Stroke
Conditions
Interventions
experimental group:4-week motor imagery-based brain–computer interface-driven active and passive lower limb training
control group:4 weeks of conventional active and passive lower limb training
Sponsors
The Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis meets the diagnostic criteria for first-ever ischemic or hemorrhagic stroke according to the Chinese Guidelines for the Diagnosis and Treatment of Cerebrovascular Diseases, confirmed by cranial CT or MRI, with lesion location in the cortex or subcortex; 2. Aged 45 to 75 years (inclusive), either sex; 3. Time from onset: 1–3 months, with relatively stable condition; 4. Motor dysfunction of the affected lower limb, with Brunnstrom stage II–IV (i.e., presence of partial synergistic movements but inability to perform coordinated, rapid voluntary movements); 5. Mini-Mental State Examination (MMSE) score >= 24, clear consciousness, ability to understand and follow simple verbal instructions, and basic communication and learning ability; 6. Signed written informed consent, voluntary participation in this study, and commitment to cooperate with all evaluation and treatment procedures.
Exclusion criteria
Exclusion criteria: 1. History of other neurological diseases (e.g., Parkinson's disease, spinal cord injury, multiple sclerosis, myasthenia gravis, etc.) that may cause lower limb dysfunction, other than the current stroke; 2. Presence of severe joint contracture, unhealed fracture, bone or joint tumor, severe osteoporosis, or active arthritis on the affected lower limb, or severe pain that affects training; 3. Presence of skull defect, ulcer, infection at the EEG signal acquisition site, or known allergy to EEG electrodes or conductive gel; 4. Severely increased muscle tone with a Modified Ashworth Scale score >= 3; 5. Any other medical or psychosocial condition that, in the investigator's judgment, makes the patient unsuitable for participation in this study; 6. Recent or ongoing participation in other clinical trials that may interfere with the results of this study, or receipt of other similar neuromodulation therapies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fugl-Meyer Assessment Lower Extremity Section; | — |
Secondary
| Measure | Time frame |
|---|---|
| Berg Balance Scale (BBS);Modified Barthel Index(MBI);Functional Ambulation Classification (FAC); | — |
Countries
China
Contacts
Public ContactHongfei Qiao
The Second Affiliated Hospital of Xi 'an Jiaotong University
Outcome results
None listed