[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100524306":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":34,"responsibleParty":125,"collaborators":18,"id":127,"slug":128,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":129,"sex":134,"minAge":135,"maxAge":18,"enrollmentInfo":136,"targetDuration":18,"studyType":139,"phases":140,"briefSummary":142,"conditions":143,"keywords":153,"overallStatus":37,"whyStopped":18,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":172},{"fullName":5,"class":6},"Wandercraft","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Exo group","EXPERIMENTAL","During the 6-week intervention period, the Exo group will complete 3 sessions per week (i.e., 18 one-hour sessions) with the Atalante device and 2 sessions per week (i.e., 12 one-hour sessions) of conventional therapy.\n\nDuring sessions with the exoskeleton, the patient will perform ambulatory exercises with the device, with a gradual increase of intensity through the sessions.\n\nConventional therapy corresponds to physiotherapy as part of post stroke standard of care of the center (tasks such as lower and upper limb practice, walking in parallel bars, etc., but this list is not exhaustive and depends on the practice of the therapists\u002Fcenters).",[13],"Device: Use of the Atalante exoskeleton",{"label":15,"type":16,"description":17,"interventionNames":18},"Control group","NO_INTERVENTION","During the 6-week intervention period, the Control group will complete 5 sessions per week of conventional therapy (i.e., 30 one-hour sessions).",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"DEVICE","Use of the Atalante exoskeleton","Six weeks of exoskeleton sessions replacing conventional therapy sessions three times a week",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Dr Rebecca Sauvagnac, MD","CONTACT","(0)179353109","rebecca.sauvagnac@wandercraft.health",{"name":32,"role":28,"phone":29,"phoneExt":18,"email":33},"Laure Bouché","laure.bouche@wandercraft.health",[35,57,74,93,108],{"facility":36,"status":37,"city":38,"state":18,"zip":18,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Hôpitaux Universitaires Henri Mondor APHP, site Albert Chenevier","RECRUITING","Créteil","France","FR",{"type":42,"coordinates":43},"Point",[44,45],2.46569,48.79266,{"lat":45,"lon":44},[48,52,55],{"name":49,"role":28,"phone":50,"phoneExt":18,"email":51},"Pr Jean-Michel Gracies, MD, PhD","+33 1 49 81 30 61","jean-michel.gracies@aphp.fr",{"name":53,"role":28,"phone":50,"phoneExt":18,"email":54},"Dr Caroline Colas, MD","caroline.gracies@aphp.fr",{"name":53,"role":56,"phone":18,"phoneExt":18,"email":18},"PRINCIPAL_INVESTIGATOR",{"facility":58,"status":37,"city":59,"state":18,"zip":18,"country":39,"countryCode":40,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Centre de Médecine Physique et de Réadaptation APAJH de Pionsat","Pionsat",{"type":42,"coordinates":61},[62,63],2.69319,46.10963,{"lat":63,"lon":62},[66,69,73],{"name":67,"role":28,"phone":18,"phoneExt":18,"email":68},"Dr Charles Orange, MD","c.orange@apajh.asso.fr",{"name":70,"role":28,"phone":71,"phoneExt":18,"email":72},"Thierry Halluin","+33 4 73 85 34 59","t.halluin@apajh.asso.fr",{"name":67,"role":56,"phone":18,"phoneExt":18,"email":18},{"facility":75,"status":76,"city":77,"state":18,"zip":18,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":84,"contacts":85},"Schön Klinik","NOT_YET_RECRUITING","Bad Aibling","Germany","DE",{"type":42,"coordinates":81},[82,83],12.01055,47.8638,{"lat":83,"lon":82},[86,89,90],{"name":87,"role":28,"phone":18,"phoneExt":18,"email":88},"Dr Friedemann Müller, MD, M.Sc.","fmueller@schoen-klinik.de",{"name":87,"role":56,"phone":18,"phoneExt":18,"email":18},{"name":91,"role":92,"phone":18,"phoneExt":18,"email":18},"Pr Klaus Jahn, MD","SUB_INVESTIGATOR",{"facility":94,"status":37,"city":95,"state":18,"zip":18,"country":78,"countryCode":79,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Vivantes Klinikum Spandau","Berlin",{"type":42,"coordinates":97},[98,99],13.41053,52.52437,{"lat":99,"lon":98},[102,105,106],{"name":103,"role":28,"phone":18,"phoneExt":18,"email":104},"Dr Anatol Kivi, MD","anatol.kivi@vivantes.de",{"name":103,"role":56,"phone":18,"phoneExt":18,"email":18},{"name":107,"role":92,"phone":18,"phoneExt":18,"email":18},"Pr Jörg Wissel, MD",{"facility":109,"status":37,"city":110,"state":18,"zip":18,"country":111,"countryCode":112,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Institut Guttmann","Barcelona","Spain","ES",{"type":42,"coordinates":114},[115,116],2.15899,41.38879,{"lat":116,"lon":115},[119,122,123],{"name":120,"role":28,"phone":18,"phoneExt":18,"email":121},"Dr Cristian Andres Figueroa Chacón, MD","cafigueroa@guttmann.com",{"name":120,"role":56,"phone":18,"phoneExt":18,"email":18},{"name":124,"role":92,"phone":18,"phoneExt":18,"email":18},"Dr Irene Sanchez Serrano, MD",{"type":126,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100524306","effects-of-atalante-exoskeleton-on-gait-recovery-in-non--or-poorly-ambulatory-patients-with-hemiparesis-in-the-acutesubacute-phase-month-1-to-4-100524306",false,"NCT06107010","Effects of Atalante Exoskeleton on Gait Recovery in Non- or Poorly Ambulatory Patients With Hemiparesis in the Acute\u002FSubacute Phase (Month 1 to 4)","EarlyExo","Inclusion Criteria:\n\n* \\>18 years old\n* First clinically significant disability due to stroke\n* Hemiparesis in acute-subacute phase (1 to 4 months since lesion) due to a stroke\n* Functional Ambulation Category score (FAC) \\\u003C2\n* Patient with health insurance\n* Informed and willing to sign an informed consent form approved by the Ethics Committee. For clarity, if a motor impairment prevents the subject from signing by himself, he\u002Fshe can still be included if the signature can be done by an impartial witness.\n\nExclusion Criteria:\n\n* Muscle overactivity in hip adductors, hamstrings, quadriceps and plantar flexors, which interferes with exoskeleton use, based on clinician investigator's opinion\n* Recent fracture (\\\u003C 3 months) or any therapy inducing secondary osteoporosis\n* Excessive joint mechanical pain in the lower limbs based on clinician investigator's opinion\n* Pressure sore grade I or more over contact zones with Atalante system, according to the International Pressure Ulcer Classification System NPUAP - EPUA\n* Medical contra-indication to medium intensity physical strain\n* Orthostatic hypotension (loss of \\> 20 mmHg systolic BP after 3 minutes in standing position)\n* Uncontrolled seizures\n* Morphological contra-indications to the use of Atalante (as per user's manual)\n* Pregnant woman\n* Adults who lack the capacity to provide informed consent, and all those persons deprived of their liberty in prisons or other places of detention\n* Concurrent participation in another interventional trial","ALL","18 Years",{"count":137,"type":138},66,"ESTIMATED","INTERVENTIONAL",[141],"NA","The present clinical investigation - EarlyExo, is an interventional, international, multicentric, prospective, single-blinded randomized controlled trial.\n\nThis clinical investigation is designed to test the hypothesis that early and intense introduction of walking sessions assisted by the Atalante exoskeleton, in a sample of hemiparetic patients with still non or poor ambulatory capacities (FAC 0 or 1) between one- and four-months post stroke, would result in a better recovery of functional walking compared to a control group only receiving conventional therapy. Improved recovery will be measured through the proportion of patients reaching a FAC score of 4 or higher at the end of the intervention period. The tested hypothesis is that this proportion will be higher in the Exo group.\n\nThe duration of the intervention period in both groups is 6 weeks.\n\n* For the Exo group: 3 sessions per week (i.e., 18 one-hour sessions) with the Atalante device and 2 sessions per week (i.e., 12 one-hour sessions) of conventional therapy.\n* For the Control group: 5 sessions per week of conventional therapy (i.e., 30 one-hour sessions).\n\nThe study will include 66 patients (33 in each arm) and takes place in two French centers, two German centers and one Spanish center.",[144,145,146,147,148,149,150,151,152],"Stroke, Acute","Stroke, Ischemic","Stroke, Subacute","Stroke Hemorrhagic","Cerebrovascular Disorders","Cerebrovascular Accident","Hemiparesis","Hemiparesis;Poststroke\u002FCVA","Hemiparesis\u002FHemiplegia (One Sided Weakness\u002FParalysis)",[154,155,156,157,158,159,160,161,162],"Robotics","Rehabilitation","Powered Exoskeleton","Walking recovery","Stroke","Acute stroke","Subacute stroke","Functional Ambulation Category","Randomized controlled study","2025-01-30",{"date":165,"type":166},"2025-02-04","ACTUAL",{"date":168,"type":166},"2023-06-12",{"date":170,"type":138},"2026-02-28",{"name":5,"class":6},5]