[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100293157":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":32,"centralContacts":36,"locations":43,"responsibleParty":61,"collaborators":64,"id":68,"slug":69,"hasResults":70,"nctId":71,"briefTitle":72,"officialTitle":72,"acronym":25,"eligibilityCriteria":73,"healthyVolunteers":70,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":25,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":88,"overallStatus":45,"whyStopped":25,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Kessler Foundation","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"EAW + TLS","EXPERIMENTAL","The EAW+TLS training group will receive 60 minutes of exoskeleton-assisted walking overground per session, for a total of 80 sessions (3x\u002Fweek, 28 wks.) with simultaneous transcutaneous lumbosacral stimulation (TLS) intervention followed by 15 minutes of over ground training without the exoskeleton. component is added to the exoskeleton assisted walking component in this group. TLS will involve placing self-adhesive stimulating electrodes bilaterally over the T11\u002FT12 lumbar region. Correct placement will be confirmed by the elicitation of posterior root muscle reflexes in the lower limb muscles. A constant-voltage stimulator (RT 50 Sage stimulator) will deliver pulses of 2 ms width. TLS will be applied while the participant walks in the Exo-skeleton-assisted walking (EAW).",[13,14],"Device: Exoskeleton-Assisted Walking","Device: Transcutaneous Lumbosacral Stimulation (TLS)",{"label":16,"type":10,"description":17,"interventionNames":18},"EAW without TLS","EAW, exoskeleton-assisted walking, an activity based therapy is a training which involves using the same exoskeleton device for all the participants. Each participant will undergo, 60 minutes of EAW as above. Each participant will undergo a stand evaluation and be instructed in proper use of the device. During the initial 3 sessions of training, the exoskeleton device will be tethered to an overhead pulley system during training to allow subjects to safely adapt to trunk, balance gait activities while walking in the exoskeleton. EAW overground walking will follow each training session with the 6-minute walk test, 10 meter walk test .",[13],[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","Exoskeleton-Assisted Walking","Exoskeleton-Assisted Walking (EAW) is an activity based therapy. Each group will receive 60 minutes of robotic intervention training per session, for a total of 80 sessions.",[9,16],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"Transcutaneous Lumbosacral Stimulation (TLS)","EAW+TLS. This group will receive 60 minutes of exoskeleton assisted overground walking with simultaneous Transcutaneous Lumbosacral Stimulation (TLS) followed by 15 minutes of overground training without exoskeleton.",[9],[31],"RT 50 Sage Stimulator",[33],{"name":34,"affiliation":5,"role":35},"Gail F. Forrest, PhD","PRINCIPAL_INVESTIGATOR",[37],{"name":38,"role":39,"phone":40,"phoneExt":41,"email":42},"Gail F Forrest, PhD","CONTACT","973-324-3518","3518","gforrest@kesslerfoundation.org",[44],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","West Orange","New Jersey","07052","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-74.23904,40.79871,{"lat":55,"lon":54},[58],{"name":59,"role":39,"phone":60,"phoneExt":25,"email":42},"Gail F Forrest, Ph.D","973 324 3518",{"type":35,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Gail Forrest","Assistant Director of HPER",[65],{"name":66,"class":67},"Kessler Institute for Rehabilitation","INDUSTRY","100293157","exoskeleton-and-spinal-cord-stimulation-for-sci-100293157",false,"NCT03096197","Exoskeleton and Spinal Cord Stimulation for SCI","Inclusion Criteria:\n\nIn order to be eligible to participate in this study a participant must:\n\n* be a non-walker with an SCI greater than 6 years post injury;\n* have a lower extremity motor score greater or equal to 16 as measured by the International Standards for Neurological Classification of SCI exam;\n* be between the ages of 18-65 years old;\n* have a spinal cord injury at a neurological level of injury as determined by study staff between C5-T-10;\n* be wheelchair reliant 100% of the time;\n* have knee bone mineral density great than .5755gm\u002Fcm2 as determined by study staff;\n\nExclusion Criteria:\n\n* have a history of broken or fractured bones.\n* have a history of bone trauma or bone disease.","ALL","18 Years","65 Years",{"count":78,"type":79},24,"ESTIMATED","INTERVENTIONAL",[82],"NA","The overall aim of this project is to assess the effect of combining transcutaneous lumbosacral stimulation (TLS) during Exoskeleton Assisted Walking (EAW) compared to EAW alone without stimulation on walking recovery.",[85,86,87],"Spinal Cord Injury","Ambulation Difficulty","Muscle Spasticity",[89,90,91],"Spinal Cord injury (SCI)","Transcutaneous lumbosacral stimulation (TLS)","Exoskeleton-Assisted Walking (EAW)","2026-01-12",{"date":94,"type":95},"2026-01-14","ACTUAL",{"date":97,"type":95},"2017-03-30",{"date":99,"type":79},"2029-09",{"name":5,"class":6},1]