[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100643041":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":25,"locations":29,"responsibleParty":50,"collaborators":25,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":25,"eligibilityCriteria":59,"healthyVolunteers":60,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":25,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":32,"whyStopped":25,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Massachusetts Institute of Technology","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Powered Prosthesis","EXPERIMENTAL","The subject will be provided with a powered ankle prosthesis to attach in place of their customary prosthesis. This powered prosthesis has the capability of providing active neural control of an ankle joint, and its control can be adjusted through a wireless link. The subject will be given as much time as necessary to practice using the prosthesis before the experiments begin.",[13],"Device: Powered Prosthesis",{"label":15,"type":16,"description":17,"interventionNames":18},"Prescribed Prosthesis","ACTIVE_COMPARATOR","The subject will be undergo the same experiments with their prescribed ankle prosthesis to act as a comparison to the standard of care.",[19],"Device: Prescribed Prosthesis",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","This powered prosthesis has the capability of providing active neural control of an ankle joint, and its control can be adjusted through a wireless link. It is motorized to provide positive power during walking.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"Subject's prescribed prosthesis",[15],[30],{"facility":31,"status":32,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"MIT Media Lab","RECRUITING","Cambridge","Massachusetts","02139","United States","US",{"type":39,"coordinates":40},"Point",[41,42],-71.10561,42.3751,{"lat":42,"lon":41},[45],{"name":46,"role":47,"phone":48,"phoneExt":25,"email":49},"Christopher Shallal, B.S.","CONTACT","704-904-6112","cshallal@mit.edu",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Christopher Shallal","Graduate Researcher","100643041","evaluation-of-a-powered-ankle-prosthesis-capable-of-bidirectional-control-via-neural-recording-and-cutaneous-stimulation-in-free-space-and-walking-tasks-100643041",false,"NCT07645729","Evaluation of a Powered Ankle Prosthesis Capable of Bidirectional Control Via Neural Recording and Cutaneous Stimulation in Free-Space and Walking Tasks","Inclusion Criteria:\n\n* Male or Female age 18-70. The patient must have a unilateral transtibial amputation . The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above).\n\nThe patient must have adequate socket to support the device.\n\nExclusion Criteria:\n\n* Women who are pregnant. Severe co morbidity, atypical skeletal anatomy, or poor general physical\u002Fmental health that, in the opinion of the Investigator, will not allow the subject to be a good study candidate (i.e. other disease processes, mental capacity, substance abuse, shortened life expectancy, vulnerable patient population, BMI \\>40, etc.).",true,"ALL","18 Years","70 Years",{"count":65,"type":66},10,"ESTIMATED","INTERVENTIONAL",[69],"NA","The purpose of this study is to evaluate the performance of a powered ankle prosthesis capable of bidirectional control via neural recording and cutaneous stimulation, during free-space and walking tasks. This research aims to assess the sense of embodiment with the device, gait symmetry, and stability of a person with lower-extremity amputation walking with a powered ankle and their prescribed prosthesis. Findings from this study will inform future developments in bionic ankle design with optimal integration with the human body, with the goal of improving prosthetic integration into daily life.",[72],"Amputation",[74,75,76,77],"prosthesis","neuroprosthesis","osseointegration","amputation","2026-06-11",{"date":80,"type":81},"2026-06-12","ACTUAL",{"date":83,"type":81},"2025-10-21",{"date":85,"type":66},"2031-09-30",{"name":5,"class":6},1]