2020年至2025年足踝软体外骨骼机器人改善脑卒中患者步行功能的Scoping综述

doi:10.3969/j.issn.1006-9771.2026.06.003

Abstract

Abstract:

Objective To explore effect of the ankle soft robotic exosuits(ASRE)on gait function in stroke patients.
Methods Databases including PubMed, Embase, Scopus, Web of Science, CNKI, Wanfang and VIP were searched for researches evaluating the impact of ASRE on gait function in stroke patients with hemiplegia, covering the period from January 1st, 2020 to May 1st, 2025. The PEDro scale and the Risk of Bias in Non-randomized Studies of Interventions tool were used to assess the quality of the included researches, and data were extracted for a scoping review.
Results A total of twelve researches were finally included, consisting of three randomized controlled trials(RCT), three cross-over controlled trials and six pre-post controlled trials, which came from three countries of China, the United States and South Korea, involving 256 patients. The three RCT were rated as high-quality, while the remaining researches were presented moderate to serious risk of bias. Five researches employed a single-session intervention; and seven used multiple-session intervention, with 30 to 60 minutes a session, two to five sessions a week, for five to 20 sessions. ASRE was effective on walking speed, walking distance, propulsive force of the hemiplegic side, gait parameters and spatiotemporal symmetry, joint range of motion, as well as the scores of scales related to lower limb motor function, balance and gait, with favorable safety and reliability.
Conclusion ASRE may improve the gait function in stroke patients.

Key words: stroke, ankle soft robotic exosuit, gait function, scoping review

CLC Number:

R743.3

GAO Huigang, LIU Yuanwen, QIN Yuling, HU Xiquan, ZHU Lin. Effect of ankle soft robotic exosuit on gait function for stroke patients: a scoping review from 2020 to 2025[J]. Chinese Journal of Rehabilitation Theory and Practice, 2026, 32(6): 645-652.

Figures/Tables 6

Table 1

Figure 1

Table 2

Table 3

Table 4

Basic characteristics of the included literatures"

纳入文献	实验设计	地区	n	年龄/岁	病程	设备/质量	比较	干预方案	评价指标	主要结果
Awad等^[14](2020)	前后对照	美国	36	57	7.3年	ReWalkReStore^TM/5 kg	干预前后	每次40 min，共5次	最大步行速度、不良事件发生率、故障率	步行速度提高，不良事件发生率、故障率低
Awad等^[24](2020)	前后对照	美国	6	52	4.2年	ReWalkReStore^TM/5 kg	WE vs. UWE	单次	10MWT、6MWT、能量消耗	步行速度、距离提高，能量消耗无变化
Yeung等^[16](2021)	RCT	中国	47	66	27 d	自研ASRE设备/0.5 kg	组内、组间比较(UWE)	每次30 min，共20次(10周)	10MWT、BBS、FAC	步行速度提高，BBS、FAC评分提高
Shin等^[25](2022)	前后对照	美国	5	46	2.7年	ReWalkReStore^TM/5 kg	干预后vs.干预前(UWE)	每次30 min，共18次(6~8周)	10MWT、6MWT、FGA、TUGT、FMA-LE、2MWT、关节运动角度、时空对称性	步行速度、距离提高，关节运动角度增加，角度对称性增加，FGA、TUGT、FMA-LE评分改善
Nuckols等^[15](2023)	前后对照	美国	4	49	12.3年	软体踝关节外骨骼/3.8 kg	干预后vs.干预前(UWE) WE vs. UWE	每次60 min，平均训练15.5次(4周)	偏瘫侧推进力、每日步数	2例偏瘫侧推进力、每日步数增加，另外2例无变化
Porciuncula等^[22](2023)	交叉对照	美国	4	49	3.8年	ReWalkReStore^TM/5 kg	干预后vs.干预前(UWE)	每次30 min，共6次(2周，洗脱期6周)	10MWT、6MWT、偏瘫侧推进力、踝关节扭矩、拖曳肢体角度、步长	步行速度、距离提高，3例偏瘫侧推进力提高，步幅提高
Sloot等^[27](2023)	前后对照	美国	19	53	8年	软体踝关节外骨骼/2 kg	WE vs. UWE	单次	步行速度、偏瘫侧推进力、摆动期离地间隙、足部着地角度、能量消耗、行走稳定性、小腿肌肉活动	步行速度提高，偏瘫侧推进力提高，踝背屈角度增加，足廓清能力提高
Swaminathan等^[26](2023)	前后对照	美国	9	52	9.5年	软体踝关节外骨骼	WE，不同阻力与无阻力比较	单次	峰值推进力、推进冲量、推进冲量对称性、踝关节峰值扭矩及功率、腓肠肌与胫前肌活动、患侧膝伸展角度、患侧肢体拖曳角度、非偏瘫侧GRFV	峰值推进力提高，踝关节扭矩、功率增加
Xie等^[10](2023)	RCT	中国	30	61	8.4周	YrobotRelink^TM/3 kg	组内、组间比较(UWE)	每次30 min，共10次(2周)	10MWT、6MWT、FAC、FMA-LE、BBS、时空参数和步态对称性	步行速度、距离提高，FMA-LE得分改善，步态对称性改善，步长增加(有组间差异)
Cataldo等^[21](2023)	交叉对照	美国	11	58	8年	ReWalkReStore^TM/5 kg	WE vs. UWE	单次	步行速度、持续时间、VO₂peak、BDNF水平、步态对称性	步行速度、持续时间、VO₂peak、BDNF水平提高
吴文杰^[20](2024)	RCT	中国	40	50	2个月	YrobotRelink^TM/3 kg	组内、组间比较(UWE)	每次30 min，共20次(4周)	6MWT、FAC、FMA-LE、步态周期、步频、步行速度、步幅、步态对称性	步行速度、距离提高(无组间差异)，步态对称性改善、踝关节运动角度改善，步幅、步频改善，FMA-LE评分改善
Lee等^[23](2025)	交叉对照	韩国	45	54	2.8年	GEMS-A/2.1 kg	WE vs. UWE	单次	步行速度、步频、步幅、步态对称性、髋膝踝运动角度、踝关节背屈/跖屈力矩、GRFV	步行速度提高，步态对称性改善，步幅、步长改善，关节运动角度改善

Table 4

Table 5

References 41

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纳入文献	1	2	3	4	7	8	9	10	11	总分
Yeung等^[16](2021)	√	√		√	√	√	√	√	√	7
Xie等^[10](2023)	√	√	√	√	√	√	√	√	√	8
吴文杰^[20](2024)	√	√		√	√	√		√	√	6

纳入文献	混杂偏倚	选择受试者偏倚	干预分类偏倚	偏离干预偏倚	缺失数据偏倚	结局测量偏倚	选择性报告偏倚	总体偏倚风险等级
Awad等^[14](2020)	±	+	+	+	+	+	+	±
Awad等^[24](2020)	-	-	+	+	+	+	+	-
Shin等^[25](2022)	-	-	+	+	+	+	+	-
Nuckols等^[15](2023)	-	±	+	+	+	+	+	-
Porciuncula等^[22](2023)	-	-	+	+	+	+	+	-
Sloot等^[27](2023)	±	+	+	+	+	+	+	±
Swaminathan等^[26](2023)	±	+	+	+	+	+	+	±
Cataldo等^[21](2023)	±	+	+	+	+	±	+	±
Lee等^[23](2025)	±	+	+	+	+	±	+	±

结局指标	研究数	总样本量	研究设计类型	证据级别
步行速度	10	251	4项RCT，6项非RCT	低
步行距离	5	105	2项RCT，3项非RCT	极低
偏瘫侧推进力	4	36	4项非RCT	极低
踝关节角度	4	109	1项RCT，3项非RCT	极低
步态对称性	5	141	3项RCT，2项非RCT	低
能量消耗	3	29	3项非RCT	极低
FMA-LE	3	75	2项RCT，1项非RCT	低
BBS	2	77	2项RCT	中

Effect of ankle soft robotic exosuit on gait function for stroke patients: a scoping review from 2020 to 2025

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