Comparative Effectiveness of Passive vs. Assistive Robotic Gait Training on Functional Recovery and Neuroplasticity Post-Stroke: A Randomized Controlled Trial

Background Robot-assisted gait training (RAGT) has gained recognition as a promising therapeutic approach, offering high-intensity and repetitive training. Despite its potential, the clinical effectiveness and ideal training protocols continue to be subjects of debate. This study seeks to compare the impacts of various RAGT modes on lower limb motor function recovery in stroke patients while exploring the corresponding neural mechanisms. Methods A double-blind, randomized controlled trial was conducted on patients aged 18 to 80 who had experienced their first unilateral stroke accompanied by walking impairments. Participants were randomly assigned to one of three groups: (1) assistive mode training combined with conventional therapies, (2) passive mode training combined with conventional therapies, or (3) a control group receiving only traditional rehabilitation. Outcomes were evaluated using the Fugl-Meyer Assessment for Lower Extremity (FMA-LE), Berg Balance Scale (BBS), Modified Barthel Index (MBI), the Functional Ambulatory Category (FAC), and functional near-infrared spectroscopy. Statistical analyses were performed using repeated measures ANOVA and non-parametric tests where appropriate, with statistical significance set at p < 0.05. Results Among the 48 patients recruited, significant time effects were observed across all groups in FMA-LE scores (p < 0.001). Notable improvements were detected in the conventional group (MD = 2.688, p = 0.005) and the passive group (MD = 3.667, p < 0.001), with the assistive mode also demonstrating a significant effect (MD = 1.789, p = 0.039). BBS scores improved across all groups; however, no significant differences were noted between the groups (p = 0.106). Similarly, MBI scores showed a significant time effect (p < 0.001), without notable group differences (p = 0.286). Crucially, the assistive mode training group exhibited significant differences in brain activation during tasks in specific regions compared to the control group, alongside notable interhemispheric connectivity differences. Conclusions All training modalities effectively enhanced motor function, balance, and daily living skills in stroke patients. Nevertheless, unique activation patterns and neural pathways suggest distinct underlying mechanisms for each training approach. Trial Registration: The study was registered with the China Clinical Trial Registration Center under the trial registration number ChiCTR2100054527.