Efficacy of a Soft Robotic Exoskeleton to Improve Lower Limb Motor Function in Children with Spastic Cerebral Palsy: A Single-Blinded Randomized Controlled Trial

Purpose: Soft robotic exoskeletons (SREs) are portable, lightweight assistive technology with therapeutic potential for improving lower limb motor function in children with cerebral palsy. To understand the effects of long-term SRE-assisted walking training on children with spastic cerebral palsy (SCP), we designed a study aiming to elucidate the effects of SRE-assisted walking training on lower limb motor function in this population. Methods: In this randomized, single-blinded (outcome assessor) controlled trial, forty children diagnosed with SCP were randomized into the routine rehabilitation (RR) group (N = 20) and the SRE group (N = 20) for comparison. The RR group received routine rehabilitation training, and the SRE group received routine rehabilitation training combined with SRE-assisted overground walking training. Assessments (without SRE) were conducted pre- and post-intervention (8 weeks after the intervention). The primary outcome measures included the 10 m walk test (10MWT) and the 6 min walk test (6MWT). Secondary outcome measures comprised the gross motor function measure-88, pediatric balance scale modified Ashworth scale, and physiological cost index. Results: Both groups showed significant improvements (p < 0.01) across all outcome measures after the 8-week intervention. Between-group comparisons using ANCOVA revealed that the SRE group demonstrated greater improvement in walking speed from the 10MWT (+6.78 m/min, 95% CI [5.74-7.83]; p < 0.001) and walking distance during the 6MWT (+34.42 m, 95% CI [28.84-39.99]; p < 0.001). The SRE group showed greater improvement in all secondary outcome measures (p < 0.001). Conclusions: The study findings suggested that the integration of SRE-assisted overground walking training with routine rehabilitation more effectively enhances lower limb motor function in children with SCP compared to routine rehabilitation alone.