[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prosthesis-user\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prosthesis-user":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,41,63,101,133,173,202,223,251,273,308],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100633129","clinical-performance-of-3d-printed-resin-and-zirconia-implant-restorations-100633129",false,"NCT07522671","Clinical Performance of 3D-Printed Resin and Zirconia Implant Restorations","Clinical Performance of 3D-Printed Resin Versus Milled Monolithic Zirconia in Implant-Supported Single Crowns and Short-Span Fixed Partial Dentures: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Participants must meet all of the following:\n* Age ≥18 years.\n* Have one or two osseointegrated dental implants requiring prosthetic restoration.\n* Demonstrate stable peri-implant tissues with no signs of inflammation or implant mobility.\n* Maintain good oral hygiene and controlled periodontal status.\n* Require either:\n* A single implant-supported crown, or\n* A short-span (maximum 3-unit) implant-supported fixed partial denture (FPD) supported by two implants in the mandibular anterior region.\n\nExclusion Criteria:\n\n* Participants are excluded if they have any of the following:\n* Severe parafunctional habits (e.g., bruxism).\n* Uncontrolled systemic diseases affecting bone metabolism or healing.\n* Peri-implantitis or compromised implant stability.\n* Requirement for cantilever prostheses or long-span restorations, or FPDs in areas other than the mandibular anterior region.","ALL","18 Years","60 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","This randomized controlled clinical trial evaluates the clinical performance of 3D-printed resin restorations compared with milled monolithic zirconia in implant-supported single crowns and short-span fixed partial dentures (FPDs). A total of patients requiring one or two implant-supported restorations in the mandibular anterior region were randomly allocated to receive either 3D-printed permanent resin restorations (CROWNTEC) or conventionally milled zirconia prostheses.\n\nAll restorations were fabricated using a standardized digital workflow and assessed over a 12-month follow-up period. The primary outcome was restoration survival rate, while secondary outcomes included technical complications, peri-implant biological parameters, marginal bone level changes, and patient-reported satisfaction.\n\nThis study aims to provide clinical evidence regarding the viability of 3D-printed definitive resin materials as an alternative to zirconia in implant prosthodontics.",[27],"Prosthesis User","RECRUITING","2026-04-08",{"date":31,"type":32},"2026-04-13","ACTUAL",{"date":34,"type":21},"2026-04-01",{"date":36,"type":21},"2028-11-01",{"name":38,"class":39},"Menoufia University","OTHER",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":22,"phases":51,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":40},"100543536","efficacy-of-early-multimodal-physiotherapy-in-patients-with-reverse-shoulder-prosthesis-100543536","NCT06357143","Efficacy of Early Multimodal Physiotherapy in Patients With Reverse Shoulder Prosthesis","Efficacy of Early Multimodal Physiotherapy in Patients With Reverse Shoulder Prosthesis: a Randomized Controlled Trial.","Inclusion Criteria:\n\n* Adults with a reverse shoulder prosthesis.\n* Age between 18 and 90 years.\n* Signed informed consent.\n\nExclusion Criteria:\n\n* Language or cultural barriers.\n* Other upper limb injury.\n* Treatment that affect physical activity capacity.","90 Years",{"count":50,"type":21},40,[24],"The present study try to evaluate the effectivenness of an early intervention program based on multimodal physiotherapy and focused on therapeutic exercise to improve the results of patients with a reverse shoulder phrostesis. This trial will be a randomized controlled trial with parallel groups, and outcomes variables will include psychometric properties through the use of specific questionnaries, and laboratory variables such as strength with a dynamometer, range of movement with a goniometer, muscle mass with an ultrasound, and kinematic parameters with inertial sensors. This study aims to develop an original intervention program in order to try to establish new protocols in the management of these patients.",[54,27],"Shoulder Fractures","2026-04-02",{"date":29,"type":32},{"date":58,"type":32},"2025-09-01",{"date":60,"type":21},"2027-12",{"name":62,"class":39},"University of Malaga",{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":70,"sex":16,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":76,"conditions":77,"keywords":82,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":100},"100481386","studies-into-touch-in-healthy-humans-to-provide-sensory-feedback-in-prostheses-100481386","NCT05548322","Studies Into Touch in Healthy Humans to Provide Sensory Feedback in Prostheses","TACTHUM","Inclusion Criteria:\n\n* Men and women aged between 20 and 70.\n* Be a member of a social security scheme, or a beneficiary of such a scheme\n* Be calm enough to sit still for four hours.\n* Specific for people participating in Arm 7 on amputees: People with an upper or lower limb amputation (unilateral) of more than 2 years.\n\nExclusion Criteria:\n\n* Have peripheral neuropathy (diabetes, Raynaud's disease) or chronic muscle and\u002For sensory pain.\n* Have a neurological or psychiatric history.\n* Be subject to epilepsy.\n* Be pregnant (declared) or breastfeeding, having given birth within the last year.\n* Be afraid of injections.\n* Being under dermatological treatment.\n* Have a pacemaker.\n* Not being able to understand the information leaflet and the consent form or sign it.\n* Be subject to a legal protection measure (declarative)\n* Be a protected adult (curatorship or guardianship)",true,"20 Years","70 Years",{"count":74,"type":21},210,[24],"Our sense of touch is essential to explore our environment and experience life and is based on signals from receptors in the body that are sensitive to different types of stimulation. The TACTHUM projects aims to investigate the fundamental firing of mechanoreceptors in the body to various external stimuli, with an end-aim to better understand the human somatosensory system and to apply this knowledge to provide comprehensive sensory feedback in prosthetics. We have a vast system of peripheral receptors in the skin and muscles that provide us with exquisitely detailed information about our everyday interactions. When there is injury to a body part, such as in amputation, there is a significant loss of somatosensory input. Prosthetic devices have greatly developmed in the past few years, especially with the introduction of useful sensory feedback. However, there is a lot to discover both about the workings of the somatosensory system and how to recreate this to give feedback in a prosthetic device.\n\nThe main objective of the TACTHUM project is to understand how to recover and apply useful somatosensory feedback in prostheses for amputees. There are a number of other sub-objectives, to:\n\n1. Determine how tactile mechanoreceptors encode the texture of natural surfaces during passive and active exploration.\n2. Investigate how our sense of touch varies with emotional state.\n3. Explore what happens to our sense of touch when we explore surfaces at different temperatures.\n4. Understand the origin of our perception of humidity.\n5. Investigate differences in the encoding of tactile information with age.\n6. Determine the perceptions generated by the stimulation of single tactile afferents.\n7. Study changes in spontaneous activity and responses to tactile stimulation on the residual limb of amputees.\n\nTo accomplish these objectives, we will primarily use the technique of microneurography, in vivo recordings from peripheral nerves, to gain direct information about the firing of peripheral neurons in humans. In conjunction with this, we will use a variety of mechanical and thermal stimuli to excite somatosensory fibers and register the activity of other physiological and perceptual measures. This will allow us to gain a fuller understanding of how the incoming somatosensory signals are interpreted and processed. Overall, we aim to explore how more naturalistic tactile interactions are encoded and how these can be translated to provide realistic prosthetic feedback.",[78,79,80,81,27],"Somatosensory Disorders","Amputation","Tactile Disorders","Aging",[83,84,85,86,87,88,89],"Touch","Temperature","Somarosensation","Prosthetics","Microneurography","Tactile","Mechanoreceptor","2026-03-03",{"date":92,"type":32},"2026-03-04",{"date":94,"type":32},"2024-04-15",{"date":96,"type":21},"2034-11-02",{"name":98,"class":99},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",2,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":109,"enrollmentInfo":110,"targetDuration":4,"studyType":22,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":124,"lastUpdatePostDateStruct":125,"startDateStruct":127,"completionDateStruct":129,"leadSponsor":131,"locationsCount":40},"100552343","clinical-and-psychological-adjustment-of-patients-with-lla-a-multidisciplinary-rehabilitative-intervention-project-100552343","NCT06471855","Clinical and Psychological Adjustment of Patients With LLA: a Multidisciplinary Rehabilitative Intervention Project","Clinical and Psychological Adjustment of Patients With Lower Limb Amputation: a Multidisciplinary Rehabilitative Intervention Project (AMP_ADinRehab Study)","AMPADinRehab","Inclusion Criteria:\n\n* Risk of amputation or Lower limb amputation or prothesis use for vascular disease and diabetes type 2\n\nExclusion Criteria:\n\n* more than 80 years older\n* severe clinical condition (ie, chronic heart failure \\[New York Heart Association Classification-IV - NYHA-IV\\], ischemic heart disease \\[Canadian Cardiovascular Society Classification-IV - CCS-IV\\], neoplastic disease, acute respiratory disease);\n* non-Italian education\n* severe visual-perceptive deficits\n* severe cognitive impairment (MMSE ≤ 26 Foderaro et al, 2022);\n* severe mental health condition or psychiatric disorder compromising participation in the study;\n* absence or withdrawal of the informed consent to participate.","80 Years",{"count":111,"type":21},70,[24],"Most of the limb amputation related to vascular disease is often secondary to a diagnosis of type 2 diabetes mellitus. The amputation involves significant motor, psychological, and social challenges for patients, with a major effect on their psycho-physical health. The psychological processes that characterize this clinical population are still poorly investigated. Adopting a biopsychosocial approach, the present randomized prospective quali-quantitative study protocol aims to evaluate the behavioural and psychological adaptation at various stages of the disease: risk of amputation, lower limb amputation, and prosthesis use. In the last phase, patients with prosthesis will receive traditional rehabilitation treatment and technology-based rehabilitation (experimental) or not (active comparator) with randomized controlled enrolment. The evaluation will be based on a semi-structured interview, specific to the disease stage and constructed using the Three Factor Model, and rating scales. Patient's medical history, functional status (ie, motor functionality, autonomy in BIM and FIM, risk of falls, subjective perceived pain), and psychological aspects (ie, emotional impact, HRQoL, anxiety and depression symptoms, personality traits, acceptance, adherence, body image, the experience of the prosthesis and technology-based rehabilitation, expectations for the future) will be investigated. The audio-recorded and transcribed interviews will be analyzed using the Interpretive Description approach.",[115,27],"Lower Limb Amputation",[117,118,119,120,121,122,123],"Amputee","Multidisciplinary rehabilitation","HRQoL","Psychological adaptation","Usability","HT\u002Frobotic rehabilitation","Psychoeducation","2026-02-20",{"date":126,"type":32},"2026-02-23",{"date":128,"type":32},"2023-06-01",{"date":130,"type":21},"2027-06",{"name":132,"class":39},"Istituti Clinici Scientifici Maugeri SpA",{"id":134,"slug":135,"hasResults":11,"nctId":136,"briefTitle":137,"officialTitle":138,"acronym":4,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":22,"phases":142,"briefSummary":143,"conditions":144,"keywords":149,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":40},"100588119","effects-of-microprocessor-controlled-prosthetic-knees-on-fall-related-health-outcomes-in-limited-community-ambulators-100588119","NCT06937242","Effects of Microprocessor-controlled Prosthetic Knees on Fall-related Health Outcomes in Limited Community Ambulators","Fall-related Health Outcome in Lower Limb Prosthesis Users: A Pragmatic Clinical Trial to Assess Effectiveness of Microprocessor-controlled Prosthetic Knees","Inclusion Criteria:\n\n* Unilateral transfemoral or knee disarticulation limb loss.\n* 6 months or longer since time of limb loss.\n* Current user of a prosthesis with a non-microprocessor-controlled prosthetic knee.\n* Received a replacement prosthesis with a non-microprocessor knee in the past 4-24 months.\n* Clinician has deemed patient limited community ambulator (Medicare functional classification level K2).\n* In addition, Medicare functional classification level K2 as determined by at least one of the following criteria:\n\n  1. Houghton Score: 5-10\n  2. Prosthetic Limb Users Survey of Mobility (PLUS-M) T-Score: if amputation etiology is vascular disease\u002Fdiabetes \\\u003C49.45, otherwise, \\\u003C36.75.\n  3. Amputee Mobility Predictor (AMPPRO) score: 27-42 collected within the last 24 months\n* Ability to read, write, and understand English.\n\nExclusion Criteria:\n\n* Any health condition that would prevent safely completing trial activities.\n* Any individuals that weigh 275 lbs or more.\n* Any individuals who wear their prosthesis less than 3 days a week or less than a total of 24 hours a week\n* Individuals with a history of acute or chronic residual limb breakdown\n* Individuals with declining health status such that he\u002Fshe subsequently reports reduced activity over the past 6 months",{"count":141,"type":21},100,[24],"The goal of this study is to find out if using microprocessor-controlled prosthetic knees (MPKs), prosthetic knees with a built-in computer, improves health outcomes related to falls in adults who use above-knee prostheses. The main questions are:\n\n* Do individuals with MPKs have fewer fall-related health issues compared to those with non-microprocessor-controlled prosthetic knees (nMPKs)?\n* Do individuals with MPKs have increased mobility, faster walking speed, and improved quality of life compared to those with nMPKs?\n\nParticipants who have recently received an nMPK as part of their regular care can join the study. Those randomized to the control group will keep using their nMPK, while those randomized to the intervention group will receive a stance-and-swing MPK or a stance-only MPK.",[79,27,145,146,147,148],"Amputation; Traumatic, Leg: Thigh, Between Hip and Knee","Limb; Absence, Congenital, Lower","Lower Limb Amputation Above Knee (Injury)","Lower Limb Amputation Above Knee",[150,151,152,153,154,155,156,157,158,159,160,161,162],"amputation","lower limb amputation","lower limb prosthesis user","mechanical knee","microprocessor knee","transfemoral amputation","knee disarticulation","prosthetic knee","falls","falling","amputee","transfemoral amputee","MPK","2026-02-03",{"date":165,"type":32},"2026-02-05",{"date":167,"type":32},"2025-07-11",{"date":169,"type":21},"2027-02",{"name":171,"class":172},"Hanger Institute for Clinical Research and Education, LLC","INDUSTRY",{"id":174,"slug":175,"hasResults":11,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":70,"sex":16,"minAge":17,"maxAge":180,"enrollmentInfo":181,"targetDuration":183,"studyType":184,"phases":4,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":193,"lastUpdatePostDateStruct":194,"startDateStruct":196,"completionDateStruct":198,"leadSponsor":200,"locationsCount":40},"100557689","effect-of-motor-imagery-ability-on-functionality-and-proprioception-in-amputees-using-myoelectric-prostheses-100557689","NCT06541379","Effect of Motor Imagery Ability on Functionality and Proprioception in Amputees Using Myoelectric Prostheses\"","Investigation of the Effect of Motor Imagery Ability on Upper Extremity Functionality and Proprioception in Transradial Amputees Using Myoelectric Prostheses","Inclusion Criteria:\n\nAmputee group inclusion criteria\n\n* Being an amputee using a unilateral transradial and myoelectric prosthesis\n* Having at least 6 months of prosthesis experience\n* Having a maximum score of 15 on the Beck Depression Inventory\n* Having a minimum score of 26 on the Standardized Mini Mental Test\n* Being willing to participate in the study\n\nControl Group inclusion criteria\n\n* Being between the ages of 18-65\n* Having a minimum score of 26 on the Standardized Mini Mental Test\n* Having signed the Informed Voluntary Consent Form\n* Having a maximum score of 15 on the Beck Depression Inventory\n* Being literate\n\nExclusion Criteria:\n\nAmputee group exclusion criteria\n\n* Having another physical problem other than amputation\n* Having a diagnosed cognitive disorder\n* Not being able to read or write\n\nExclusion criteria for the control group from the study\n\n* Having any neurological, orthopedic, psychological (such as schizophrenia, psychosis) and systemic problems\n* Having an unchangeable visual or auditory disability","65 Years",{"count":182,"type":21},30,"1 Day","OBSERVATIONAL","The purpose of this study is to evaluate the motor imagery ability in transradial amputees using myoelectric prosthesis, compare it with the control group and investigate its effect on functionality and proprioception.",[187,27],"Amputation of Upper Limb Below Elbow",[189,117,190,191,192],"Imagery","Prosthetic","Functional","Myoelectric","2025-11-24",{"date":195,"type":32},"2025-12-02",{"date":197,"type":32},"2025-06-01",{"date":199,"type":21},"2026-06-01",{"name":201,"class":39},"Medipol University",{"id":203,"slug":204,"hasResults":11,"nctId":205,"briefTitle":206,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":208,"targetDuration":4,"studyType":22,"phases":210,"briefSummary":211,"conditions":212,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":217,"completionDateStruct":219,"leadSponsor":221,"locationsCount":40},"100598723","caesar-foot-take-home-validation-testing-100598723","NCT07075198","Caesar Foot Take-Home Validation Testing","Inclusion Criteria:\n\n* Have transtibial limb absence of one or both limbs\n* Express interest in running, but do not currently have a running blade (as determined by self-report)\n* Are at least 18 years of age\n* Are at least six months post amputation\n* Are classified as K3 or K4 ambulator status as determined by a certified prosthetist\n* Have an AMP score of at least 37\n* Are capable of running safely as determined by a certified prosthetist's clinical judgement\n* Have a well-fitting socket as determined by a certified prosthetist\n* Have adequate clearance between distal end of the residual limb and ground for the Caesar foot\n* Meets the foot size and weight class of one of the available Caesar prototypes\n\nExclusion Criteria:\n\n* Present or sustained injuries to residual limb or contralateral leg affecting functional ability\n* Non-English speaking participants will be excluded from this study due to limited access to interpreter services. These services would be needed for several visits, including training to learn how to use the device safely, along with requested verbal feedback from the participant to evaluate the design and usability of the system.\n* Using a prosthetic foot that an individual is unfamiliar with for higher activity tasks may increase the risk of falling. Therefore, pregnant women should not participate in the study and will be screened by self-disclosure.\n\nIndividuals can be excluded at the discretion of the investigator for other unforeseen disqualifying criteria (such as specific cognitive issues, etc.).",{"count":209,"type":21},18,[24],"The rationale for this study is to conduct a take-home clinical trial to evaluate the impact of the bimodal Caesar foot in a real-world environment. Participants will take the device home and use it throughout their daily life for two months. A one-month baseline period, using their usual foot, will be completed both before and after the two-month period with the Caesar foot condition. Self-report surveys and performance-based measures will be collected in the clinic at the end of each condition. The intent of this study is to determine the Caesar foot's feasibility in a real-world environment. Data will be collected to understand impact to the user's daily life and physical activity through outcomes and participant feedback. The feedback obtained during this study will be essential to informing the design intended for commercialization.",[27,213],"Lower Limb Amputation Below Knee (Injury)","2025-10-09",{"date":216,"type":32},"2025-10-14",{"date":218,"type":21},"2025-10",{"date":220,"type":21},"2026-08",{"name":222,"class":172},"Liberating Technologies, Inc.",{"id":224,"slug":225,"hasResults":11,"nctId":226,"briefTitle":227,"officialTitle":228,"acronym":4,"eligibilityCriteria":229,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":230,"targetDuration":4,"studyType":22,"phases":232,"briefSummary":233,"conditions":234,"keywords":239,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":248,"leadSponsor":250,"locationsCount":100},"100593821","effects-of-myoelectric-channel-count-and-targeting-for-upper-limb-prosthetic-control-100593821","NCT07011420","Effects of Myoelectric Channel Count and Targeting for Upper Limb Prosthetic Control","Evaluation of Functional Performance of Persons With Limb Differences to Optimize Pattern Recognition Control of Powered Upper Limb Prosthesis","Inclusion Criteria:\n\n* Unilateral transradial level limb absence\n* Current or past user of myo-electric controlled prostheses\n* Six months or more post-amputation\n* Have adequate limb length such that a wrist rotation device can fit in the check socket\n* Well-fitting socket as determined by a Socket-Comfort Score of 6 or above\n* Capable of wearing and operating a prosthesis with a wrist rotator and multi-articulating hand\n* Capable of understanding and following multi-step instructions and completing the tasks as described\n* English speaking\n\nExclusion Criteria:\n\n* Significant new injury that would prevent use of a prosthesis: The ability to consistently wear a prosthesis and perform activities of daily living and specific performance tasks is necessary to evaluate the relative benefits of the interventions.\n* Cognitive impairment sufficient to adversely affect understanding of or compliance with study requirements, ability to communicate experiences, or ability to give informed consent: The ability to understand and comply with requirements of the study is essential for the study to generate useable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study.",{"count":231,"type":21},32,[24],"The goal of this clinical trial is to systematically evaluate whether or not two commonly held fundamental assumptions for pattern recognition control translates to functional performance when tested on individuals aged 18 years or older with upper limb absence at the transradial level while wearing a physical prosthesis.\n\nThe specific aims of this study are:\n\n1. To evaluate the effect of changing untargeted myoelectric channel count on the functional performance of transradial prosthesis users wearing a fully functional prosthesis via functional outcomes measures such as the Box and Blocks test.\n2. To evaluate the effect of changing myoelectric channel targeting of a fixed number of myoelectric channels on the functional performance of transradial prosthesis users wearing a fully functional prosthesis via functional outcomes measures such as the Box and Blocks test.\n\nResearchers will perform a randomized crossover study to compare system configurations with different number of sensor channels and with various strategies for sensor placement on the limb. Participants will be assigned to a random test sequence that includes the following four different EMG channel conditions:\n\nCondition A: 4 untargeted channels Condition B: 8 untargeted channels Condition C: Up to 16 untargeted channels Condition D: 8 targeted channels\n\nResearchers will evaluate the effects of changing myoelectric channel counts on the functional prosthesis performance of individuals with transradial limb loss via functional outcome measures.\n\nParticipants will:\n\n* Attend up to 5 in-lab sessions that are expected to last 4 hours.\n* Conduct site visits every 1-2 weeks to complete functional and self reported outcome measures with each condition.\n* Play virtual games with the Coapt Cuff for 15 minutes a day, 3 days a week in between visits.",[79,235,236,27,237,238],"Amputation, Traumatic","Amputation, Congenital","Upper Limb Amputation Below Elbow (Injury)","Amputation; Traumatic, Arm: Forearm, Between Elbow and Wrist",[160,240,241,242,243],"upper limb amputee","transradial amputee","prosthetic arm","upper limb prosthesis user","2025-09-02",{"date":246,"type":32},"2025-09-03",{"date":218,"type":21},{"date":249,"type":21},"2026-06",{"name":222,"class":172},{"id":252,"slug":253,"hasResults":11,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":22,"phases":260,"briefSummary":261,"conditions":262,"keywords":264,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":267,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":40},"100531057","clinical-outcomes-with-non-powered-vs-powered-prosthetic-knees-by-k2-level-amputees-100531057","NCT06194838","Clinical Outcomes With Non-Powered vs. Powered Prosthetic Knees by K2-level Amputees","Clinical Outcomes Associated With At Home Use of Non-Powered vs. Powered Prosthetic Knees by K2-level Individuals With Transfemoral Amputations","Inclusion Criteria:\n\n* Are at least 18 years old\n* Transfemoral prosthesis user (limb absence between the knee and hip)\n* Current user of a mechanical knee\n* Regularly wears prosthesis at least 5 days per week\n* Have adequate clearance between distal end and ground for necessary knee and foot components\n* Current Medicare Functional Classification Level (K-Level) of 2 as determined by the healthcare team\n* Socket-Comfort Score: 6 or above to ensure adequate socket fit\n* Six months or more experience on a prosthesis\n* Body weight between 50kg and 116kg (110lbs - 256lbs)\n* Height between 1.2m and 1.95m (47.2in and 76.8in)\n* Has a phone to answer periodic study calls\n\nExclusion Criteria:\n\n* Present injuries to residual limb or contralateral leg affecting functional ability\n* Contralateral amputation proximal to MTP (metatarsophalangeal) joint\n* Socket issues\u002Fchanges in the last 6 weeks\n* Users with bone-anchored implants\n* Health or medical condition, diagnosis, or other cause that would prevent participant from effectively following study protocol, performing required outcome measures, and\u002For completing the study\n\nSubjects can be excluded at the discretion of the investigator for other unforeseen disqualifying criteria (such as specific cognitive issues, etc.).\n\nIf subjects experience a health or medical condition that leaves them immobile for more than 2 weeks, they may be given the option to restart the study condition upon recovery, as long as eligibility criteria is still met, and comparable baseline functionality is demonstrated with outcomes measures.\n\nUsing a knee that the subject is unfamiliar with may increase the risk of falling. Therefore, pregnant women should not participate in the study and will be screened by self-disclosure.",{"count":259,"type":21},26,[24],"The goal of this proposed project is to gather community-based data from the K2-level Transfemoral Amputee (TFA) population to aid in evidence-based prescription of powered prosthetic knees (i.e., choosing the right device to maximize the benefit for each patient). The investigators intend to use this trial data along with a concurrent study being conducted within the K3-K4 level population to guide the implementation of effective prescriptions towards those that can benefit most from a given device and limit prescription to those who would not see benefit in order to ensure the most judicious use of Department of Defense (DoD) and Veteran's Affairs healthcare dollars. The findings will also be shared with the research community to help drive the design of future devices by identifying what features and functions are most beneficial to which patient populations when the devices are used outside of the laboratory. In summary, more community-based data on how powered prosthetic knees compare with the current standard in TFA populations is needed to allow for improved clinical decision making and clinical outcomes.",[79,263,146,27,147,145],"Amputation; Traumatic, Leg, Lower",[160,265,161,157,266,153,152],"lower limb amputee","power knee",{"date":246,"type":32},{"date":269,"type":32},"2023-09-12",{"date":271,"type":21},"2026-08-31",{"name":222,"class":172},{"id":274,"slug":275,"hasResults":11,"nctId":276,"briefTitle":277,"officialTitle":278,"acronym":4,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":184,"phases":4,"briefSummary":282,"conditions":283,"keywords":286,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":298,"lastUpdatePostDateStruct":299,"startDateStruct":301,"completionDateStruct":303,"leadSponsor":305,"locationsCount":40},"100428144","evaluating-the-experience-of-upper-limb-prosthesis-use-100428144","NCT04855214","Evaluating the Experience of Upper Limb Prosthesis Use","Patient-specific Requirements and Experiences of Upper Limb Prosthetic Technology","Inclusion Criteria:\n\n* 18 years or older\n* Ability to give verbal informed consent\n* Ability to speak and understand English\n* Unilateral acquired trans-radial or trans-humeral amputee\n* At least six months from time of limb loss\n* Current user of an upper limb prosthesis\n* Use of the device they will be describing for at least six months (with the exception of sensory augmentation)\n\nExclusion Criteria:\n\n* Significant hearing impairment which would prevent telephone communication.\n* Unwillingness or inability to discuss experiences with prostheses\n* Emotional disturbance related to discussion the prosthesis or limb loss",{"count":281,"type":21},178,"The goal is to understand the critical factors associated with outcome acceptance following upper limb loss. The investigators aim to develop a unified theoretical model that describes the psychosocial experience of upper limb prosthesis use and predicts outcome acceptance following upper limb loss. The investigators will also examine experiences with prosthesis education, selection, and training as well as how psychological and social issues impact prosthesis use. In addition, the investigators will use the findings to develop a prototype decision tool to assist with matching persons to prostheses. Study findings will help providers, technology developers, and researchers better understand the complex experience of upper limb prosthesis use.\n\nThis conceptual framework will enable clinicians and researchers to evaluate and predict patient outcomes following limb loss, and to design interventions that improve outcomes. The proposed study is a mixed methods (qualitative and quantitative) study using an observational design. The qualitative component of the study will involve data collection through telephone interviews with 42 participants and analyses using a grounded theory approach with constant comparison methods. The quantitative component involves administration of standardized measures quantifying constructs of the theoretical model in 120 participants and analyses to produce a structural equation model of outcome acceptance. Participants will include persons with unilateral acquired upper limb loss at the trans radial or trans humeral level who use currently available prosthetic devices. Up to 16 individuals will participate in a series of focus groups that will be conducted to provide feedback on the model generated from previous data.",[27,79,284,285,237],"Upper Limb Amputation at the Wrist","Upper Limb Amputation Above Elbow (Injury)",[287,288,289,290,291,192,292,293,294,295,117,296,297],"Upper Limb Prosthesis User","Survey","Interview","User Experience","Body-powered","Multiple degree of freedom","Sensory Feedback","Prosthetic device features","Upper Limb Loss","Outcome Acceptance","Qualitative Research","2025-04-01",{"date":300,"type":32},"2025-04-04",{"date":302,"type":32},"2020-12-16",{"date":304,"type":21},"2026-09-30",{"name":306,"class":307},"Louis Stokes VA Medical Center","FED",{"id":309,"slug":310,"hasResults":11,"nctId":311,"briefTitle":312,"officialTitle":312,"acronym":4,"eligibilityCriteria":313,"healthyVolunteers":70,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":314,"targetDuration":316,"studyType":184,"phases":4,"briefSummary":317,"conditions":318,"keywords":323,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":328,"lastUpdatePostDateStruct":329,"startDateStruct":331,"completionDateStruct":333,"leadSponsor":335,"locationsCount":40},"100520125","3d-evaluation-of-the-lip-support-in-a-full-arch-implant-supported-rehabilitations-100520125","NCT06052501","3D Evaluation of the Lip Support in a Full-arch Implant-supported Rehabilitations","Inclusion Criteria:\n\n* Individuals with at least a full-arch implant supported rehabilitation in the upper arch\n* Individuals with a provisional or a definitive implant-supported prosthesis\n* Individuals with a stable occlusion function\n* Individuals with compliance to collaborate with the research protocol\n\nExclusion Criteria:\n\n* Individuals with history of hypersensitivity to external light or any similar condition\n* Individuals in an active surgical treatment period\n* Individuals in an active orthodontic treatment in the opposite arch\n* Individuals in an active facial treatment\n* Individuals who did not attend the maintenance visits",{"count":315,"type":21},20,"1 Year","The goal of this observational study is to evaluate the impact of a full arch implant-supported prostheses in the lip support. In a complex rehabilitation cases, the process between the diagnosis and the delivery of a prostheses may lead with many clinical and laboratorial choices which influence the final design of the prosthetic work and consequently the facial profile of the patient.\n\nThe use of 3D facial scanners and advanced superimposition methodology allows the investigators to objectively measure several relevant parameters such as vertical occlusion of dimension and lip support.",[319,27,320,321,322],"Digital Technology","Lip","Oral Soft Tissue Conditions","Occlusion",[324,325,326,327],"three-dimensional imaging","prosthodontics","full-arch","facial scanner","2024-06-24",{"date":330,"type":32},"2024-06-26",{"date":332,"type":32},"2024-03-30",{"date":334,"type":21},"2024-12-15",{"name":336,"class":39},"Implantology Institute"]