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.
Key Research Questions:
Efficacy: Does the new simulator significantly improve arm function compared to standard rehabilitation techniques?
BCI Technology: Which approach - motor imagery of only the paretic arm or both the paretic and healthy arm - yields greater functional improvements?
VR Contribution: How does the integration of VR enhance rehabilitation outcomes?
Safety and Tolerability: What potential side effects or adverse events may arise from using the new simulator?
Participants 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.
Researchers will assess the impact of the new technology on arm function to determine its efficacy in promoting recovery.
Signed written informed consent.
Age 18 to 80 years at the time of stroke onset.
Early rehabilitation period (up to 6 months post-stroke).
Diagnosis of acute cerebrovascular accident confirmed by MRI or CT.
Montreal Cognitive Assessment scale (MoCA) score less than 10 points.
Hamilton Depression Rating Scale (Ham-D) score greater than 18 points.
Modified Rankin Scale (mRS) score greater than 4 points.
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).
Neurotechnika
Lead sponsor
Samara State Medical University
Collaborator
Samara Regional Clinical Hospital V.D. Seredavin
Collaborator