Prospective, Randomized, Parallel-Controlled Study of Brain Computer Interface Integrated Robotic Mirror Therapy for Post-Stroke Upper Limb Motor Function Disorder

This is a prospective, single-center, open-label, outcome-assessor-blinded, randomized, parallel-controlled clinical study initiated by investigators. Based on the post-stroke compensatory model theory, this study innovatively combines brain-computer interface and mirror robot technology to build a dynamic closed-loop feedback system. Using the contralesional compensatory activation mechanism and a designed robot training paradigm, it explores the efficacy of the intervention in improving upper limb motor function and its underlying neural recovery mechanisms.

Inclusion criteria

• Aged 30 to 80 years
• Patients with unilateral upper limb motor dysfunction caused by primary ischemic/hemorrhagic stroke within 1 to 6 months prior to enrollment
• Cerebral magnetic resonance diffusion-weighted imaging (DWI) at the time of onset indicating that the stroke lesion is limited to the unilateral basal ganglia region
• Modified Rankin Scale (mRS) score of 0 to 2 before stroke onset
• Fugl-Meyer Motor Function Assessment of Upper Extremities (FMA-UE) score of 10 to 42
• Montreal Cognitive Assessment (MoCA) score > 18
• Fugl-Meyer Balance Assessment score > 6
• Normal binocular visual acuity or corrected visual acuity
• Normal hearing and intact verbal comprehension ability
• Provided written informed consent

Exclusion criteria

• Patients with other severe cardiovascular and cerebrovascular diseases and unstable vital signs
• Patients with motor dysfunction caused by other etiologies, such as amyotrophic lateral sclerosis, myasthenia gravis, muscular dystrophy, hypokalemic periodic paralysis, spondylitis, arthritis, osteomyelitis, etc.
• Patients with severe diseases of the lungs, liver, kidneys and other vital organs
• Patients with limb movement impairment caused by diseases such as fractures and arthritis
• Modified Ashworth Scale (MAS) score > 3
• Patients unable to understand and cooperate with limb rehabilitation training due to factors such as severe aphasia
• Presence of severe visual field defects or visual impairments (e.g., hemianopsia, hemispatial neglect, etc.
• History of previous stroke
• A history of severe motor injury and/or surgical intervention of the affected upper limb, such as muscle tear, tendon rupture, rhabdomyolysis
• Life expectancy of less than 1 year due to the underlying disease
• Undergoing major surgery within the past 30 days or planning to undergo major surgery within the next 90 days
• Pregnant or lactating women
• History of drug or alcohol abuse, head trauma or central nervous system infection; current use of cognition-impairing medications such as psychoactive or sedative drugs
• With definite psychiatric and psychological disorders, such as depression, anxiety disorder, obsessive-compulsive disorder, schizophrenia, autism, chronic sleep disorder, consciousness disorder, etc.
• Having implanted electronic devices in the body that interfere with magnetic resonance imaging (MRI), such as cochlear implants, cardiac pacemakers/defibrillators, drug delivery pumps
• Poor compliance of the subject, their family members and caregivers, or inability to complete at least 12 months of follow-up as required by the study
• Having been enrolled in other clinical studies that conflict with this study
• Judged by the Indication Evaluation Committee as ineligible for or not falling within the scope of this study.