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).
Parallel
Neurorehabilitation simulator
DeviceThe participant must complete a mental task - imagine the movement of his arm. If successful, the robotic simulator moves the paralyzed limb.
Standard course
Procedure/SurgeryThe participant receives a standard course of intervention as prescribed by the attending physician in accordance
FMA-UE A-D
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.
ARAT
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.
NIHSS
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.
Ashworth
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.
RMI
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.
MRS
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.
ICF
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
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Neurotechnika
Lead sponsor
Samara State Medical University
Collaborator
Samara Regional Clinical Hospital V.D. Seredavin
Collaborator
