BCI-PT: the Effectiveness of Brain-computer Interface-pedaling Training System on the Rehabilitation of Stroke
Study Details
Study Description
Brief Summary
Stroke has become the first cause of death and disability among Chinese adults. 70%-80% of patients cannot live independently due to disability, which has brought a heavy burden to families, medical institutions and society. How to better evaluate and improve post-stroke motor and cognitive dysfunction has always been a hot research topic. With the rapid development of brain-computer interface technology, rehabilitation assessment based on quantitative EEG analysis is gradually being applied in the medical field. So we designed a brain-computer interface based on hierarchical task induction-pedaling rehabilitation training system to investigate the effectiveness on the rehabilitation of stroke patients.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Brain-computer Interface-Pedaling Training System
|
Device: Brain-computer Interface-Pedaling Training System
The Brain-computer Interface-Pedaling Training System includes four parts: computer, monitor, EEG testing equipment and pedaling training equipment. The patient wears an EEG detection device, which calculates brain movement participation every 0.5 seconds. The system will provide real-time visual/auditory/somatosensory feedback to patients based on the results of participation, so that patients can participate in motor function training more attentively.
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| Sham Comparator: Traditional Pedaling Training System Patients wear the same EEG equipment that only collect data, but not guide training. |
Device: Traditional Pedaling Training System
The patient will wear the same EEG equipment that will only collect data, but not guide training.
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Outcome Measures
Primary Outcome Measures
- The change of Fugl-Meyer motor function score of lower limbs [Two weeks after enrollment.]
The score range is 0-34 points, the higher the score, the better the motor function of lower limb.
Secondary Outcome Measures
- Attention index [Two weeks after enrollment.]
We used EEG equipment to calculate attention index which ranges 0-100 points. The higher the score, the higher the participation.
- Digital Span Test (DST) [Two weeks after enrollment.]
The more correct numbers you recite, the greater your attention span.
- Symbol Digit Modalities Test (SDMT) [Two weeks after enrollment.]
The more numbers converted, the better the ability to shift and maintain attention.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Aged 40-80 years old；
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Patients with first ischemic stroke onset from 1 week to 3 months；
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Hemiplegia and cognitive impairment (Mini-Mental State Examination (MMSE) score <28 or Montreal Cognitive Assessment (MoCA) <25)；
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Consciousness, sitting balance level 1 or above, can cooperate with assessment and treatment;
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The patient or its authorized agent signs the informed consent form.
Exclusion Criteria:
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Severely impaired cognition, unable to pay attention to and understand screen information;
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Severe pain and limited mobility of lower extremity.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | First Affiliated Hospital of Xi'an Jiaotong University | Xi'an | Shaanxi | China | 710000 |
Sponsors and Collaborators
- First Affiliated Hospital Xi'an Jiaotong University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- XJUFH-R-001