[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100549410":3},{"organization":4,"armGroups":7,"interventions":26,"overallOfficials":32,"centralContacts":45,"locations":55,"responsibleParty":74,"collaborators":32,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":32,"eligibilityCriteria":82,"healthyVolunteers":79,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":32,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":32,"overallStatus":57,"whyStopped":32,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Shirley Ryan AbilityLab","OTHER",[8,15,22],{"label":9,"type":10,"description":11,"interventionNames":12},"Transfemoral Amputee participants: Ottobock Cleg4 + Ottobock foot; Hybrid Knee + Polycentric Ankle","ACTIVE_COMPARATOR","Participant is fit with the commercially available device (Ottobock Cleg 4\u002FOttobock foot), they will receive standard of care clinical training for 3-4 sessions over 4 weeks, plus 1 session for outcome assessments.\n\nParticipant is then fit with the SRALAB Hybrid knee and SRALAB Polycentric Ankle prosthesis, they again will receive clinical training for 3-4 sessions over 4 weeks, plus 1 session for outcome assessments.",[13,14],"Device: Ottobock CLeg4 + Ottobock foot","Device: SRALAB Hybrid Knee + Polycentric Ankle",{"label":16,"type":17,"description":18,"interventionNames":19},"Transfemoral Amputee participants: Ottobock CLeg4 + Polycentric Ankle, Hybrid Knee + Passive Ankle","EXPERIMENTAL","For this arm, transfemoral amputees will participate in an AB\u002FBA randomized crossover study.\n\nBefore each arm of the cross-over, baseline data will be taken with the Ottobock Cleg 4\u002FOttobock foot or their clinically prescribed microprocessor knee unit\u002Ffoot.\n\nCondition A is CLeg + Polycentric Ankle\n\nCondition B is SRALab Hybrid knee + Passive Ankle\n\nSubjects will participate in 2 sessions over 2 weeks, each lasting 2-3 hours to have the device tuned for the specific condition (A or B). On the third week, they will participate in 2 visits to complete functional outcome measures, biomechanical and metabolic assessments. They will then switch conditions, and repeat the protocol for the second condition.\n\nThere will not be a washout period between conditions, but subjects will complete outcome measures with the Ottobock Cleg 4\u002FOttobock foot or their clinically prescribed microprocessor knee unit\u002Ffoot prior to each arm of the crossover to obtain baseline data.",[20,21],"Device: SRALAB Hybrid Knee + Passive Ankle","Device: Ottobock CLeg 4 + Polycentric Ankle",{"label":23,"type":17,"description":24,"interventionNames":25},"Transfemoral Amputee participants: SRALAB Hybrid knee + Polycentric Ankle, Ottobock Cleg4 + OB foot","During this arm, participants will receive intensive clinical training with the SRALAB Hybrid knee + Polycentric Ankle twice per week over 8 weeks, lasting 2-3 hours. Training will include patient-driven therapy to achieve participants' individual therapy goals, functional mobility and community skills.\n\nAt the end of the 8-week training period, subjects will complete the same set of functional outcome measures, biomechanical and metabolic assessments in previous arms.\n\nTo complete this arm, participants will again complete training and outcome measures with the Ottobock Cleg4\u002FOttobock or their clinically prescribed microprocessor knee unit\u002Ffoot over 3 visits.",[13,14],[27,33,37,41],{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"DEVICE","Ottobock CLeg4 + Ottobock foot","Commercially available Ottobock CLeg 4 microprocessor knee unit and Ottobock foot.",[9,23],null,{"type":28,"name":34,"description":35,"armGroupLabels":36,"otherNames":32},"SRALAB Hybrid Knee + Polycentric Ankle","Experimental powered prosthesis: SRALAB Hybrid Knee and powered polycentric ankle.",[9,23],{"type":28,"name":38,"description":39,"armGroupLabels":40,"otherNames":32},"SRALAB Hybrid Knee + Passive Ankle","Experimental powered prosthesis: SRALAB Hybrid Knee and passive ankle.",[16],{"type":28,"name":42,"description":43,"armGroupLabels":44,"otherNames":32},"Ottobock CLeg 4 + Polycentric Ankle","Commercially available Ottobock CLeg 4 prosthetic knee and SRALAB powered polycentric ankle.",[16],[46,51],{"name":47,"role":48,"phone":49,"phoneExt":32,"email":50},"Suzanne Finucane, MS, PTA","CONTACT","312-238-0937","sfinucane@sralab.org",{"name":52,"role":48,"phone":53,"phoneExt":32,"email":54},"Levi Hargrove, PhD","312-238-2080","lhargrove@sralab.org",[56],{"facility":5,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"RECRUITING","Chicago","Illinois","60611","United States","US",{"type":64,"coordinates":65},"Point",[66,67],-87.65005,41.85003,{"lat":67,"lon":66},[70,71,72],{"name":47,"role":48,"phone":49,"phoneExt":32,"email":50},{"name":52,"role":48,"phone":53,"phoneExt":32,"email":54},{"name":52,"role":73,"phone":32,"phoneExt":32,"email":32},"PRINCIPAL_INVESTIGATOR",{"type":73,"investigatorFullName":75,"investigatorTitle":76,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Levi Hargrove","Scientific Chair, Center for Bionic Medicine","100549410","understanding-how-powered-componentry-impacts-k2-level-transfemoral-amputee-gait-100549410",false,"NCT06433648","Understanding How Powered Componentry Impacts K2-Level Transfemoral Amputee Gait","Inclusion Criteria:\n\n* Ages 18-95\n* A unilateral transfemoral amputation\n* At least 6 months since definitive prosthesis fitting\n* Able to walk 50 meters (55 yards) with a prosthesis without the assistance of another person.\n* Medically cleared by physician to participate in study\n* English speaking\n\nExclusion Criteria:\n\n* Weight greater than 250 pounds\n* Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions.\n* Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential in order for the study to generate useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study.\n* Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers.","ALL","18 Years","95 Years",{"count":87,"type":88},20,"ESTIMATED","INTERVENTIONAL",[91],"NA","The goal of this study is to understand how providing power at the knee or ankle individually, or providing power at both the knee and ankle, impacts ambulation for K2 level transfemoral amputees.\n\nAim 1: measure functional performance of K2 level ambulators when using a commercially available passive microprocessor knee prosthesis (Ottobock Cleg\u002FOttobock foot) or a powered knee and ankle prosthesis (SRALab Hybrid Knee and SRAlab Polycentric Powered Ankle.\n\nAim 2: Participants will be evaluated on the contribution of adding power at the knee only or the ankle only.\n\nAim 3: The investigators will evaluate the functional performance after intensive clinical gait training on the powered knee and ankle prosthesis (SRALab Hybrid Knee and SRALab Polycentric Powered Ankle).\n\nOur hypothesis is that providing powered componentry will improve function and that intensive training will magnify those improvements.",[94,95,96,97],"Amputation","Amputation, Traumatic","Amputation of Knee","Amputation; Traumatic, Limb","2024-05-28",{"date":100,"type":101},"2024-05-30","ACTUAL",{"date":103,"type":101},"2023-05-01",{"date":105,"type":88},"2029-06-30",{"name":5,"class":6},1]