Brain-computer Interface, Rehabilitation, Stroke
Conditions
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.
Interventions
DEVICEBrain-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.
DEVICETraditional Pedaling Training System
The patient will wear the same EEG equipment that will only collect data, but not guide training.
Sponsors
First Affiliated Hospital Xi'an Jiaotong University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Outcome results
None listed