Purpose: The effectiveness of robot-assisted gait training (RAGT) in children with cerebral palsy (CP), especially in terms of improving the performance of daily activities, remains unclear. Therefore, we aimed to investigate the effectiveness of RAGT in children with CP. Methods: In this single-center, single-blinded, randomized cross-over trial, we enrolled 20 children with CP with Gross Motor Function Classification System (GMFCS) levels II–IV (13 males; age range, 6.75 ± 2.15 years). The participants were randomized into the RAGT/standard care (SC) (n = 10) and SC/RAGT/SC sequence groups (n = 10). Using a Walkbot-K system, the RAGT program comprised 3 × 30-min sessions/week for 6 weeks with a continued SC program. The SC program comprised 2–4 conventional physiotherapy sessions/week for 6 weeks. The Gross Motor Function Measure-88 (GMFM-88), the pediatric functional independence measure (WeeFIM), and the Canadian occupational performance measure (COPM) scores were assessed pre- and post-RAGT or SC periods and treatment, period, follow-up, and carry-over effects were analyzed. Energy expenditure and body composition were measured pre- and post-RAGT. Results: Significant treatment effects were observed in dimensions D and E of the GMFM (D: p = 0.018; E: p = 0.021) scores, WeeFIM mobility subtotal (p = 0.007), and COPM performance (p < 0.001) and satisfaction (p = 0.001) measure scores. The period, follow-up, and carry-over effects were not statistically significant. The gross energy cost significantly decreased (p = 0.041) and the skeletal muscle mass increased (p = 0.014) at post-RAGT assessment. The factors associated with functional outcomes showed significant improvements in the GMFM D scores and were mainly observed in children with GMFCS levels II–III compared to those classified at level IV (p = 0.038). Conclusion: RAGT had training benefits for children with CP. Specifically, it improved locomotor function and functional capability for daily activities. These effects were better in ambulatory children with CP. However, as SC interventions continued during the RAGT period, these improvements may be also related to multiple treatment effects.
Lessons learned from conducting a pragmatic, randomized, crossover trial on robot-assisted gait training in children with cerebral palsy (PeLoGAIT)