612922":3},{"organization":4,"outcomesModule":7,"designInfo":41,"detailedDescription":40,"studyPopulation":40,"armGroups":50,"interventions":62,"overallOfficials":40,"centralContacts":40,"locations":40,"responsibleParty":73,"collaborators":77,"id":86,"slug":40,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":87,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":40,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":40,"overallStatus":105,"whyStopped":40,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":40},{"fullName":5,"class":6},"University of Pisa","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":40},[9],{"measure":10,"description":11,"timeFrame":12},"Changes in the Fugl-Meyer for the upper limb functional scale (UEFM)","The scale ranges from 0 to 66, with higher scores indicating better performance","From the pre-training evaluation (T0) to the follow up (T2), about 11 weeks after T0",[14,17,20,22,25,28,31,34,37],{"measure":15,"description":16,"timeFrame":12},"Changes in the Bimanual Activity Test scale (BAT)","The scale ranges from 0 to 100, with higher scores indicating better performance",{"measure":18,"description":19,"timeFrame":12},"Changes in the modified Ashworth scale (MAS)","The scale ranges from 0 to 6, with lower scores indicating better performance",{"measure":21,"description":16,"timeFrame":12},"Changes in the Stroke Impact Scale (SIS)",{"measure":23,"description":24,"timeFrame":12},"Changes in the Visual Analogue Scale (VAS)","The scale ranges from 0 to 10, with higher scores indicating higher pain",{"measure":26,"description":27,"timeFrame":12},"Changes in the Quick Dash scale","The scale ranges from 0 to 100, with higher scores indicating higher level of disability",{"measure":29,"description":30,"timeFrame":12},"Changes in weighted Phase Lag Index (wPLI) cortico-cortical brain connectivity (EEG)","The investigators will be measuring variations in the weighted Phase Lag Index (wPLI)",{"measure":32,"description":33,"timeFrame":12},"Changes in weighted Symbolic Mutual Information (wSMI) cortico-cortical brain connectivity (EEG)","The investigators will be measuring variations in the weighted Symbolic Mutual Information (wSMI)",{"measure":35,"description":36,"timeFrame":12},"Changes in muscular synergies (EMG)","The investigators wil be measuring changes in muscle synergy patterns using the non-negative matrix factorization (NMF) algorithm",{"measure":38,"description":39,"timeFrame":12},"Changes in kinematic movement smoothness (SPARC)","The investigators will measure changes in movement smoothness using the SPARC parameter",null,{"allocation":42,"interventionModel":43,"interventionModelDescription":40,"primaryPurpose":44,"observationalModel":40,"timePerspective":40,"maskingInfo":45},"NON_RANDOMIZED","PARALLEL","TREATMENT",{"masking":46,"maskingDescription":40,"whoMasked":47},"DOUBLE",[48,49],"CARE_PROVIDER","INVESTIGATOR",[51,58],{"label":52,"type":53,"description":54,"interventionNames":55},"Left hemisphere lesion group","EXPERIMENTAL","The stroke patients with left hemisphere lesion will be performing the bilateral robotic treatment with the exoskeleton ALEx-RS followed by a standard manual treatment",[56,57],"Device: Bilateral robotic treatment for the upper limbs","Behavioral: Standard physiotherapy",{"label":59,"type":53,"description":60,"interventionNames":61},"Right hemisphere lesion group","The stroke patients with right hemisphere lesion will be performing the bilateral robotic treatment with the exoskeleton ALEx-RS followed by a standard manual treatment",[56,57],[63,68],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":40},"DEVICE","Bilateral robotic treatment for the upper limbs","Patients will perform a specific sequence of exercises with the exoskeleton for the upper limbs ALEx-RS, including passive and active-assisted movements, unilateral and bilateral reaching tasks with visual feedback, and symmetric and asymmetric bimanual coordination tasks.",[52,59],{"type":69,"name":70,"description":71,"armGroupLabels":72,"otherNames":40},"BEHAVIORAL","Standard physiotherapy","After the robotic treatment, patients will undergo 20 minutes of conventional treatment consisting of passive and active-assisted mobilization with the help of a physiotherapist.",[52,59],{"type":74,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":40,"oldOrganization":40},"PRINCIPAL_INVESTIGATOR","Carmelo Chisari","Professor",[78,80,82,84],{"name":79,"class":6},"Azienda Ospedaliero, Universitaria Pisana",{"name":81,"class":6},"Villa Beretta Rehabilitation Center",{"name":83,"class":6},"Fondazione Don Carlo Gnocchi Onlus",{"name":85,"class":6},"Ospedale Policlinico San Martino","100612922",false,"NCT07259876","Efficacy of a Bilateral Robotic Treatment in Chronic Patients","Efficacy and Neurophysiological Correlates of a Bilateral Robotic Treatment for the Upper Limbs in Patients With Chronic Stroke Outcomes","BUILT","Inclusion Criteria:\n\n* Subjects aged between 18 and 80 years, of either sex\n* Subjects able to understand and provide, or have provided on their behalf, informed consent\n* History of a single unilateral ischemic or hemorrhagic cerebrovascular event in the chronic phase (\\> 6 months)\n* Subjects with mild to moderate functional impairment of the right or left upper limb (ability to perform antigravity active movements)\n\nExclusion Criteria:\n\n* Subjects with cognitive deficits that impair understanding of the required tasks (MMSE score corrected for age and education \\\u003C 24\u002F30)\n* Subjects with severe visual deficits\n* Subjects with upper limb spasticity preventing the use of robotic devices (spasticity measured using the Modified Ashworth Scale \\> 3)\n* Inability or unwillingness to provide informed consent\n* Left-handed subjects","ALL","18 Years","80 Years",{"count":97,"type":98},60,"ESTIMATED","INTERVENTIONAL",[101],"NA","The goal of this clinical trial is to evaluate how manual dominance influences the effectiveness of bilateral robotic treatment in right-handed patients with chronic stroke.\n\nResearchers will compare the outcome of a bilateral robotic treatment for the upper limbs in left vs right hemisphere lesions following stroke.\n\nParticipants will:\n\n* perform a bilateral robotic treatment for the upper limb (15 sessions in three weeks) followed by 20-minutes standard manual rehabilitative sessions\n* be evaluated before and after treatment with clinical scales, resting- state EEG and kinematic measurements",[104],"Stroke","NOT_YET_RECRUITING","2026-04-27",{"date":108,"type":109},"2026-04-28","ACTUAL",{"date":111,"type":98},"2026-07",{"date":113,"type":98},"2026-12",{"name":5,"class":6}]