[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100641537":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":33,"studyPopulation":30,"armGroups":34,"interventions":45,"overallOfficials":53,"centralContacts":57,"locations":63,"responsibleParty":80,"collaborators":30,"id":82,"slug":30,"hasResults":83,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":52,"eligibilityCriteria":87,"healthyVolunteers":83,"sex":88,"minAge":89,"maxAge":90,"enrollmentInfo":91,"targetDuration":30,"studyType":94,"phases":95,"briefSummary":97,"conditions":98,"keywords":101,"overallStatus":106,"whyStopped":30,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":111,"completionDateStruct":113,"leadSponsor":115,"locationsCount":116},{"fullName":5,"class":6},"University Rehabilitation Institute, Republic of Slovenia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"Perturbation strength","Perturbation strength that can be reliably counteracted - difference score (minimum 0N, no upper limit, stronger perturbation means better outcome, larger difference means better outcome)","Difference between the two assessments - one day before the first and one day after the last training session",[14,17],{"measure":15,"description":16,"timeFrame":12},"mini-BESTest","Mini Balance Evaluation Systems Test - difference score (score range 0-28, higher score means better outcome, larger difference means better outcome)",{"measure":18,"description":19,"timeFrame":12},"ABC Scale","Activities-Specific Balance Confidence Scale - difference score (score range 0%-100%, higher score means better outcome, larger difference means better outcome)",[21],{"measure":22,"description":23,"timeFrame":24},"Adverse events","Number of adverse events (fatigue, pain, secured falls) during training (fewer events mean better outcome)","During all the nine training sessions across the three weeks",{"allocation":26,"interventionModel":27,"interventionModelDescription":28,"primaryPurpose":29,"observationalModel":30,"timePerspective":30,"maskingInfo":31},"NON_RANDOMIZED","PARALLEL","Two groups, each group will follow the ABA protocol with A meaning no intervention and B meaning intervention. There will therefore be four assessment points.","PREVENTION",null,{"masking":32,"maskingDescription":30,"whoMasked":30},"NONE","Two convenience samples will be recruited to serve as self-controls, 20 post-stroke adults and 30 community-dwelling older adults. Participants post stroke will be recruited after discharge from their regular rehabilitation. Each subject will undergo individually customised perturbation-based training sessions with safety harnesses. The participants will be assessed at four time points: at baseline, after 3 weeks (at the beginning of training), at the end of 3-week training, and at 3-week follow-up. Safety, usability and efficacy of training will be evaluated using slip-, trip- and platform-movement-based perturbations induced by a Stewart platform and dual-belt treadmill, whereby the perturbation strength that can be reliably counteracted will be recorded, and using standardised clinical outcome measures.",[35,41],{"label":36,"type":37,"description":38,"interventionNames":39},"Post-stroke patients","EXPERIMENTAL","Each participant will undergo perturbation-based training and assessment according to an ABA (no intervention\u002Fintervention\u002Fno intervention) design with assessment at the beginning and end of each phase (four time-points).",[40],"Device: PBT",{"label":42,"type":43,"description":38,"interventionNames":44},"Elderly adults","ACTIVE_COMPARATOR",[40],[46],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"DEVICE","PBT","Each subject will undergo 9 perturbation-based training sessions with safety harnesses, and the device will deliver waist pulls during treadmill walking. Training sessions will be individually customised. Perturbation intensity will be progressively increased by a physiotherapist according to the subject's abilities. Training sessions will last approximately 30 minutes, 2-3 times per week.",[42,36],[52],"PACE-R",[54],{"name":55,"affiliation":5,"role":56},"Zlatko Matjačić, PhD","PRINCIPAL_INVESTIGATOR",[58],{"name":59,"role":60,"phone":61,"phoneExt":30,"email":62},"Katja Groleger Sršen, MD, PhD","CONTACT","+386 1 4758283","katja.groleger@ir-rs.si",[64],{"facility":5,"status":30,"city":65,"state":30,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"Ljubljana","1000","Slovenia","SI",{"type":70,"coordinates":71},"Point",[72,73],14.50513,46.05108,{"lat":73,"lon":72},[76],{"name":77,"role":60,"phone":78,"phoneExt":30,"email":79},"Urška Puh, PT, PhD","+386 1 4758152","urska.puh@ir-rs.si",{"type":81,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100641537",false,"NCT07654335","Experimental PBT Study in Fall-prone Subjects","Experimental Perturbation-based-training Study in Patients After Stroke and Older Adults","Inclusion Criteria for both arms:\n\n* ability for independent community walking without aids;\n* sufficient cognitive, visual, and communication abilities for study participation.\n\nExclusion Criteria for both arms:\n\n* musculoskeletal impairments;\n* cardiovascular health-related problems;\n* other health conditions that could interfere with the training.\n\nAdditional Inclusion Criteria for post-stroke patients:\n\n* discharge from their regular rehabilitation;\n* at least 6 months after first unilateral cerebral stroke;\n* 18 to 70 years of age;\n* absence of additional neurologic conditions.\n\nAdditional Inclusion Criteria for older adults:\n\n* age 65 to 75 years;\n* no known health-related problems significantly affecting balance and walking.","ALL","18 Years","75 Years",{"count":92,"type":93},50,"ESTIMATED","INTERVENTIONAL",[96],"NA","The study will investigate safety, usability, feasibility and preliminary efficacy of perturbation-based training in participants post-stroke and older adults with mild balance deficits. Both group will receive three weks of training. The primary outcome measure will be derived from laboratory-induced falls.",[99,100],"Stroke","Aging",[102,103,104,105],"Accidental Falls","Walking","Fall prevention","Perturbation-based training","NOT_YET_RECRUITING","2026-06-19",{"date":109,"type":110},"2026-06-24","ACTUAL",{"date":112,"type":93},"2026-09",{"date":114,"type":93},"2028-09",{"name":5,"class":6},1]