[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585914":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":37,"locations":49,"responsibleParty":79,"collaborators":81,"id":84,"slug":85,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":90,"eligibilityCriteria":91,"healthyVolunteers":86,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":26,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":51,"whyStopped":26,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"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) perform 30 minutes (16 sessions, 4 days\u002Fweek, for 4 weeks) of balance rehabilitation exercises using non-immersive virtual reality with the OAK device (Khymeia Group, Italy).",[13],"Device: Experimental: Interactive balance rehabilitation based on serious games.",{"label":15,"type":16,"description":17,"interventionNames":18},"Active comparator (CG)","ACTIVE_COMPARATOR","Partecipants assigned to Control Group (CG) follow 30 minutes (4 days\u002Fweek, for 4 weeks) of conventional rehabilitative treatments for balance without the use of technological devices.",[19],"Other: Active Comparator: conventional balance rehabilitation without the use of technological devices.",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Experimental: Interactive balance rehabilitation based on serious games.","The intervention of the Experimental Group consists of 30 minutes (16 sessions, 4 days\u002Fweek, for 4 weeks) of balance rehabilitation exercises using non-immersive virtual reality through the OAK device (Khymeia Group, Italy). The system includes exercises that require the patient to reach visual targets by shifting their Center of Pressure (COP). The exercises are categorized based on the direction of COP displacement and can be performed with increasing difficulty, as determined by the physiotherapist during the rehabilitation process.",[9],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Active Comparator: conventional balance rehabilitation without the use of technological devices.","Intervention of the Control Group (CG) consists of 30 minutes (4 days\u002Fweek, for 4 weeks) of conventional balance rehabilitation treatments without the use of technological devices. The motor exercises will focus on the rehabilitation of balance, the trunk, and the lower limbs and will be carried out with a physiotherapist who will tailor the treatment according to the patient's characteristics and needs. Primary attention will be given to recovering trunk control and seated posture. This phase will focus on restoring and maintaining muscle trophism in the anterior and posterior kinetic chains of the thigh and lower leg, as well as the hip's range of motion, through isometric exercises and gentle joint mobilizations while adhering to anti-dislocation guidelines.\n\nThe process will continue with the reacquisition of the upright stance, emphasizing proprioceptive, coordination, and balance abilities. Once the upright position is stabilized, gait re-education will be introduced.",[15],[32,35],{"name":33,"affiliation":5,"role":34},"Prof. Marco Franceschini, MD","STUDY_CHAIR",{"name":33,"affiliation":5,"role":36},"PRINCIPAL_INVESTIGATOR",[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Dr. Sanaz Pournajaf, DPT","CONTACT","+390652252405","32405","sanaz.pournajaf@sanraffaele.it",{"name":45,"role":40,"phone":46,"phoneExt":47,"email":48},"Dr. Carlotta Maria Manzia, DT","+39-0652252338","32338","carlotta.manzia@sanraffaele.it",[50,67],{"facility":5,"status":51,"city":52,"state":53,"zip":54,"country":53,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"RECRUITING","Rome","Italy","00163","IT",{"type":57,"coordinates":58},"Point",[59,60],12.51133,41.89193,{"lat":60,"lon":59},[63,65],{"name":39,"role":40,"phone":64,"phoneExt":42,"email":43},"+39 0652252405",{"name":39,"role":66,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"facility":68,"status":51,"city":69,"state":53,"zip":70,"country":53,"countryCode":55,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Casa di Cura San Raffaele Sulmona","Sulmona","67039",{"type":57,"coordinates":72},[73,74],13.92578,42.04945,{"lat":74,"lon":73},[77],{"name":78,"role":36,"phone":26,"phoneExt":26,"email":26},"Dr. Giorgio Felzani, MD",{"type":80,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[82],{"name":83,"class":6},"Ministero della Salute, Italy","100585914","balance-rehabilitation-based-on-serious-games-100585914",false,"NCT06908564","Balance Rehabilitation Based on Serious Games","Efficacy of BalancE RehabiliTation Based on Serious Games in People With Hip Arthroplasty: a Pilot Non-Randomized Multicenter Study","BERTHA","Inclusion Criteria:\n\n* Age over 18 years;\n* First elective hip arthroplasty;\n* Cognitive ability to understand and perform the exercises outlined in the protocol;\n* Ability to sign the informed consent.\n\nExclusion Criteria:\n\n* Unable to adhere to the exercise program due to poor compliance;\n* Previous contralateral hip arthroplasty;\n* Surgical wound complications;\n* Severe cognitive, linguistic, or visual impairments (inability to understand and follow the study procedures);\n* Conditions that, in the investigator's judgment, may interfere with the study or contraindicate participation for safety reasons;\n* Diagnosis of epilepsy;\n* Presence of implanted cardiac pacemakers;\n* Lack of signed informed consent for the study.","ALL","18 Years","85 Years",{"count":96,"type":97},20,"ESTIMATED","INTERVENTIONAL",[100],"NA","The effects of new technologies, particularly exergames, on the rehabilitation process of patients with hip arthroplasty have not yet been verified. For this reason, the aim of this study is to evaluate the effectiveness, in terms of balance recovery, of a balance rehabilitation program based on serious games in individuals with hip arthroplasty compared to conventional treatment.",[103],"Hip Replacement, Total",[105,106,107,108,109,110,111,112,113],"Hip Arthroplasty Replacement","Lower Limb","Balance","Rehabilitation","Robotic-Assisted Therapy","Range Of Motion","Pain","Activity of Daily Living","Hip Replacement Total","2025-04-07",{"date":116,"type":117},"2025-04-09","ACTUAL",{"date":119,"type":117},"2023-06-23",{"date":121,"type":97},"2026-03-23",{"name":5,"class":6},2]