[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100557578":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":21,"centralContacts":26,"locations":32,"responsibleParty":52,"collaborators":56,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":66,"acronym":21,"eligibilityCriteria":67,"healthyVolunteers":64,"sex":68,"minAge":69,"maxAge":21,"enrollmentInfo":70,"targetDuration":21,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":35,"whyStopped":21,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Infinite Biomedical Technologies","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Multiple Baseline","EXPERIMENTAL","Participants act as their own controls. Participants are fit with a prosthesis system, which includes IBT's Core2 controller, IBT Electrodes, FlexCell batteries, and prosthetic componentry chosen by the patient and their clinical team. The provided controller can operate in two modes of operation: (1) in Direct Control (or DC); and (2) using the Glide control strategy. Participants progress through an AB multiple baseline protocol, where they use the provided prosthesis system for four evaluation periods (totaling 24-weeks in duration). During the A-phase, participants use the system with DC and during the B-phase, participants use the system with the Glide control strategy. For both interventions, the required hardware is the same, while the control software will differ.",[13,14],"Device: Glide","Device: Direct Control",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DEVICE","Glide","Glide is a myoelectric prosthesis control strategy which enables multifunctional control using a limited set of input EMG signals (as few as two). The Glide control strategy uses the relative contributions of multiple electrode inputs to create a virtual cursor, calculated from a vector summation of multiple EMG channels, to select the type and speed of a movement from a circular map.",[9],null,{"type":17,"name":23,"description":24,"armGroupLabels":25,"otherNames":21},"Direct Control","Direct Control (DC) is the most common method of control for powered prostheses, which directly links the activity recorded from a single electromyography (EMG) electrode to a prosthesis action. Typically, a pair of EMG electrodes are placed over a pair of agonist\u002Fantagonist muscle groups to operate a single DOF (e.g., for transradial amputees the flexor muscles in the forearm may be mapped to the prosthetic hand closing and the forearm extensor muscles mapped to hand opening).",[9],[27],{"name":28,"role":29,"phone":30,"phoneExt":21,"email":31},"Rahul R Kaliki, Ph.D","CONTACT","(443) 451-7175","rahul@i-biomed.com",[33],{"facility":34,"status":35,"city":36,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Advanced Arm Dynamics","RECRUITING","Redondo Beach","California","90277","United States","US",{"type":42,"coordinates":43},"Point",[44,45],-118.38841,33.84918,{"lat":45,"lon":44},[48],{"name":49,"role":29,"phone":50,"phoneExt":21,"email":51},"John M Miguelez, CP, FAAOP (D)","(310) 372-3050","jmiguelez@armdynamics.com",{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":21,"oldOrganization":21},"PRINCIPAL_INVESTIGATOR","Rahul Kaliki","Chief Executive Officer",[57,60],{"name":58,"class":59},"Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)","NIH",{"name":34,"class":61},"UNKNOWN","100557578","regulatory-clearance-of-the-glide-control-strategy-for-upper-limb-prostheses-100557578",false,"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","ALL","18 Years",{"count":71,"type":72},7,"ESTIMATED","INTERVENTIONAL",[75],"NA","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.",[78,79],"Amputation","Upper Limb",[81,82,83,84,85],"amputation","upper limb","myoelectric control","prosthesis","glide","2026-05-27",{"date":88,"type":89},"2026-05-29","ACTUAL",{"date":91,"type":89},"2024-09-16",{"date":93,"type":72},"2027-03-31",{"name":5,"class":6},1]