Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2025-12-30 @ 4:05 PM
Study NCT ID:
NCT06753006
Status:
RECRUITING
Last Update Posted:
2025-01-01
First Post:
2024-12-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Research on the Effectiveness of Neurorehabilitation After Stroke
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000083242', 'term': 'Ischemic Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants will be evaluated by blinded assessors before being assigned to one of the study arms, and their rehabilitation outcomes will also be assessed by blinded assessors.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomly assigned to either one of three experimental groups or a control group.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-31', 'studyFirstSubmitDate': '2024-12-21', 'studyFirstSubmitQcDate': '2024-12-21', 'lastUpdatePostDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'ICF', 'timeFrame': 'From enrollment to the end of treatment at 2-3 weeks', 'description': 'The International Classification of Functioning, Disability and Health, known more commonly as ICF, is a classification of health and health-related domains. The ICF will be used to assess the impairment of body functions resulting from a stroke. Details available at https://www.who.int/standards/classifications/international-classification-of-functioning-disability-and-health'}], 'primaryOutcomes': [{'measure': 'FMA-UE A-D', 'timeFrame': 'From enrollment to the end of treatment at 2-3 weeks', 'description': "The Fugl-Meyer Assessment for Upper Extremity, parts A-D (FMA-UE A-D) evaluates a patient's motor function, with scores ranging from 0 (indicating the most severe impairment) to 66 (indicating no impairment). Details available at https://www.gu.se/en/neuroscience-physiology/fugl-meyer-assessment."}, {'measure': 'ARAT', 'timeFrame': 'From enrollment to the end of treatment at 2-3 weeks', 'description': "The Action Research Arm Test (ARAT) evaluates a patient's ability to handle objects of various sizes, weights, and shapes, making it a specific measure of arm-related activity limitations. Scores range from 0 (indicating the most severe impairment) to 57 (indicating no impairment). Details available at https://strokengine.ca/en/assessments/action-research-arm-test-arat."}], 'secondaryOutcomes': [{'measure': 'NIHSS', 'timeFrame': 'From enrollment to the end of treatment at 2-3 weeks', 'description': "Dynamics according to the National Institutes of Health Stroke Scale (NIHSS) that assesses a stroke patient's neurological impairment and degree of recovery for patients with stroke in the range from 0 (no impairment) to 42 (very severe impairment). Details available at https://strokengine.ca/en/assessments/nihss."}, {'measure': 'Ashworth', 'timeFrame': 'From enrollment to the end of treatment at 2-3 weeks', 'description': "Dynamics according to the Ashworth Spasticity Scale that assesses a patient's spasticity in the range from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension). Details available at https://www.sralab.org/rehabilitation-measures/ashworth-scale-modified-ashworth-scale."}, {'measure': 'RMI', 'timeFrame': 'From enrollment to the end of treatment at 2-3 weeks', 'description': "Dynamics according to the Rivermead Mobility Index (RMI) that assesses a patient's functional abilities such as gait, balance, and transfers in the range from 0 (worst mobility performance) to 15 (best mobility performance). Details available at https://strokengine.ca/en/assessments/rivermead-mobility-index-rmi."}, {'measure': 'MRS', 'timeFrame': 'From enrollment to the end of treatment at 2-3 weeks', 'description': "Dynamics according to the Modified Rankin Scale (MRS) that assesses a patient's level of functional independence in the range from 0 (no symptoms) to 5 (severe disability). Details available at https://strokengine.ca/en/assessments/modified-rankin-scale-mrs."}, {'measure': 'SF-36', 'timeFrame': 'From enrollment to the end of treatment at 2-3 weeks', 'description': "The SF-36 is a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being. Scores range from 0 (maximum disability) to 100 (no disability). Details available at https://nexusipe.org/advancing/assessment-evaluation/short-form-sf-36-health-survey."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Stroke', 'Rehabilitation', 'Brain-Computer Interface', 'Motor Imagery', 'Robotics', 'Virtual Reality', 'Neurofeedback'], 'conditions': ['Stroke', 'Stroke Acute', 'Stroke with Hemiparesis', 'Stroke, Acute', 'Stroke, Acute, Ischemic', 'Stroke, Ischemic']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "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/or heart attack within the 30 days preceding the study.\n* Recurrent stroke.\n* Uncontrolled arterial hypertension.\n* Ataxia.\n* Presence of a pacemaker and/or 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."}, 'identificationModule': {'nctId': 'NCT06753006', 'briefTitle': 'Research on the Effectiveness of Neurorehabilitation After Stroke', 'organization': {'class': 'INDUSTRY', 'fullName': 'Neurotechnika'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'NT-STROKE-2024-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': '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.', 'interventionNames': ['Procedure: Standard course']}, {'type': 'EXPERIMENTAL', 'label': 'MI+VR', 'description': '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.', 'interventionNames': ['Device: Neurorehabilitation simulator', 'Procedure: Standard course']}, {'type': 'EXPERIMENTAL', 'label': 'MI2+VR', 'description': '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.', 'interventionNames': ['Device: Neurorehabilitation simulator', 'Procedure: Standard course']}, {'type': 'EXPERIMENTAL', 'label': 'MI2', 'description': '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.', 'interventionNames': ['Device: Neurorehabilitation simulator', 'Procedure: Standard course']}], 'interventions': [{'name': 'Neurorehabilitation simulator', 'type': 'DEVICE', 'description': 'The participant must complete a mental task - imagine the movement of his arm. If successful, the robotic simulator moves the paralyzed limb.', 'armGroupLabels': ['MI+VR', 'MI2', 'MI2+VR']}, {'name': 'Standard course', 'type': 'PROCEDURE', 'description': 'The participant receives a standard course of intervention as prescribed by the attending physician in accordance', 'armGroupLabels': ['Control', 'MI+VR', 'MI2', 'MI2+VR']}]}, 'contactsLocationsModule': {'locations': [{'zip': '443095', 'city': 'Samara', 'state': 'Samara Oblast', 'status': 'RECRUITING', 'country': 'Russia', 'contacts': [{'name': 'Alexander Zakharov, Ph.D.', 'role': 'CONTACT', 'email': 'a.v.zaharov@samsmu.ru', 'phone': '+79171620301'}, {'name': 'Alexander Zakharov, Ph.D.', 'role': 'CONTACT'}], 'facility': 'Samara Regional Clinical Hospital named after V.D. Seredavin', 'geoPoint': {'lat': 53.20767, 'lon': 50.13553}}], 'centralContacts': [{'name': 'Vladimir Bulanov', 'role': 'CONTACT', 'email': 'vb@ntech.team', 'phone': '+79272081176'}, {'name': 'Alexander Zakharov, Ph.D.', 'role': 'CONTACT', 'phone': '+79171620301'}], 'overallOfficials': [{'name': 'Alexander Zakharov, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Samara State Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Only authorized members of the research team will have access to individual participant data (IPD). The research team will not share any IPD with third parties. However, de-identified demographic and clinical data-such as treatment details, baseline characteristics, and outcome measures-will be made publicly available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Neurotechnika', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Samara State Medical University', 'class': 'OTHER'}, {'name': 'Samara Regional Clinical Hospital V.D. Seredavin', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}