[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100453677":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":62,"collaborators":26,"id":66,"slug":67,"hasResults":68,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":68,"sex":74,"minAge":75,"maxAge":26,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Swiss Paraplegic Research, Nottwil","NETWORK",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Ekso and FES","EXPERIMENTAL","Participants will train for 8 weeks, 3 times per week (i.e. 24 sessions in total) for 30 minutes effective training time per session using the EksoNR powered exoskeleton combined with gait-synchronized FES using the FES RehaMove2.",[13,14],"Device: Ekso (EksoNR, Ekso Bionics)","Device: FES (RehaMove2, Hasomed)",{"label":16,"type":17,"description":18,"interventionNames":19},"Ekso without FES","ACTIVE_COMPARATOR","Participants will train for 8 weeks, 3 times per week (i.e. 24 sessions in total) for 30 minutes effective training time per session using the EksoNR powered exoskeleton without applying FES.",[13],[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Ekso (EksoNR, Ekso Bionics)","The EksoNR is a powered exoskeleton designed to be used in a rehabilitation setting. The device meets the provision of the Council Directive 93\u002F42\u002FEEC concerning medical devices and is used for gait training in neurorehabilitation.",[9,16],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"FES (RehaMove2, Hasomed)","RehaMove 2 sends electrical impulses via electrodes to nerves to evoke muscle contraction. The device meets the provision of the Council Directive 93\u002F42\u002FEEC concerning medical devices.",[9],[32],{"name":33,"affiliation":5,"role":34},"Mario Widmer, PhD","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","+41 41 939 51 97","mario.widmer@paraplegie.ch",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"Ines Bersch, PhD","+41 419 39 42 06","ines.bersch@paraplegie.ch",[45],{"facility":46,"status":47,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Swiss Paraplegic Centre","RECRUITING","Nottwil","Canton of Lucerne","6207","Switzerland","CH",{"type":54,"coordinates":55},"Point",[56,57],8.13774,47.13469,{"lat":57,"lon":56},[60],{"name":33,"role":37,"phone":61,"phoneExt":26,"email":39},"+41419395197",{"type":63,"investigatorFullName":64,"investigatorTitle":65,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Mario Widmer","Principal Investigator","100453677","effectiveness-of-a-powered-exoskeleton-combined-with-fes-for-patients-with-chronic-sci-a-rct-100453677",false,"NCT05187650","Effectiveness of a Powered Exoskeleton Combined With FES for Patients With Chronic SCI: a RCT","Effectiveness of a Powered Exoskeleton Combined With Functional Electric Stimulation for Patients With Chronic Spinal Cord Injury: a Randomized Controlled Trial","Ekso-FES","Inclusion Criteria:\n\n* chronic, incomplete SCI (\\> 1 year, AIS B-D)\n* traumatic or non-traumatic lesion\n* capacity to stand up and perform a 10MWT with or without medical aids\n* partially wheelchair dependent\n* intact lower motoneuron on the segmental innervation level of M. glutaeus maximus, Mm. ischiocrurales, M. tibialis anterior and M. quadriceps (to guarantee the stimulability with FES)\n\nExclusion Criteria:\n\n* Exoskeleton device related contraindications: \\> 100 kg body weight; Body height: \\\u003C 155 cm or \\> 190 cm; pelvic width: \\> 46 cm\n* orthopedic limitations (acute fractures of the lower limb)\n* contractures\n* heterotrophic ossification\n* spasticity (modified Ashworth Scale \\>3)\n* skin injuries of the lower limbs in areas where the skin has contact with the exoskeleton\n* Unstable circulation (unable to stand for at least 10 minutes)\n* acute deep vein thrombosis\n* pregnancy (tested in women of childbearing age (15 - 49 years))","ALL","18 Years",{"count":77,"type":78},34,"ESTIMATED","INTERVENTIONAL",[81],"NA","While there are a number of prospective studies evaluating powered exoskeletons in SCI patients, to date, not a single well-designed, randomized clinical trial has been published. However, there is evidence for beneficial effects of over-ground exoskeleton therapy on walking function post-intervention from a meta-analysis on non-randomized, uncontrolled studies. Functional electrical stimulation (FES), on the other hand, is a common and established method for the rehabilitation of persons with SCI and has been demonstrated to be beneficial in, e.g., improving muscle force, power output and endurance.\n\nCombining FES and overground robotic therapy within the same therapy session could potentially merge and potentiate the effects of each separate treatment, making it a very powerful and efficient therapy method. Up to date, however, comparative studies evaluating benefits of this combined approach (i.e., powered exoskeleton and FES) to robotic therapy without FES are missing.",[84,85],"Spinal Cord Injuries","Gait Disorders, Neurologic",[87,88,89,90,91],"SCI","Functional Electrical Stimulation","Exoskeleton","Robotic device","Robotic overground gait training","2025-12-10",{"date":94,"type":95},"2025-12-18","ACTUAL",{"date":97,"type":95},"2022-03-18",{"date":99,"type":78},"2027-12-31",{"name":64,"class":6},1]