China National Clinical Research Center for Neurological Diseases
Beijing, Beijing Municipality, 100070, China
NCT Number: NCT04387474
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.
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Beijing, Beijing Municipality, 100070, China
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
brain-computer interface rehabilitation training.
traditional rehabilitation training.
Time frame: 1 month after randomization compared with traditional rehabilitation strategy.
Tested by Fugl-Meyer Assessment (FMA) scale.
Time frame: 3 months after randomization compared with traditional rehabilitation strategy .
Tested by Fugl-Meyer Assessment (FMA) scale.
Time frame: 1, 3 months after randomization compared with traditional rehabilitation strategy.
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.
Tested by the Modified Ashworth scale (MAS).
Time frame: 1, 3 months after randomization compared with traditional rehabilitation strategy.
Tested by Instrumental Activity of Daily living (IDAL).
Time frame: 1 month and 3 months after randomization.
Evaluated by fMRI before and after rehabilitaion.
Beijing Tiantan Hospital
Other
China National Clinical Research Center for Neurological Diseases
Acronym: REBUILT
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