[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100507518":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":32,"locations":38,"responsibleParty":58,"collaborators":62,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":26,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":26,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":41,"whyStopped":26,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},{"fullName":5,"class":6},"Infinite Biomedical Technologies","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental","EXPERIMENTAL","Participants will be provided with the take-home MyoTrain system, which includes the MyoTrain armband, iPad, and MyoTrain software. Participants will progress through the training modules of the MyoTrain software, starting with eliciting paired single DoF antagonistic movements and ending with the proportional control of complex, 2-DoF hand and wrist movements.",[13],"Device: MyoTrain",{"label":15,"type":16,"description":17,"interventionNames":18},"Control","ACTIVE_COMPARATOR","Participants will be provided motor imagery exercises that involve brief attempts to move the missing limb in a similar manner to how they would control their pattern recognition system to strengthen their muscles. These exercises do not involve any real-time control feedback.",[19],"Behavioral: Motor Imagery",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","MyoTrain","MyoTrain is a virtual prosthesis control training system. From a hardware perspective it consists of an Apple iPad tablet computer and an eight-channel EMG armband, based on the Element electrode platform, which interfaces with the tablet via Bluetooth™. From a software perspective, MyoTrain was developed in the cross-platform Unity 4.0 game development environment.",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"BEHAVIORAL","Motor Imagery","Motor imagery describes the process by which a prosthesis user mentally simulates the execution of a desired limb movement and activates the musculature of the residual limb that would generate the desired movement.",[15],[33],{"name":34,"role":35,"phone":36,"phoneExt":26,"email":37},"Rahul R Kaliki","CONTACT","443-451-7175","rahul@i-biomed.com",[39],{"facility":40,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Hanger Clinic - Grand Rapids","RECRUITING","Grand Rapids","Michigan","49546","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-85.66809,42.96336,{"lat":51,"lon":50},[54],{"name":55,"role":35,"phone":56,"phoneExt":26,"email":57},"Ryan Sheridan, CPO, FAAOP","(616) 940-0878","rsheridan@hanger.com",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Rahul Kaliki","Chief Executive Officer",[63,66,69],{"name":64,"class":65},"National Institute of Neurological Disorders and Stroke (NINDS)","NIH",{"name":67,"class":68},"Johns Hopkins University","OTHER",{"name":70,"class":68},"Hanger Clinic: Prosthetics & Orthotics","100507518","study-of-efficacy-of-the-myotrain-system-in-a-population-of-individuals-with-trans-radial-limb-loss-100507518",false,"NCT05888428","Study of Efficacy of the MyoTrain System in a Population of Individuals With Trans-radial Limb Loss","Regulatory Clearance of a Rehabilitation System for Individuals With Upper Limb Loss","Inclusion Criteria:\n\n* Trans-radial unilateral limb loss\n* Candidate for a 2+ degree-of-freedom myoelectric pattern recognition prosthesis as determined by prosthetist\n* Fluent in English\n* Age of 18 years or greater\n\nExclusion Criteria:\n\n* Prior experience with pattern recognition control\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 impactive full participation in the study as determined upon clinical evaluation\n* Serious uncontrolled medical problems as judged by the project therapist","ALL","18 Years",{"count":81,"type":82},16,"ESTIMATED","INTERVENTIONAL",[85],"NA","The investigators propose to evaluate the efficacy of MyoTrain in a prospective clinical study involving 16 individuals with trans-radial upper-limb loss over a period of 206 days. These individuals will be randomized to Group A (Control Group using standard motor imagery training) and Group B (who are provided the MyoTrain system).\n\nThe investigators will test three hypotheses:\n\n1. The use of MyoTrain results in skills transference to control of the final prosthesis\n2. The virtual outcome measures in MyoTrain are correlated with real-world functional outcome measures\n3. The use of MyoTrain results in improved clinical outcomes as measured by functional, subjective and usage metrics\n\nFollowing a baseline functional assessment, participants will undergo a 30-day pre-prosthetic training period specific to their assigned Group. After this training period, participants will receive their prosthetic device and occupational therapy consistent with the current clinical care standard, after which they will again undergo clinical assessment. Post-device delivery, participants will then complete 3 56-day blocks of at-home prosthesis use, in between which they will return to clinic for assessment.",[88,89],"Amputation","Upper Limb",[91,92,93,94,95],"amputation","upper limb","myoelectric","training","prosthesis","2025-10-27",{"date":98,"type":99},"2025-10-29","ACTUAL",{"date":101,"type":99},"2024-02-02",{"date":103,"type":82},"2026-08-31",{"name":5,"class":6},1]