[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT00623389":3,"trial-entities:NCT00623389":140,"trial-summary:NCT00623389":149},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":24,"study_type":28,"primary_purpose":29,"phases":30,"enrollment_info":32,"interventions":35,"primary_outcomes":42,"secondary_outcomes":56,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":68,"locations":71,"central_contacts":103,"overall_officials":107,"references":111,"see_also_links":139},"NCT00623389","EB-001889","Evaluation of an Advanced Lower Extremity Neuroprostheses","Evaluation of Advanced Lower Extremity Neuroprostheses","RECRUITING","2027-12-31","2026-07","2026-07-10","2018-06-01","Case Western Reserve University","OTHER",true,"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.","Protocol Outline: Patents undergo surgery in which electrodes are implanted into muscles of the trunk and legs. Electrode leads are connected to an stimulator\u002Ftelemeter. Following implantation, patients undergo training in standing, transfers and other advanced mobility skills using the functional electrical stimulation system. A prescribed course of exercise, functional training and rehabilitation with the implanted stimulation system, followed by laboratory assessments of strength, balance and functional abilities with and without the system, as well as the technical performance of the implanted components. Home-based training follows prior to discharge for home use of the system.\n\nPatients are followed at 6 and 12 months after discharge and then annually thereafter.",[19,20,21,22,23],"Spinal Cord Injuries","Stroke","Paralysis","Tetraplegia","Paraplegia",[25,26,27,20,23,22],"Neurologic disorders","Rare disease","Spinal cord injuries","INTERVENTIONAL","DEVICE_FEASIBILITY",[31],"NA",{"count":33,"type":34},10,"ESTIMATED",[36],{"type":37,"name":38,"description":39,"armGroupLabels":40},"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.",[41],"Implant",[43,47,50,53],{"measure":44,"description":45,"timeFrame":46},"Device reliability and technical performance measuring changes in standing duration from baseline at discharge to 12 months after discharge","Repeated measures of standing duration in minutes","Change from immediately after intervention and 1 year after intervention",{"measure":48,"description":49,"timeFrame":46},"Device reliability and technical performance measuring changes in standing loads from baseline at discharge to 12 months after discharge","Repeated measures of arm\u002Fleg loading measured in Kg",{"measure":51,"description":52,"timeFrame":46},"Device reliability and technical performance measuring changes in walking distance from baseline at discharge to 12 months after discharge","Repeated measures of walking distance in meters",{"measure":54,"description":55,"timeFrame":46},"Device reliability and technical performance measuring changes in walking duration from baseline at discharge to 12 months after discharge","Repeated measures of walking time in minutes",[57],{"measure":58,"description":59,"timeFrame":46},"Device operability measuring changes in functional activities of daily living from baseline at discharge and 12 months after discharge","Repeated measures of standing reach in cm, and transfer height in cm","ALL","21 Years","75 Years",false,{"inclusion":65,"exclusion":66,"raw_text":67},[],[],"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.",[69,70],"ADULT","OLDER_ADULT",[72,92],{"facility":73,"status":8,"city":74,"state":75,"zip":76,"country":77,"contacts":78,"geoPoint":89},"Louis Stokes Cleveland VA Medical Center","Cleveland","Ohio","44106","United States",[79,85],{"name":80,"role":81,"phone":82,"phoneExt":83,"email":84},"Lisa M Lombardo, MPT","CONTACT","216-791-3800","4909","lisa.lombardo2@va.gov",{"name":86,"role":81,"phone":82,"phoneExt":87,"email":88},"Maura Malenchek, PTA","64989","maura.malenchek@va.gov",{"lat":90,"lon":91},41.4995,-81.69541,{"facility":93,"status":8,"city":74,"state":75,"zip":94,"country":77,"contacts":95,"geoPoint":102},"MetroHealth System","44109",[96,98,99],{"name":80,"role":81,"phone":82,"phoneExt":97,"email":84},"64909",{"name":86,"role":81,"phone":82,"phoneExt":87,"email":88},{"name":100,"role":101},"Ronald J Triolo, Ph.D.","PRINCIPAL_INVESTIGATOR",{"lat":90,"lon":91},[104,105],{"name":80,"role":81,"phone":82,"phoneExt":97,"email":84},{"name":86,"role":81,"phone":82,"phoneExt":87,"email":106},"maura.malencheck@va.gov",[108,109],{"name":100,"affiliation":13,"role":101},{"name":110,"affiliation":73,"role":101},"Musa L Audu, Ph.D.",[112,116,119,122,125,128,132,135],{"pmid":113,"type":114,"citation":115},"17946304","BACKGROUND","Dutta A, Kobetic R, Triolo RJ. Ambulation after incomplete spinal cord injury with electromyogram-triggered functional electrical stimulation. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:5408-11. doi: 10.1109\u002FIEMBS.2006.259257.",{"pmid":117,"type":114,"citation":118},"15218941","Uhlir JP, Triolo RJ, Davis JA Jr, Bieri C. Performance of epimysial stimulating electrodes in the lower extremities of individuals with spinal cord injury. IEEE Trans Neural Syst Rehabil Eng. 2004 Jun;12(2):279-87. doi: 10.1109\u002FTNSRE.2004.827224.",{"pmid":120,"type":114,"citation":121},"15077659","Bogie KM, Triolo RJ. Effects of regular use of neuromuscular electrical stimulation on tissue health. J Rehabil Res Dev. 2003 Nov-Dec;40(6):469-75. doi: 10.1682\u002Fjrrd.2003.11.0469.",{"pmid":123,"type":114,"citation":124},"14582528","Agarwal S, Triolo RJ, Kobetic R, Miller M, Bieri C, Kukke S, Rohde L, Davis JA Jr. Long-term user perceptions of an implanted neuroprosthesis for exercise, standing, and transfers after spinal cord injury. J Rehabil Res Dev. 2003 May-Jun;40(3):241-52.",{"pmid":126,"type":114,"citation":127},"11767968","Davis JA Jr, Triolo RJ, Uhlir J, Bieri C, Rohde L, Lissy D, Kukke S. Preliminary performance of a surgically implanted neuroprosthesis for standing and transfers--where do we stand? J Rehabil Res Dev. 2001 Nov-Dec;38(6):609-17.",{"pmid":129,"type":130,"citation":131},"17947042","RESULT","Fisher LE, Miller ME, Nogan SJ, Davis JA, Anderson JS, Murray LM, Tyler DJ, Triolo RJ. Preliminary evaluation of a neural prosthesis for standing after spinal cord injury with four contact nerve-cuff electrodes for quadriceps stimulation. Conf Proc IEEE Eng Med Biol Soc. 2006;2006:3592-5. doi: 10.1109\u002FIEMBS.2006.260833.",{"pmid":133,"type":130,"citation":134},"17873417","Mushahwar VK, Jacobs PL, Normann RA, Triolo RJ, Kleitman N. New functional electrical stimulation approaches to standing and walking. J Neural Eng. 2007 Sep;4(3):S181-97. doi: 10.1088\u002F1741-2560\u002F4\u002F3\u002FS05. Epub 2007 Aug 22.",{"pmid":136,"type":137,"citation":138},"28899825","DERIVED","Triolo RJ, Bailey SN, Foglyano KM, Kobetic R, Lombardo LM, Miller ME, Pinault G. Long-Term Performance and User Satisfaction With Implanted Neuroprostheses for Upright Mobility After Paraplegia: 2- to 14-Year Follow-Up. Arch Phys Med Rehabil. 2018 Feb;99(2):289-298. doi: 10.1016\u002Fj.apmr.2017.08.470. Epub 2017 Sep 9.",[],{"nct_id":4,"conditions":141,"biomarkers":148},[142,143,21,23,144,145,146,20,147],"Multiple Sclerosis","Nervous System Disorder","Quadriplegia","Rare Disorder","Spinal Cord Injury","Traumatic Encephalopathy",[],{"nct_id":4,"found":15,"summary":150,"prompt_version":160},{"design":151,"status":152,"heading":153,"summary":154,"follow_up":155,"word_count":156,"commitments":157,"compensation":158,"drugs_mentioned":159},"This is an interventional study with a planned enrollment of 10 participants. It is not specified if it is randomized or blinded.","completed","Evaluation of an Advanced Lower Extremity Neuroprostheses for Paralysis","This study is evaluating a surgically implanted system called IST (Implanted Stimulator-Telemeter) for people with paralysis from conditions like spinal cord injuries or stroke. The IST system uses electrical stimulation to help with exercise, standing, stepping, and balance. To join, you must be between 21 and 75 years old, have skeletal maturity, and have paralysis that is not ventilator-dependent, affecting your trunk and\u002For lower limbs. Researchers will measure how well the device works and its technical performance by looking at changes in how long you can stand, how much weight you can bear while standing, and how far you can walk, from immediately after the intervention to 12 months later. The current status of this study is unclear.","Participants are followed at 6 and 12 months after discharge, and then annually thereafter.",118,"You would undergo surgery to implant electrodes and the IST system, followed by training and rehabilitation with the system. This includes exercise, functional training, and laboratory assessments, with home-based training before discharge.","Not stated in the trial record.",[38],"v2"]