[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100104456":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":28,"locations":39,"responsibleParty":68,"collaborators":20,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":20,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":95,"overallStatus":41,"whyStopped":20,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":108},{"fullName":5,"class":6},"Case Western Reserve University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Implant","EXPERIMENTAL","Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in post-operative training and follow-up procedures.",[13],"Device: IST (Implanted Stimulator-Telemeter)",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","IST (Implanted Stimulator-Telemeter)","Pre-surgical exercise with surface electrical stimulation, surgery including electrode and IST- implanted pulse generator insertion, exercise and physical therapy with the implanted system, functional training and laboratory assessment of clinical and technical performance.",[9],null,[22,25],{"name":23,"affiliation":5,"role":24},"Ronald J Triolo, Ph.D.","PRINCIPAL_INVESTIGATOR",{"name":26,"affiliation":27,"role":24},"Musa L Audu, Ph.D.","Louis Stokes Cleveland VA Medical Center",[29,35],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},"Lisa M Lombardo, MPT","CONTACT","216-791-3800","64909","lisa.lombardo2@va.gov",{"name":36,"role":31,"phone":32,"phoneExt":37,"email":38},"Maura Malenchek, PTA","64989","maura.malencheck@va.gov",[40,58],{"facility":27,"status":41,"city":42,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"RECRUITING","Cleveland","Ohio","44106","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-81.69541,41.4995,{"lat":51,"lon":50},[54,56],{"name":30,"role":31,"phone":32,"phoneExt":55,"email":34},"4909",{"name":36,"role":31,"phone":32,"phoneExt":37,"email":57},"maura.malenchek@va.gov",{"facility":59,"status":41,"city":42,"state":43,"zip":60,"country":45,"countryCode":46,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},"MetroHealth System","44109",{"type":48,"coordinates":62},[50,51],{"lat":51,"lon":50},[65,66,67],{"name":30,"role":31,"phone":32,"phoneExt":33,"email":34},{"name":36,"role":31,"phone":32,"phoneExt":37,"email":57},{"name":23,"role":24,"phone":20,"phoneExt":20,"email":20},{"type":24,"investigatorFullName":69,"investigatorTitle":70,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Ronald J. Triolo","Biomedical Engineer","100104456","evaluation-of-an-advanced-lower-extremity-neuroprostheses-100104456",false,"NCT00623389","Evaluation of an Advanced Lower Extremity Neuroprostheses","Evaluation of Advanced Lower Extremity Neuroprostheses","LE-IST","Phase I Inclusion Criteria\n\n1. Skeletal maturity and ability to sign informed consent (\\>18 years)\n2. Non-ventilator dependent paralysis resulting from injuries such as: mid cervical\u002Fthoracic (C4 or below) spinal cord injuries, poststroke hemiparesis, TBI, or MS, affecting the trunk and\u002For lower limbs\n3. Innervated and excitable lower extremity and trunk musculature\n4. Adequate social support and stability\n5. Willingness to comply with follow-up procedures\n\nPhase I Exclusion Criteria\n\n1. Non-English speaking\n2. Females who are pregnant\n3. Current pressure injuries that would be exacerbated by study activities\n4. Severe contractures or uncontrolled spasticity of any major joint of the upper or lower extremities that results in a fixed deformity that would interfere with study activities\n5. History of spontaneous fractures or other evidence of excessively low bone density\n6. History of vestibular dysfunction, balance problems, or spontaneous falls\n7. Acute and or\u002Funtreated orthopedic problems that would prevent a participant from weight bearing or exercising such as a dislocation or fracture.","ALL","21 Years","75 Years",{"count":83,"type":84},10,"ESTIMATED","INTERVENTIONAL",[87],"NA","The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate exercise, standing, stepping and\u002For balance in people with various degrees of paralysis.",[90,91,92,93,94],"Spinal Cord Injuries","Stroke","Paralysis","Tetraplegia","Paraplegia",[96,97,98,91,94,93],"Neurologic disorders","Rare disease","Spinal cord injuries","2025-06-12",{"date":101,"type":102},"2025-06-15","ACTUAL",{"date":104,"type":102},"2018-06-01",{"date":106,"type":84},"2027-12-31",{"name":5,"class":6},2]