[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633054":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":44,"responsibleParty":66,"collaborators":68,"id":75,"slug":76,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":77,"sex":83,"minAge":84,"maxAge":24,"enrollmentInfo":85,"targetDuration":24,"studyType":88,"phases":89,"briefSummary":91,"conditions":92,"keywords":97,"overallStatus":102,"whyStopped":24,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Odense University Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ankle stirrup","EXPERIMENTAL","Active ankel dorsal and plantar flexion during use of the ankle stirrup",[13],"Other: Ankle stirrup",{"label":15,"type":16,"description":17,"interventionNames":18},"Foot-ankle brace (walker)","ACTIVE_COMPARATOR","Immobilisation during use of the foot-ankle brace",[19],"Other: Foot-ankle brace",[21,25],{"type":6,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"Four weeks of weight-bearing as tolerated using an ankle stirrup",[9],null,{"type":6,"name":26,"description":27,"armGroupLabels":28,"otherNames":24},"Foot-ankle brace","Four weeks of weight-bearing as tolerated using a foot-ankle brace (walker)",[15],[30],{"name":31,"affiliation":32,"role":33},"Anders Holsgaard-Larsen, PhD","Department of Orthopaedic Surgery and Traumatology, Odense University Hospital, Denmark, and Department of Clinical Research, University of Southern Denmark, Denmark.","STUDY_CHAIR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":24,"email":39},"Katrine K Krag-Andersen, PT, MSc","CONTACT","+4522466435","kanderse@health.sdu.dk",{"name":41,"role":37,"phone":42,"phoneExt":24,"email":43},"Jonas A Ipsen, PT, PhD","+4523925264","Jonas.Ammundsen.Ipsen@rsyd.dk",[45],{"facility":5,"status":24,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Odense","Region Syddanmark","5000","Denmark","DK",{"type":52,"coordinates":53},"Point",[54,55],10.38831,55.39594,{"lat":55,"lon":54},[58,62],{"name":59,"role":37,"phone":60,"phoneExt":24,"email":61},"Bjarke Viberg, MD, PhD","+4528669059","bjarke.viberg@rsyd.dk",{"name":63,"role":37,"phone":64,"phoneExt":24,"email":65},"Louise D Petersen, Clinical Research Coordinator","+45 51435711","Louise.Dyhring.Petersen@rsyd.dk",{"type":67,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[69,71,73],{"name":70,"class":6},"Aarhus University Hospital",{"name":72,"class":6},"Zealand University Hospital",{"name":74,"class":6},"Sygehus Lillebaelt","100633054","physical-recovery-during-bracing-after-ankle-fracture-re-baf-100633054",false,"NCT07521696","Physical Recovery During Bracing After Ankle Fracture (Re-BAF)","Physical Recovery During Bracing After Ankle Fracture (Re-BAF): A Multi-Center Superiority Analysis Nested Within a Non-inferiority Randomised Controlled Trial (BAF; NCT07163091)","Re-BAF","Inclusion Criteria:\n\n* 18 years or older\n* Surgically or non-surgically treated ankle fracture\n\nExclusion Criteria:\n\n* Pathological fractures\n* Open fractures (skin perforation)\n* Prolonged need for immobilisation (e.g. non-union or insufficient wound healing)\n* Non-weight bearing treatment\n* Inability to adhere to trial procedures (e.g. neuropathy or severe psychiatric disorder)\n* Allergy to SENS Motion adhesive patches\n* Inability to read or speak Danish\n* Uninterest in participating","ALL","18 Years",{"count":86,"type":87},280,"ESTIMATED","INTERVENTIONAL",[90],"NA","Ankle fractures are among the most common fractures and represent the second most frequent fracture type requiring surgery. Many patients experience long-term pain, stiffness, and reduced ankle function, which substantially limits their physical activity. Even five years after injury, more than a third of patients have not regained their pre-injury activity levels.\n\nStandard treatment typically involves immobilisation using a rigid foot-ankle brace (walker). Although effective in protecting fracture healing, these braces may be overly restrictive, contributing to ankle stiffness, swelling, delayed physical recovery and return to daily activities, and reduced quality of life. Patients increasingly express a preference for lighter, movement-permitting ankle supports, such as minimal ankle stirrups. Recent evidence suggests that braces and elastic bands that allow more ankle movement than walkers may enhance faster recovery without increasing complications.\n\nHowever, high quality evidence is necessary for more robust conclusions. The Scandinavian Bracing after Ankle Fracture (BAF) multicentre randomised controlled trial (NCT07163091) therefore investigates whether an ankle stirrup is non-inferior to a standard walker with respect to patient-reported ankle pain and function, measured by the Manchester-Oxford Foot Questionnaire (MOXFQ) three months after ankle fracture. The primary hypothesis is that ankle stirrups better align with patients' preferences for less restrictive bracing while providing sufficient stability during fracture healing. Secondarily, ankle stirrups may promote faster recovery and physical activity.\n\nThe Re-BAF trial is nested within a larger multicentre non-inferiority trial (Bracing after Ankle Fracture \\[BAF\\], ClinicalTrials.gov ID: NCT07163091), aiming to investigate whether an ankle stirrup is non-inferior to a standard foot-ankle brace in improving patient-reported foot and ankle function, as measured by the Manchester-Oxford Foot Questionnaire (\\[MOXFQ\\], primary BAF outcome) after ankle fracture.\n\nThe aim of the Re-BAF trial is to investigate whether ankle stirrups are superior to standard foot-ankle braces in improving physical activity, assessed using objectively measured thigh-worn accelerometry from baseline (i.e. randomisation) to 12-week follow-up. We hypothesize that early and continuous movement during rehabilitation, enabled by an ankle stirrup, is superior in improving physical activity compared with a foot-ankle brace, without compromising fracture healing.",[93,94,95,96],"Ankle Fracture","Recovery","Physical Activity","Rehabilitation",[98,94,96,99,100,101],"Ankle Fractures","Braces","Physical activity","Randomized Controlled Trial","NOT_YET_RECRUITING","2026-04-07",{"date":105,"type":106},"2026-04-13","ACTUAL",{"date":108,"type":87},"2026-04-01",{"date":110,"type":87},"2029-09-30",{"name":5,"class":6},1]