[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"lower-limb-amputation-below-knee\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:lower-limb-amputation-below-knee":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,50,80,108,136],{"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":28,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":5},"100638105","clinical-evaluation-of-the-access-socket-flexible-socket-for-transtibial-prosthesis-100638105",false,"NCT07592325","Clinical Evaluation of the Access Socket Flexible Socket for Transtibial Prosthesis","AS-TT","Inclusion Criteria:\n\n* Unilateral or bilateral transtibial amputation\n* Currently fitted with a definitive carbon rigid socket\n* Any residual-limb shape\n* Any etiology\n* Able to understand simple instructions, read, write, and provide informed consent - or able to be accompanied by a trusted person in case of inability to read\u002Fwrite autonomously\n* Provided free written informed consent\n* Aged 18 years or older\n* Affiliated to a social security system\n\nExclusion Criteria:\n\n* Use of hydroalcoholic solution (HAS) for socket donning\n* Currently fitted with a provisional socket\n* Neurological pathology limiting capacity to participate in activities\n* Orthopedic pathology limiting capacity to participate in activities\n* Pregnant or breastfeeding women\n* Minors\n* Persons not under legal protection or unable to express consent\n* Persons under guardianship or curatorship\n* Persons under judicial protection","ALL","18 Years",{"count":19,"type":20},25,"ESTIMATED","INTERVENTIONAL",[23],"NA","Transtibial amputation significantly impacts patient autonomy and quality of life, primarily due to the limitations of conventional rigid sockets, which restrict comfort and joint range of motion. The Access Socket (AS) is an innovative prosthetic socket combining a rigid carbon-fiber structure in key load-bearing areas with flexible urethane-resin (ProtheFLEX®) zones in regions typically rigid in conventional sockets. This hybrid design aims to improve comfort and pressure distribution while preserving the mechanical properties required for ambulation.\n\nThe AS has already demonstrated benefits in transfemoral amputees and is now reimbursed in France for that population. A preliminary uncontrolled study in 12 transtibial amputees suggested significant improvements in perceived function, comfort, satisfaction, and mobility.\n\nThis multicenter, randomized, open-label, two-arm crossover study aims to compare the (AS) with the standard rigid socket (RS) in 25 adults with transtibial amputation. Participants will wear each socket for approximately 4 weeks (after a 1-2 week adaptation period) in a randomized order. The primary outcome is the Patient Specific Functional Scale (PSFS). Secondary outcomes include comfort (SCS), satisfaction (OPUS), psychosocial adjustment (TAPES-R), mobility (PLUS-M), prosthesis utility (PEQ-U), and the proportion of patients electing to keep the AS at study completion.",[26,27],"Transtibial Amputation","Lower Limb Amputation Below Knee",[29,30,31,32,33,34,35,36,37],"Transtibial prosthesis","Prosthetic socket","Flexible socket","Access Socket","Comfort","Quality of life","Rehabilitation","cross over trial","Patient Specific Scale","RECRUITING","2026-05-13",{"date":41,"type":42},"2026-05-18","ACTUAL",{"date":44,"type":42},"2026-04-27",{"date":46,"type":20},"2027-10-30",{"name":48,"class":49},"Union de Gestion des Etablissements des Caisses d'Assurance Maladie - Nord Est","OTHER",{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":58,"enrollmentInfo":59,"targetDuration":4,"studyType":21,"phases":61,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":79},"100627416","tens-for-restoring-somatotopic-sensory-feedback-in-lower-limb-amputees-and-improving-phantom-limb-perception-100627416","NCT07448350","TENS for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception","Transcutaneous Electrical Nerve Stimulation for Restoring Somatotopic Sensory Feedback in Lower Limb Amputees and Improving Phantom Limb Perception","SENSE-P","Inclusion Criteria:\n\n* Age between 18 and 80 years;\n* unilateral TTA or TFA at least two months prior the study;\n* stable clinical conditions;\n* skin integrity;\n* absence of cognitive deficits;\n* able to walk using the prosthesis;\n* no previous experience with TENS.\n\nExclusion Criteria:\n\n* Bilateral amputation;\n* open wounds or sores on the residual limb;\n* cognitive deficits;\n* pregnancy;\n* presence of implanted medical device (e.g., cardiac defibrillators, pacemakers or infusion pumps);\n* refusal to sign the informed consent.","80 Years",{"count":60,"type":20},15,[23],"The aim of the study is to evaluate the changes induced by a course of Transcutaneous Electrical Nerve Stimulation (TENS) treatment on the perception of phantom limb pain.\n\nIn particular, we want to evaluate the changes induced by a course of TENS treatment on posture, balance, and gait.\n\nFor each patient, the study will consist of a total of 20 sessions (4 mapping sessions, 3 Stimulus Intensity Discrimination sessions, 10 rehabilitation treatments, and 3 evaluation sessions).\n\nOne session will be carried out each day. Each session will last 60 minutes, except for the evaluation sessions, which are expected to last approximately 90 minutes.\n\nFor the patient, the study ends with the last evaluation, voluntary withdrawal from the study, or the patient's death.",[64,27],"Lower Limb Amputation Above Knee",[66,67,68,69,70],"prosthetics","somatotopic sensations","Transcutaneous Electrical Nerve Stimulation","rehabilitation","sensory feedback restoration","2026-05-12",{"date":39,"type":42},{"date":74,"type":20},"2026-05-05",{"date":76,"type":20},"2027-12-31",{"name":78,"class":49},"Campus Bio-Medico University",1,{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":88,"enrollmentInfo":89,"targetDuration":4,"studyType":21,"phases":91,"briefSummary":92,"conditions":93,"keywords":94,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":79},"100570772","automatic-prosthetic-foot-stiffness-modulation-to-improve-balance-100570772","NCT06711588","Automatic Prosthetic Foot Stiffness Modulation to Improve Balance","Automatic Activity-Dependent and Phase-Varying Prosthetic Foot Stiffness Modulation to Improve Balance Control in Individuals With Lower-Limb Amputations","OSA","Inclusion Criteria:\n\n* Unilateral transtibial (below-knee) amputation\n* Been fit with a prosthesis and used it for at least 6 months\n* Wear the prosthesis for 4 or more hours on average per day\n* Be at least one-year post-amputation\n* Able to walk on a treadmill\n\nExclusion Criteria:\n\n* Presence of disorder, pain, or injury other than amputation that interferes with gait\n* Current skin irritation or injury on residual limb\n* Use of an assistive device for walking (cane, walker, etc.)","70 Years",{"count":90,"type":20},20,[23],"The goal of this clinical trial is to identify prosthesis stiffness that optimizes balance control in individuals with below knee amputations. The main question this clinical trial will answer is:\n\n• Is there an optimal stiffness that improves balance control for specific ambulatory activities and users? Participants will wear a novel prosthesis assembled with three prosthetic feet with a range of stiffness levels: each individual's clinically-prescribed foot stiffness and ± two stiffness categories. While wearing the study prostheses, participants will perform nine ambulatory activities of daily living (walking at different speeds, turning, ramp ascent\u002Fdescent, while carrying a load, and while walking on uneven terrain).",[27],[95,96,97,98,99],"lower limb prosthesis","transtibial amputation","below knee amputation","biomechanics","gait","2026-05-11",{"date":39,"type":42},{"date":103,"type":42},"2024-12-19",{"date":105,"type":20},"2026-08",{"name":107,"class":49},"Seattle Institute for Biomedical and Clinical Research",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":116,"briefSummary":117,"conditions":118,"keywords":121,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":79},"100617860","clinical-application-observation-on-the-evaluation-of-phantom-limb-pain-with-the-suralis-system-100617860","NCT07324109","Clinical Application Observation on the Evaluation of Phantom Limb Pain With the Suralis System","Clinical Application Observation: Evaluation of Phantom Limb Pain After 3 Weeks of Use of a Feedback System Using Vibration (Suralis, Manufacturer: Saphenus)","Inclusion Criteria:\n\n* Unilateral major lower-limb amputation (transtibial or transfemoral)\n* Presence of persistent phantom limb pain, defined as daily pain intensity ≥ 3\u002F10 on the Visual Analog Scale (VAS) during the baseline period\n* Regular daily use of a prosthetic limb (minimum 4 hours\u002Fday)\n* Adequate German language proficiency to understand and complete study questionnaires and follow study procedures\n* Ability to provide informed consent\n\nExclusion Criteria:\n\n* Unstable wound or skin condition at the residual limb\n* Inconsistent prosthetic use (less than daily or \\\u003C 4 hours\u002Fday)\n* Poorly fitting or non-functional prosthesis (as determined by study team)\n* Incapacity to provide informed consent (e.g., due to cognitive impairment or severe psychiatric illness)\n* Insufficient German language skills to comprehend study materials or complete assessments reliably",{"count":90,"type":20},[23],"This study tests whether a vibration-based feedback device (Suralis) can reduce phantom limb pain in people with lower-leg amputations over 3 weeks. Participants wear the device daily and report pain levels, walking ability, and quality of life - with no known risks, as it's a CE-certified medical device. If pain improves, the study team will help participants apply for insurance coverage to keep using the system long-term. The goal is to offer a simple, non-drug option that may help ease chronic pain and improve daily function for amputees. Participation is voluntary and can be stopped anytime without affecting medical care.",[119,64,27,120],"Phantom Limb Pain After Amputation","Lower Limb Amputation Knee",[122,123,124,125,126],"Phantom limb pain","Vibrotactile feedback","Lower limb amputation","Suralis system","Pain management","2025-12-23",{"date":129,"type":42},"2026-01-07",{"date":131,"type":42},"2025-04-01",{"date":133,"type":20},"2026-07-31",{"name":135,"class":49},"Median",{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":142,"eligibilityCriteria":143,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":144,"targetDuration":4,"studyType":21,"phases":146,"briefSummary":147,"conditions":148,"keywords":149,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":5},"100609431","study-on-a-prosthetic-foot-with-adjustable-heel-height-100609431","NCT07214493","Study on a Prosthetic Foot With Adjustable Heel Height","Impact of a Prosthetic Foot With Adjustable Heel Height on Physical Appearance and Participation: a Randomized Crossover Trial.","ADJUST","Inclusion Criteria :\n\n* Adult patient with a major lower limb amputation whose life project includes:\n* movement in buildings other than the home (ICF d4601),\n* movement outside the home and other buildings (ICF d4602),\n* and other specified activities related to movement in other various places (ICF d4608).\n* Patient who has been using an Enregy storage and Return (ESR) foot for at least 3 months\n* Patient who wishes to walk with shoes with different heel heights, and\u002For barefoot\n\nExclusion Criteria:\n\n* Patient with a high impact level (e.g.: sport)\n* Patient with hip disarticulation or equivalent\n* Patient with an unstabilised residual limb and\u002For an unsuitable socket\n* Patient who cannot be fitted with a Taleo Adjust foot due to the technical characteristics of the product (user weight greater than 115kg; required foot size \\\u003C22 or \\>28; mounting height less than 118 mm)\n* Patient whose usual foot has a heel height adjustment system\n* Patient unavailable for the duration of the study and\u002For unable to understand the instructions and\u002For answer questionnaires in French\n* Patient already participating in another study\n* Patient in an emergency situation or pregnant woman",{"count":145,"type":20},30,[23],"Most prosthetic feet have a fixed heel height, which requires users to always wear shoes with the same heel height. A fixed heel height is a significant constraint, whereas the ability to choose one's clothing freely is an important aspect of coping with a physical disability.\n\nThe Taleo Adjust is a prosthetic foot with a hydraulic ankle that allows the user to adjust the heel height from 0 to 7 cm, depending on the type of shoe worn.\n\nThis study aims to evaluate the impact of an adjustable-heel-height foot on physical appearance and participation.",[64,27],[124,150,151,152],"Prosthetic foot","Adjustable heel height","Hydraulic ankle","2025-11-20",{"date":155,"type":42},"2025-11-25",{"date":157,"type":42},"2025-10-08",{"date":159,"type":20},"2026-06-06",{"name":161,"class":162},"Otto Bock France SNC","INDUSTRY"]