[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lower-limb-amputation-above-knee-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lower-limb-amputation-above-knee-injury":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,45,85,110,137],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100548355","prosthetic-performance-enhancement-trial-100548355",false,"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","ALL","18 Years",{"count":19,"type":20},35,"ESTIMATED","INTERVENTIONAL",[23],"NA","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.",[26,27,28,29,30,31],"Amputation","Lower Limb Amputation Below Knee (Injury)","Lower Limb Amputation Above Knee (Injury)","Lower Limb Amputation at Ankle (Injury)","Lower Limb Amputation Knee","Lower Limb Amputation at Hip (Injury)","RECRUITING","2026-06-18",{"date":35,"type":36},"2026-06-23","ACTUAL",{"date":38,"type":36},"2025-06-26",{"date":40,"type":20},"2027-07",{"name":42,"class":43},"University of Nevada, Las Vegas","OTHER",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":55,"conditions":56,"keywords":61,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":44},"100588119","effects-of-microprocessor-controlled-prosthetic-knees-on-fall-related-health-outcomes-in-limited-community-ambulators-100588119","NCT06937242","Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators","Fall-related Health Outcome in Lower Limb Prosthesis Users: A Pragmatic Clinical Trial to Assess Effectiveness of Microprocessor-controlled Prosthetic Knees","Inclusion Criteria:\n\n* Unilateral transfemoral or knee disarticulation limb loss.\n* 6 months or longer since time of limb loss.\n* Current user of a prosthesis with a non-microprocessor-controlled prosthetic knee.\n* Received a replacement prosthesis with a non-microprocessor knee in the past 4-24 months.\n* Clinician has deemed patient limited community ambulator (Medicare functional classification level K2).\n* In addition, Medicare functional classification level K2 as determined by at least one of the following criteria:\n\n  1. Houghton Score: 5-10\n  2. Prosthetic Limb Users Survey of Mobility (PLUS-M) T-Score: if amputation etiology is vascular disease\u002Fdiabetes \\\u003C49.45, otherwise, \\\u003C36.75.\n  3. Amputee Mobility Predictor (AMPPRO) score: 27-42 collected within the last 24 months\n* Ability to read, write, and understand English.\n\nExclusion Criteria:\n\n* Any health condition that would prevent safely completing trial activities.\n* Any individuals that weigh 275 lbs or more.\n* Any individuals who wear their prosthesis less than 3 days a week or less than a total of 24 hours a week\n* Individuals with a history of acute or chronic residual limb breakdown\n* Individuals with declining health status such that he\u002Fshe subsequently reports reduced activity over the past 6 months",{"count":53,"type":20},100,[23],"The goal of this study is to find out if using microprocessor-controlled prosthetic knees (MPKs), prosthetic knees with a built-in computer, improves health outcomes related to falls in adults who use above-knee prostheses. The main questions are:\n\n* Do individuals with MPKs have fewer fall-related health issues compared to those with non-microprocessor-controlled prosthetic knees (nMPKs)?\n* Do individuals with MPKs have increased mobility, faster walking speed, and improved quality of life compared to those with nMPKs?\n\nParticipants who have recently received an nMPK as part of their regular care can join the study. Those randomized to the control group will keep using their nMPK, while those randomized to the intervention group will receive a stance-and-swing MPK or a stance-only MPK.",[26,57,58,59,28,60],"Prosthesis User","Amputation; Traumatic, Leg: Thigh, Between Hip and Knee","Limb; Absence, Congenital, Lower","Lower Limb Amputation Above Knee",[62,63,64,65,66,67,68,69,70,71,72,73,74],"amputation","lower limb amputation","lower limb prosthesis user","mechanical knee","microprocessor knee","transfemoral amputation","knee disarticulation","prosthetic knee","falls","falling","amputee","transfemoral amputee","MPK","2026-02-03",{"date":77,"type":36},"2026-02-05",{"date":79,"type":36},"2025-07-11",{"date":81,"type":20},"2027-02",{"name":83,"class":84},"Hanger Institute for Clinical Research and Education, LLC","INDUSTRY",{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":95,"conditions":96,"keywords":98,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":44},"100531057","clinical-outcomes-with-non-powered-vs-powered-prosthetic-knees-by-k2-level-amputees-100531057","NCT06194838","Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees","Clinical Outcomes Associated With At Home Use of Non-Powered vs. Powered Prosthetic Knees by K2-level Individuals With Transfemoral Amputations","Inclusion Criteria:\n\n* Are at least 18 years old\n* Transfemoral prosthesis user (limb absence between the knee and hip)\n* Current user of a mechanical knee\n* Regularly wears prosthesis at least 5 days per week\n* Have adequate clearance between distal end and ground for necessary knee and foot components\n* Current Medicare Functional Classification Level (K-Level) of 2 as determined by the healthcare team\n* Socket-Comfort Score: 6 or above to ensure adequate socket fit\n* Six months or more experience on a prosthesis\n* Body weight between 50kg and 116kg (110lbs - 256lbs)\n* Height between 1.2m and 1.95m (47.2in and 76.8in)\n* Has a phone to answer periodic study calls\n\nExclusion Criteria:\n\n* Present injuries to residual limb or contralateral leg affecting functional ability\n* Contralateral amputation proximal to MTP (metatarsophalangeal) joint\n* Socket issues\u002Fchanges in the last 6 weeks\n* Users with bone-anchored implants\n* Health or medical condition, diagnosis, or other cause that would prevent participant from effectively following study protocol, performing required outcome measures, and\u002For completing the study\n\nSubjects can be excluded at the discretion of the investigator for other unforeseen disqualifying criteria (such as specific cognitive issues, etc.).\n\nIf subjects experience a health or medical condition that leaves them immobile for more than 2 weeks, they may be given the option to restart the study condition upon recovery, as long as eligibility criteria is still met, and comparable baseline functionality is demonstrated with outcomes measures.\n\nUsing a knee that the subject is unfamiliar with may increase the risk of falling. Therefore, pregnant women should not participate in the study and will be screened by self-disclosure.",{"count":93,"type":20},26,[23],"The goal of this proposed project is to gather community-based data from the K2-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., choosing the right device to maximize the benefit for each patient). The investigators intend to use this trial data along with a concurrent study being conducted within the K3-K4 level population to guide the implementation of effective prescriptions towards those that can benefit most from a given device and limit prescription to those who would not see benefit in order to ensure the most judicious use of Department of Defense (DoD) and Veteran's Affairs healthcare dollars. The findings will also be shared with the research community to help drive the design of future devices by identifying what features and functions are most beneficial to which patient populations when the devices are used outside of the laboratory. In summary, more community-based data on how powered prosthetic knees compare with the current standard in TFA populations is needed to allow for improved clinical decision making and clinical outcomes.",[26,97,59,57,28,58],"Amputation; Traumatic, Leg, Lower",[72,99,73,69,100,65,64],"lower limb amputee","power knee","2025-09-02",{"date":103,"type":36},"2025-09-03",{"date":105,"type":36},"2023-09-12",{"date":107,"type":20},"2026-08-31",{"name":109,"class":84},"Liberating Technologies, Inc.",{"id":111,"slug":112,"hasResults":11,"nctId":113,"briefTitle":114,"officialTitle":115,"acronym":116,"eligibilityCriteria":117,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":118,"enrollmentInfo":119,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":122,"conditions":123,"keywords":124,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":44},"100564936","assessment-of-the-prosthetic-system-impact-on-mental-workload-in-above-knee-lower-limb-amputees-100564936","NCT06635655","Assessment of the Prosthetic System Impact on Mental Workload in Above-knee Lower Limb Amputees.","Evaluation of Medical Benefit of a New Prosthetic Leg Designed to Decrease Mental Workload in People With Lower Limb Amputation","INCREMENT","Inclusion Criteria:\n\n* above-knee lower limb amputation\n* using an above-knee prosthesis with prosthetic knee and foot\n* eligible to use Synsys\n* able to design therapeutic objectives for the GAS\n* having a smartphone\n\nExclusion Criteria:\n\n* protected person\n* pregnant or breast-feeding lady\n* knee-to-ground height lower than 43cm\n* weighting more than 125kg\n* using their prosthesis for less than 2 weeks\n* not covered by health insurance\n* aged less than 18 or more than 84 years old\n* bilateral amputee or hip disarticulated","84 Years",{"count":120,"type":20},9,"OBSERVATIONAL","New generation of lower limb prosthesis provide improved functionalities. They are usually studied in the scope of biomechanics, sometimes PROMs like quality of life. Following users feedback, it is desirable to better understand why and how mental workload is impacted by new technologies or features. This clinical investigation will try to measure a difference between different prosthetic systems, in lab and in daily life.",[28],[125,126,127],"microprocessor controlled","lower limb prosthesis","mental workload","2025-07-08",{"date":130,"type":36},"2025-07-09",{"date":132,"type":36},"2025-02-21",{"date":134,"type":20},"2026-12-31",{"name":136,"class":84},"Proteor Group",{"id":138,"slug":139,"hasResults":11,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":145,"sex":16,"minAge":146,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":21,"phases":149,"briefSummary":150,"conditions":151,"keywords":4,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":44},"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).",true,"50 Years",{"count":148,"type":20},82,[23],"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.",[152,26,28,27,30],"Behavior","2024-07-19",{"date":155,"type":36},"2024-07-23",{"date":157,"type":36},"2022-10-14",{"date":159,"type":20},"2026-02-01",{"name":161,"class":43},"University of British Columbia"]