中国组织工程研究 ›› 2024, Vol. 28 ›› Issue (2): 321-328.doi: 10.12307/2023.868

• 组织构建循证医学 evidence-based medicine in tissue construction • 上一篇    

康复外骨骼机器人对脑卒中下肢运动功能障碍疗效的Meta分析

常万鹏1,张钟文2,杨钰琳1,訾  阳3,杨梦琦1,杜冰玉1,王  楠1,于少泓3,4   

  1. 1山东中医药大学康复医学院,山东省济南市  250355;2山东第一医科大学第一附属医院山东省千佛山医院,山东省济南市  250014;3山东中医药大学第二附属医院,山东省济南市  250001;4山东中医药大学医学院,山东省济南市  250355
  • 收稿日期:2022-12-03 接受日期:2023-01-10 出版日期:2024-01-18 发布日期:2023-06-30
  • 通讯作者: 于少泓,副教授,山东中医药大学医学院,山东省济南市 250355;山东中医药大学第二附属医院,山东省济南市 250001
  • 作者简介:常万鹏,男,1998年生,山东省聊城市人,汉族,山东中医药大学在读硕士。
  • 基金资助:
    国家自然科学基金(青年项目)(82000788),项目负责人:张钟文;横向课题:HX-2020-13(SDAM202009003),项目负责人:于少泓

Efficacy of rehabilitation exoskeleton robots on post-stroke lower limb motor dysfunction: a Meta-analysis

Chang Wanpeng1, Zhang Zhongwen2, Yang Yulin1, Zi Yang3, Yang Mengqi1, Du Bingyu1, Wang Nan1, Yu Shaohong3, 4   

  1. 1College of Rehabilitation Medicine, Shandong University of Traditional Chinese Medicine, Jinan 250355, Shandong Province, China; 2The First Affiliated Hospital of Shandong First Medical University & Shandong Provincial Qianfoshan Hospital, Jinan 250014, Shandong Province, China; 3The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250001, Shandong Province, China; 4College of Medicine, Shandong University of Traditional Chinese Medicine, Jinan 250355, Shandong Province, China
  • Received:2022-12-03 Accepted:2023-01-10 Online:2024-01-18 Published:2023-06-30
  • Contact: Yu Shaohong, Associate professor, The Second Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan 250001, Shandong Province, China; College of Medicine, Shandong University of Traditional Chinese Medicine, Jinan 250355, Shandong Province, China
  • About author:Chang Wanpeng, Master candidate, College of Rehabilitation Medicine, Shandong University of Traditional Chinese Medicine, Jinan 250355, Shandong Province, China
  • Supported by:
    the National Natural Science Foundation of China (Youth Program), No. 82000788 (to ZZW); Cross-cutting project: HX-2020-13, No. SDAM202009003 (to YSH)

摘要:


文题释义:

康复外骨骼机器人:是一种康复设备,通过辅助下肢运动功能障碍的脑卒中患者训练正常行走,提供针对性的步行训练方案,提高下肢运动能力。
脑卒中:又称为“中风”,是由于脑部血管破裂或因血管阻塞导致血液不能流入大脑而引起脑组织损伤的一组疾病,导致中枢神经系统局灶性损伤引起神经功能障碍,包括缺血性卒中和出血性卒中。


目的:运用Meta分析方法系统评价康复外骨骼机器人对脑卒中患者下肢运动功能的康复疗效,并比较不同下肢外骨骼机器人的疗效差异,为脑卒中下肢运动功能障碍患者选择适合的外骨骼机器人提供科学理论依据。

方法:计算机检索Cochrane Library、PubMed、Web of Science、Embase、中国知网、维普和万方数据库的相关文献,收集从建库至2022年11月发表的关于探讨下肢康复外骨骼机器人改善脑卒中患者下肢运动功能的随机对照临床试验。由2名研究人员进行文献检索与筛选,使用Cochrane 5.1.0偏倚风险评估工具和Jadad量表对纳入文献进行质量评价。采用RevMan 5.4和Stata 17.0软件对结局指标进行Meta分析。
结果:①最终纳入22篇文献,Jadad评分显示均为高质量文献,共865例患者,试验组436例、对照组429例。②Meta分析结果显示,与对照组相比,外骨骼机器人可显著提高脑卒中患者下肢运动功能(Fugl-Meyer Assessment of Lower Extremity,FMA-LE)评分(MD=2.63,95%CI:1.87-3.38,P < 0.05)、平衡功能(Berg Balance Scale,BBS)评分(MD=3.62,95%CI:1.21-6.03,P < 0.05)、站起-走测试量表(Timed Up and Go,TUG)评分(MD=-2.77,95%CI:-4.48至-1.05,P < 0.05)和步频(MD=3.15,95%CI:1.57-4.72,P < 0.05),但对功能性步行量表(Functional Ambulation Category Scale,FAC)评分(MD=0.30,95%CI:-0.01-0.61,P > 0.05)和6 min步行测试(6-minute walk test,6MWT)评分(MD=3.77,95%CI:-6.60-14.14,P > 0.05)的提高不明显。③网状Meta分析结果显示,FMA-LE评分:平地行走式外骨骼(MD=10.23,95%CI:3.81-27.49,P < 0.05)和减重式外骨骼(MD=33.66,95%CI:11.49-98.54,P < 0.05)与常规康复治疗相比均能改善FMA-LE评分,排序结果为减重式外骨骼>平地行走式外骨骼>常规康复治疗;BBS评分:减重式外骨骼(MD=79.86,95%CI:2.34-2 725.99,P < 0.05)与常规康复治疗相比能显著改善BBS评分,排序结果为减重式外骨骼>平地行走式外骨骼>常规康复治疗;FAC评分:平地行走式外骨骼(MD=1.38,95%CI:1.00-1.90,P < 0.05)与常规康复治疗相比能显著改善FAC评分,排序结果为平地行走式外骨骼>减重式外骨骼>常规康复治疗;TUG评分:减重式外骨骼与常规康复治疗相比(MD=0.07,95%CI:0.01-0.51,P < 0.05)能显著改善TUG评分,排序结果为平地行走式外骨骼>减重式外骨骼>常规康复治疗。

结论:康复外骨骼机器人可以改善脑卒中患者平衡、步行以及日常生活活动能力,其中减重式外骨骼在提高下肢运动功能和平衡功能方面疗效更优,平地行走式外骨骼在提高功能性步行和转移能力方面疗效更佳。

https://orcid.org/0000-0002-7509-5767(常万鹏);https://orcid.org/0000-0003-4025-4104(于少泓)

中国组织工程研究杂志出版内容重点:组织构建;骨细胞;软骨细胞;细胞培养;成纤维细胞;血管内皮细胞;骨质疏松;组织工程

关键词: 脑卒中, 中风, 下肢运动功能, 步态, 步行, 平衡, 康复机器人, 外骨骼, 系统评价, 网状Meta分析

Abstract: OBJECTIVE: To systematically evaluate the efficacy of rehabilitation exoskeleton robots on the lower limb motor function of stroke patients using Meta-analysis and to compare the efficacy of different lower limb exoskeleton robots, so as to provide a theoretical basis for the scientific selection of suitable exoskeleton robots for patients with post-stroke lower limb motor dysfunction.
METHODS: Computer searches of the Cochrane Library, PubMed, Web of Science, Embase, CNKI, VIP, and WanFang Data were conducted to collect randomized controlled clinical studies on exploring lower extremity rehabilitation exoskeleton robots to improve lower limb motor function in stroke patients published from database inception to November 2022. Two researchers conducted the literature search and screening. The quality of the included literature was evaluated using the Cochrane 5.1.0 risk of bias assessment tool and the Jadad scale. Meta-analysis was performed using RevMan 5.4 and Stata 17.0 software.
RESULTS: (1) Finally 22 publications were included, involving 865 patients (n=436 in the test group and n=429 in the control group), and the Jadad score showed that all the included articles were  of high quality. (2) Meta-analysis results showed that the exoskeleton robot significantly improved the Fugl-Meyer Assessment of Lower Extremity score (mean difference [MD]=2.63, 95% confidence interval [CI]: 1.87-3.38, P < 0.05), Berg Balance Scale score (MD=3.62, 95% CI: 1.21-6.03, P < 0.05), Timed Up and Go score (MD=-2.77, 95% CI: -4.48 to -1.05, P < 0.05) and step frequency score (MD=3.15, 95% CI: 1.57-4.72, P < 0.05) in stroke patients compared with the control group. However, there was no significant improvement in the Functional Ambulation Category Scale score (MD=0.30, 95% CI: -0.01 to 0.61, P > 0.05) and 6-minute walk test score (MD=3.77, 95% CI: -6.60 to 14.14, P > 0.05). (3) Network Meta-analysis results showed that  compared with the conventional rehabilitation therapy, both the level-walking exoskeleton (MD=10.23, 95% CI: 3.81-27.49, P < 0.05) and the body-weight support exoskeleton (MD=33.66, 95% CI: 11.49-98.54, P < 0.05) improved the Fugl-Meyer Assessment of Lower Extremity score. Compared with the conventional rehabilitation therapy, body-weight support exoskeleton significantly improved the Berg Balance Scale scores (MD=79.86, 95% CI: 2.34-2 725.99, P < 0.05). In terms of Fugl-Meyer Assessment of Lower Extremity and Berg Balance Scale scores, the ranking results were body-weight support exoskeleton > level-walking exoskeleton > conventional rehabilitation therapy. Compared with the conventional rehabilitation therapy, level-walking exoskeleton significantly improved the Functional Ambulation Category Scale score (MD=1.38, 95% CI: 1.00-1.90, P < 0.05) and body-weight support exoskeleton significantly improved the Timed Up and Go score (MD=0.07, 95% CI: 0.01-0.51, P < 0.05). In terms of Functional Ambulation Category Scale and Timed Up and Go scores, the ranking results were level-walking exoskeleton > body-weight support exoskeleton > conventional rehabilitation therapy.
CONCLUSION: Rehabilitation exoskeleton robots can improve balance, walking and activities of daily living in stroke patients, with body-weight support exoskeleton being more effective in improving lower limb motor function and balance and level walking exoskeleton being more effective in improving functional walking and transfer.

Key words: stroke, strokes, lower extremity motor function, gait, walking, balance, rehabilitation robot, exoskeleton, systematic review, network meta-analysis

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