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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | brain-computer interface rehabilitation training and traditional rehabilitation training. |
|
| Control group | Other | traditional rehabilitation training. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain-computer interface | Device | brain-computer interface rehabilitation training. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The improvement of upper limb motor function at 1 month after randomization. | Tested by Fugl-Meyer Assessment (FMA) scale. | 1 month after randomization compared with traditional rehabilitation strategy. |
| Measure | Description | Time Frame |
|---|---|---|
| The improvement of upper limb motor function at 3 month after randomization. | Tested by Fugl-Meyer Assessment (FMA) scale. | 3 months after randomization compared with traditional rehabilitation strategy . |
| The improvement of upper limb motor function at 1, 3 month after randomization. |
| Measure | Description | Time Frame |
|---|---|---|
| The changes of brain network properties. | Evaluated by fMRI before and after rehabilitaion. | 1 month and 3 months after randomization. |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China National Clinical Research Center for Neurological Diseases | Beijing | Beijing Municipality | 100070 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38642555 | Derived | Wang A, Tian X, Jiang D, Yang C, Xu Q, Zhang Y, Zhao S, Zhang X, Jing J, Wei N, Wu Y, Lv W, Yang B, Zang D, Wang Y, Zhang Y, Wang Y, Meng X. Rehabilitation with brain-computer interface and upper limb motor function in ischemic stroke: A randomized controlled trial. Med. 2024 Jun 14;5(6):559-569.e4. doi: 10.1016/j.medj.2024.02.014. Epub 2024 Apr 19. |
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All data described in the outcomes section are available on request to the corresponding author. The protocol and SAP was uploaded in the supplemental materials with the paper
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| Traditional rehabilitation |
| Other |
traditional rehabilitation training. |
|
Tested by Action Research Arm Test (ARAT), The Wolf Motor Function Test (WMFT). |
| 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). | 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). | 1, 3 months after randomization compared with traditional rehabilitation strategy. |
| ID | Term |
|---|---|
| D062207 | Brain-Computer Interfaces |
| ID | Term |
|---|---|
| D055615 | Electrical Equipment and Supplies |
| D004864 | Equipment and Supplies |
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