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

Author:

Hui Zhichong1ORCID,Qi Weihang1,Zhang Yi1,Wang Mingmei1,Zhang Jiamei1,Li Dong1,Zhu Dengna12ORCID

Affiliation:

1. Department of Rehabilitation Medicine, The Third Affiliated Hospital of Zhengzhou University, Zhengzhou 450052, China

2. Zhengzhou Key Laboratory of the Prevention and Cure of Cerebral Palsy Children, Zhengzhou 450052, China

Abstract

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.

Publisher

MDPI AG

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