This study aims to utilize non-invasive brain-computer interface technology in conjunction with mirror therapy to design a new paradigm for rehabilitation robots to induce compensatory movements on the healthy side in stroke patients, evaluate the potential rehabilitation value of this paradigm for patients with severely impaired motor areas on the affected side, explore the neural rehabilitation compensation mechanism, and provide more personalized rehabilitation treatment strategies for patients with post-stroke motor dysfunction.
Aged 30 to 80 years
Patients with unilateral upper limb motor dysfunction caused by primary ischemic/hemorrhagic stroke within 1 to 6 months prior to enrollment
Cerebral magnetic resonance diffusion-weighted imaging (DWI) at the time of onset indicating that the stroke lesion is limited to the unilateral basal ganglia region
Modified Rankin Scale (mRS) score of 0 to 2 before stroke onset
Patients with other severe cardiovascular and cerebrovascular diseases and unstable vital signs
Patients with motor dysfunction caused by other etiologies, such as amyotrophic lateral sclerosis, myasthenia gravis, muscular dystrophy, hypokalemic periodic paralysis, spondylitis, arthritis, osteomyelitis, etc.
Patients with severe diseases of the lungs, liver, kidneys and other vital organs
Patients with limb movement impairment caused by diseases such as fractures and arthritis
Parallel
Brain computer interface-robotic mirror therapy
DeviceBCI-RMT was performed by acquiring electroencephalographic signals from the unaffected hemisphere via a brain-computer interface, analyzing the signals with artificial intelligence, and finally delivering assisted motor function rehabilitation for the affected upper extremity via an intelligent exoskeleton training robot.
Changes in Fugl-Meyer Assessment of the Upper Extremity for the affected upper limb at the forth week after enrollment.
The primary outcome measure of this study was the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE), which was employed to assess upper limb motor function in patients. The FMA-UE consists of 33 items, each graded on a 0-2 scale (0 = unable to perform, 1 = partially accomplished, 2 = fully accomplished), with a total score ranging from 0 to 66; higher scores indicate superior upper limb motor function. This scale enables comprehensive evaluation of joint range of motion, reflex activity, isolated motor control, and coordination in the hemiplegic upper extremity of stroke patients.
The improvement in the Fugl-Meyer Assessment of the Upper Extremity (FMA-UE) for the affected upper limb at the eighth week after enrollment.
The FMA-UE consists of 33 items, each graded on a 0-2 scale (0 = unable to perform, 1 = partially accomplished, 2 = fully accomplished), with a total score ranging from 0 to 66; higher scores indicate superior upper limb motor function. This scale enables comprehensive evaluation of joint range of motion, reflex activity, isolated motor control, and coordination in the hemiplegic upper extremity of stroke patients.
Changes in neural conduction pathways at the forth week after enrollment.
Diffusion Tensor Imaging (DTI) enables visualization of cerebral white matter fiber tracts and assessment of the repair of neural conduction pathways. In this study, the unaffected primary motor cortex (M1) was used as the seed region, and the ipsilesional cervical spinal cord was set as the target region. Fractional Anisotropy (FA) values of the fiber tract were extracted. A higher FA value indicates greater integrity of the fiber tract and stronger neural conduction ability.
Differences in changes of electroencephalographic (EEG) signals at the forth week after enrollment.
Electroencephalographic signal acquisition enables the analysis of time-frequency characteristics, spatial features, and functional connectivity in patients before and after rehabilitation intervention. Time-frequency analysis serves as a primary approach to evaluating the efficacy of BCI-RMT training. Spatial feature analysis enables the detailed visualization of the spatial distribution of ERD/ERS in the form of brain topographic maps, which is particularly well-suited for monitoring the spatial pattern of compensatory activation in the unaffected hemisphere and its longitudinal changes throughout the training process. Functional connectivity analysis is primarily employed to investigate information connectivity and exchange patterns among motor-related brain regions.
Improvements in the Wolf Motor Function Test of the affected upper extremity at the forth week and the eighth week after enrollment.
The Wolf Motor Function Test (WMFT) also enables quantitative evaluation of motor function in the hemiplegic upper extremity among stroke patients, with a specific emphasis on the quality of movement execution. As a complementary measure to the FMA-UE, it simulates daily functional activities more comprehensively, covering tasks from single-joint isolated movements (e.g., lateral elbow extension) to multi-joint complex actions (e.g., towel folding). The WMFT comprises 15 items scored according to movement fluency, coordination and accuracy, with each item rated on a 0-5 scale and a total score ranging from 0 to 75; higher scores reflect better upper extremity motor function.
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