Stroke
Conditions
Interventions
Experimental Group:Brain Computer Interface Integrated Robotic Mirror Therapy
Sponsors
Beijing Tiantan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
30 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged 30 to 80 years; 2.Patients with unilateral upper limb motor dysfunction caused by primary ischemic/hemorrhagic stroke within 1 to 6 months prior to enrollment; 3.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; 4.Modified Rankin Scale (mRS) score of 0 to 2 before stroke onset; 5.Fugl-Meyer Motor Function Assessment of Upper Extremities (FMA-UE) score of 10 to 42; 6.Montreal Cognitive Assessment (MoCA) score > 18; 7.Fugl-Meyer Balance Assessment score > 6; 8.Normal binocular visual acuity or corrected visual acuity; 9.Normal hearing and intact verbal comprehension ability; 10.Provided written informed consent;
Exclusion criteria
Exclusion criteria: 1.Patients with other severe cardiovascular and cerebrovascular diseases and unstable vital signs; 2.Patients with motor dysfunction caused by other etiologies, such as amyotrophic lateral sclerosis, myasthenia gravis, muscular dystrophy, hypokalemic periodic paralysis, spondylitis, arthritis, osteomyelitis, etc. 3.Patients with severe diseases of the lungs, liver, kidneys and other vital organs; 4.Patients with limb movement impairment caused by diseases such as fractures and arthritis; 5.Modified Ashworth Scale (MAS) score > 3; 6.Patients unable to understand and cooperate with limb rehabilitation training due to factors such as severe aphasia; 7.Presence of severe visual field defects or visual impairments (e.g., hemianopsia, hemispatial neglect, etc. 8.History of previous stroke; 9.A history of severe motor injury and/or surgical intervention of the affected upper limb, such as muscle tear, tendon rupture, rhabdomyolysis; 10.Life expectancy of less than 1 year due to the underlying disease; 11.Undergoing major surgery within the past 30 days or planning to undergo major surgery within the next 90 days; 12.Pregnant or lactating women; 13.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; 14.With definite psychiatric and psychological disorders, such as depression, anxiety disorder, obsessive-compulsive disorder, schizophrenia, autism, chronic sleep disorder, consciousness disorder, etc. 15.Having implanted electronic devices in the body that interfere with magnetic resonance imaging (MRI), such as cochlear implants, cardiac pacemakers/defibrillators, drug delivery pumps; 16.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; 17.Having been enrolled in other clinical studies that conflict with this study; 18.Judged by the Indication Evaluation Committee as ineligible for or not falling within the scope of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer Motor Function Assessment of Upper Extremities; | — |
Secondary
| Measure | Time frame |
|---|---|
| Montreal Cognitive Assessment;functional Magnetic Resonance Imaging;Modified Barthel Index;Electroencephalographic;Modified Ashworth Scale;Wolf Motor Function Test; | — |
Countries
China
Contacts
Public ContactCao Yong
Beijing Tiantan Hospital, Capital Medical University
Outcome results
None listed