+As children with cerebral palsy (CP) experience gait impairments that significantly impact daily activities and social integration, a key therapeutic goal in children with cerebral palsy (CP) is to enhance their walking ability. The technologically advanced robot-assisted gait training (RAGT) may contribute to effective rehabilitation; however, evidence on their effectiveness in children with CP is weak and inconsistent. Specifically, there is a lack of multicenter large-scale randomized clinical trials examining the effects of overground wearable exoskeleton RAGT in children with CP. Torque-assisted wearable RAGT device is a recently developed robotic suit that allows training on various terrains and can assist joint motion based on assist-as-needed control; however, few have been tailored for children. This prospective, single-blinded randomized clinical trial thus investigated the effects of overground RAGT using an untethered, torque-assisted, wearable exoskeletal robot in children with CP from 5 pediatric rehabilitation centers in Korea. 90 children with CP aged 6 to 15 years and 98 to 150 cm tall were randomly assigned 1:1 to the intervention or control group. The experimental group underwent 30 minutes of RAGT, whereas the control group underwent 30 minutes of conventional physical therapy (PT) 3 days per week for 6 weeks. Functional and kinematic assessments were performed for all patients at baseline, at the end of the 6-week intervention, and after the 4-week follow-up to investigate effect maintenance. In total, 78 participants completed the intervention, with 37 participants in the RAGT group (mean [SD] age, 9.57 [2.38] years; 18 [48.6%] female), and 41 participants in the control group (mean [SD] age, 9.32 [2.37] years; 15 [36.6%] female). Post-intervention assessments found that compared to the control group, the RAGT group showed significantly improved gross motor function as measured by the GMFM-88 total (mean difference, 2.64; 95% CI, 0.50-4.78), dimension E (mean difference, 2.70; 95% CI, 0.08-5.33), and GMFM-66 (mean difference, 2.52; 95% CI, 0.42-4.63) scores. Changes in Pediatric Evaluation of Disability Inventory–Computer Adaptive Test (PEDI-CAT) responsibility domain scores were also greater in the RAGT group compared with the control group (mean difference, 2.52; 95% CI, 0.42-4.63), indicating independence in daily living. As immediate increases in the GMFM-88 total, dimension E, and GMFM-66 scores in the RAGT group were 2.7%, 2.3%, and 1.2%, respectively, minimal clinically important difference (MCID) thresholds were achieved after the intervention, indicating clinically significant improvements. Furthermore, compared to the control at the 4-week follow-up, the RAGT group showed significantly greater improvements in balance control (mean difference, 1.48; 95% CI, 0.03-2.94) and Gait Deviation Index (mean difference, 6.48; 95% CI, 2.77- 10.19). Overall, study results suggest that this new torque-assisted wearable exoskeletal robot can provide adequate assistance and therapeutic support that can complement standard rehabilitation for children with CP.
+©2024 2 Minute Medicine, Inc. All rights reserved. No works may be reproduced without expressed written consent from 2 Minute Medicine, Inc. Inquire about licensing here. No article should be construed as medical advice and is not intended as such by the authors or by 2 Minute Medicine, Inc.