[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584204":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":32,"responsibleParty":55,"collaborators":58,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":25,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":25,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":35,"whyStopped":25,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"machine learning based prosthesis control","EXPERIMENTAL","A non-invasive upper limb prosthesis whose control is facilitated through machine learning applied to myoelectric signals. The movements on the prosthesis are triggered by intuitive muscular contractions performed at the residual limb.",[13],"Device: Prosthetic controller",{"label":15,"type":16,"description":17,"interventionNames":18},"conventional direct control","ACTIVE_COMPARATOR","A non-invasive upper limb prosthesis whose control is enable by standard-in-care movement control strategy. The movements on the prosthesis are sequentially triggered through simple thresholds applied to myoelectric signals.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Prosthetic controller","The intervention includes an upper limb prosthesis composed at the minimum by skin-surface electrodes for myoelectric signals, a vibrotactile actuator, a multi-articulated and instrumented hand prosthesis and a centralized control system. The centralized prosthetic controller processes the myoelectric signals acquired at the residual limb to enable the movements on the multi-articulated prosthesis.",[15,9],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Enzo Mastinu, MSc, BSc, PhD","CONTACT","0039 050 883111","enzo.mastinu@santannapisa.it",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"IRCCS Istituto Ortopedico Rizzoli","RECRUITING","Bologna","Bo","40136","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],11.33875,44.49381,{"lat":45,"lon":44},[48,52],{"name":49,"role":29,"phone":50,"phoneExt":25,"email":51},"Paolo Sassu, Medical Doctor, Surgeon, PhD","0039 051 636 6111","paolo.sassu@ior.it",{"name":53,"role":54,"phone":25,"phoneExt":25,"email":25},"Paolo Sassu, Medical Director, Clinic IV","PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":56,"investigatorTitle":57,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Christian Cipriani","Full Professor",[59],{"name":60,"class":61},"IRCCS Istituto Ortopedico Rizzoli di Bologna","UNKNOWN","100584204","clinical-evaluation-of-intuitive-bidirectional-strategies-for-the-control-of-multi-articulated-prostheses-for-upper-limb-amputation-100584204",false,"NCT06886295","Clinical Evaluation of Intuitive, Bidirectional Strategies for the Control of Multi-articulated Prostheses for Upper Limb Amputation","Inclusion Criteria:\n\n* subjects with transradial amputation, and minimum experience in the use of myoelectric prosthesis;\n* subjects who have expressed informed consent to participate in the study and consent to data processing.\n\nExclusion Criteria:\n\n* subjects with obvious visual and oculomotor defects;\n* concomitant comorbidities\u002Fdisabilities\u002Fchronic conditions, general or localized (Multiple Sclerosis, Parkinson's disease, muscle tone disorders, malignant neoplasms, etc.), which may interfere with the performance of the study;\n* pregnancy or breastfeeding;\n* declared or evident cognitive deficits that compromise the understanding of the required tasks (mini Mental State Examination≤ 24);\n* difficulty in understanding the Italian language.","ALL","18 Years","65 Years",{"count":72,"type":73},14,"ESTIMATED","INTERVENTIONAL",[76],"NA","The investigators propose to validate a non-invasive upper limb prosthesis capable of combining: 1) intuitive movement control through machine learning applied to myoelectric signals, and 2) vibrotactile sensory feedback in response to touch and object release events. The prosthesis is composed at the minimum of skin-surface electrodes for myoelectric signals, vibrotactile actuators, a multi-articulated and instrumented hand prosthesis and a centralized control system. Such system is validated for several weeks in non-supervised environments.",[79],"Upper Limb Amputation",[81,82,83,84,85,86,87,88],"amputation","prosthesis","pattern recognition","regression","vibrotactile","sensory feedback","myoelectric","EMG","2025-04-02",{"date":91,"type":92},"2025-04-03","ACTUAL",{"date":94,"type":73},"2025-04-01",{"date":96,"type":73},"2026-12-31",{"name":5,"class":6},1]