[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Neurotechnika\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":52},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":33,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":5},"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":20,"type":21},44,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27,28,29,30,31,32],"Stroke","Stroke Acute","Stroke with Hemiparesis","Stroke, Acute","Stroke, Acute, Ischemic","Stroke, Ischemic",[27,34,35,36,37,38,39],"Rehabilitation","Brain-Computer Interface","Motor Imagery","Robotics","Virtual Reality","Neurofeedback","RECRUITING","2024-12-31",{"date":43,"type":44},"2025-01-01","ACTUAL",{"date":46,"type":44},"2024-08-27",{"date":48,"type":21},"2025-07",{"name":50,"class":51},"Neurotechnika","INDUSTRY",""]