[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100498717":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":38,"locations":47,"responsibleParty":92,"collaborators":94,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":100,"sex":106,"minAge":107,"maxAge":108,"enrollmentInfo":109,"targetDuration":26,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":118,"overallStatus":76,"whyStopped":26,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"IRCCS San Raffaele Roma","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group (EG)","EXPERIMENTAL","The Experimental Group (EG) will carry out 30 sessions (3-5 days\u002Fweek, for 6-10 weeks) of motor, speech, and cognitive rehabilitation exercises using the VRRS Tablet home TR system (Khymeia srl, Noventa Padovana, Italy).",[13],"Device: VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy)",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group (CG)","ACTIVE_COMPARATOR","The Control Group (CG) will carry out 30 sessions (3-5 days\u002Fweek, for 6-10 weeks) of conventional rehabilitation treatments (including physiotherapy, occupational therapy, speech therapy, psychotherapy) without the use of any technological devices.",[19],"Other: Conventional rehabilitation",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy)","The patients will carry out motor, speech, and cognitive rehabilitation exercises using the VRRS Tablet (Khymeia s.r.l., Noventa Padovana, Italy).\n\nThe motor exercises will be performed using inertial sensors for the acquisition and processing of the movement performed by the patient. This data is shown to the patient with visual and auditory feedback in a serious games environment. The exercises will cover the rehabilitation of balance and lower limbs, for example Balance on one leg, March in place, Stand on tiptoe, Squat, etc. The physiotherapists involved in the study will define a protocol of exercises in TR mode customized according to the characteristics and needs of the patient. The exercises in the speech therapy and cognitive domains will be defined by the specialized staff based on the characteristics of the patient.\n\nThe duration of the rehabilitation treatments is 9 hours per week.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Conventional rehabilitation","The patients will carry out conventional rehabilitation treatments (including physiotherapy, occupational therapy, speech therapy, psychotherapy) without the use of any technological devices.\n\nThe motor exercises will concern the rehabilitation of balance, trunk, and lower limbs and will be performed with a physiotherapist who will customize the treatment based on the characteristics and needs of the patient. The occupational therapy, speech therapy, psychotherapy treatments will be defined by the specialized staff based on the characteristics of the patient.\n\nThe duration of the rehabilitation treatments is 9 hours per week.",[15],[32,35],{"name":33,"affiliation":5,"role":34},"Dr. Sanaz Pournajaf, DPT","PRINCIPAL_INVESTIGATOR",{"name":36,"affiliation":5,"role":37},"Prof. Marco Franceschini, MD","STUDY_CHAIR",[39,44],{"name":33,"role":40,"phone":41,"phoneExt":42,"email":43},"CONTACT","+39 0652252405","32405","sanaz.pournajaf@sanraffaele.it",{"name":45,"role":40,"phone":26,"phoneExt":26,"email":46},"Dr. Raimondo Torcisi, PT","raimondo.torcisi@sanraffaele.it",[48,75],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"San Raffaele Cassino","NOT_YET_RECRUITING","Cassino","Frosinone","03043","Italy","IT",{"type":57,"coordinates":58},"Point",[59,60],13.82835,41.48581,{"lat":60,"lon":59},[63,66,69,71,73],{"name":64,"role":40,"phone":26,"phoneExt":26,"email":65},"Maria Francesca De Pandis, MD.","maria.depandis@sanraffaele.it",{"name":67,"role":68,"phone":26,"phoneExt":26,"email":26},"Maria Gaglione, Dr.","SUB_INVESTIGATOR",{"name":70,"role":68,"phone":26,"phoneExt":26,"email":26},"Lorenza Leonardi, Dr.",{"name":72,"role":68,"phone":26,"phoneExt":26,"email":26},"Francesco Barbato, MD",{"name":74,"role":68,"phone":26,"phoneExt":26,"email":26},"Catia Apisa, Dr.",{"facility":5,"status":76,"city":77,"state":54,"zip":78,"country":54,"countryCode":55,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"RECRUITING","Rome","00163",{"type":57,"coordinates":80},[81,82],12.51133,41.89193,{"lat":82,"lon":81},[85,88,90],{"name":86,"role":40,"phone":26,"phoneExt":26,"email":87},"Dr. Lucia Gatta, PhD","lucia.gatta@sanraffaele.it",{"name":89,"role":68,"phone":26,"phoneExt":26,"email":26},"Prof. Fabrizio Stocchi, MD, PhD",{"name":91,"role":68,"phone":26,"phoneExt":26,"email":26},"Dr. Laura Vacca, MD",{"type":93,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[95],{"name":96,"class":97},"Ministry of Health, Italy","OTHER_GOV","100498717","telerehabilitation-in-people-with-parkinsons-disease-100498717",false,"NCT05773885","Telerehabilitation in People With Parkinson's Disease","Home Telerehabilitation Based on Serious Games for Continuity of Care in People With Parkinson's Disease","TEMPO","Inclusion Criteria:\n\n* age between 30 and 80 years;\n* diagnosis of Parkinson's Disease according to the \"Movement Disorders Society's diagnostic criteria\";\n* Hoehn \\& Yahr (H\\&Y) score between 2 and 3 (ON-state);\n* absence of dyskinesias assessed by the MDS-UPDRS with a score to items 4.1 and 4.2 ≤ 2;\n* absence of cognitive impairment measured by the MoCA total score ≥ 18;\n* stabilized drug treatment;\n* have access to the Internet for TR;\n* have a caregiver available during rehabilitation sessions in TR;\n* have sufficient cognitive and linguistic level to understand and comply with study procedures;\n* sign informed consent.\n\nExclusion Criteria:\n\n* having any cognitive problems or low compliance that prevent using the TR system;\n* other neurological pathologies, psychiatric complications or personality disorders;\n* musculoskeletal diseases that impair movement;\n* presence of dyskinesias assessed by the MDS-UPDRS with a score to items 4.1 and 4.2 \\> 2;\n* presence of cognitive impairment measured by the MoCA total score \\\u003C 18;\n* severe cognitive or linguistic deficits (inability to understand and comply with study procedures);\n* presence of blurred or low vision problems;\n* hearing and speech impairment affecting participation in the system;\n* absence of signature of the informed consent.","ALL","30 Years","80 Years",{"count":110,"type":111},40,"ESTIMATED","INTERVENTIONAL",[114],"NA","Although TeleRehabilitation (TR) is widely accepted as an appropriate model for the provision of professional health services in the field of physiotherapy, with already established standards, guidelines and policies, there are still few studies in the literature on the use of TR as a rehabilitation tool in people with Parkinson's Disease (PD). Therefore, further studies on the efficacy of TR in the management of motor and non-motor symptoms of PD are needed.\n\nThe study TEMPO aims at assessing the efficacy (in terms of autonomy in carrying out the activities of daily life) of a home TR program based on serious games in people with PD compared to conventional day-hospital treatment.",[117],"Parkinson's Disease",[119,120,121,122,123,124],"Parkinson","Telerehabilitation","Activities of daily living","Quality of life","Belance","Compliance","2025-03-28",{"date":127,"type":128},"2025-03-30","ACTUAL",{"date":130,"type":128},"2022-09-01",{"date":132,"type":111},"2026-03-31",{"name":5,"class":6},2]