[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100343350":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":35,"centralContacts":46,"locations":56,"responsibleParty":72,"collaborators":35,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":35,"eligibilityCriteria":80,"healthyVolunteers":81,"sex":82,"minAge":83,"maxAge":35,"enrollmentInfo":84,"targetDuration":35,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":35,"overallStatus":93,"whyStopped":35,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":103},{"fullName":5,"class":6},"Sword Health, SA","INDUSTRY",[8,17],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental","EXPERIMENTAL","Participants included in this arm will benefit from a 12-week exercise program using the novel biofeedback rehabilitation device, under remote monitoring from a physical therapist",[13,14,15,16],"Device: Biofeedback device","Behavioral: Education on falls risk","Other: Medication review","Diagnostic Test: Visual and auditory screening",{"label":18,"type":19,"description":20,"interventionNames":21},"Standard of Care","PLACEBO_COMPARATOR","Patients included in this arm will benefit from the standard of care currently in place in the Primary Care facility: education on risk factors for falls, medication review, visual and auditory acuity screening.",[14,15,16],[23,30,36,41],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DEVICE","Biofeedback device","12-week exercise program performed through the device",[9],[29],"SWORD Phoenix",{"type":31,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"BEHAVIORAL","Education on falls risk","Education on falls risk factors and how to minimize them",[9,18],null,{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":35},"OTHER","Medication review","Medication will be reviewed to reduce sedative drugs and minimize interactions",[9,18],{"type":42,"name":43,"description":44,"armGroupLabels":45,"otherNames":35},"DIAGNOSTIC_TEST","Visual and auditory screening","Patients will go through visual and auditory screening as part of their regular care",[9,18],[47,52],{"name":48,"role":49,"phone":50,"phoneExt":35,"email":51},"Fernando Correia, MD","CONTACT","+351966557789","fanacorreia@gmail.com",{"name":53,"role":49,"phone":54,"phoneExt":35,"email":55},"Mariana Sant'Ana, MD","+351918448914","mariana.magsant@gmail.com",[57],{"facility":58,"status":35,"city":59,"state":35,"zip":35,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"USF Aldoar","Porto","Portugal","PT",{"type":63,"coordinates":64},"Point",[65,66],-8.61097,41.1485,{"lat":66,"lon":65},[69],{"name":70,"role":49,"phone":71,"phoneExt":35,"email":35},"Mariana Sant'Ana","+351918448194",{"type":73,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100343350","clinical-impact-of-a-digital-home-based-falls-prevention-program-on-elderly-people-100343350",false,"NCT03750500","Clinical Impact of a Digital Home-based Falls Prevention Program on Elderly People","Clinical Impact of a Digital Home-based Falls Prevention Program on Elderly People - a Randomized Controlled Trial","Inclusion Criteria:\n\n1. Patients aged over 65 years old\n2. Ability to walk at least 20 meters, unaided or with unilateral support\n3. Ability to understand motor complex commands\n4. Mini-Mental State Examination (MMSE) score \\> 24 points\n5. Functional independence for instrumental activities of daily living\n6. Risk of recurrent falls, defined as 5xSST score \\> 15,00 seconds\n\nExclusion Criteria:\n\n1. Patients residing in nursing homes, daycare units or assisted-living facilities\n2. Aphasia, dementia or psychiatric comorbidity, significantly interfering with communication or compliance with a home-based exercise program\n3. Severe visual our hearing, interfering with communication or with compliance to a home-based exercise program\n4. Cardiac, respiratory or other condition incompatible with at least 30 minutes of light to moderate physical activity\n5. Osteoarticular conditions (e.g. severe osteoarthrosis), which prevent the patient from complying with a home-based exercise program\n6. Patients with neurologic conditions (e.g. stroke, multiple sclerosis, Parkinson's disease)\n7. Other medical complications, which prevent the patient from complying with a home-based exercise program\n8. Illiteracy",true,"ALL","65 Years",{"count":85,"type":86},100,"ESTIMATED","INTERVENTIONAL",[89],"NA","This study is a single-center, prospective, non-blind, parallel-group, randomized controlled trial with an experimental and a control group with the aim of evaluating the clinical impact of a home-based falls prevention program using a new biofeedback system on community-dwellers older adults with fall risk in comparison with standard of care.\n\nThe experimental group will perform a 12-week exercise program at home, under remote monitoring from a clinical team, whereas the control group will benefit from standard medical care currently in place at the participating primary care facility.\n\nThe hypothesis is that the home-based falls prevention program will lead to a lower risk of falling than standard medical care.",[92],"Fall","NOT_YET_RECRUITING","2024-12-04",{"date":96,"type":97},"2024-12-06","ACTUAL",{"date":99,"type":86},"2025-05",{"date":101,"type":86},"2026-11",{"name":5,"class":6},1]