[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573955":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":40,"centralContacts":45,"locations":53,"responsibleParty":72,"collaborators":74,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":34,"eligibilityCriteria":85,"healthyVolunteers":81,"sex":86,"minAge":87,"maxAge":88,"enrollmentInfo":89,"targetDuration":34,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":103,"overallStatus":56,"whyStopped":34,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":119},{"fullName":5,"class":6},"Neurotechnika","INDUSTRY",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Control","ACTIVE_COMPARATOR","The Control group receives a standard course of intervention (14-21 days) as prescribed by the attending physician, in accordance with the standards of the Ministry of Health of the Russian Federation for the provision of medical care to people who have suffered a stroke.",[13],"Procedure: Standard course",{"label":15,"type":16,"description":17,"interventionNames":18},"MI+VR","EXPERIMENTAL","In addition to the standard course of intervention, the MI+VR group undergoes 10-12 sessions using a novel simulator involving the paretic arm with immersion in virtual reality.",[19,13],"Device: Neurorehabilitation simulator",{"label":21,"type":16,"description":22,"interventionNames":23},"MI2+VR","In addition to the standard course of intervention, the MI2+VR group undergoes 10-12 sessions using a novel simulator involving both arms (healthy and paretic) with immersion in virtual reality.",[19,13],{"label":25,"type":16,"description":26,"interventionNames":27},"MI2","In addition to the standard course of intervention, the group MI2 undergoes 10-12 sessions using a novel simulator involving both arms (healthy and paretic) without immersion in virtual reality, using a computer display instead.",[19,13],[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DEVICE","Neurorehabilitation simulator","The participant must complete a mental task - imagine the movement of his arm. If successful, the robotic simulator moves the paralyzed limb.",[15,25,21],null,{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":34},"PROCEDURE","Standard course","The participant receives a standard course of intervention as prescribed by the attending physician in accordance",[9,15,25,21],[41],{"name":42,"affiliation":43,"role":44},"Alexander Zakharov, Ph.D.","Samara State Medical University","PRINCIPAL_INVESTIGATOR",[46,51],{"name":47,"role":48,"phone":49,"phoneExt":34,"email":50},"Vladimir Bulanov","CONTACT","+79272081176","vb@ntech.team",{"name":42,"role":48,"phone":52,"phoneExt":34,"email":34},"+79171620301",[54],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"Samara Regional Clinical Hospital named after V.D. Seredavin","RECRUITING","Samara","Samara Oblast","443095","Russia","RU",{"type":63,"coordinates":64},"Point",[65,66],50.13553,53.20767,{"lat":66,"lon":65},[69,71],{"name":42,"role":48,"phone":52,"phoneExt":34,"email":70},"a.v.zaharov@samsmu.ru",{"name":42,"role":48,"phone":34,"phoneExt":34,"email":34},{"type":73,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[75,77],{"name":43,"class":76},"OTHER",{"name":78,"class":76},"Samara Regional Clinical Hospital V.D. Seredavin","100573955","research-on-the-effectiveness-of-neurorehabilitation-after-stroke-100573955",false,"NCT06753006","Research on the Effectiveness of Neurorehabilitation After Stroke","A Study of Neurorehabilitation Based on Robotics, Brain-Computer Interface (BCI) and Virtual Reality (VR) in Patients with Upper Limb Paresis Due to Stroke in the Early Rehabilitation Period","Inclusion Criteria:\n\n* Signed written informed consent.\n* Age 18 to 80 years at the time of stroke onset.\n* Early rehabilitation period (up to 6 months post-stroke).\n* Diagnosis of acute cerebrovascular accident confirmed by MRI or CT.\n* Upper limb paresis severity between 0 and 3 on the 6-point Medical Research Council (MRC) muscle strength scale.\n* Ability and willingness to comply with the study protocol.\n* Demonstrated motivation for rehabilitation.\n\nExclusion Criteria:\n\n* Montreal Cognitive Assessment scale (MoCA) score less than 10 points.\n* Hamilton Depression Rating Scale (Ham-D) score greater than 18 points.\n* Modified Rankin Scale (mRS) score greater than 4 points.\n* Pre-existing conditions that cause decreased muscle strength or increased muscle tone in the upper limbs (e.g., cerebral palsy, traumatic brain injury) or rigidity (e.g., Parkinson's disease, contractures).\n* Advanced arthritis or significant limitation of upper limb range of motion.\n* Absence of part of the upper limb due to amputation for any reason.\n* Any medical condition that may affect the conduct of the study or patient safety (e.g., mental illness).\n* Alcohol abuse or recreational drug use within the 12 months preceding the study.\n* Use of experimental medications or medical devices within the 30 days preceding the study.\n* Inability to comply with research procedures, as determined by the researcher.\n* The severity of the patient's condition, based on neurological or physical status, does not permit full rehabilitation.\n* Visual acuity less than 0.2 in the weakest eye according to the Sivtsev visual acuity chart.\n* Unstable angina and\u002For heart attack within the 30 days preceding the study.\n* Recurrent stroke.\n* Uncontrolled arterial hypertension.\n* Ataxia.\n* Presence of a pacemaker and\u002For other implanted electronic devices.\n* Use of muscle relaxants.\n* Peripheral neuropathy.\n* Coexisting diseases in an exacerbation or decompensated stage requiring active treatment.\n* Allergic reactions or other skin lesions at the EEG electrode application sites at the time of the study.\n* Acute urinary tract infections.\n* Acute thrombophlebitis.\n* Any form of epilepsy.\n* Benign and malignant neoplasms.","ALL","18 Years","80 Years",{"count":90,"type":91},44,"ESTIMATED","INTERVENTIONAL",[94],"NA","This clinical trial aims to investigate the effectiveness of a novel neurorehabilitation technology for treating stroke in adults. The study will evaluate a simulator that combines robotic orthosis, a non-invasive brain-computer interface (BCI), and a virtual reality (VR) display. The goal of this trial is to advance stroke rehabilitation by exploring the potential benefits of these cutting-edge technologies.\n\nKey Research Questions:\n\nEfficacy: Does the new simulator significantly improve arm function compared to standard rehabilitation techniques?\n\nBCI Technology: Which approach - motor imagery of only the paretic arm or both the paretic and healthy arm - yields greater functional improvements?\n\nVR Contribution: How does the integration of VR enhance rehabilitation outcomes?\n\nSafety and Tolerability: What potential side effects or adverse events may arise from using the new simulator?\n\nParticipants who have suffered a stroke will undergo a standard rehabilitation course, during which 10-12 sessions will take place using the innovative simulator: a robotic device moves a patient's paralyzed arm at the command of a non-invasive brain-computer interface to perform a game task resembling real-life activities, augmented by a virtual reality display.\n\nResearchers will assess the impact of the new technology on arm function to determine its efficacy in promoting recovery.",[97,98,99,100,101,102],"Stroke","Stroke Acute","Stroke with Hemiparesis","Stroke, Acute","Stroke, Acute, Ischemic","Stroke, Ischemic",[97,104,105,106,107,108,109],"Rehabilitation","Brain-Computer Interface","Motor Imagery","Robotics","Virtual Reality","Neurofeedback","2024-12-31",{"date":112,"type":113},"2025-01-01","ACTUAL",{"date":115,"type":113},"2024-08-27",{"date":117,"type":91},"2025-07",{"name":5,"class":6},1]