FreeD-Enabled Robotic Gait Training Enhances Recovery in Incomplete SCI With Poor Ambulatory Capacity: A Randomized Controlled Trial

Study design Randomized controlled trial Objective To investigate whether dynamic pelvic movement via the FreeD module enhances the effect of robotic gait training in individuals with incomplete spinal cord injury (SCI), and to explore its differential impact based on baseline ambulatory function. Setting Tertiary rehabilitation hospital. Methods Thirty participants with incomplete SCI within 6 months of injury were assigned to one of three groups: (1) conventional therapy (control), (2) Lokomat-assisted gait training without FreeD module (wo-FDM), and (3) Lokomat with FreeD module (w-FDM). All received 20 sessions over 4 weeks. Primary outcomes were the Lower Extremity Motor Score (LEMS), Ambulatory Motor Index (AMI), and proprioception score. Secondary outcomes included the Berg Balance Scale (BBS), Walking Index for SCI-II (WISCI-II), and SCIM-III. Subgroup analyses were performed based on baseline AMI scores. Results Both Lokomat groups showed significant improvements in motor and functional outcomes. AMI improved in the wo-FDM (12.0 to 17.0, p = 0.034) and w-FDM groups (13.0 to 19.5, p = 0.002). Post-hoc analysis confirmed greater AMI gains in w-FDM versus control (p = 0.040). Among participants with low baseline AMI, w-FDM led to significant gains in both LEMS (25.0 to 34.0, p = 0.009) and AMI (12.0 to 16.0, p = 0.009), with significant between-group differences in ΔLEMS (p = 0.024) and ΔAMI (p = 0.028). Conclusions Lokomat-assisted gait training improved motor and functional outcomes in individuals with incomplete SCI. The effect was most pronounced in individuals with lower baseline motor scores, supporting a personalized approach to robotic rehabilitation.