[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"upper-limb-amputation-above-elbow-injury\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:upper-limb-amputation-above-elbow-injury":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"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":31,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100595461","neuromusculoskeletal-interface-for-bionic-arms-100595461",false,"NCT07032753","Neuromusculoskeletal Interface for Bionic Arms","Neuromusculoskeletal Interface for Bionic Arms: A Randomized Crossover Study","Inclusion Criteria:\n\n* Between the ages of 18 and 70 years old\n* Unilateral transhumeral level absence\n* Candidate for a myoelectric prosthesis (can generate mV level electromyographic EMG signals as detected by surface electrodes).\n* Candidate for TMR surgery as verified by surgical team\n* Candidate for OPRA surgery as verified by surgical team\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 in order for the study to generate usable, reliable data. The ability to obtain relevant user feedback through questionnaires and informal discussion adds significant value to this study. These cognitive impairments would be confirmed with the Mini-Mental State exam.\n* Proximal nerve injury that would prevent TMR or sensory feedback\n* Significant other comorbidity: Any other medical issues or injuries that would preclude completion of the study, use of the prostheses, or that would otherwise prevent acquisition of useable data by researchers. Examples include: injuries to the shoulder, cervical spine or sound side joint pain that would prohibit the participants from being able use a prosthesis. Medical conditions including unregulated high blood pressure or advanced heart disease that would exclude the participant as an appropriate surgical candidate.\n* Individuals who smoke. This may interfere with the OPRA process from both bone healing and soft tissue standpoints.\n* Individuals with active implants. This has been a restriction of prior FDA IDE to investigate e-OPRA.\n* Pregnant women\n* Non-English speaking","ALL","18 Years","70 Years",{"count":20,"type":21},12,"ESTIMATED","INTERVENTIONAL",[24],"NA","The overall objective of this proposal is to perform a first-in-human home trial of the Electronic Osseoanchored Prostheses for the Rehabilitation of Amputees (e-OPRA) implant system in individuals with transhumeral amputations who have had Targeted Muscle Reinnervation (TMR) surgery and use a pattern recognition-controlled myoelectric prosthesis. The purpose of the study is to capture preliminary safety and effectiveness information on the e-OPRA device when used with the prosthetic systems. The investigators expect that the e-OPRA implant system will be safe and provide clinically and statistically significant improvements in control and comfort.\n\nSpecifically, the investigators hypothesize that the e-OPRA system will (1) allow for training of more functional prosthesis controllers, (2) provide more stable electromyographic (EMG) signals, reducing the need to recalibrate the prosthetic control system, and (3) be more comfortable, as it does not require a tethered arm-band to record surface EMG signals.\n\nPhase 1: Perform TMR and e-OPRA surgeries in 8 persons with transhumeral amputations.\n\nPhase 2: Perform a randomized cross-over study to compare the OPRA and e-OPRA system (without sensory feedback) in 8 transhumeral amputees who have received TMR.\n\nPhase 3: Perform a randomized cross-over study to compare the e-OPRA system with and without sensory feedback in 8 transhumeral amputees who have received TMR.",[27,28,29,30],"Amputation","Amputation, Traumatic","Amputation, Surgical","Upper Limb Amputation Above Elbow (Injury)",[32],"eOPRA for transhumeral amputees","NOT_YET_RECRUITING","2025-06-12",{"date":36,"type":37},"2025-06-24","ACTUAL",{"date":39,"type":21},"2026-01-01",{"date":41,"type":21},"2029-05-31",{"name":43,"class":44},"Shirley Ryan AbilityLab","OTHER",1,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":61,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":45},"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":54,"type":21},178,"OBSERVATIONAL","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.",[58,27,59,30,60],"Prosthesis User","Upper Limb Amputation at the Wrist","Upper Limb Amputation Below Elbow (Injury)",[62,63,64,65,66,67,68,69,70,71,72,73,74],"Upper Limb Prosthesis User","Survey","Interview","User Experience","Body-powered","Myoelectric","Multiple degree of freedom","Sensory Feedback","Prosthetic device features","Upper Limb Loss","Amputee","Outcome Acceptance","Qualitative Research","RECRUITING","2025-04-01",{"date":78,"type":37},"2025-04-04",{"date":80,"type":37},"2020-12-16",{"date":82,"type":21},"2026-09-30",{"name":84,"class":85},"Louis Stokes VA Medical Center","FED"]