[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659785":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":20,"studyPopulation":13,"armGroups":21,"interventions":28,"overallOfficials":34,"centralContacts":42,"locations":13,"responsibleParty":52,"collaborators":13,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":13,"enrollmentInfo":63,"targetDuration":13,"studyType":66,"phases":67,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":74,"whyStopped":13,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":13},{"fullName":5,"class":6},"Bionic Mobility Solutions, S.L.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Number of patients able to perform walking functions","To confirm the design and operating specifications of the bionic system permit that patient performs the walking function.","Up to 20 sessions that corresponds up to 8 weeks",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"NA","SINGLE_GROUP","DEVICE_FEASIBILITY",{"masking":19,"maskingDescription":13,"whoMasked":13},"NONE","The main objective of this study is to demonstrate that the AWAKE device is safe and functions properly for its intended use and for the users for whom it is designed; that is, so that patients with hemiplegia or hemiparesis secondary to a stroke (ACV) can safely perform walking functions together with a companion, provided that both have successfully completed the planned training program.\n\nThe secondary objectives are:\n\nTo evaluate the usability of the AWAKE device for the patient and, To evaluate the usability of AWAKE device for the regular caregiver of the patient.\n\nAdditionally, it will be assessed the following exploratory objectives:\n\nEvaluate the degree of dependence, functional status, gait quality, and quality of life of the patients at the beginning and end of the study. Evaluate the patients' perception of the usefulness of the AWAKE device.",[22],{"label":23,"type":24,"description":25,"interventionNames":26},"Robotic orthesis","EXPERIMENTAL","This arm permits to assess the usability of the device (bionic system) from the patient point of view",[27],"Device: Bionic System (AWAKE)",[29],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":13},"DEVICE","Bionic System (AWAKE)","Intervention involving the use of this bionic system to perform walking functions",[23],[35,39],{"name":36,"affiliation":37,"role":38},"Julian Mateus","Hospital d'Atenció Intermèdia Colisée Barcelona Isabel Roig","PRINCIPAL_INVESTIGATOR",{"name":40,"affiliation":41,"role":38},"Gabriel Fernando Sandoval","Germans Trias i Pujol Hospital",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":13,"email":47},"Comité de Ética de la Incestigació Germans Trias i Pujol","CONTACT","+34 93 497 8956","ceic.germanstrias@gencat.cat",{"name":49,"role":45,"phone":50,"phoneExt":13,"email":51},"Robopedics","+34 659440164","ivan@robopedics.com",{"type":53,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100659785","evaluation-of-the-safety-and-performance-of-the-awake-device-in-patients-with-hemiplegia-or-hemiparesis-secondary-to-stroke-acv-100659785",false,"NCT07867847","Evaluation of the Safety and Performance of the AWAKE Device in Patients With Hemiplegia or Hemiparesis Secondary to Stroke (ACV).","VAWAKE","Inclusion Criteria:\n\n* Adult, over 18 years old, diagnosed with hemiplegia or hemiparesis secondary to stroke.\n* Subacute or chronic phase of stroke.\n* Height between 155 and 185 cm. Weight between 50 and 100 kg.\n* Spasticity \\\u003C=3 according to the Modified Ashworth Scale (MAS) in the lower extremity affected.\n* Range of motion in the joints between 0º and 110º of flexion in the knee and 120º of flexion and 20º of extension in the hip.\n* To have a minimum functional level that permit the safe use of the device, including sufficient strength on the unaffected side, trunk control, and the ability to perform basic transfers with assistance. This requirement is met if the patient can maintain a supported standing position for at least 30 seconds and safely perform bed-to-chair and chair-to-standing transfers with assistance\u002Fsupervision","ALL","18 Years",{"count":64,"type":65},20,"ESTIMATED","INTERVENTIONAL",[15],"Stroke is a leading cause of disability in adults, with gait impairment being a key functional limitation. Although lower limb exoskeletons are used in rehabilitation, the available evidence focuses on bilateral devices used in clinical settings with continuous supervision by healthcare professionals, and is limited for solutions with alternative configurations and usage conditions.\n\nThe AWAKE device is designed as a compensatory solution for gait impairment following stroke. It features a unilateral configuration, low weight, and a design intended for use with a companion (not necessarily a medical professional) in broader settings. The purpose of this study is to demonstrate that the AWAKE device is safe and functions properly for its intended use in patients with hemiplegia or hemiparesis secondary to a stroke, together with a companion, provided that both have successfully completed the planned training and education program.\n\nThis is a prospective, multicenter, single-arm, open-label, interventional clinical study designed to evaluate the safety and performance of the AWAKE device in patients with hemiplegia or hemiparesis secondary to stroke, along with their usual companion.\n\nThe total number of patients will be:\n\nTwenty pairs (patient + regular companion) will be recruited and equally divided between two participating centers.\n\nEach pair will undergo 10 to 20 sessions, two or three times per week, under the supervision of healthcare professionals previously trained by the manufacturer.",[70,71],"Hemiplegia","Hemiparesis",[73,70,71],"Stroke","NOT_YET_RECRUITING","2026-10-08",{"date":77,"type":78},"2026-10-09","ACTUAL",{"date":80,"type":65},"2026-09-21",{"date":82,"type":65},"2026-12-31",{"name":5,"class":6}]