[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584525":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":20,"centralContacts":21,"locations":27,"responsibleParty":46,"collaborators":48,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":62,"enrollmentInfo":63,"targetDuration":20,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":75,"overallStatus":83,"whyStopped":20,"lastUpdateSubmitDate":84,"lastUpdatePostDateStruct":85,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":93},{"fullName":5,"class":6},"Fondazione Don Carlo Gnocchi Onlus","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Upper limbs robotic intervention","EXPERIMENTAL","The intervention, which includes the upper limb robotic device MOTORE+ and the new scenario, consists of:\n\n* Enrollment (Session 1): assessment of the inclusion criteria. Informed consent is obtained.\n* Baseline evaluation (Session 2): assessment of upper limb function and hemi-inattention. Additionally, robotic performance parameters are collected.\n* Training sessions (Sessions 3-12): these are the actual training sessions with the robotic device. Each session consists of three phases.\n\nIn the first phase, the therapist provides the patient with the necessary information for the session.\n\nIn the second phase, patients complete a pre-scenario session, during which the robotic parameters are adjusted.\n\nIn the third phase, the scenario is used for motor and cognitive training.\n\n-Final evaluation (Session 13): final functional, clinical, and psychological assessments.\n\nThe sessions are conducted five times per week, each lasting 45 minutes.",[13],"Device: Upper-limb planar robotic intervention",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Upper-limb planar robotic intervention","The training sessions consist of three phases.\n\nIn the first, the therapist provides the patient with the necessary information for the session.\n\nIn the second, patients undergo a pre-scenario phase, in which the parameters of the robot (ratio between virtual and physical space, viscosity, and weight) are adjusted.\n\nIn the third phase, the scenario is used for motor and cognitive exercise.\n\nSpecifically, the scenario consists of a reaching exercise involving sequential stimuli placed in different spatial areas. The scenario has adaptive characteristics regarding:\n\n* Type of stimuli\n* Size of the stimuli\n* Visual and auditory cues\n* Number of stimuli, related to the space in which they are displayed.\n\nEach of these characteristics is adjusted differently according to the scenario's difficulty level. Regardless of the difficulty level, the scenario provides assistance as needed through a guided path (both visual and movement-based) toward the target.",[9],null,[22],{"name":23,"role":24,"phone":25,"phoneExt":20,"email":26},"Francesca Cecchi, Prof","CONTACT","+393388627184","fcecchi@dongnocchi.it",[28],{"facility":29,"status":20,"city":30,"state":31,"zip":32,"country":33,"countryCode":34,"cosmosGeoPoint":35,"geoPoint":40,"contacts":41},"IRCCS Fondazione Don Carlo Gnocchi onlus","Florence","Firenze","50143","Italy","IT",{"type":36,"coordinates":37},"Point",[38,39],11.24626,43.77925,{"lat":39,"lon":38},[42],{"name":43,"role":24,"phone":44,"phoneExt":20,"email":45},"Fabio Carlotti","+3905573931","ctu@dongnocchi.it",{"type":47,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR",[49],{"name":50,"class":51},"Humanware S.r.l.","UNKNOWN","100584525","robotic-rehabilitation-scenario-for-patients-with-neglect-100584525",false,"NCT06890481","Robotic rEhabilitation sCenario fOr patieNts With NeglECT","Collaborative Development of a Virtual Reality Scenario, Integrated Into a Robotic Upper Limb Rehabilitation Device, for the Treatment of Unilateral Spatial Negligence (NSU) Through Mutisensory Stimulation: Feasibility and Usability Pilot Study","RECONNECT","Inclusion Criteria:\n\n* Presence of a diagnosis of right hemispheric stroke\n* Presence of a diagnosis of hemi-inattention (Apple test)\n* Presence of left hemiplegia (Fugl-Meyer Assessment Upper Limb ≤58)\n* Adjusted Montreal Cognitive Assessment \\\u003C20\n* Written informed consent\n\nExclusion Criteria:\n\n* Presence of cognitive decline prior to the event\n* Presence of previous stroke events\n* Presence of osteoarticular rigidity (e.g., ankylosis, functional limitations with traumatic or degenerative origin) or spasticity in the affected upper limb (Modified Ashworth Scale ≥3 on shoulder, elbow, or wrist)\n* Inability to maintain a sitting position\n* Presence of severe visual disabilities\n* Recent injection of botulinum toxin in the upper limb or planned injection of botulinum toxin during the study period\n* Orthopaedic, neurological, or psychiatric disorders that could interfere with the study procedures and motor or cognitive assessments\n* Unstable fractures of the upper limb\n* Severe osteoporosis\n* Skin lesions on the upper limb","ALL","20 Years","80 Years",{"count":64,"type":65},12,"ESTIMATED","INTERVENTIONAL",[68],"NA","The goal of this pilot clinical trial is to develop an integrated motor and cognitive rehabilitation program and evaluate the usability and acceptability of a new virtual reality scenario designed for the MOTORE device. This study will focus on the rehabilitation of the upper limbs in post-stroke patients with plegia and left-sided hemi-inattention. The main questions it aims to answer are:\n\n* The evaluation of the usability and acceptability of the newly developed scenario\n* The evaluation of the effects of the new scenario on patients' hemi-inattention\n* The evaluation of changes in upper limb functional parameters\n\nParticipants will undergo a total of 13 rehabilitation sessions, each lasting 45 minutes, using the new scenario, including an initial and final assessment.",[71,72,73,74],"Stroke","Ischemic Stroke","Haemorrhagic Stroke","Neglect, Hemispatial",[76,77,78,79,80,81,82],"stroke","robotics","end-effector","upper-limbs","rehabilitation","neglect","usability","NOT_YET_RECRUITING","2025-03-31",{"date":86,"type":87},"2025-04-03","ACTUAL",{"date":89,"type":65},"2025-04-01",{"date":91,"type":65},"2026-04-01",{"name":5,"class":6},1]