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Kickstart外骨骼下肢行走系统对改善亚急性脑卒中患者下肢行走能力的影响:一项随机对照试验

Effect of the Kickstart exoskeleton lower extremity walking system on improving lower extremity walking ability in subacute stroke patients: a randomized controlled trial.

作者信息

Liang Chengpan, Wan Chunli, Yang Jinyu, Shen Xiaowen, Yu Cui, Shao Yi, Che Pei, Zhang Yuting, Li Yongqiang

机构信息

Wuxi Central Rehabilitation Hospital, The Affiliated Mental Health Center of Jiangnan University, Wuxi, 214151, Jiangsu, China.

The First Affiliated Hospital of Nanjing Medical University, 300 Guangzhou Road, Gulou District, Nanjing City, Jiangsu Province, China.

出版信息

J Neuroeng Rehabil. 2025 Jul 9;22(1):155. doi: 10.1186/s12984-025-01676-y.

Abstract

BACKGROUND

Walking dysfunction is a primary cause of a reduced ability to perform activities of daily living and decreased quality of life in stroke patients. The Kickstart Walk assist system is portable and easy to don and remove. There is a lack of high-quality, randomized controlled trials to validate its effectiveness. The aim of this study was to evaluate the effectiveness of the Kickstart Walk Assist system in improving lower limb muscle strength and walking ability in stroke patients.

METHODS

Forty-six patients were enrolled and randomly assigned to either a control group (n = 23) or a Kickstart group (n = 23). Both groups received conventional rehabilitation therapy. In addition, patients in the Kickstart group wore the Kickstart Walk Assist system for 20 min, and patients in the control group received walking training for 20 min. The outcome measures included the Fugl-Meyer Assessment of Lower Extremity Motor Function (FMA-LE), gait parameters, the 10MWT, the Borg Subjective Fatigue Scale (Borg), and surface electromyography (sEMG).

RESULTS

Compared with the control group, the Kickstart group showed more significant improvements in FMA-LE at 4 and 8 weeks (P = 0.025, P = 0.028), 10-MWT (P = 0.256), Borg at 8 weeks (P = 0.035), sEMG (P < 0.05), and gait parameters (P > 0.05). No adverse events were observed during or after the intervention.

CONCLUSION

The Kickstart Walk assist system can increase stroke patients' lower limb strength and motor function and improve their walking ability.

TRIAL REGISTRATION

This study was registered in the Chinese Clinical Trial Registry (Unique Identifier ChiCTR2300067605) on January 13, 2023.

摘要

背景

步行功能障碍是导致中风患者日常生活活动能力下降和生活质量降低的主要原因。Kickstart Walk辅助系统便于携带,穿戴和拆卸都很容易。目前缺乏高质量的随机对照试验来验证其有效性。本研究的目的是评估Kickstart Walk辅助系统对改善中风患者下肢肌肉力量和步行能力的有效性。

方法

招募了46名患者,随机分为对照组(n = 23)和Kickstart组(n = 23)。两组均接受常规康复治疗。此外,Kickstart组的患者佩戴Kickstart Walk辅助系统20分钟,对照组的患者接受20分钟的步行训练。结局指标包括下肢运动功能Fugl-Meyer评估(FMA-LE)、步态参数、10米步行试验(10MWT)、Borg主观疲劳量表(Borg)和表面肌电图(sEMG)。

结果

与对照组相比,Kickstart组在第4周和第8周的FMA-LE(P = 0.025,P = 0.028)、10MWT(P = 0.256)、第8周的Borg(P = 0.035)、sEMG(P < 0.05)和步态参数(P > 0.05)方面有更显著的改善。干预期间及干预后未观察到不良事件。

结论

Kickstart Walk辅助系统可以增强中风患者的下肢力量和运动功能,提高他们的步行能力。

试验注册

本研究于2023年1月13日在中国临床试验注册中心注册(唯一标识符ChiCTR2300067605)。

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