[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lower-limb-amputation-below-knee-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lower-limb-amputation-below-knee-injury":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,47,73,99,121,145,167],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100550831","restoration-of-normative-postural-control-100550831",false,"NCT06452186","Restoration of Normative Postural Control","Toward Restoration of Normative Postural Control and Stability Using Neural Control of Powered Prosthetic Ankles","Inclusion Criteria:\n\n* 18 years or older;\n* unilateral bower limb amputee\n* K-level 2 or higher (who are frequent prosthesis users and may benefit from the proposed prosthesis training and use of dEMG controlled powered prosthesis)\n* Amputation occurred over 2 years ago\n* At least 1 year of experience using their prosthetic leg\n* Has used the current socket for at least 6 months without a significant skin issue or major modification\n* Are willing to come to NC State University's Centennial Campus to participate in research and be photographed while doing research activities\n\nExclusion Criteria:\n\n* Have a very short residual shank (the length of the residual limb is ≤15% of the length of intact limb)\n* Cannot perform functional ambulation in the community on a daily basis without assistive devices\n* Cognitive or visual impairment that affects the participant's ability to provide informed consent or to follow simple instructions during the experiments\n* Congenital amputees\n* Amputees who use powered prosthetic ankles\n* Weight more than 300lbs\n* Pregnant Person\n* Allergic to latex, which is often contained in medical tapes.","ALL","18 Years","99 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"NA","The objective of this proposal is to investigate the effects of training to use direct electromyographic (dEMG) control of a powered prosthetic ankle on transtibial amputees'.\n\nThe aimed questions to answer:\n\n1. whether dEMG control will improve balance and postural stability of amputees,\n2. whether dEMG control will lead to more natural neuromuscular control and coordination, 3) whether dEMG control will reduce cognitive processes.\n\nParticipants will go through PT guided training on using dEMG controlled prosthetic ankles and are evaluated for their capability on functional tasks.\n\nThe results will be compared with a comparison group, which goes through the same training but with their everyday passive prostheses on balance capability, neuromuscular coordination, and cognitive load during locomotion.",[27],"Lower Limb Amputation Below Knee (Injury)",[29,30,31,32,33],"powered ankle prosthesis","direct EMG control","balance","cognitive load","muscle synergy","RECRUITING","2026-06-30",{"date":37,"type":38},"2026-07-02","ACTUAL",{"date":40,"type":38},"2023-10-01",{"date":42,"type":21},"2028-06-30",{"name":44,"class":45},"North Carolina State University","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":46},"100548355","prosthetic-performance-enhancement-trial-100548355","NCT06419920","Prosthetic Performance Enhancement Trial","PROSPER","Inclusion Criteria:\n\n* lower limb amputation at ankle (Symes) level and above\n* age 18+ years\n* fitted with a walking prosthesis and use it regularly for home and\u002For community ambulation\n* good socket fit, assessed by a score of 8-10 on the socket fit comfort scale\n* able to walk for three minutes at a time with or without an assistive device\n\nExclusion Criteria:\n\n* leg\u002Ffoot ulcer or other conditions that cause pain during weight-bearing\n* poor skin integrity that could cause tissue breakdown by walking\n* cardiovascular, respiratory or other critical health conditions that preclude moderate physical activity\n* unilateral or bilateral upper limb absence or loss at the wrist and above that precludes use of handrails bilaterally, or would require asymmetrical adaptation to body posture for use.\n* pregnancy",{"count":55,"type":21},35,[24],"The purpose of this research is to determine the feasibility of an uneven terrain walking program for lower limb prosthesis users. The training is designed to induce step-to-step variability during walking within a safe environment, with the aim of improving walking skill and confidence.",[59,27,60,61,62,63],"Amputation","Lower Limb Amputation Above Knee (Injury)","Lower Limb Amputation at Ankle (Injury)","Lower Limb Amputation Knee","Lower Limb Amputation at Hip (Injury)","2026-06-18",{"date":66,"type":38},"2026-06-23",{"date":68,"type":38},"2025-06-26",{"date":70,"type":21},"2027-07",{"name":72,"class":45},"University of Nevada, Las Vegas",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":80,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":46},"100448837","an-automatically-adjusting-prosthetic-socket-for-people-with-transtibial-amputation-100448837","NCT05124652","An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation","An Automatically-adjusting Prosthetic Socket for People With Transtibial Amputation","* 18 years or older\n* Unilateral or bilateral trans-tibial amputation at least 12 months prior\n* Have a limb of length 9 cm or greater\n* Are capable of at least 5 minutes of continuous walking\n* Are capable of at least 1 hour of intermittent walking\n* Regularly use a definitive prosthesis with a pin-lock suspension system and no or few pads\n* Have adequate sensation to verbalize a socket that is too large or too small to be tolerated\n* Do not regularly use assistive devices (e.g., cane, walker) for ambulation\n* Do not have open wounds on their residual limb at the time of enrollment",true,{"count":82,"type":21},100,[24],"People with leg amputations often experience daily changes in the size (volume) of their residual limb. These daily changes can cause a prosthesis to fit poorly. They can also cause limb problems like pain or skin breakdown. Prosthetic socket systems that accommodate limb volume changes can help address these issues, but they require users to make adjustments throughout the day. The aim of this research is to create a system that will automatically adjust the fit of the socket and create a well-fitting prosthesis for people with leg amputations who experience volume fluctuations when using their prosthesis.",[27,86],"Diurnal Residual Limb Fluid Volume Fluctuation",[88,89],"amputee","prosthetic","2026-05-05",{"date":92,"type":38},"2026-05-07",{"date":94,"type":38},"2021-10-18",{"date":96,"type":21},"2027-06",{"name":98,"class":45},"University of Washington",{"id":100,"slug":101,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":105,"targetDuration":4,"studyType":22,"phases":107,"briefSummary":108,"conditions":109,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":46},"100598723","caesar-foot-take-home-validation-testing-100598723","NCT07075198","Caesar Foot Take-Home Validation Testing","Inclusion Criteria:\n\n* Have transtibial limb absence of one or both limbs\n* Express interest in running, but do not currently have a running blade (as determined by self-report)\n* Are at least 18 years of age\n* Are at least six months post amputation\n* Are classified as K3 or K4 ambulator status as determined by a certified prosthetist\n* Have an AMP score of at least 37\n* Are capable of running safely as determined by a certified prosthetist's clinical judgement\n* Have a well-fitting socket as determined by a certified prosthetist\n* Have adequate clearance between distal end of the residual limb and ground for the Caesar foot\n* Meets the foot size and weight class of one of the available Caesar prototypes\n\nExclusion Criteria:\n\n* Present or sustained injuries to residual limb or contralateral leg affecting functional ability\n* Non-English speaking participants will be excluded from this study due to limited access to interpreter services. These services would be needed for several visits, including training to learn how to use the device safely, along with requested verbal feedback from the participant to evaluate the design and usability of the system.\n* Using a prosthetic foot that an individual is unfamiliar with for higher activity tasks may increase the risk of falling. Therefore, pregnant women should not participate in the study and will be screened by self-disclosure.\n\nIndividuals can be excluded at the discretion of the investigator for other unforeseen disqualifying criteria (such as specific cognitive issues, etc.).",{"count":106,"type":21},18,[24],"The rationale for this study is to conduct a take-home clinical trial to evaluate the impact of the bimodal Caesar foot in a real-world environment. Participants will take the device home and use it throughout their daily life for two months. A one-month baseline period, using their usual foot, will be completed both before and after the two-month period with the Caesar foot condition. Self-report surveys and performance-based measures will be collected in the clinic at the end of each condition. The intent of this study is to determine the Caesar foot's feasibility in a real-world environment. Data will be collected to understand impact to the user's daily life and physical activity through outcomes and participant feedback. The feedback obtained during this study will be essential to informing the design intended for commercialization.",[110,27],"Prosthesis User","2025-10-09",{"date":113,"type":38},"2025-10-14",{"date":115,"type":21},"2025-10",{"date":117,"type":21},"2026-08",{"name":119,"class":120},"Liberating Technologies, Inc.","INDUSTRY",{"id":122,"slug":123,"hasResults":11,"nctId":124,"briefTitle":125,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":128,"targetDuration":4,"studyType":22,"phases":130,"briefSummary":131,"conditions":132,"keywords":133,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":46},"100471971","r21-an-easy-to-use-intelligent-affordable-liner-enable-system-for-socket-fit-assessment-100471971","NCT05425810","R21: An Easy-to-use, iNtelligent, Affordable LinEr (ENABLE) System for Socket Fit Assessment","ENABLE","Inclusion Criteria:\n\n* Unilateral transtibial amputees\n* At least 1 year of experience using his\u002Fher prosthetic leg\n* Has used the current socket for at least 6 months without a significant skin issue or major modification\n* Can comfortably walk 3 mins without pausing to rest\n* The fibula length on the residual limb must be greater than half of the length of the fibula on the unaffected side\n\nExclusion Criteria:\n\n* Cognitive or visual impairment that affects the participant's ability to provide informed consent or to follow simple instructions during the experiments\n* neuropathy observed on the residual limb\n* regnant female",{"count":129,"type":21},3,[24],"Lower limb amputees (LLA) rely on their prosthetic legs to remain active and lead an independent life. For most LLAs, a well-fitted prosthetic socket is the only option to interface with their prosthetic leg, however, it is a real challenge to make a prosthetic socket to interface with residual limbs accurately. One of the reasons is that there lack of accurate approaches to evaluate the pressure distribution on the residual limb accurately and effectively. To overcome this issue, the research team will develop an innovative sensing system, which permits the prosthetists to track the pressure distribution on the residual limb visually. The capability of the new sensing system will be demonstrated on lower limb amputees.",[27],[88,134,135,136],"prosthetic socket","residual skin","pressure ulcer","2025-05-19",{"date":139,"type":38},"2025-05-20",{"date":141,"type":38},"2021-04-20",{"date":143,"type":21},"2026-02-27",{"name":44,"class":45},{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":80,"sex":16,"minAge":17,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":22,"phases":155,"briefSummary":156,"conditions":157,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":46},"100502142","human-prosthetic-interaction-brain--technology-after-lower-limb-loss-100502142","NCT05818410","Human-Prosthetic Interaction: Brain & Technology After Lower-Limb Loss","HumanIT","Inclusion Criteria:\n\n* Unilateral transtibial (below knee) amputation\n* Healthy subject\n* Medicare Functional Classification Level: K3-4\n\nExclusion Criteria:\n\n* Any neurological disease\n* Upper limb or bilateral amputation\n* Osso-integration\n* Metal implants\n* Diabetes","65 Years",{"count":154,"type":21},60,[24],"This study evaluates brain neuroplasticity and functional performance in people with unilateral lower limb amputation.",[27],"2025-02-20",{"date":160,"type":38},"2025-02-24",{"date":162,"type":38},"2024-01-16",{"date":164,"type":21},"2028-12",{"name":166,"class":45},"Vrije Universiteit Brussel",{"id":168,"slug":169,"hasResults":11,"nctId":170,"briefTitle":171,"officialTitle":172,"acronym":173,"eligibilityCriteria":174,"healthyVolunteers":80,"sex":16,"minAge":175,"maxAge":4,"enrollmentInfo":176,"targetDuration":4,"studyType":22,"phases":178,"briefSummary":179,"conditions":180,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":182,"lastUpdatePostDateStruct":183,"startDateStruct":185,"completionDateStruct":187,"leadSponsor":189,"locationsCount":46},"100435679","self-management-for-amputee-rehabilitation-using-technology-100435679","NCT04953364","Self-Management for Amputee Rehabilitation Using Technology.","Self-management for Amputee Rehabilitation Using Technology (SMART) Program: a Peer Supported mHealth Approach for Rehabilitation After Lower Limb Amputation","SMART","Inclusion Criteria:\n\n* Has a unilateral LLA (transtibial or transfemoral) due to diabetes or vascular disease\n* Received initial casting of their prosthesis within the past 2 years\n* Be aged ≥ 50 years (85% of adults with LLA)\n* Self-identifies as being able to speak and read English.\n* Has access to computer or tablet and internet.\n* Individuals living in British Columbia or Ontario, Canada.\n\nExclusion Criteria:\n\n* Substantial health conditions (e.g., congestive heart failure, diagnosed dementia)\n* Those anticipating further surgery (e.g. LLA revision) as identified by our study sites' physiatrists\n* an inability to use a tablet (e.g. using hands for typing).","50 Years",{"count":177,"type":21},82,[24],"Lower Limb Amputations (LLAs) are a substantial burden on the Canadian health services with nearly 50,000 cases reported between 2006 and 2011. To address the challenging nature of a LLA (e.g., decreased mobility, pain, depression), patients need to go through extensive rehabilitation programs. Effective self-management programs can help those with LLA to monitor their own condition and improve their quality of life. However, a lack of self-management programs, a limited healthcare budget, and a decrease in quality of services (e.g. shorter lengths of stay for inpatients and rapid movement to outpatient services) pose further challenges for patients with LLA. Self-management programs can be provided to clients through online mobile technologies (e.g., tablet) and offer accessible, low-cost, and potentially augmentative rehabilitation after discharge, in both urban and rural areas. To address these needs, an online educational and training platform for individuals with LLA called, Self-Management for Amputee Rehabilitation using Technology (SMART) was designed and developed. SMART focuses on LLA education, prosthetic limb management, and weekly support of peers. It is monitored by a trainer through a website. SMART will be evaluated in men and women with LLA aged 50 years and over, admitted to prosthetic rehabilitation throughout BC and ON. SMART has the potential to influence a client's post-LLA needs with direct (e.g., individual's health) and indirect (e.g., healthcare utilization) benefits. The purpose of this randomized controlled trial is to evaluate the effect of SMART in community dwelling older adults with unilateral, above or below, knee amputation.",[181,59,60,27,62],"Behavior","2024-07-19",{"date":184,"type":38},"2024-07-23",{"date":186,"type":38},"2022-10-14",{"date":188,"type":21},"2026-02-01",{"name":190,"class":45},"University of British Columbia"]