the Effectiveness of Brain-computer Interface-pedaling Training System on the Rehabilitation of Stroke

Study Overview
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Brief Summary
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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.

Official Title
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the Effectiveness of Brain-computer Interface-pedaling Training System on Motor and Cognitive Function Rehabilitation of Stroke Patients

Conditions
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Rehabilitation, Stroke, Brain-computer Interface

Intervention / Treatment
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* Device: Brain-computer Interface-Pedaling Training System
* Device: Traditional Pedaling Training System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Aged 40-80 years old； Patients with first ischemic stroke onset from 1 week to 3 months； Hemiplegia and cognitive impairment (Mini-Mental State Examination (MMSE) score <28 or Montreal Cognitive Assessment (MoCA) <25)； Consciousness, sitting balance level 1 or above, can cooperate with assessment and treatment; The patient or its authorized agent signs the informed consent form. Exclusion Criteria: Severely impaired cognition, unable to pay attention to and understand screen information; Severe pain and limited mobility of lower extremity.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brain-computer Interface-Pedaling Training System<br> | Device: Brain-computer Interface-Pedaling Training System<br>* 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.<br>|
| Sham Comparator: Traditional Pedaling Training System<br>Patients wear the same EEG equipment that only collect data, but not guide training. | Device: Traditional Pedaling Training System<br>* The patient will wear the same EEG equipment that will only collect data, but not guide training.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of Fugl-Meyer motor function score of lower limbs | The score range is 0-34 points, the higher the score, the better the motor function of lower limb. | Two weeks after enrollment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attention index | We used EEG equipment to calculate attention index which ranges 0-100 points. The higher the score, the higher the participation. | Two weeks after enrollment. | 
| Digital Span Test (DST) | The more correct numbers you recite, the greater your attention span. | Two weeks after enrollment. | 
| Symbol Digit Modalities Test (SDMT) | The more numbers converted, the better the ability to shift and maintain attention. | Two weeks after enrollment. |