[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582823":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":26,"centralContacts":35,"locations":41,"responsibleParty":82,"collaborators":26,"id":85,"slug":26,"hasResults":86,"nctId":87,"briefTitle":88,"officialTitle":89,"acronym":26,"eligibilityCriteria":90,"healthyVolunteers":91,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":26,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":26,"overallStatus":43,"whyStopped":26,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":114},{"fullName":5,"class":6},"University of Kentucky","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","ACTIVE_COMPARATOR","Control group will wear the Loadsol Pros in-shoe insoles, with the auditory biofeedback function disabled",[13,14,15],"Other: Walking","Other: Rucking","Other: Running",{"label":17,"type":18,"description":19,"interventionNames":20},"auditory biofeedback (AudFB) gait training","EXPERIMENTAL","AudFB group will wear the Loadsol Pros in-shoe insoles with the audible noise emitted from the iOS device",[13,14,15],[22,27,31],{"type":6,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"Walking","Weeks 1-2, Sessions 1-4: The first condition will be walking with the speed self-selected based on \"a comfortable pace to walk for exercise\" as determined during the Baseline testing session. This speed will be held constant for the 10-minute walking portion prior to each condition but will be progressed for the remaining walking condition sessions (Sessions 2-4). The minimum speed will be limited to 1 mph.",[9,17],null,{"type":6,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Rucking","Weeks 3-4, Session 5-8: The second condition will require participants to wear a standard rucksack equal to 20% of their body weight (minimum ruck weight: 15 pounds, maximum ruck weight: 45 pounds). The initial speed used during this condition will be self-selected based on \"a comfortable pace to walk for exercise carrying this weight\" as determined during the Baseline testing session.",[9,17],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Running","Weeks 5-6, Sessions 9-12: The final condition is running. The self-selected running pace will be chosen as a pace that the participant can \"sustain for a leisure run for 20 minutes,\" as determined at the Baseline testing session. Participants will only run for the 15-minute condition period.",[9,17],[36],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Danielle M Torp, PhD, ATC","CONTACT","18593239835","danielle.torp@uky.edu",[42,63],{"facility":5,"status":43,"city":44,"state":45,"zip":46,"country":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Lexington","Kentucky","40506","United States",{"type":49,"coordinates":50},"Point",[51,52],-84.47772,37.98869,{"lat":52,"lon":51},[55,58,61],{"name":56,"role":57,"phone":26,"phoneExt":26,"email":26},"Danielle Torp, PhD, ATC","PRINCIPAL_INVESTIGATOR",{"name":59,"role":60,"phone":26,"phoneExt":26,"email":26},"Kyle Kosik, PhD, ATC","SUB_INVESTIGATOR",{"name":62,"role":60,"phone":26,"phoneExt":26,"email":26},"Matt Hoch, PhD, ATC",{"facility":64,"status":65,"city":66,"state":67,"zip":68,"country":47,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"University of North Carolina at Charlotte","NOT_YET_RECRUITING","Charlotte","North Carolina","28223",{"type":49,"coordinates":70},[71,72],-80.84313,35.22709,{"lat":72,"lon":71},[75,79,80],{"name":76,"role":38,"phone":77,"phoneExt":26,"email":78},"Luke Donovan, PhD, ATC","704-687-8611","ldonova2@charlotte.edu",{"name":76,"role":57,"phone":26,"phoneExt":26,"email":26},{"name":81,"role":60,"phone":26,"phoneExt":26,"email":26},"Abbey Thomas, PhD, ATC",{"type":57,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Danielle Torp","Assistant Professor","100582823",false,"NCT06868316","Auditory Biofeedback Gait Training Individuals With Chronic Ankle Instability","Optimizing Retention on Duty in Patients With Chronic Ankle Instability Using Auditory Biofeedback Gait Training: A Multisite Randomized Controlled Trial","Inclusion Criteria:\n\n* Physically active adults (defined as participants reporting a score of =4 on the National Aeronautics and Space Administration (NASA) Activity Instrument and indicating they can run for at least 20 consecutive minutes)\n* History of ankle sprain\n* 2 episodes of \"giving way\" in the past 6-months\n* must answer \"yes\" to =5 questions on the Ankle Instability Instrument (AII) and =11 on the Identification of Functional Ankle Instability (IdFAI)\n\nExclusion Criteria:\n\n* an ankle sprain in the previous four weeks or lower extremity neuromusculoskeletal injury other than to the ankle in the last 12 months\n* history of surgery in the lower extremity\n* fracture to the lower extremity in the past 12 months or a fracture that required open-reduction internal fixation\n* history of neurological disease, vestibular or visual disturbance or any other pathology that would impair sensorimotor performance or gait\n* current participation in a formal ankle joint rehabilitation program\n* a concussion in the last 12 months\n* report a cardiovascular, metabolic, or renal disease, or signs and symptoms that suggest such condition or have been told by a medical provider not to engage in vigorous physical activity (such as running).",true,"ALL","18 Years","45 Years",{"count":96,"type":97},100,"ESTIMATED","INTERVENTIONAL",[100],"NA","The goal of this randomized clinical controlled trial is examine the effects of gait training with auditory biofeedback (AudFB) on gait biomechanics, clinical measures of ankle joint health, and patient-centered outcomes. The following specific aims will achieve this objective:\n\n* Specific Aim 1: Determine if a 6-week gait training with AudFB intervention improves lower extremity biomechanics compared to a Control condition in participants with CAI.\n* Specific Aim 2: Determine if a 6-week gait training with AudFB reduces talar cartilage deformation compared to a Control condition in participants with CAI.\n* Specific Aim 3: Determine if a 6-week gait training with AudFB reduces episodes of ankle giving-way and reduces self-perceived severity of symptoms relative to a Control condition in participants with CAI.\n\nParticipants will:\n\n* Complete 12 intervention sessions over a 6-week period of walking, ruck marching, and runninig.\n* Complete testing sessions before and after the intervention, then after 6 and 12-months following the intervention.",[103,104],"Ankle Sprains","Ankle Injuries and Disorders","2025-10-01",{"date":107,"type":108},"2025-10-07","ACTUAL",{"date":110,"type":108},"2025-05-27",{"date":112,"type":97},"2028-09",{"name":5,"class":6},2]