Background Brain computer interface (BCI) technology, as an innovative means to improve the limb function of stroke patients, has received extensive attention in recent years. However, there are few reports on the application of BCI technology in robot assisted stroke rehabilitation training and its impact on the rehabilitation effect of patients.

Objective To evaluate the clinical efficacy of robotic-assisted rehabilitation training for subacute stroke patients under the aegis of BCI technology and elucidate its influence on pertinent serum biomarkers.

Methods This study was a single-center, randomized, prospective clinical trial design. A total of 57 subacute stroke patients admitted to the First Affiliated Hospital of Air Force Medical University from March 2017 to August 2022 were selected, with 49 completing the study. Patients were randomly assigned into two groups using an envelope method: the control group received conventional rehabilitation training, while the BCI group underwent robot-assisted rehabilitation training with BCI technology assistance. The intervention period was 4 weeks. Motor function assessments and biochemical indicators were evaluated and compared between the two groups at baseline (T0), 1 week post-intervention (T1), 2 weeks post-intervention (T2), and 4 weeks post-intervention (T3).

Results There were no significant differences in baseline characteristics between the two groups. At baseline, there was no significant difference in the Loewenstein Occupational Therapy Cognitive Assessment (LOTCA) scores between the two groups (P=0.902). However, at the end of the intervention, the LOTCA scores in the BCI group were significantly higher than those in the control group (81.56 ± 13.26 vs 73.56 ± 12.81, P=0.037). Although there were no significant inter-group differences in Fugl-Meyer Assessment for Lower Extremity (FMA-LE) and Fugl-Meyer Assessment for Balance (FMA-B) scores at various time points (P＞0.05), both groups showed a significant improvement in FMA-LE and FMA-B scores from T0 at the end of the intervention (18.98 ± 5.16 vs 10.22 ± 3.69, 16.33 ± 7.05 vs 11.66 ± 5.98, P＜0.05; 9.55 ± 2.98 vs 3.66 ± 2.16, 8.35 ± 3.56 vs 4.11 ± 2.81, P＜0.05). In terms of neurotrophic factors (BDNF), there were no significant inter-group differences at baseline or at the end of the intervention (P=0.912, P=0.130), but BDNF levels at the end of the intervention were significantly higher than at baseline (106.59 ± 23.51 vs 89.69 ± 20.16, 96.35 ± 20.55 vs 90.35 ± 19.66, P＜0.05).

Conclusion The integration of BCI-controlled robotic training with conventional rehabilitation protocols holds promise for the amelioration of cognitive functions, enhancement of lower limb motor capabilities, and elevation of BDNF levels in subacute stroke patients.