[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585839":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":23,"centralContacts":24,"locations":34,"responsibleParty":107,"collaborators":23,"id":110,"slug":111,"hasResults":112,"nctId":113,"briefTitle":114,"officialTitle":114,"acronym":115,"eligibilityCriteria":116,"healthyVolunteers":117,"sex":118,"minAge":119,"maxAge":120,"enrollmentInfo":121,"targetDuration":23,"studyType":124,"phases":125,"briefSummary":127,"conditions":128,"keywords":131,"overallStatus":37,"whyStopped":23,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"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},"Motor Data Analysis for Healthy Subjects","EXPERIMENTAL","All subjects who are recruited in the study undergo sensors administration for motor analysis at the enrollement",[13],"Device: Motor Data Analysis",{"label":15,"type":10,"description":11,"interventionNames":16},"Motor Data Analysis for patients with Parkinson's disease",[13],[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DEVICE","Motor Data Analysis","The SensMode System includes wearable devices for upper and lower limb motion analysis. The upper limb device, SensHand, consists of 3 sensorized elements: 2 sensorized rings to be placed at the level of the distal phalanx of the thumb and forefinger of the hand and 1 sensorized wristband to be placed at the level of the distal portion of the forearm near the wrist. Each element of SensHand allows the acquisition of inertial data with respect to the biomechanics of the arm-forearm-wrist and the first three fingers of the hand, measuring the 3 components in space of linear acceleration, angular velocity, and magnetic field. The lower limb device, SensFoot, is a device that integrates the same electronic components as the bracelet and is placed in a plastic housing shaped like a small rectangular parallelepiped that is placed over the shoe.",[9,15],null,[25,30],{"name":26,"role":27,"phone":28,"phoneExt":23,"email":29},"Filippo Cavallo","CONTACT","+390552758663","filippo.cavallo@santannapisa.it",{"name":31,"role":27,"phone":32,"phoneExt":23,"email":33},"Erika Rovini","+390553758663","erika.rovini@unifi.it",[35,54,68,79,93],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Ospedale Santa Maria Annunziata AUSL Toscana Centro","RECRUITING","Bagno a Ripoli","Firenze","50012","Italy","IT",{"type":44,"coordinates":45},"Point",[46,47],11.32252,43.75115,{"lat":47,"lon":46},[50],{"name":51,"role":27,"phone":52,"phoneExt":23,"email":53},"Paola Vanni","+390552313862","paola.vanni@uslcentro.toscana.it",{"facility":55,"status":37,"city":56,"state":23,"zip":57,"country":41,"countryCode":42,"cosmosGeoPoint":58,"geoPoint":62,"contacts":63},"Azienda Ospedaliero Universitaria Careggi","Florence","50134",{"type":44,"coordinates":59},[60,61],11.24626,43.77925,{"lat":61,"lon":60},[64],{"name":65,"role":27,"phone":66,"phoneExt":23,"email":67},"Silvia Ramat","+390557947956","silvia.ramat@unifi.it",{"facility":69,"status":37,"city":56,"state":23,"zip":70,"country":41,"countryCode":42,"cosmosGeoPoint":71,"geoPoint":73,"contacts":74},"IRCCS Fondazione Don Carlo Gnocchi Firenze","50143",{"type":44,"coordinates":72},[60,61],{"lat":61,"lon":60},[75],{"name":76,"role":27,"phone":77,"phoneExt":23,"email":78},"Gemma Lombardi","+3905557393917","glombardi@dongnocchi.it",{"facility":80,"status":37,"city":81,"state":23,"zip":82,"country":41,"countryCode":42,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Ospedale Apuane AUSL Toscana Nord Ovest","Massa","54100",{"type":44,"coordinates":84},[85,86],10.13927,44.03541,{"lat":86,"lon":85},[89],{"name":90,"role":27,"phone":91,"phoneExt":23,"email":92},"Carlo Maremmani","+3905854931","carlo.maremmani@uslnordovest.toscana.it",{"facility":94,"status":37,"city":95,"state":23,"zip":96,"country":41,"countryCode":42,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"IRCCS Istituto Auxologico Italiano, Ospedale San Luca","Milan","20149",{"type":44,"coordinates":98},[99,100],12.59836,42.78235,{"lat":100,"lon":99},[103],{"name":104,"role":27,"phone":105,"phoneExt":23,"email":106},"Andrea Ciammola","+39026191129","a.ciammola@auxologico.it",{"type":108,"investigatorFullName":26,"investigatorTitle":109,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"PRINCIPAL_INVESTIGATOR","Associate Professor","100585839","a-novel-accessible-and-widespread-healthcare-service-model-based-on-technology-innovation-for-objective-early-diagnosis-and-therapeutic-monitoring-of-parkinsons-disease-promoting-continuity-of-care-100585839",false,"NCT06907589","A Novel Accessible and Widespread Healthcare Service Model Based on Technology Innovation for Objective (Early) Diagnosis and Therapeutic Monitoring of Parkinson's Disease Promoting Continuity of Care","OLIMPIA","Inclusion Criteria:\n\n1. Healthy subjects - Inclusion Criteria:\n\n   * Adult subjects, both sexes, aged 50-80 years old\n   * MMSE score \\>= 24 absence of olfactory deficit detected on IOIT olfactory test (22). Age class 50-59 years: normal with score \\\u003C=5; age class 60-69 years: normal with score \\\u003C=6; age class \\> 70 years: normal with score \\\u003C=7\n   * absence of neurological diseases\n   * absence of functional deficit in the sphere of locomotion as a result of traumatic injury or from other cause to the upper and\u002For lower limbs and\u002For pelvis and\u002For spine\n   * expression of informed consent to participate in the study\n2. Subjects with Parkinson's disease -- Inclusion criteria:\n\n   * adult subjects, both sexes, 50-80 years of age\n   * MMSE score \\>= 24\n   * subjects with Parkinson's disease in the absence of motor fluctuations and dyskinesias, or subjects with Parkinson's disease with mild motor fluctuations throughout the day, but to be examined in the ON phase and in the absence of dyskinesias\n   * Hoehn and Yahr stage 1, 2, 3\n   * absence of functional deficit in the sphere of locomotion as a result of traumatic injury or from other cause to the upper and\u002For lower limbs and\u002For pelvis and\u002For spine\n   * expression of informed consent to participate in the study\n\nExclusion Criteria:\n\n1. Healthy subjects - Exclusion criteria:\n\n   * denial of informed consent to participate in the study\n   * Presence of olfactory deficit detected on IOIT olfactory test. Age class 50-59 years: hyposmia with score \\>=6; age class 60-69 years: hyposmia with score \\>=7; age class \\> 70 years: hyposmia with score \\>=8\n   * body weight greater than 120 kg\n   * insufficient degree of cooperation\n   * malignant neoplasm in progress or with negative follow-up of less than 6 years\n   * structured joint stiffness in the upper and\u002For lower extremities preventing proper execution of movements\n   * paresis and\u002For plegia of upper and\u002For lower limb muscle groups from both peripheral and central nerve injury\n   * mono\u002Fmulti\u002Fpoly sensory and\u002For motor neuropathy\n   * chronic inflammatory diseases with joint involvement of the upper and\u002For lower limbs\n   * vertiginous syndromes in the acute phase\n   * neurodegenerative diseases\n   * fever\n   * venous thrombosis\n   * cardiovascular disorders or other acute or chronic conditions capable of affecting the proper performance of motor exercises\n   * spinal or joint pain of various etiologies that may affect the performance of motor exercises\n   * positive history of recurrent acute cervico-brachialgia and\u002For lumbosciatica\n2. Subjects with Parkinson's disease - Exclusion criteria:\n\n   * Denial of informed consent to participate in the study\n   * Hoenn and Yahr stage 4, 5\n   * Patient who needs to use an aid (cane or walker) while walking or cannot walk unless aided by a person\n   * body weight greater than 120 kg\n   * insufficient degree of cooperation\n   * malignant neoplasm in place or with negative follow-up of less than 6 years\n   * structured joint stiffness in the upper and\u002For lower extremities that prevents proper execution of movements\n   * paresis and\u002For plegia of upper and\u002For lower limb muscle groups from both peripheral and central nerve injury mono\u002Fmulti\u002Fpoly sensory and\u002For motor neuropathy\n   * chronic inflammatory diseases with joint involvement of the upper and\u002For lower limbs\n   * vertiginous syndromes in the acute phase\n   * neurodegenerative diseases, excluding Parkinson's disease\n   * fever\n   * venous thrombosis\n   * cardiovascular disorders or other acute or chronic conditions capable of affecting the proper performance of motor exercises\n   * spinal or joint pain of various etiologies that may affect the performance of motor exercises\n   * positive history of recurrent acute cervico-brachialgia and\u002For low back pain",true,"ALL","50 Years","80 Years",{"count":122,"type":123},250,"ESTIMATED","INTERVENTIONAL",[126],"NA","The present study aims to use the SensMode System - a system composed of wearable devices for upper and lower limb movement analysis and electronic device for data acquisition and processing - on healthy subjects, subjects with idiopathic hyposmia, patients with Parkinson's disease, and subjects with de-novo drug-naïve extrapyramidal syndrome. The purpose is to identify normative data of objective motor measures obtained with such a system, as well as to increase knowledge about the potential contribution such a solution can make to the preclinical diagnosis of Parkinson's disease and the management of patients with this disease.",[129,130],"Parkinson Disease","Healthy Adult",[132,133,134],"parkinson's disease","wearable sensors","motor data","2025-03-26",{"date":137,"type":138},"2025-04-02","ACTUAL",{"date":140,"type":138},"2024-05-13",{"date":142,"type":123},"2026-01-08",{"name":5,"class":6},5]