To evaluate the effectiveness and safety of rehabilitation training based on brain-computer interface in improving the upper motor function, self-care ability in daily life and quality of life in patients with ischemic stroke. This study adopts centralized uniform random 1:1 grouping, subjects will be randomly assigned to the experimental group and the control group. Randomization schemes are generated by statistical professionals using SAS software.
Brain computer interface(BCI) is a noninvasive nervous system intervention. As a new method, it is applied in rehabilitation by stimulating peripheral nerve, such as motor, vibration, sensory, in combination with other stimulations, such as transcranial magnetic stimulation, transcranial electrical stimulation, etc. In traditional rehabilitation therapy, hand-holding training is completed by physical therapist. Rehabilitation robot is also used for auxiliary training. BCI therapy will stimulate patients to take part in rehabilitation training more actively and obtain better effects on the rehabilitation of stroke.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
brain-computer interface rehabilitation training.
traditional rehabilitation training.
China National Clinical Research Center for Neurological Diseases
Beijing, Beijing Municipality, China
The improvement of upper limb motor function at 1 month after randomization.
Tested by Fugl-Meyer Assessment (FMA) scale.
Time frame: 1 month after randomization compared with traditional rehabilitation strategy.
The improvement of upper limb motor function at 3 month after randomization.
Tested by Fugl-Meyer Assessment (FMA) scale.
Time frame: 3 months after randomization compared with traditional rehabilitation strategy .
The improvement of upper limb motor function at 1, 3 month after randomization.
Tested by Action Research Arm Test (ARAT), The Wolf Motor Function Test (WMFT).
Time frame: 1, 3 months after randomization compared with traditional rehabilitation strategy.
The improvement in muscle tone at 1, 3 month after randomization.
Tested by the Modified Ashworth scale (MAS).
Time frame: 1, 3 months after randomization compared with traditional rehabilitation strategy.
The improvement of patients' ability to take care of themselves in daily life
Tested by Instrumental Activity of Daily living (IDAL).
Time frame: 1, 3 months after randomization compared with traditional rehabilitation strategy.
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