An interventional study of Non-invasive BCI training and Traditional Physiotherapy protocol in Stroke, Acute, sponsored by Xuanwu Hospital, Beijing. Status unknown. Open to participants aged 35 Years to 60 Years. Per ClinicalTrials.gov, last updated 2021-01-11.
Sponsored by Xuanwu Hospital, Beijing · Not applicable, Interventional, and Treatment
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.
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.
7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 5,369 interventional studies indexed under Stroke.
Browse Stroke studies →Xuanwu Hospital, Beijing is the lead sponsor of 346 studies on the registry; 217 are open to participants now.
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Exclusion Criteria:
The experimental group will receive brain computer interface-based lower limb function training (BCI-LLT), 30 minutes/time, 5 times/week, with a 4-week training period.. The training using the lower limb orthosis targeted the patient's ability to walk.
Device: Non-invasive BCI training
The control group will only receive traditional physical therapy protocol. The traditional physical therapy protocol of lower limb conducted with the same treatment frequency, intensity and duration of treatment, including muscle strength training, balance training and walking training, etc.
Other: Traditional Physiotherapy protocol
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.
In the control group，the participants receive the traditional physiotherapy protocol, including muscle strength training, balance training and walking training, etc.
Change in Fugl-Meyer score of lower limbs from baseline to 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.
Time frame: 0-4 weeks.
Functional ambulation category scale
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).
Time frame: 4 weeks and 90 days.
10-meter walk test
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).
Time frame: 4 weeks and 90 days.
Modified Barthel index
Scale range: 0-100 (with higher scores indicating a greater ability to complete activities of daily living)
Time frame: 4 weeks and 90 days.
National Institutes of Health Stroke Scale
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.
Time frame: 4 weeks and 90 days.
Gait analysis ( stride frequency, step length and velocity)
To evaluate the walking ability
Time frame: 4 weeks and 90 days.
Nodal functional connectivity strength analysis by functional magnetic resonance imaging
To evaluate the brain function and network
Time frame: 4 weeks and 90 days.
Changes in oxyhaemoglobin in related cortex by Functional near-infrared spectroscopy
To evaluate the brain cortex function.
Time frame: 4 weeks and 90 days.
The translocator protein(TSPO)-positron emission tomography (PET)
Respond to inflammation in the brain
Time frame: 4 weeks.
Fugl-Meyer score of lower limbs
It consists of 17 individual assessments that are summed to generate a total score. Scores range from 0-34, the higher the better.
Time frame: 90 days.
No study locations are listed for this record.
This study is status unknown, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Xuanwu Hospital, Beijing