[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100648410":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":33,"locations":39,"responsibleParty":91,"collaborators":93,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":101,"sex":107,"minAge":108,"maxAge":109,"enrollmentInfo":110,"targetDuration":32,"studyType":113,"phases":114,"briefSummary":116,"conditions":117,"keywords":121,"overallStatus":42,"whyStopped":32,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"University of South Florida","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Conventional Ankle Foot Orthosis (AFO)","ACTIVE_COMPARATOR","Limited function; thermoplastic or thermoset material",[13],"Device: Conventional Ankle Foot Orthosis (AFO)",{"label":15,"type":10,"description":16,"interventionNames":17},"Advanced Ankle Foot Orthosis (AFO)","Return stored energy; laminated; may include posterior struts; higher activity",[18],"Device: Advanced Ankle Foot Orthosis (AFO)",[20,26],{"type":21,"name":15,"description":22,"armGroupLabels":23,"otherNames":24},"DEVICE","Subjects will be initially fit with the AFO category they do not use on a daily basis to ensure they have both AFO categories for the study. These \"advanced\" AFOs have been developed to offer energy-storing-and-returning (ESR) properties to the user. Advanced Ankle Foot Orthoses include designs that are widely believed to return stored energy in late stance. These designs are laminated and may include posterior struts.",[15],[25],"Advanced AFO",{"type":21,"name":9,"description":27,"armGroupLabels":28,"otherNames":29},"Subjects will be initially fit with the AFO category they do not use on a daily basis to ensure they have both AFO categories for the study. Conventional Ankle Foot Orthoses have been more commonly used in past decades. AFOs within the conventional category generally include designs that will not return stored energy in late stance. These designs may vary in material construction and componentry. For instance, mechanical joints can be incorporated but do not have to be for inclusion in this group. AFOs in this category may be thermoplastic materials or thermoset laminate. The devices may be off-the-shelf or custom molded to the patient.",[9],[30,31],"Conventional AFO","Traditional AFO",null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Stephanie L Carey, PhD","CONTACT","813-974-5765","scarey3@usf.edu",[40,58,71],{"facility":41,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"University of South Florida, Rehabilitation Robotics & Prosthetics Testbed (RRT)","RECRUITING","Tampa","Florida","33620","United States","US",{"type":49,"coordinates":50},"Point",[51,52],-82.45843,27.94752,{"lat":52,"lon":51},[55,56],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},{"name":35,"role":57,"phone":32,"phoneExt":32,"email":32},"PRINCIPAL_INVESTIGATOR",{"facility":59,"status":42,"city":43,"state":44,"zip":60,"country":46,"countryCode":47,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},"James A. Haley VA Center of Innovation of Disability & Rehab Research","33637",{"type":49,"coordinates":62},[51,52],{"lat":52,"lon":51},[65,69],{"name":66,"role":36,"phone":67,"phoneExt":32,"email":68},"Sam Phillips, PhD","813-558-3995","Samuel.Phillips@va.gov",{"name":70,"role":57,"phone":32,"phoneExt":32,"email":32},"Sam Phillips",{"facility":72,"status":42,"city":73,"state":73,"zip":74,"country":46,"countryCode":47,"cosmosGeoPoint":75,"geoPoint":79,"contacts":80},"VA New York Harbor Healthcare System","New York","10010",{"type":49,"coordinates":76},[77,78],-74.00597,40.71427,{"lat":78,"lon":77},[81,86,90],{"name":82,"role":36,"phone":83,"phoneExt":84,"email":85},"Jason Maikos, PhD","212-686-7500","17482","jason.maikos@va.gov",{"name":87,"role":36,"phone":88,"phoneExt":32,"email":89},"Michael Hyre, MS","929-617-0975","michael.hyre@va.gov",{"name":82,"role":57,"phone":32,"phoneExt":32,"email":32},{"type":92,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[94,97],{"name":95,"class":96},"Tampa VA Healthcare System","UNKNOWN",{"name":72,"class":98},"FED","100648410","im-able-2-injuries-managed-with-advanced-bracing-for-lower-extremities-100648410",false,"NCT07721792","IM ABLE 2: Injuries Managed With Advanced Bracing for Lower Extremities","The IM ABLE 2 Study: Long Term Outcomes to Advance Care for Warriors and Veterans Using Advanced Ankle Foot Orthoses","IM ABLE 2","Inclusion Criteria:\n\n* Lower extremity injury of any etiology requiring current use of an AFO\n* Age 18-80 years\n* 100-275 lbs\n* Greater than 1 month of AFO experience\n* Use of an AFO for activities of daily living\n* English or Spanish speaking\n* Able to comply with study procedures\n\nExclusion Criteria:\n\n* Body mass less than 100 or greater than 275 lbs.\n* Over 80 years of age\n* Known cognitive impairment (e.g. diagnoses such as moderate\u002Fsevere traumatic brain injury, dementia)\n* Inability to comply with instructions.\n* Pregnancy\n* Medical conditions that would preclude safe involvement\n* Unable to provide written informed consent.","ALL","18 Years","80 Years",{"count":111,"type":112},75,"ESTIMATED","INTERVENTIONAL",[115],"NA","The purpose of the study is to test different categories of ankle foot orthoses (AFOs) with patients who have had lower limb salvage, reconstruction or other problems impacting limb function.",[118,119,120],"Lower Limb Injury","Ankle Foot Orthosis (AFO)","Lower Limb Trauma",[122,123,124,125,126,127],"Ankle foot orthosis (AFO)","activity monitor","lower limb injury","gait","activities of daily living","lower extremity trauma","2026-07-20",{"date":130,"type":131},"2026-07-23","ACTUAL",{"date":133,"type":112},"2026-07-31",{"date":135,"type":112},"2029-01-31",{"name":5,"class":6},3]