[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07645729":3,"trial-entities:NCT07645729":83,"trial-summary:NCT07645729":87},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":24,"primary_purpose":25,"phases":26,"enrollment_info":28,"interventions":31,"primary_outcomes":41,"secondary_outcomes":49,"sex":50,"minimum_age":51,"maximum_age":52,"healthy_volunteers":53,"eligibility_criteria":54,"std_ages":60,"locations":63,"central_contacts":79,"overall_officials":80,"references":81,"see_also_links":82},"NCT07645729","2508001761","Evaluation of a Powered Ankle Prosthesis Capable of Bidirectional Control Via Neural Recording and Cutaneous Stimulation in Free-Space and Walking Tasks","RECRUITING","2031-09-30","2026-06","2026-06-12","2025-10-21","Massachusetts Institute of Technology","OTHER",false,"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.","In summary there will be 3 cohorts in this study, 1) a group of subjects that have an osseointegrated fixture with implanted electrodes, 2) a group that does not have implanted electrodes, and 3) non-amputee healthy control group to serve as a baseline comparison. In summary, the groups will be asked to wear a number of non-invasive sensors and the amputee groups will use a powered ankle prosthesis in place of their customary prosthesis. Data will be collected from various wearable sensors and other motion-capture devices as the subjects walk. At certain points during the study, the control settings of the powered prosthesis will be adjusted, either manually or automatically. Trials will also be conducted with the subjects prescribed prosthesis.",[18],"Amputation",[20,21,22,23],"prosthesis","neuroprosthesis","osseointegration","amputation","INTERVENTIONAL","DEVICE_FEASIBILITY",[27],"NA",{"count":29,"type":30},10,"ESTIMATED",[32,37],{"type":33,"name":34,"description":35,"armGroupLabels":36},"DEVICE","Powered 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. It is motorized to provide positive power during walking.",[34],{"type":33,"name":38,"description":39,"armGroupLabels":40},"Prescribed Prosthesis","Subject's prescribed prosthesis",[38],[42,46],{"measure":43,"description":44,"timeFrame":45},"Kinematic Measures of Lower-Limb Biomechanics","Quantitative analysis of lower-limb kinematics (joint angles in degrees) during level-ground walking, stair navigation, and other functional tasks.","Multiple sessions across 1-2 weeks",{"measure":47,"description":48,"timeFrame":45},"Kinetic Measures of Lower-Limb Biomechanics","Quantitative analysis of kinetic biomechanics including ground reaction and joint forces (Newtons) during level-ground walking, stair navigation, and other functional tasks.",[],"ALL","18 Years","70 Years",true,{"inclusion":55,"exclusion":57,"raw_text":59},[56],"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).",[58],"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.).","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.).",[61,62],"ADULT","OLDER_ADULT",[64],{"facility":65,"status":7,"city":66,"state":67,"zip":68,"country":69,"contacts":70,"geoPoint":76},"MIT Media Lab","Cambridge","Massachusetts","02139","United States",[71],{"name":72,"role":73,"phone":74,"email":75},"Christopher Shallal, B.S.","CONTACT","704-904-6112","cshallal@mit.edu",{"lat":77,"lon":78},42.3751,-71.10561,[],[],[],[],{"nct_id":4,"conditions":84,"biomarkers":86},[85],"Transtarsal amputation",[],{"nct_id":4,"found":14,"summary":88,"prompt_version":88},null]