[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"amputation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:amputation":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,66,0,25,[9,47,71,101,121,145,190,218,235,266,294,320,344,371,401,425,450,479,504,537,559,579,602,629,650],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100613328","gait-training-and-artificial-intelligence-100613328",false,"NCT07265154","Gait Training and Balance Using Artificial Intelligence","Gait Training and Balance in Above Knee Amputation Patients Using Artificial Intelligence","Inclusion Criteria:\n\n* All patients have above-knee amputations.\n* All patients have no other neurological diseases affecting gait.\n* All patients have no other neurological diseases affecting muscle balance.\n* All patients have no other complications affecting joint ROM.\n\nExclusion Criteria:\n\n* Patients have any complications affecting joint ROM.\n* Patients have any neurological condition affecting muscle balance.\n* Patients have any neurological condition affecting gait.","ALL","16 Years","50 Years",{"count":21,"type":22},40,"ESTIMATED","INTERVENTIONAL",[25],"NA","Effect of Using Artificial Intelligence on Gait Training and Balance in Above Knee Amputation Patients",[28,29],"Above Knee Amputation","Amputation",[29,28,31,32,33],"Artificial Intelligence","Gait training","Balance","RECRUITING","2026-08-15",{"date":37,"type":38},"2026-08-18","ACTUAL",{"date":40,"type":38},"2026-06-01",{"date":42,"type":22},"2026-09-30",{"name":44,"class":45},"South Valley University","OTHER",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":17,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":23,"phases":57,"briefSummary":58,"conditions":59,"keywords":61,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":46},"100305759","short-term-implanted-electrodes-following-regenerative-peripheral-nerve-surgery-for-improving-prosthetic-limb-control-signals-100305759","NCT03260400","Short-term Implanted Electrodes Following Regenerative Peripheral Nerve Surgery for Improving Prosthetic Limb Control Signals","Inclusion Criteria:\n\n* Participants must be 22 years of age or older.\n* Participants must have previously undergone an upper limb amputation proximal to the wrist or are scheduled to undergo an upper limb amputation proximal to the wrist.\n* For participants without existing RPNI grafts (at the time of enrollment), the residual limb must have sufficient soft tissue quality to support performance of the RPNI operative procedure. Participants sustaining severe crushing or avulsion injuries with substantial superficial and deep scarring may not be appropriate candidates for inclusion in the study.\n* Participants must be in good health and American Society of Anesthesiologists (ASA) Class I or II (low surgical risk).\n* Participants must have reliable transportation.\n* Participants must be able to attend at minimum 6 hours of experiments per month while electrodes remain implanted.\n* Participants must be at least 6 months post-amputation.\n* Participants who will receive an amputation at the same time as RPNI grafts and electrodes must be undergoing an elective amputation surgery where loss of useful function of the hand has occurred. They must be at least 6 months post-injury or failed limb salvage to participate.\n\nExclusion Criteria:\n\n* Participants may not be suffering from any severe pain syndrome including complex regional pain syndrome or severe phantom pain. All of these conditions would suggest pathological activity of the nerve and would exclude the participant from participation.\n* Participants must not be suffering from any untreated mental health disorders and if they have any DSM-5 diagnoses, they must receive approval to participate from their mental health professional.\n* Participants must not have any medical conditions that, in the opinion of the Principal Investigator, would place them at high risk for a surgical procedure including recent myocardial infarction, cerebrovascular accidents, deep venous thrombosis, pulmonary embolus, uncontrolled diabetes, or end stage renal disease.\n* Participants must not have used tobacco for at least one month prior to enrollment in the study.\n* Participants must agree to not use tobacco for the duration of the study.\n* Participants cannot have sustained bilateral upper extremity amputation.\n* Participants cannot be pregnant.\n* Participants must not have other indwelling electronic implants like pacemakers, implantable cardioverter defibrillators, implantable neurostimulators, body worn insulin pumps, or body worn patient monitoring devices.\n* Participants must not have severe peripheral vascular occlusive disease, venous hypertension of the extremity, or severe lymphedema of the extremity.\n* Participants must not have an autoimmune condition which is not well controlled by medication.\n* Participants will not be considered for enrollment in Primary Upper Limb Amputation with RPNI Grafts and Electrode Implantation if their amputation is a traumatic injury or cancer related","22 Years","75 Years",{"count":56,"type":22},10,[25],"The device, a bipolar percutaneous intramuscular electromyography electrode, is intended for use in upper-limb amputation patients who have received the regenerative peripheral nerve interface surgical procedure, in order to enable the use of advanced prosthetic arms and hands.",[60,29],"Amputation Neuroma",[62,63],"RPNI","Regenerative Peripheral Nerve Interface",{"date":37,"type":38},{"date":66,"type":38},"2017-12-11",{"date":68,"type":22},"2029-05-05",{"name":70,"class":45},"University of Michigan",{"id":72,"slug":73,"hasResults":12,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":12,"sex":17,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":23,"phases":81,"briefSummary":82,"conditions":83,"keywords":84,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":46},"100613399","influence-of-a-slope-adaptive-foot-on-participation-of-veterans-with-lower-limb-amputations-100613399","NCT07266077","Influence Of A Slope Adaptive Foot On Participation Of Veterans With Lower-Limb Amputations","Inclusion Criteria:\n\n* US military Veterans willing to travel to the Minneapolis VA Health Care System\n* Unilateral, below-knee amputation\n* Use of a definitive prosthesis for at least 12 months (limb volume has stabilized and has accommodated to prosthesis use post-amputation)\n* Medicare Functional Classification Level K3 ambulator (unlimited community ambulator)\n* Well-fitting and well-aligned prosthesis\n* Uses a prescribed energy storage and return foot (ESAR)\n* Blessed Orientation-Memory-Concentration (Short Blessed) test score between 0-6 (no cognitive impairment)\n* Access to computer, tablet, or smartphone and internet for video conferencing and REDCap data collection\n\nExclusion Criteria:\n\n* Residual-limb skin problems\n* Not a regular prosthesis user\n* Mass over 125 kg (275 lbs)\n* Residual limb too long to accommodate the study feet (104 mm of build height)\n* Has used a hydraulic foot previously as part of clinical care or a research study\n* Documented major neurocognitive disorder (i.e., dementia) with evidence of impact on activities of daily living and\u002For instrumental activities of daily living\n* Baseline PROMIS-APSRA or PROMIS-SSRA scores at the maximum levels (no room for improvement on primary outcomes)","18 Years","89 Years",{"count":80,"type":22},30,[25],"Veterans with below-knee amputations are limited by prosthetic feet that cannot adapt to sloped and uneven terrain. This limitation results in reduced mobility, reduced balance confidence, and a higher risk of falls among some individuals who use below-knee prostheses, which have been shown to negatively impact participation in daily and recreational activities. The investigative group has designed a novel Slope Adaptive Foot (SAF) that is mechanically passive, capable of slope adaption on every step of walking, and maintains high levels of energy storage and return. Pilot testing of the SAF with Veterans has generated excellent results to date, with comments suggesting potential improvements in participation. This study will evaluate the extent to which participation and fall-related health outcomes are influenced by using the SAF versus a typical hydraulic foot in a cross-over randomized controlled trial. Using mixed-methods, the investigators will also collect long-term data of Veterans using their preferred foot to inform the development of evidence-based education materials for use in clinical decision making.",[29],[85,29,86,87,88,89,90],"Artificial Limbs","Leg Prosthesis","Ankle","Community Participation","Social Participation","Falls","2026-07-28",{"date":93,"type":38},"2026-07-30",{"date":95,"type":38},"2026-07-01",{"date":97,"type":22},"2029-08-01",{"name":99,"class":100},"VA Office of Research and Development","FED",{"id":102,"slug":103,"hasResults":12,"nctId":104,"briefTitle":105,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":12,"sex":17,"minAge":77,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":109,"conditions":110,"keywords":4,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":46},"100575840","advancing-antimicrobial-photodynamic-therapy-to-prevent-infection-in-osseointegrated-prosthesis-patients-100575840","NCT06777511","Advancing Antimicrobial Photodynamic Therapy to Prevent Infection in Osseointegrated Prosthesis Patients","Inclusion Criteria:\n\n* All patients with osseointegrated prostheses 18 years of age or older\n\nExclusion Criteria:\n\n* Ongoing infection\n* Pregnant\n* Anticipated issues with compliance or follow-up",{"count":56,"type":22},"OBSERVATIONAL","This will be a prospective observational trial enrolling 20 patients with osseointegrated prostheses. Participants will be recruited from the orthopaedic outpatient clinic at Walter Reed National Military Medical Center in Bethesda, MD.\n\nAll eligible consenting patients will undergo daily stoma management per standard of care.\n\nPatients will integrate antimicrobial photodynamic therapy into their stoma management program. The first treatment will take place in the orthopaedic clinic. All others will take place at home. Topical 5-ALA will be applied to the metal at the penetration site. After 2 hours, the light delivery device will be utilized and light will be administered for 15 minutes.\n\nData collection: After obtaining informed consent, study personnel will record injury-specific variables, surgery-specific variables, other variables related to their hospital course, demographic variables as well as comorbidities on the study case report forms (CRFs). They will obtain this information directly from the participant, from the participant's medical record, and the participant's treating orthopaedic surgeon or other health care providers. Baseline data collection points include participant characteristics and amputation details such as age, sex, comorbidities, highest education level achieved, social support, initial reason for amputation, type of amputation and all surgical dates. Study participants will be followed at 1 and 2 weeks after initiation of PDT treatment. To ensure research participant safety, serious adverse events (SAEs) will be documented and promptly submitted to the local IRB as per the required reporting processes.\n\nFollow-up: Study participants will be followed at 1 week and 2 weeks.",[29,111],"Osseointegration","NOT_YET_RECRUITING",{"date":114,"type":38},"2026-07-29",{"date":116,"type":22},"2026-10",{"date":118,"type":22},"2028-10",{"name":120,"class":45},"Dartmouth-Hitchcock Medical Center",{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":125,"acronym":4,"eligibilityCriteria":126,"healthyVolunteers":12,"sex":17,"minAge":77,"maxAge":127,"enrollmentInfo":128,"targetDuration":4,"studyType":23,"phases":130,"briefSummary":131,"conditions":132,"keywords":133,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":46},"100622755","assessing-ambulatory-and-non-ambulatory-community-mobility-in-people-with-lower-limb-amputation-100622755","NCT07387744","Assessing Ambulatory and Non-ambulatory Community Mobility in People With Lower Limb Amputation","Inclusion Criteria:\n\n* Unilateral or bilateral major lower limb amputation (e.g., proximal to or through the ankle joint)\n* \\>6 months since LLA Fitted with a prosthetic limb\n* Fitted with a prosthetic limb\n* Use a wheelchair or scooter for mobility for part of a day at least once per week\n\nExclusion Criteria:\n\n* Unstable heart condition (including unstable angina, uncontrolled cardiac dysrhythmia, acute myocarditis, hypertension, and acute pericarditis)\n* Acute systemic infection Prisoner or institutionalized such that self-determined mobility is restricted\n* Prisoner or institutionalized such that self-determined mobility is restricted\n* Decisionally challenged individuals (Modified Telephone Interview for Cognitive Status score ≤24)\n* Undergoing active cancer treatment\n* Participating in prosthetic rehabilitation\n* Clinical discretion of the principal investigator to exclude patients who are determined to be unsafe and\u002For inappropriate to participate in the protocol\n* Inability to communicate verbally in English","85 Years",{"count":129,"type":22},50,[25],"Mobility is a fundamental aspect of daily life, enabling individuals to participate in social, occupational, and recreational activities. Community mobility, defined as movement in environments outside the home, is particularly important for quality-of-life. Following lower limb amputation (LLA), mobility limitations are common and persistent. With rehabilitation and prosthetic training, many regain the ability to ambulate but results vary as only 25 - 58% of patients regain ambulatory ability and less than half of those who become ambulatory achieve sufficient ability to walk in community settings. As a result, \\~40% of people with LLA are ambulatory but also use wheeled mobility (e.g., wheelchair, scooter) for some or all of their community mobility tasks. To date, the complementary role of wheeled and ambulatory mobility in maximizing community mobility has been overlooked, with clinical research overwhelmingly focused on assessing and improving ambulatory ability despite its impracticality for many community settings.",[29],[134,135],"Lower Limb Amputation (LLA)","Global Positioning System (GPS)","2026-07-23",{"date":138,"type":38},"2026-07-27",{"date":140,"type":38},"2026-04-21",{"date":142,"type":22},"2027-08",{"name":144,"class":45},"Virginia Commonwealth University",{"id":146,"slug":147,"hasResults":12,"nctId":148,"briefTitle":149,"officialTitle":149,"acronym":4,"eligibilityCriteria":150,"healthyVolunteers":12,"sex":151,"minAge":77,"maxAge":152,"enrollmentInfo":153,"targetDuration":4,"studyType":23,"phases":155,"briefSummary":158,"conditions":159,"keywords":168,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":46},"100239468","phase-2-human-penile-allotransplantation-100239468","NCT02395497","Human Penile Allotransplantation","Donor Inclusion Criteria:\n\n* Males aged 16 - 65 years.\n* Brain dead meeting the criteria for Determination of Death.\n* Family consent for penile graft donation.\n* Stable donor (i.e., does not require excessive vasopressors to maintain blood pressure).\n* Same blood type as recipient.\n* Negative lymphocytotoxic crossmatch.\n* Accurately matched for skin tone\n\nRecipient Inclusion Criteria:\n\n* Males of any race, color or ethnicity; aged 18-69 years.\n* Recent (≥6 months) or remote (i.e., several decades) penile injury resulting in the loss of ≥75% of the phallus.\n* Penectomy secondary to penile cancer\n* Penile Cancer Survivors \\> 5 years\n* Micropenis associated with congenital\u002Fbirth defect and severely ambiguous male genitalia\n* Must have completed a clinic appointment with one of the study surgeons to discuss all penile reconstructive options.\n* Completes the protocol informed consent form(s).\n* No co-existing medical condition which, in the opinion of the study team, could affect the immunomodulatory protocol, surgical procedure, or functional results (If the condition is amenable to treatment, the study team must agree that said condition should not significantly enhance the surgical risks of penile transplantation.).\n* No co-existing psycho-social problems (i.e., alcoholism, drug abuse).\n* Negative for malignancy for past 5 years.\n* Negative for HIV at transplant.\n* Negative crossmatch with donor.\n* Consents to sample (i.e., skin biopsy) collection and storage and bone marrow infusion as part of the treatment regimen.\n* USA citizen or equivalent.\n* Patient agrees to comply with the protocol and states a dedication to the immunomodulatory treatment regimen.\n\nRecipient and Donor Exclusion Criteria:\n\n* Untreated sepsis.\n* HIV (active or seropositive).\n* Active tuberculosis.\n* Active Hepatitis B infection.\n* Hepatitis C.\n* Viral encephalitis.\n* Toxoplasmosis.\n* Malignancy (within past 5 years).\n* Current\u002Frecent (within 3 months of donation\u002Fscreening consent) IV drug abuse.\n* Paralysis of ischemic or traumatic origin.\n* Inherited peripheral neuropathy.\n* Infectious, post infectious, or inflammatory (axonal or demyelinating) neuropathy.\n* Toxic neuropathy (i.e. heavy metal poisoning, drug toxicity, industrial agent exposure).\n* Mixed connective tissue disease.\n* Severe deforming rheumatoid or osteoarthritis in the limb.\n\nDonor Only Exclusion Criteria:\n\n* Evidence of active herpes simplex virus-2 (HSV-2) infection.\n* Tattoos: non-professional tattoo within the last 6 months, or personally identifiable tattoo (i.e., donor name) on potential transplant.\n\nRecipient Only Exclusion Criteria:\n\n* Conditions that, in the opinion of the study team, may impact the immunomodulatory protocol potentially exposing the recipient to an unacceptable risk under immunosuppressive treatment.\n* Sensitized recipients with high levels (50%) of panel-reactive human leukocyte antigen (HLA) antibodies.\n* Conditions that may impact the success of the surgical procedure or increase the risk of postoperative complications including inherited coagulopathies like Hemophilia, Von-Willebrand's disease, Protein C and S deficiency, Thrombocythemias, Thalassemias, Sickle Cell disease, etc.\n* Conditions that may impact functional outcomes including Lipopolysaccharidosis and amyloidosis (may impact nerve regeneration).\n* Patients considered psychologically\u002Fpsychiatrically unsuitable.","MALE","69 Years",{"count":154,"type":22},60,[156,157],"PHASE2","PHASE3","Injuries to the genitalia are of concern to the military with emphasis placed on the surgical reconstruction and psychological health of these Wounded Warriors. However, despite significant surgical advances in microvascular surgery and autologous free tissue transfer, conventional reconstructions cannot truly replace the complicated structures and functions of the penis including the urethra, erogenous sensation, and erectile corporal bodies. Conventional reconstruction poses several challenges: patients may not have sufficient donor tissue due to other injuries or previous surgery; multiple operations are often needed to restore the neophallus; the final reconstruction only approximates the penis' native form; recreating the urethra is challenging and the new urethra is prone to stricture and fistula formation; the erectile function necessary for sexual intercourse is often lacking; and insufficient protective sensation can lead to penile implant extrusion, infection, subsequent explantation or loss of the reconstruction.\n\nThe investigators propose this clinical trial to determine functional outcomes and quality of life for Wounded Warriors and civilians who choose to undergo penile allotransplantation. The investigators will combine extensive experience performing total penile reconstruction in a large population affected by congenital, traumatic, and therapeutically extirpated Genitourinary deformities and expertise in reconstructive transplantation using an immunomodulatory protocol to for this study. The investigators anticipate penile transplantation can potentially replace \"like with like,\" restoring the appearance, anatomy, and function of the recipient in a manner far superior to autologous reconstruction. This project will establish the ability to perform penile allotransplantation using an immunomodulatory protocol and will compare outcomes with conventional phalloplasty patient results.\n\nStudy Design: This is a non-randomized subject self-controlled clinical trial to implement a cell-based immunomodulatory protocol for penile allotransplantation. An intermediate deliverable is achieving allograft survival and functional return with reduced dosing\u002Ffrequency of maintenance immunosuppression on steroid-free monotherapy (tacrolimus) immunosuppression. The long-term deliverable and goal is to demonstrate superior outcomes when compared to satisfaction and QOL in conventional phalloplasty patients 12-60 months post-transplant.",[29,160,161,162,163,164,165,166,167],"Wounds and Injuries","Amputation, Traumatic","Urologic Surgical Procedures, Male","Amputation, Traumatic\u002FSurgery","Penis\u002FTransplantation","Penis\u002FSurgery","Penis\u002FInjuries","Congenital Anomaly, Male Genitalia",[169,170,171,172,29,173,174,175,176,177,178,179,180],"Penile Transplant","Vascularized Composite Allotransplantation (VCA)","Composite Tissue Allotransplantation (CTA)","Penis","Immunosuppression","Composite Tissue","Male","Humans","Allotransplantation","Micropenis","Severely Aambiguous Male Genitalia","congenital\u002Fbirth defect","2026-07-13",{"date":183,"type":38},"2026-07-14",{"date":185,"type":38},"2014-06",{"date":187,"type":22},"2039-06",{"name":189,"class":45},"Johns Hopkins University",{"id":191,"slug":192,"hasResults":12,"nctId":193,"briefTitle":194,"officialTitle":195,"acronym":4,"eligibilityCriteria":196,"healthyVolunteers":197,"sex":17,"minAge":77,"maxAge":198,"enrollmentInfo":199,"targetDuration":4,"studyType":23,"phases":201,"briefSummary":202,"conditions":203,"keywords":204,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":215,"locationsCount":217},"100367385","ami-construction-in-lower-extremity-residual-limbs-100367385","NCT04063592","AMI Construction in Lower Extremity Residual Limbs","A Novel Approach to Lower Extremity Residual Limb Revision to Augment Volitional Motor Control, Restore Proprioception and Reverse Limb Atrophy","Inclusion Criteria:\n\n* Between the ages of 18-65\n* Has already undergone a standard AKA or BKA procedure\n* Suffers from symptoms such as:\n\n  * Intractable pain\n  * Deterioration of skin on or around stump\n  * Suffering from other sources of discomfort arising from stump\n* Intact inherent wound healing\n* Adequate communication skills\n* High motivation\n\nExclusion Criteria:\n\n* Inadequate health to undergo operative procedure using standard anesthesia (i.e. cardiopulmonary)\n* Individuals with impaired wound healing\n* Individuals suffering from extensive peripheral neuropathies\n* Active smokers\n* Individuals with a history of poor compliance\n* Women who are pregnant or plan to become pregnant before surgical intervention",true,"65 Years",{"count":200,"type":22},26,[25],"This study will involve the development of a novel approach to lower extremity residual limb surgical revision that offers the promise of augmenting volitional motor control, restore proprioception and reverse atrophy",[29],[29,205,206,207,208],"Residual limb pain","Phantom pain","Residual limb atrophy","Prosthesis control","2026-07-07",{"date":211,"type":38},"2026-07-09",{"date":213,"type":38},"2020-02-24",{"date":42,"type":22},{"name":216,"class":45},"Brigham and Women's Hospital",3,{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":222,"acronym":4,"eligibilityCriteria":223,"healthyVolunteers":197,"sex":17,"minAge":77,"maxAge":198,"enrollmentInfo":224,"targetDuration":4,"studyType":23,"phases":226,"briefSummary":227,"conditions":228,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":233,"locationsCount":234},"100353452","a-novel-approach-to-upper-extremity-amputation-to-augment-volitional-control-and-restore-proprioception-100353452","NCT03882073","A Novel Approach to Upper Extremity Amputation to Augment Volitional Control and Restore Proprioception","Inclusion Criteria:\n\n* Males or females between the ages of 18 and 65\n* Candidates for elective unilateral or bilateral upper extremity amputation at either the above elbow or below elbow level due to traumatic injury, congenital limb deformities or progressive arthritis\n* Must demonstrate sufficiently sound health to undergo the operative procedure, including adequate cardiopulmonary stability to undergo general anesthesia (specifically, American Society of Anesthesiology Class I or II)\n* Must have intact inherent wound healing capacity\n* Must demonstrate adequate communication skills to convey the status of their sensorimotor recovery throughout the postoperative phase,\n* Must exhibit proper level of motivation to comply with postoperative follow up requirements\n* Must be willing to also consent to study activities taking place at Massachusetts Institute of Technology (approved under same IRB protocol via ceded IRB review) as some outcome measures will be assessed at that site\n\nExclusion Criteria:\n\n* Patients beyond the stated age restrictions\n* Those with severe illness rendering them unable to undergo the operative procedure safely (e.g., unresolved sepsis or cardiopulmonary instability manifest as documented coronary artery disease and\u002For chronic obstructive pulmonary disease)\n* Patients with active infections, particularly deep infections in the arm to be amputated\n* Patients who are taking immunosuppressive agents\n* Patients with impairment in inherent wound healing pathways, such as those with primary connective tissue disorders or those on chronic steroid therapy\n* Patients with extensive peripheral neuropathies (diabetic or otherwise) that would potentially inhibit appropriate reinnervation of the surgical constructs\n* Active smokers; those patients willing to undergo tobacco cessation will need to be completely abstinent from tobacco use for at least 6 weeks preoperatively\n* Patients who are unable to provide informed consent and those with a demonstrated history of poor compliance\n* Pregnant women will not be considered due to the potential risks of general anesthesia\n\nPatients will not be excluded from participation in the study on the grounds of minority status, religious status, race or gender. Non-English speaking patients will not be excluded from the study; interpreters will be made available to them for translation of both verbal interactions and written documents.",{"count":225,"type":22},20,[25],"The hypothesis of this research protocol is that the investigators will be able to redesign the manner in which upper limb amputations are performed so as to enable volitional control of next generation prosthetic devices and restore sensation and proprioception to the amputated limb. The investigators will test this hypothesis by performing modified above elbow or below elbow amputations in ten intervention patients, and compare their outcomes to ten control patients who have undergone tradition amputations at similar levels. The specific aims of the project are:\n\n1. To define a standardized approach to the performance of a novel operative procedure for both below elbow (BEA) and above elbow amputations (AEA)\n2. To measure the degree of volitional motor activation and excursion achievable in the residual limb constructs, and to determine the optimal configuration and design of such constructs\n3. To describe the extent of proprioceptive feedback achievable through the employment of these modified surgical techniques\n4. To validate the functional and somatosensory superiority of the proposed amputation technique over standard approaches to BEA and AEA\n5. To develop a modified acute postoperative rehabilitation strategy suited to this new surgical approach\n\nThis will be a phase I\u002Fpilot clinical trial to be performed over a three-year period as a collaborative initiative involving Brigham \\& Women's Hospital\u002FBrigham \\& Women's Faulkner Hospital (BWH\u002FBWFH), Walter Reed National Military Medical Center (WRNMMC), and the Massachusetts Institute of Technology (MIT). The investigators will plan to perform 6 of the 10 amputations at BWH\u002FBWFH, and 4 of the amputations at WRNMMC.",[29],{"date":211,"type":38},{"date":231,"type":38},"2019-05-01",{"date":42,"type":22},{"name":216,"class":45},4,{"id":236,"slug":237,"hasResults":12,"nctId":238,"briefTitle":239,"officialTitle":240,"acronym":241,"eligibilityCriteria":242,"healthyVolunteers":12,"sex":17,"minAge":243,"maxAge":244,"enrollmentInfo":245,"targetDuration":4,"studyType":23,"phases":247,"briefSummary":248,"conditions":249,"keywords":252,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":258,"lastUpdatePostDateStruct":259,"startDateStruct":261,"completionDateStruct":262,"leadSponsor":264,"locationsCount":46},"100637147","bio-leg-advancing-mobility-bam-100637147","NCT07613502","Bio Leg: Advancing Mobility (BAM)","Adaptive Mobility Technology: A Comparative Study of C-Leg and Bio Leg","BAM","Inclusion Criteria:\n\n* Adults 40 to 70 years of age\n* Unilateral transfemoral amputation \\> 1 year\n* K3 or K4 ambulator (based on the K classification system) and able to walk with no greater assistances than a single point cane\n* Current microprocessor-controlled prosthesis (C-leg) user with \\> 6 months experience and able to walk without a device of using a single point cane\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Severe cardiovascular condition or other disease limiting study participation\n* Skin lesions or wounds, acute or unstable fracture, diagnosis of osteoarthritis or bone impairments affecting safe participation in walking activities\n* Residual limb dysfunction (i.e. joint contracture) limiting mobility or study participation\n* Pain that limits walking of participation in walking activities\n* Current participation in rehabilitation to address walking function","40 Years","70 Years",{"count":246,"type":22},12,[25],"Following transfemoral amputation, regaining functional mobility, particularly the ability to navigate curbs, ramps, long distances, and the ability to stand is challenging and often unattainable. Use of advanced prosthetic limb technology can dramatically influence mobility outcomes. The purpose of this study is to compare walking function in individuals with transfemoral amputations who are current users of the C-leg (micro-processor controlled prosthetic knee; current clinical standard) to function achieved when using the Bio Leg powered micro-processor prosthetic knee.",[250,251,29],"Amputation of Lower Limb Above Knee","Amputee",[29,28,253,254,255,256,257,251],"AKA","Prosthetic Use","Prostheses","C-leg","BioLeg","2026-07-02",{"date":260,"type":38},"2026-07-06",{"date":40,"type":38},{"date":263,"type":22},"2028-07",{"name":265,"class":45},"University of Florida",{"id":267,"slug":268,"hasResults":12,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":272,"eligibilityCriteria":273,"healthyVolunteers":12,"sex":17,"minAge":77,"maxAge":4,"enrollmentInfo":274,"targetDuration":276,"studyType":108,"phases":4,"briefSummary":277,"conditions":278,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":283,"lastUpdatePostDateStruct":284,"startDateStruct":286,"completionDateStruct":288,"leadSponsor":290,"locationsCount":293},"100585912","cryo-nerve-block-extremity-amputation-registry-for-post-operative-and-phantom-limb-pain-100585912","NCT06908538","Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain","Cryo NerVe Block Extremity AmputatioN RegIStry for Post Operative and pHantom Limb Pain (VANISH)","VANISH","Inclusion Criteria:\n\n* Patients who have or will have an amputation procedure;\n* Patients who are willing and capable of providing informed consent;\n* Patients whose age is 18 years or above, or of legal age to give informed consent specific to state and national law.\n\nExclusion Criteria:\n\n* Women of childbearing potential who are, or plan to become, pregnant during the time of the study;\n* Other medical, social, or psychological conditions that in the opinion of the Investigator precludes the subject from appropriate consent or adherence to the protocol.",{"count":275,"type":22},2000,"5 Years","The goal of this Registry is to see how the device is used when freezing nerves during an amputation procedure.",[29,279,280,281,163,282],"Amputation of Lower Limb","Amputation of Upper Limb","Amputation, Limb Loss","Cryo Analgesia","2026-06-25",{"date":285,"type":38},"2026-06-26",{"date":287,"type":38},"2025-04-01",{"date":289,"type":22},"2035-04",{"name":291,"class":292},"AtriCure, Inc.","INDUSTRY",5,{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":298,"acronym":299,"eligibilityCriteria":300,"healthyVolunteers":12,"sex":17,"minAge":77,"maxAge":4,"enrollmentInfo":301,"targetDuration":4,"studyType":23,"phases":303,"briefSummary":304,"conditions":305,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":311,"lastUpdatePostDateStruct":312,"startDateStruct":314,"completionDateStruct":316,"leadSponsor":318,"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":302,"type":22},35,[25],"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.",[29,306,307,308,309,310],"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)","2026-06-18",{"date":313,"type":38},"2026-06-23",{"date":315,"type":38},"2025-06-26",{"date":317,"type":22},"2027-07",{"name":319,"class":45},"University of Nevada, Las Vegas",{"id":321,"slug":322,"hasResults":12,"nctId":323,"briefTitle":324,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":197,"sex":17,"minAge":77,"maxAge":244,"enrollmentInfo":326,"targetDuration":4,"studyType":23,"phases":327,"briefSummary":328,"conditions":329,"keywords":330,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":336,"startDateStruct":338,"completionDateStruct":340,"leadSponsor":342,"locationsCount":46},"100643041","evaluation-of-a-powered-ankle-prosthesis-capable-of-bidirectional-control-via-neural-recording-and-cutaneous-stimulation-in-free-space-and-walking-tasks-100643041","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.).",{"count":56,"type":22},[25],"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.",[29],[331,332,333,334],"prosthesis","neuroprosthesis","osseointegration","amputation","2026-06-11",{"date":337,"type":38},"2026-06-12",{"date":339,"type":38},"2025-10-21",{"date":341,"type":22},"2031-09-30",{"name":343,"class":45},"Massachusetts Institute of Technology",{"id":345,"slug":346,"hasResults":12,"nctId":347,"briefTitle":348,"officialTitle":349,"acronym":350,"eligibilityCriteria":351,"healthyVolunteers":12,"sex":17,"minAge":77,"maxAge":4,"enrollmentInfo":352,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":354,"conditions":355,"keywords":357,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":335,"lastUpdatePostDateStruct":363,"startDateStruct":365,"completionDateStruct":367,"leadSponsor":369,"locationsCount":46},"100565659","usability-of-the-smart-hallway-system-in-clinical-setting-100565659","NCT06645054","Usability of the Smart Hallway System in Clinical Setting","Smart Hallway for Gait Assessment","SmartHallway","Inclusion Criteria:\n\n* ability to walk at least 10 metres without help of a person,\n* no severe cognitive problems (able to answer questionnaires),\n* native Slovenian speakers,\n* wiling to participate (signed informed consent)\n\nExclusion Criteria:\n\n* severe cognitive impairment,\n* not being able to walk with or without a prosthesis or orthosis.",{"count":353,"type":22},100,"The aim of the study is to examine suitability of data and processed reports acquired from the Smart Hallway system for clinical settings in terms of user acceptability and accuracy for use in clinical practice.",[29,356],"Gait Disorders, Neurologic",[358,359,360,361,362],"Gait analysis","Computerised assessment","Rehabilitation","Lower limb loss","Prosthetics and orthotics",{"date":364,"type":38},"2026-06-15",{"date":366,"type":38},"2024-03-24",{"date":368,"type":22},"2026-09",{"name":370,"class":45},"University Rehabilitation Institute, Republic of Slovenia",{"id":372,"slug":373,"hasResults":12,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":12,"sex":17,"minAge":77,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":23,"phases":381,"briefSummary":382,"conditions":383,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":400},"100492978","phase-3-po-vs-iv-antibiotics-for-the-treatment-of-infected-nonunion-of-fractures-after-fixation-100492978","NCT05699174","PO vs IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation","PO Versus IV Antibiotics for the Treatment of Infected Nonunion of Fractures After Fixation","POvIV2","Inclusion Criteria:\n\n1. 1\\. Bone fracture (proximal to and including the tarsal\u002Fmetatarsal joint (Lisfranc) or proximal to the carpal joints (includes distal radius fractures), excluding pelvis and spine) that has previously undergone fixation and has not healed and requires fixation to be retained or replaced at least until bone union. Fractures that have not healed and require revision fixation are also eligible.\n2. Infection as determined by either\n\n   1. FRI criteria\n   2. CDC criteria (without the timeframe) This includes the possibility of culture negative, but determined to be infection by treating surgeon\n3. Systemic antibiotic treatment regimen scheduled for at least 6 weeks\n\nExclusion Criteria:\n\n1. Patients with a high risk of amputation based on the initial managing physician\n2. Patients undergoing treatment of any other investigational therapy within the month preceding infection treatment or planned within the 12 months following infection treatment\n3. Incarcerated or institutionalized patients\n4. Patients who are unable to return for required follow-up visits and\u002For medical co-morbidities which preclude treatment with a general anesthetic\n5. Patients with a prior history of chronic infection at the index site before fracture fixation\n6. Patients with pathological fractures from a neoplastic process\n7. History of Paget's Disease\n8. The patient, or a designated proxy, unwilling to provide consent\n9. The patient must be available for follow-up for at least 12 months following infection treatment",{"count":380,"type":22},250,[157],"This is a Phase III clinical randomized control trial to investigate differences between patient with an infected nonunion treated by PO vs. IV antibiotics. The study population will be 250 patients, 18 years or older, being treated for infected nonunion after internal fixation of a fracture with a segmental defect less than one centimeter. Patients will be randomly assigned to either the treatment (group 1) PO antibiotics for 6 weeks or the control group (group 2) IV antibiotics for 6 weeks. The primary hypothesis is that the effectiveness of oral antibiotic therapy is equivalent to traditional intravenous antibiotic therapy for the treatment of infected nonunion after fracture internal fixation, when such therapy is combined with appropriate surgical management. Clinical effectiveness will be measured as the primary outcome as the number of secondary re-admissions related to injury and secondary outcomes of treatment failure (re-infection, nonunion, antibiotic complications) within the first one year of follow-up, as defined by specified criteria and determined by a blinded data assessment panel. In addition, treatment compliance, the cost of treatment, the number of surgeries required, the type and incidence of complications, and the duration of hospitalization will be measured.",[384,385,386,387,29,388,389,390,391],"Infections","Infected Wound","Nonunion of Fracture","Injury Leg","Internal Fixation; Complications, Infection or Inflammation","Fracture","Lower Extremity Fracture","Antibiotic Side Effect","2026-06-09",{"date":335,"type":38},{"date":395,"type":38},"2023-05-30",{"date":397,"type":22},"2028-09-29",{"name":399,"class":45},"Major Extremity Trauma Research Consortium",13,{"id":402,"slug":403,"hasResults":12,"nctId":404,"briefTitle":405,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":197,"sex":17,"minAge":77,"maxAge":198,"enrollmentInfo":407,"targetDuration":4,"studyType":23,"phases":408,"briefSummary":409,"conditions":410,"keywords":413,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":418,"lastUpdatePostDateStruct":419,"startDateStruct":420,"completionDateStruct":422,"leadSponsor":424,"locationsCount":46},"100358467","phase-2-autologous-volar-fibroblast-injection-into-the-stump-site-of-amputees-100358467","NCT03947450","Autologous Volar Fibroblast Injection Into the Stump Site of Amputees","Inclusion Criteria:\n\nPatients interested in study participation must meet all of the following inclusion criteria:\n\n* May be male or female\n* Must be between 18 years and 65 years of age\n* Must have a below the knee amputation.\n* Must be using a prosthetic for the vicinity of 3 months or have had osteo-integration of a prosthetic in place for 1 month.\n* In the opinion of the investigator, must be medically able to undergo the administration of study material determined by laboratory tests obtained within 7 days before baseline for which the investigator identified no clinically significant abnormality.\n* Be able to comprehend the informed consent document and provide consent for participation\n* Females of childbearing potential must:\n\n  * have a negative pregnancy test at screening\n  * agree to not become pregnant or breastfeed for the period of the study through 1 month after completion of the study\n  * be willing to use a reliable form of contraception during the study\n* Be willing and able to comply with the scheduled visits, biopsy\u002Finjection procedures, wound care instructions treatment plan, and other study procedures for the duration of the study.\n\nExclusion Criteria:\n\nPatients meeting any of the following criteria will be ineligible for study participation:\n\n* A skin erosion deeper than the skin dermis.\n* Having received any investigational drug within 30 days prior to study entry\n* An allergy history to any study materials including local anesthetic, dimethyl sulfoxide, human albumin, or bovine constituents, hetastarch, or EMLA (lidocaine 2.5% and prilocaine 2.5%).\n* Pregnant, lactating, or trying to become pregnant\n* A history of keloid formation\n* Having a significant medical history that the investigator feels is not safe for study participation (for example, some forms of autoimmune conditions, metastatic cancer, infectious diseases such as HIV, HTLV I\u002FII, Hepatitis B, Hepatitis C). Biopsies taken from individuals with infections that are not allowed to enter the cell therapy core will make it such that these individuals cannot participate.\n* Specifically we will exclude those with autoimmune diseases affecting the skin such as lupus.\n* Presence of necrotic ischemic tissue on any stump ulcers, and\u002For capillary refill on stump skin of greater than 3 seconds\n* Active infection of the residual limb.\n* Active smoker during the study\n* We will also exclude those who are on chronic immunosuppressive therapies such as oral steroids, but also those on chronic topical steroids in the area of investigation.\n* Recent amputee who has not yet been approved to use a prosthetic.\n* Use of a prosthetic for less than 3 months.\n* Amputees with neuromas of the terminal limb within the last 3 months.\n* Known bleeding disorder.\n* For those receiving Bellafill\u002Fcollagen skin test: history of serious allergy, such as anaphylaxis.\n* For whole stump injections: Have a history of congenital or idiopathic methemoglobinemia, glucose-6-phosphate deficiencies, or use of medications associated with drug-induced methemoglobinemia. (specifically: Sulfonamides, Acetaminophen, Acetanilid, Aniline dyes, Benzocaine, Chloroquine, Dapsone, Naphthalene, Nitrates and Nitrites, Nitrofurantoin, Nitroglycerin, Nitroprusside, Pamaquine, Para-aminosalicylic acid, Phenacetin, Phenobarbital, Phenytoin, Primaquine, or Quinine.)",{"count":129,"type":22},[156],"This study is a clinical trial testing the safety and efficacy of volar fibroblast (skin cells from the palm or sole) injections for thickening the epidermal (skin) layer at the stump site in people with below the knee amputations. The study will enroll adults seen at Johns Hopkins.",[29,411,412],"Skin Wound","Stem Cell",[334,414,415,416,417],"stem cells","autologous fibroblast","skin wound","skin breakdown","2026-06-08",{"date":392,"type":38},{"date":421,"type":38},"2019-09-05",{"date":423,"type":22},"2028-04-01",{"name":189,"class":45},{"id":426,"slug":427,"hasResults":12,"nctId":428,"briefTitle":429,"officialTitle":430,"acronym":4,"eligibilityCriteria":431,"healthyVolunteers":12,"sex":17,"minAge":77,"maxAge":4,"enrollmentInfo":432,"targetDuration":4,"studyType":23,"phases":434,"briefSummary":435,"conditions":436,"keywords":438,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":442,"lastUpdatePostDateStruct":443,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":449},"100598711","comparing-the-attentional-demands-and-functional-outcomes-in-people-with-transradial-amputation-100598711","NCT07075042","Comparing the Attentional Demands and Functional Outcomes in People With Transradial Amputation","Comparing the Attentional Demands and Functional Outcomes of Pattern Recognition and Direct Myoelectric Control in People With Transradial Amputation","Inclusion Criteria:\n\n* 18 years of age or older\n* Unilateral transradial limb loss\n* At least 6 months since loss\n* Previous or current use of a myoelectric device for 3 months or longer\n* Use of a prosthesis at least 4 days each week\n* Ability to read, write, and understand English\n* Willingness to use each control strategy as primary device for 3 months each (6 months commitment total)\n\nExclusion Criteria:\n\n* Any health condition that would prevent safely completing trial activities\n* Discontinued use of a myoelectric prosthesis due to non-financial reasons",{"count":433,"type":22},32,[25],"Different ways of controlling an upper-limb prosthesis can affect how easy it is to use and how helpful it is in everyday activities. One common method, called direct control, uses signals from two muscles and can make switching between movements difficult. Another clinically available option, called pattern recognition control, uses signals from several muscles to better understand the user's intended movement and may feel more natural to use. This study compares these two control methods to see how they affect function for adults with below-the-elbow limb loss.",[29,437],"Prosthesis Use",[439,440,441],"Transradial Amputation","Direct Myoelectric Control","Pattern Recognition Controller (PRC)","2026-06-05",{"date":418,"type":38},{"date":445,"type":22},"2026-07",{"date":447,"type":22},"2027-12",{"name":144,"class":45},2,{"id":451,"slug":452,"hasResults":12,"nctId":453,"briefTitle":454,"officialTitle":454,"acronym":455,"eligibilityCriteria":456,"healthyVolunteers":12,"sex":17,"minAge":77,"maxAge":19,"enrollmentInfo":457,"targetDuration":459,"studyType":108,"phases":4,"briefSummary":460,"conditions":461,"keywords":463,"overallStatus":112,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":477,"locationsCount":46},"100640874","the-association-between-amputation-level-and-chronic-low-back-pain-after-combat-related-amputation-100640874","NCT07626294","The Association Between Amputation Level and Chronic Low Back Pain After Combat-Related Amputation","LEVEL-BACK","Inclusion Criteria:\n\n* Age ≥18 years\n* Combat-related lower limb amputation\n* Transtibial, transfemoral, or bilateral lower limb amputation\n* Time since amputation ≥3 months\n* Current or planned prosthesis use\n* Ability to participate in rehabilitation assessment\n* Ability to report low back pain intensity\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Traumatic spinal injury related to the initial combat trauma\n* Previous spinal surgery before amputation\n* Known severe spinal deformity\n* Active spinal infection or malignancy\n* Severe neurological disorder affecting mobility\n* Non-combat-related amputation\n* Inability to complete follow-up assessments\n* Refusal or inability to provide informed consent",{"count":458,"type":22},300,"6 Months","Patients with combat-related lower limb amputations frequently experience chronic low back pain during long-term rehabilitation and prosthetic use. Altered biomechanics, asymmetric loading, gait disturbances, and changes in spinal alignment after limb loss may contribute to the development of persistent back pain. The severity and characteristics of low back pain may vary according to the level of amputation.\n\nThe LEVEL-BACK Study is a prospective observational study designed to evaluate the relationship between amputation level and chronic low back pain after combat-related amputation.\n\nParticipants with different levels of lower limb amputation will undergo clinical assessment of low back pain intensity, functional limitations, prosthesis use, and rehabilitation outcomes during follow-up.\n\nThe goal of the study is to improve understanding of how amputation level influences chronic low back pain after combat-related limb loss and to identify patients at increased risk for persistent spinal pain during rehabilitation.",[462,29],"Low Back Pain",[464,465,466,467,468,469,470,360],"Chronic low back pain","Combat-related amputation","Amputation level","Transtibial amputation","Transfemoral amputation","Bilateral amputation","Prosthesis use","2026-05-30",{"date":473,"type":38},"2026-06-04",{"date":475,"type":22},"2026-09-15",{"date":475,"type":22},{"name":478,"class":45},"Ukrainian Society of Regional Anesthesia and Pain Therapy",{"id":480,"slug":481,"hasResults":12,"nctId":482,"briefTitle":483,"officialTitle":483,"acronym":4,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":17,"minAge":77,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":23,"phases":487,"briefSummary":488,"conditions":489,"keywords":491,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":500,"leadSponsor":502,"locationsCount":46},"100557578","regulatory-clearance-of-the-glide-control-strategy-for-upper-limb-prostheses-100557578","NCT06539936","Regulatory Clearance of the Glide Control Strategy for Upper Limb Prostheses","Inclusion Criteria:\n\n* Trans-radial unilateral limb loss\n* Candidate for a multi-articulated myoelectric hand prosthesis as determined by the study prosthetist\n* Minimal residual limb length for myoelectric control as determined by the clinical team\n* Age of 18 years or greater\n\nExclusion Criteria:\n\n* Patients with a residual limb that is unhealed from the amputation surgery\n* Patients with easily damaged or sensitive skin who would not tolerate EMG electrodes\n* Unhealed wounds\n* Significant cognitive deficits as determined upon clinical evaluation\n* Significant neurological deficits as determined upon clinical evaluation\n* Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation\n* Uncontrolled pain or phantom pain impacting full participation in the study as determined upon clinical evaluation\n* Serious uncontrolled medical problems as judged by the project therapist",{"count":486,"type":22},7,[25],"The investigators will test the following hypothesis: Use of Glide results in improved functional performance, satisfaction, and usage metrics as compared to use of a standard Direct Control (DC) prosthesis.\n\nThis study will compare the use of Glide \\[Experimental\\] prosthesis with a DC \\[Standard\\] prosthesis in a clinical setting and in unsupervised daily activity. We will follow a multiple baseline design, specifically an AB design. Each of the subjects will use the Experimental and Standard systems over a total of 24-weeks. The A phase is the baseline phase where the DC prosthesis will be used, and the B phase will be the treatment phase where the Glide prosthesis will be used. Participants will undergo an A phase of either 10-weeks, 12-weeks, or 14-weeks duration, with the remaining 14-, 12-, or 10-weeks of the study being dedicated to the B phase.",[29,490],"Upper Limb",[334,492,493,331,494],"upper limb","myoelectric control","glide","2026-05-27",{"date":497,"type":38},"2026-05-29",{"date":499,"type":38},"2024-09-16",{"date":501,"type":22},"2027-03-31",{"name":503,"class":292},"Infinite Biomedical Technologies",{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":4,"eligibilityCriteria":510,"healthyVolunteers":12,"sex":17,"minAge":77,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":23,"phases":513,"briefSummary":514,"conditions":515,"keywords":522,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":529,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":449},"100638631","personalizing-thromboprophylaxis-for-patients-with-peripheral-artery-disease-100638631","NCT07613840","Personalizing Thromboprophylaxis for Patients With Peripheral Artery Disease","Personalizing Post Surgical Thromboprophylaxis for Patients With Peripheral Artery Disease","Inclusion Criteria:\n\n* Patients with a named arterial extremity injury or named vessel revascularization for atherosclerosis requiring open and\u002For closed revascularization.\n* Patients at the age of 18 or older\n\nExclusion Criteria:\n\n* Patients who are younger than 18 years old\n* Known pregnancy (females of childbearing potential will have a pregnancy test prior to surgery as per standard of care)\n* Prisoners, defined as those who have been directly admitted from a correctional facility.\n* No atherosclerosis\n* Subject has active stomach ulcers\n* Subject has severe hepatic impairment\n* Subject has a recent history of intracranial hemorrhage. If the patient has a history of cerebral hemorrhage with no new central nervous system disease of \\>1 year, the study team will consult with the",{"count":512,"type":22},484,[25],"The goal of this clinical trial is to determine whether a personalised blood clot prevention plan is more effective than standard treatment in adults with peripheral artery disease (PAD) who have undergone a procedure to restore blood flow to their legs.\n\nThe main questions it aims to answer are:\n\n* Does the personalized plan lower the rate of blood clots in the treated leg one year after the procedure?\n* Does the personalized plan lower rates of amputation, repeat procedures, bleeding, and death compared to standard treatment?\n\nResearchers will compare the personalized TARGET plan which uses a blood test to tailor each person's blood clot prevention medication to the standard treatment to see if the personalized approach works better.\n\nParticipants will:\n\n* Be randomly assigned to either the personalized TARGET plan or standard treatment after their procedure\n* Have blood tests at 1 week and at 1, 3, 6, 9, and 12 months after their procedure\n* Have medications adjusted based on blood test results if assigned to the TARGET group",[516,29,517,518,519,520,521],"Peripheral Arterial Disease (PAD)","Thrombosis","Thrombosis (Stent Thrombosis)","Platelet Aggregation Inhibitors","Thromboelastography (TEG)","PRU(Platelet Reactivity Unit)",[523,524,525,526,527,528],"Peripheral Artery Disease Thromboprophylaxis","Personalizing Blood Thinners","Clopidogrel Resistance","Thromboelastography with Platelet Mapping (TEG-PM)","Graft\u002F Stent Thrombosis","Platelet Inhibition","2026-05-21",{"date":497,"type":38},{"date":532,"type":38},"2025-04-29",{"date":534,"type":22},"2027-06-30",{"name":536,"class":45},"Massachusetts General Hospital",{"id":538,"slug":539,"hasResults":12,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":4,"eligibilityCriteria":543,"healthyVolunteers":12,"sex":17,"minAge":77,"maxAge":54,"enrollmentInfo":544,"targetDuration":4,"studyType":23,"phases":545,"briefSummary":546,"conditions":547,"keywords":549,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":551,"lastUpdatePostDateStruct":552,"startDateStruct":554,"completionDateStruct":556,"leadSponsor":558,"locationsCount":46},"100537242","regenerative-peripheral-nerve-interface-for-control-of-lower-limb-prostheses-100537242","NCT06275282","Regenerative Peripheral Nerve Interface for Control of Lower Limb Prostheses","Regenerative Peripheral Nerve Interfaces to Enhance Function and Sensation in People With Transfemoral Amputation","Inclusion Criteria:\n\n* Unilateral amputation of the leg proximal to the knee at least 6 months prior to enrollment.\n* Low surgical risk (American Society of Anesthesiologists Class I and II).\n* For participants without existing RPNI grafts (at the time of enrollment), the residual limb must have sufficient soft tissue quality to support performance of the RPNI operative procedures. Participants sustaining severe crushing or avulsion injuries with substantial superficial and deep scarring may not be appropriate candidates for inclusion in the study.\n* Amputee Mobility Predictor with prosthesis (AMPPRO) score of at least 37 (Gailey et al. 2002).\n* Sufficient clearance to a motorized prosthetic leg without the necessity for shoe lifts or extenders on the contralateral limb.\n\nExclusion Criteria:\n\n* Severe pain syndrome including complex regional pain syndrome or severe phantom pain. All of these conditions would suggest pathological activity of the nerve and would exclude the participant from participation.\n* Untreated mental health disorders and if they have any DSM-5 diagnoses, they must receive approval to participate from their mental health professional.\n* Any medical conditions that, in the opinion of the Principal Investigator, would place them at high risk for a surgical procedure including recent myocardial infarction, cerebrovascular accidents, deep venous thrombosis, pulmonary embolus, uncontrolled diabetes, or end stage renal disease.\n* Participants must not have used tobacco for at least one month prior to enrollment in the study.\n* Participants must agree to not use tobacco for the duration of the study.\n* Pregnancy.\n* No other indwelling electronic implants like pacemakers, implantable cardioverter defibrillators, implantable neurostimulators, body worn insulin pumps, or body worn patient monitoring devices.\n* Severe peripheral vascular occlusive disease, venous hypertension of the extremity, or severe lymphedema of the extremity.\n* An autoimmune condition which is not well controlled by medication.\n* A significant injury of the contralateral limb.\n* Significant, uncorrected vision problems.\n* Impaired mental capacity that negatively impacts verbal communication with the clinicians and research team or requires a Legally Authorized Representative to facilitate communication.",{"count":217,"type":22},[25],"Individuals with an above-knee lower limb amputation are known to walk more slowly, expend more energy, have a greater risk of falling, and have reduced quality of life compared to individuals without amputation and those with below knee amputation. One of the driving factors behind these deficits is the lack of active function provided by above-knee prostheses with prosthetic knees and ankles. While many prosthetic devices have been developed for functional restoration after major lower extremity amputation, there remains no stable interface to facilitate reliable, long-term volitional control of an advanced robotic limb capable moving multiple joints. Moreover, there is no existing interface that provides useful sensory feedback that in turn enhances the functional capabilities of the prosthesis. To achieve both greater signal specificity and long-term signal stability, we have developed a biologic interface known as the Regenerative Peripheral Nerve Interface (RPNI). An RPNI consists of a peripheral nerve that is implanted into a free muscle graft that would otherwise go unused in the residual limb. As the nerve grows, it reinnervates the free muscle graft which undergoes a predictable sequence of revascularization and regeneration.\n\nThe main questions it aims to answer are:\n\n1. Can the amplitude, movement specificity and stability of sciatic nerve RPNI electromyography (EMG) signals be detected up to one year post RPNI surgery?\n2. Do RPNIs contain information to enable control of a physical motorized prosthetic leg with multiple degrees of freedom?\n3. Does stimulation of sciatic nerve RPNIs provides meaningful sensory feedback?\n\nConsenting participants with unilateral transfemoral amputation (TFA) will:\n\n1. Undergo RPNI surgery and electrode implantation in the residual limb.\n2. Attend regular follow-up visits following surgery to assess the health and signal strength of the RPNIs and their ability to use a prescribed prosthesis between 3- and 12-months following implantation.\n3. Undergo explantation of electrodes following the conclusion of data collection.",[29,548],"Prostheses and Implants",[62,63,550],"Implanted Electrodes","2026-05-18",{"date":553,"type":38},"2026-05-19",{"date":555,"type":38},"2025-02-13",{"date":557,"type":22},"2027-09-30",{"name":70,"class":45},{"id":560,"slug":561,"hasResults":12,"nctId":562,"briefTitle":563,"officialTitle":563,"acronym":564,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":17,"minAge":77,"maxAge":4,"enrollmentInfo":566,"targetDuration":4,"studyType":23,"phases":567,"briefSummary":568,"conditions":569,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":573,"completionDateStruct":575,"leadSponsor":577,"locationsCount":46},"100420141","early-evaluation-of-the-introduction-of-pre--and-post-operative-psychological-and-physiotherapeutic-follow-up-in-vascular-surgery-in-amputee-patients-100420141","NCT04750876","Early Evaluation of the Introduction of Pre- and Post-operative Psychological and Physiotherapeutic Follow-up in Vascular Surgery in Amputee Patients","EPKIVA","Inclusion Criteria:\n\n* Patient over the age of majority, no age limit\n* Amputation related to obliterative arteriopathy of the lower limbs\n* Trans-tibial or trans-femoral amputation\n* Patient with an indication of discharge to a rehabilitation and re-education service\n* Patient with the ability to understand the protocol\n* Patient who has agreed to participate in the study and has given express oral consent\n* Patient receiving social security cover or entitled to it\n\nExclusion Criteria:\n\n* Trauma related amputation\n* Amputation of upper limb, trans-metatarsal or one or more toes\n* Amputation of comfort in a palliative care setting\n* Patient leaving home after surgery\n* Patient undergoing psychological or psychiatric treatment\n* Pregnant or breastfeeding woman, or a woman who is able to procreate without effective contraception\n* Patient unable to follow the protocol as judged by the investigator\n* Patient participating in another interventional research protocol involving a drug or medical device\n* Patient under guardianship, curators or legal protection measure",{"count":21,"type":22},[25],"An amputation represents a real ordeal for the person who will have to overcome the loss of a limb and face long months of rehabilitation. It is most often carried out following arterial insufficiency.\n\nAs paramedical professionals, we see in our daily practice a physical and psychological suffering for amputee patients. In spite of our skills acquired through training and professional experience, we are unable to offer comprehensive care for these patients and therefore feel that we are offering incomplete care. A multidisciplinary care, including a medical and paramedical team, would seem to us to be more appropriate for patients with lower limb amputations.\n\nFollowing this observation, we would like to highlight the interest for the patient and the care team to include a psychologist and a physiotherapist in the care offer to evaluate the improvement of the physical and emotional state of the amputee patient.",[29],"2026-05-12",{"date":572,"type":38},"2026-05-15",{"date":574,"type":38},"2021-04-08",{"date":576,"type":22},"2027-10-18",{"name":578,"class":45},"Centre Hospitalier Departemental Vendee",{"id":580,"slug":581,"hasResults":12,"nctId":582,"briefTitle":583,"officialTitle":584,"acronym":4,"eligibilityCriteria":585,"healthyVolunteers":12,"sex":17,"minAge":77,"maxAge":198,"enrollmentInfo":586,"targetDuration":4,"studyType":23,"phases":587,"briefSummary":588,"conditions":589,"keywords":590,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":593,"lastUpdatePostDateStruct":594,"startDateStruct":596,"completionDateStruct":598,"leadSponsor":600,"locationsCount":46},"100478095","can-an-array-of-micro-electrodes-implanted-in-a-human-nerve-record-neural-signals-and-provide-feedback-100478095","NCT05505513","Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Feedback?","Can an Array of Micro-electrodes Implanted in a Human Nerve Record Neural Signals and Provide Sensory Feedback Useful for Controlling a Prosthetic Device?","Inclusion Criteria:\n\n* at least 18 years of age and less than 65 years of age\n* unilateral and bilateral traumatic or elective upper extremity amputations at the transradial level\n\nExclusion Criteria:\n\n* incarceration\n* pregnancy\n* inability to consent\n* psychiatric comorbidity\n* medical conditions that significantly increase the risk of adverse effects of general anesthesia",{"count":217,"type":22},[25],"The investigators will investigate the device feasibility of human peripheral nerves and muscles recording and stimulation using percutaneous Utah Slanted Electrode Arrays (pUSEAs) implanted into residual peripheral arm nerves and EMG electrodes implanted in the residual muscles of patients with limb amputations in order to determine the ability of the HAPTIX (Hand Proprioception and Touch Interfaces) System to control an upper-extremity prosthesis, and to provide a sense of cutaneous touch and muscle proprioceptive feedback to the amputee.",[29],[591,29,592],"Micro-Electrodes","Prosthetic Device","2026-05-08",{"date":595,"type":38},"2026-05-13",{"date":597,"type":38},"2020-12-21",{"date":599,"type":22},"2028-12",{"name":601,"class":45},"University of Utah",{"id":603,"slug":604,"hasResults":12,"nctId":605,"briefTitle":606,"officialTitle":606,"acronym":607,"eligibilityCriteria":608,"healthyVolunteers":12,"sex":17,"minAge":77,"maxAge":4,"enrollmentInfo":609,"targetDuration":4,"studyType":23,"phases":610,"briefSummary":612,"conditions":613,"keywords":616,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":621,"lastUpdatePostDateStruct":622,"startDateStruct":623,"completionDateStruct":625,"leadSponsor":627,"locationsCount":46},"100613235","phase-1-influence-of-prosthetic-foot-stiffness-on-transtibial-osseointegrated-bone-anchored-limb-outcomes-100613235","NCT07263945","Influence of Prosthetic Foot Stiffness on Transtibial Osseointegrated Bone-Anchored Limb Outcomes","TBAL","Inclusion Criteria:\n\n* Unilateral transtibial amputation due to traumatic, congenital, or cancer-related causes\n* \\> 12-months bone-anchored limb implantation surgery (Bone Anchored Limb group)\n* \\> 12-months limb amputation (Socket Control group)\n* Non-vascular amputation etiology\n* Low profile prosthetic foot (nominal)\n* Can walk unassisted for 5-minutes\n* \\> 18 years old\n\nExclusion Criteria:\n\n* Major amputation on contralateral limb\n* Vascular amputation etiology\n* Neurologic pathology that impairs coordination\u002Fbalance\n* Regular assistive device use required for community ambulation\n* Inflammatory diseases or diabetes\n* Pregnancy or breastfeeding",{"count":154,"type":22},[611],"PHASE1","A clinical trial utilizing cross-over study design in which individuals with transtibial amputation using either a bone-anchored limb or standard socket prosthesis will perform activities of daily living with varying prosthetic foot stiffness categories to complete the following 4 Specific Aims: 1) Determine the influence of prosthetic foot stiffness on dynamic bone-implant loading, 2) Determine how prosthetic foot stiffness influences function, pain, and multi-joint biomechanics outcomes, 3) Establish how prosthetic foot stiffness influences osseoperception and fall risk, and 4) Establish target ranges of optimal foot stiffness based on the sensitivity biomechanical outcomes to variability in foot stiffness.",[29,614,615,111],"Transtibial Amputation - Unilateral","Bone Anchored Devices",[334,617,333,618,619,620],"bone anchored limb","transtibial amputation","below knee amputation","prosthetics","2026-04-20",{"date":140,"type":38},{"date":624,"type":38},"2025-11-25",{"date":626,"type":22},"2030-05-31",{"name":628,"class":45},"University of Colorado, Denver",{"id":630,"slug":631,"hasResults":12,"nctId":632,"briefTitle":633,"officialTitle":633,"acronym":634,"eligibilityCriteria":635,"healthyVolunteers":197,"sex":17,"minAge":77,"maxAge":636,"enrollmentInfo":637,"targetDuration":4,"studyType":108,"phases":4,"briefSummary":639,"conditions":640,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":641,"lastUpdatePostDateStruct":642,"startDateStruct":644,"completionDateStruct":646,"leadSponsor":648,"locationsCount":46},"100576104","quantification-of-motor-compensation-following-biomechanical-proprioceptive-and-physiological-alterations-post-lower-limb-amputation-100576104","NCT06780943","Quantification of Motor Compensation Following Biomechanical, Proprioceptive and Physiological Alterations Post-lower Limb Amputation.","QAMPA","Inclusion Criteria:\n\n* The patient must have given their free and informed consent and signed the consent form\n* The patient must be a member or beneficiary of a health insurance plan\n* Persons with unilateral transtibial or transfemoral amputees followed in the MPR department at the Nîmes University Hospital, RRL department, Grau du Roi University Rehabilitation Hospital.\n* All etiologies: vascular, traumatic and septic.\n* Adapted equipment validated by the rehabilitation doctor.\n* Able to walk for 5 minutes on a treadmill without technical assistance\n\nInclusion criteria specific to healthy volunteers:\n\n* Adults (\\>18 years old) and under 40 years old\n* Able to walk for 5 minutes on a treadmill without technical assistance.\n* Body mass index between 18 and 25\n\nExclusion Criteria:\n\n* The patient is participating in an interventional or a drug\u002Fmedical device study, or is in a period of exclusion determined by a previous study\n* The patient unable to express consent\n* It is impossible to give the patient informed information\n* The patient is under safeguard of justice or state guardianship\n* Patient who has already been included in this study.\n* Pregnant, parturient or breastfeeding patient.\n* Appearance of a stump wound during the study requiring unloading.\n* Patient for whom the implementation of vibration stimulation is not possible\n\nExclusion criteria for amputee patients:\n\n* Patient suffering from uncorrected or untreated visual disorders.\n* Patient with major cognitive disorders (MoCA \\\u003C23).\n* Patient with vestibular disorders or uncontrolled epilepsy.\n* Patient with an unhealed amputation stump.\n* Patient with a weight \\> 135kg or \\\u003C 20kg\n* Patients with a FAC of 1 (i.e. patients who need firm and continuous assistance from a person to support their weight and maintain balance) or less.\n* Sensory impairment that makes it impossible to perceive stimulation\n* Significantly reduced bone density\n* Patient in whom it is impossible to correctly adjust the GRAIL System harness to the corresponding body part due to:\n\n  * Body shape\n  * Colostomy bags\n  * Skin lesions that cannot be adequately protected.\n  * Any other reason that prevents a good, painless adjustment of the harness.\n* Patient in whom it is impossible to correctly adjust the CON-TREX System:\n\n  * Body shape\n  * Colostomy bags\n  * Skin lesions that cannot be adequately protected.\n  * Any other reason that prevents a good, painless adjustment of the support systems.\n\nExclusion criteria for healthy volunteers:\n\n* History of significant injury or surgery affecting the lower limbs (such as hip or knee replacement or knee\u002Fankle ligament reconstruction) that could impact walking\n* History of neurological or psychiatric disorders that could affect locomotion or the processing of sensorimotor information.\n* Drug treatments affecting locomotion: drugs likely to alter walking or balance, such as sedatives, muscle relaxants or neuroleptics.","80 Years",{"count":638,"type":22},75,"Lower limb amputation causes segmental loss that alters locomotor organization. The human body, designed to function in a multisegmental manner, must adapt to this new configuration where segments are missing, depending on the level of amputation. These adaptations are directly linked to the biomechanical, physiological and proprioceptive alterations caused by the loss of the amputated segments. Without mechanoreceptive afferents essential for regulating locomotion, the sensory system uses alternative information to maintain efficient locomotor function. The prosthesis partially compensates, but remains limited on the biomechanical and proprioceptive levels. Current prosthetic technologies, inspired by biomimicry, aim to imitate evolutionary solutions to restore walking, although current algorithms do not allow real-time modulation. This research aims to characterize post-amputation locomotor adaptations through biomechanical, physiological and proprioceptive exploration to develop a \"locomotor characterization\" model.\n\nThe study authors hypothesize that the post-amputation alterations are exacerbated in contexts of continuous and discontinuous constraints (e.g., ascent\u002Fdescent and destabilization), and that the addition of a prosthesis, although inspired by biomimicry, only restores partial compensation of locomotor functions.",[29],"2026-04-10",{"date":643,"type":38},"2026-04-15",{"date":645,"type":38},"2025-05-06",{"date":647,"type":22},"2026-11",{"name":649,"class":45},"Centre Hospitalier Universitaire de Nīmes",{"id":651,"slug":652,"hasResults":12,"nctId":653,"briefTitle":654,"officialTitle":655,"acronym":4,"eligibilityCriteria":656,"healthyVolunteers":12,"sex":17,"minAge":77,"maxAge":78,"enrollmentInfo":657,"targetDuration":4,"studyType":23,"phases":659,"briefSummary":660,"conditions":661,"keywords":662,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":664,"lastUpdatePostDateStruct":665,"startDateStruct":667,"completionDateStruct":669,"leadSponsor":670,"locationsCount":46},"100485499","impact-of-improving-footwear-options-100485499","NCT05601869","Impact of Improving Footwear Options","Impact of Improving Footwear Options for Women Veterans With Amputations","Inclusion Criteria:\n\n* US military Veterans that identify as women\n* Transtibial (below-knee) amputation\n* Using a definitive prosthesis for at least 6 months (limb has accommodated to prosthesis use post-amputation)\n* Well fitting and well aligned prosthesis\n* Blessed Orientation-Memory-Concentration (Short Blessed) score between 0-6\n* Access to computer, tablet, or smart phone and internet for video conferencing and RedCap data collection\n\nExclusion Criteria:\n\n* Residual limb skin problems\n* Residual limb too long to accommodate the RECOVER prosthetic ankle-feet system\n* Unable or unwilling to travel to Minneapolis\n* Not a regular prosthesis user\n* Mass over 125 kg\n* Documented neurocognitive disorder (e.g., dementia) with evidence of impact on activities of daily living and\u002For instrumental activities of daily living\n* Baseline ABIS-R or PROMIS-APSRA scores at the maximum levels (no room for improvement on primary outcomes)",{"count":658,"type":22},18,[25],"Veterans with leg amputations have limited footwear options because their artificial feet do not change shapes for different shoes. Studies have shown that women with amputations receive more frequent prosthetics care than men, but are less satisfied with the fit, comfort, and appearance of their prostheses. The investigators' previous research indicates that women Veterans would like to be able to wear a broader variety of footwear, and those who perceive more footwear limitations tend to have poorer body image and community participation. A new prosthesis designed by the investigators' group allows Veterans with amputations to use their footwear of choice using 3D-printed artificial feet with a single ankle. The novel prosthesis will be tested in this project with women Veterans with amputations to determine the impact of improving footwear options on body image and community participation.",[29],[85,29,86,663,88,89],"Body Image","2026-04-01",{"date":666,"type":38},"2026-04-07",{"date":668,"type":38},"2023-09-01",{"date":501,"type":22},{"name":99,"class":100}]