Stroke, Acute
Conditions
Keywords
Brain Computer Interface, Lower Limb Function Recovery, Brain Machine Interface
Brief summary
In order to explore the role and expound the mechanism of rehabilitative brain computer interface (BCI)-based training (referred to as the Walk Again Neurorehabilitation protocol) in neurofunctional reconstruction in acute phase of cerebral infarction, the investigators choose non-invasive BCI to study lower limb function of patients with acute cerebral infarction. The investigators evaluate lower limb function, the influence on the central brain functional network and relevant immuno-inflammatory indicators, so that the investigators can explore the therapeutic effect and mechanism in the acute phase of cerebral infarction and provide theoretical bases and feasible guidances for the treatment of post-stroke dyskinesia.
Detailed description
The participants will be randomly divided into experimental group and control group. The experimental group will receive BCI-based lower limb functional training, 30 minutes per time, 5 times per week, with a 4-week training period; the control group will only receive routine lower limb training, with the same treatment frequency, intensity and duration. Statistical analysis will be performed to compare the relevant evaluation indexes of the experimental group and the control group after treatment and 90 days. In this study, the investigators will use Lower Extremity Fugl-Meyer Assessment (LE-FMA) to comprehensively evaluate the function of lower limbs, Functional Ambulation Category Scale (FAC) and 10-meter walking test (10MWT) for walking ability, modified Barthel index (MBI) for daily living abilities, functional magnetic resonance imaging（fMRI）and near infrared functional brain imaging (NIRS) to evaluate brain function and network reconstruction, the translocator protein(TSPO)-positron emission tomography (PET) and blood immune inflammation indicators to evaluate systemic and intracranial immune status.
Interventions
DEVICENon-invasive BCI training
In the experimental group, the participants receive non-invasive rehabilitative BCI training. The training using the lower limb orthosis targeted the patient's ability to walk.
OTHERTraditional Physiotherapy protocol
In the control group，the participants receive the traditional physiotherapy protocol, including muscle strength training, balance training and walking training, etc.
Sponsors
Xuanwu Hospital, Beijing
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. The diagnosis of cerebral infarction conforms to the diagnostic criteria of Chinese guidelines for diagnosis and treatment of acute ischemic stroke 2018. 2. 35 ≤ age ≤ 60 . 3. Onset (last-seen-well) time to randomization time from 24-72 hours. 4. First onset. 5. The lesion is assessed by MRI as a single subcortical infarction of the anterior circulation. 6. 5 ≤NIHSS≤15 (and 1 ≤6a/b≤3 ). 7. 1 ≤FAC functional walking scale score ≤ 3. 8. Signed informed consent from subject or legally authorized representative.
Exclusion criteria
1. Unstable vital signs. 2. Progressive stroke. 3. Patients have received intravenous thrombolysis or endovascular treatment. 4. Cardiogenic cerebral embolism. 5. Presence of moderate or higher vascular stenosis or vulnerable plaque based on Imaging assessment. 6. With other diseases of the nervous system. 7. With serious diseases of other systems (severe circulatory system, respiratory system, motor system) and other diseases unsuitable for training, such as atrial fibrillation, heart failure, lung infection, severe liver or kidney insufficiency, lower extremity venous thrombosis. 8. Lower limb dysfunction caused by other reasons, such as fracture, lower limb deformity, etc. 9. With contraindications in imaging examinations, such as metal implantation, fear of claustrophobia, and severe obesity. 10. Patient who cannot cooperate with training, such as mental disorders, cognitive dysfunction, Mini-Mental State Examination (MMSE) \<21 points, etc. 11. Other reasons: alcoholism; pregnancy; skull defect; indwelling urinary catheter; vision defects affect training, etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Fugl-Meyer score of lower limbs from baseline to 4 weeks. | 0-4 weeks. | It consists of 17 individual assessments that are summed to generate a total score. Scores range from 0-34, the higher the better. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 10-meter walk test | 4 weeks and 90 days. | Gait speed will be measured as the average of 3 times 10-meter walk tests. Participants will be asked to walk at their normal comfortable pace (handheld assistive device is acceptable if needed). |
| Modified Barthel index | 4 weeks and 90 days. | Scale range: 0-100 (with higher scores indicating a greater ability to complete activities of daily living) |
| National Institutes of Health Stroke Scale | 4 weeks and 90 days. | The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. The range of scores is from 0 (normal) to 42, with higher scores indicating greater stroke severity. |
| Gait analysis ( stride frequency, step length and velocity) | 4 weeks and 90 days. | To evaluate the walking ability |
| Functional ambulation category scale | 4 weeks and 90 days. | This scale indicates the ability to walk independently and serves as the primary outcome measure.Participants will be asked to walk at their normal comfortable pace (handheld assistive device is acceptable if needed). |
| Changes in oxyhaemoglobin in related cortex by Functional near-infrared spectroscopy | 4 weeks and 90 days. | To evaluate the brain cortex function. |
| The translocator protein(TSPO)-positron emission tomography (PET) | 4 weeks. | Respond to inflammation in the brain |
| Fugl-Meyer score of lower limbs | 90 days. | It consists of 17 individual assessments that are summed to generate a total score. Scores range from 0-34, the higher the better. |
| Nodal functional connectivity strength analysis by functional magnetic resonance imaging | 4 weeks and 90 days. | To evaluate the brain function and network |
Contacts
Primary ContactJunwei Hao, MD,PHD
Backup ContactHaijie Liu, MD,PHD
Outcome results
None listed