[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100633069":3},{"organization":4,"armGroups":7,"interventions":16,"overallOfficials":31,"centralContacts":36,"locations":46,"responsibleParty":63,"collaborators":65,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":22,"enrollmentInfo":79,"targetDuration":22,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":99,"whyStopped":22,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Norwegian University of Science and Technology","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Single Cohort: Three Suspension Systems","EXPERIMENTAL","Participants with unilateral transtibial amputation will attend one study visit at the research site. During this visit, they will complete three movement tasks-treadmill walking, overground turning, and isometric leg rotation-while using three different prosthetic suspension systems in a partly randomized order (pin lock, passive vacuum, and active vacuum). Each of the three movement tasks will be performed with each of the three suspension systems. Biomechanical, performance, and patient-reported outcomes will be recorded for each suspension condition.",[13,14,15],"Device: Pin-Lock Suspension System","Device: Passive Vacuum Suspension System","Device: Active Vacuum Suspension System",[17,23,27],{"type":18,"name":19,"description":20,"armGroupLabels":21,"otherNames":22},"DEVICE","Pin-Lock Suspension System","Participants perform all tasks using a pin-lock suspension system applied to their test socket.",[9],null,{"type":18,"name":24,"description":25,"armGroupLabels":26,"otherNames":22},"Passive Vacuum Suspension System","Participants perform all tasks using a passive vacuum suspension system applied to their test socket.",[9],{"type":18,"name":28,"description":29,"armGroupLabels":30,"otherNames":22},"Active Vacuum Suspension System","Participants perform all tasks using an active vacuum suspension system applied to their test socket.",[9],[32],{"name":33,"affiliation":34,"role":35},"Karin Roeleveld","National Taiwan Normal University","PRINCIPAL_INVESTIGATOR",[37,42],{"name":38,"role":39,"phone":40,"phoneExt":22,"email":41},"Karin Roeleveld, PhD","CONTACT","+47 48177279","karin.roeleveld@ntnu.no",{"name":43,"role":39,"phone":44,"phoneExt":22,"email":45},"Maria J Lequerica, MSc","+47 48684299","maria.j.lequerica@ntnu.no",[47],{"facility":48,"status":22,"city":49,"state":22,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"NTNU's Movement analysis laboratory at Helgasetr","Trondheim","7030","Norway","NO",{"type":54,"coordinates":55},"Point",[56,57],10.39506,63.43049,{"lat":57,"lon":56},[60,62],{"name":61,"role":39,"phone":44,"phoneExt":22,"email":45},"Maria J Lequerica, MSc - PhD candidate",{"name":38,"role":39,"phone":40,"phoneExt":22,"email":41},{"type":64,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[66],{"name":67,"class":68},"Trøndelag Ortopediske Verksted (English translation: Trøndelag Orthopedic Workshop)","UNKNOWN","100633069","socket-leg-interface-movements-in-transtibial-amputees-100633069",false,"NCT07521891","Socket-leg Interface Movements in Transtibial Amputees","Socket-leg Interface Movements as a Measure of Dynamic Prosthetic Fit for Transtibial Amputees: An Exploratory Study","SLMinTTA","Inclusion Criteria:\n\n* Age ≥16 years\n* Unilateral transtibial amputation\n* Activity level K2-K4\n* Actively using a prosthesis for ≥12 months\n* Ability to understand and communicate in Norwegian (oral and written)\n* Digital file of current socket model available (required for test socket fabrication)\n\nExclusion Criteria:\n\n* Use of a thigh corset attached to the prosthesis\n* Requirement of a walker for ambulation\n* Open wounds, skin ulcers, or blisters on the residual limb\n* No liner\n* Missing digital socket model file\n* Medical advice to avoid physical activity similar to study tasks\n* Other medical conditions that may worsen with activity and have not been cleared by a healthcare professional","ALL","16 Years",{"count":80,"type":81},20,"ESTIMATED","INTERVENTIONAL",[84],"NA","This exploratory interventional study investigates dynamic prosthetic fit in unilateral transtibial prosthesis users by objectively measuring socket-leg interface movements (SLMs) during functional activities. During one single study visit, participants complete standardized laboratory tasks using three different suspension systems (pin-lock, passive vacuum, and active vacuum) applied to a transparent replica of their current prosthetic socket. Motion capture, force measurements, and patient-reported outcomes are used to evaluate how suspension systems influence interface motion, rotation resistance, gait characteristics, and user comfort. The study aims to improve clinical understanding of prosthetic fit and support more informed prosthetic decision-making in routine care.",[87],"Transtibial Amputation - Unilateral",[89,90,91,92,93,94,95,96,97,98],"Transtibial amputation","Lower-limb prosthesis","Prosthetic socket fit","3D motion capture","Prosthesis comfort","Prosthetic rotation resistance","Pistoning","Prosthetic suspension systems","Prosthetic alignment","gait","NOT_YET_RECRUITING","2026-04-07",{"date":102,"type":103},"2026-04-13","ACTUAL",{"date":105,"type":81},"2026-04-20",{"date":107,"type":81},"2029-12-27",{"name":5,"class":6},1]