Department of Rehabilitation Medicine, Hanyang University College of Medicine, Seoul, Korea.
Department of Rehabilitation Medicine, Hanyang University Guri Hospital, Guri, Korea.
J Korean Med Sci. 2021 Mar 29;36(12):e80. doi: 10.3346/jkms.2021.36.e80.
Spinal cord injury (SCI) is a serious clinical condition that impacts a patient's physical, psychological, and socio-economic status. The aim of this pilot study was to evaluate the effects of training with a newly developed powered wearable exoskeleton (Hyundai Medical Exoskeleton [H-MEX]) on functional mobility, physiological health, and quality of life in non-ambulatory SCI patients.
Participants received 60 minutes of walking training with a powered exoskeleton 3 times per week for 10 weeks (total 30 sessions). The 6-minute walking test (6MWT) and timed-up-and-go test (TUGT) were performed to assess ambulatory function. The physiological outcomes of interest after exoskeleton-assisted walking training were spasticity, pulmonary function, bone mineral density, colon transit time, and serum inflammatory markers. Effects of walking training on subjective outcomes were estimated by the Korean version of the Falls Efficacy Scale-International and the 36-Item Short-Form Health Survey version 2.
Ten participants finished 30 sessions of training and could ambulate independently. No severe adverse events were reported during the study. After training, the mean distance walked in the 6MWT (49.13 m) was significantly enhanced compared with baseline (20.65 m). The results of the TUGT also indicated a statistically significant improvement in the times required to stand up, walk 3 m and sit down. Although not statistically significant, clinically meaningful changes in some secondary physiological outcomes and/or quality of life were reported in some participants.
In conclusion, this study demonstrated that the newly developed wearable exoskeleton, H-MEX is safe and feasible for non-ambulatory SCI patients, and may have potential to improve quality of life of patients by assisting bipedal ambulation. These results suggest that the H-MEX can be considered a beneficial device for chronic non-ambulatory SCI patients.
ClinicalTrials.gov Identifier: NCT04055610.
脊髓损伤（SCI）是一种严重的临床病症，会影响患者的身体、心理和社会经济状况。本初步研究旨在评估使用新开发的动力可穿戴式外骨骼（现代医疗外骨骼[H-MEX]）对非步行性 SCI 患者的功能移动性、生理健康和生活质量的影响。
参与者每周接受 3 次、每次 60 分钟的外骨骼步行训练，共 10 周（共 30 次）。使用 6 分钟步行测试（6MWT）和计时起立行走测试（TUGT）评估步行功能。外骨骼辅助步行训练后，评估感兴趣的生理结果包括痉挛、肺功能、骨密度、结肠传输时间和血清炎症标志物。通过韩国版跌倒效能量表-国际版和 36 项简短健康调查问卷版本 2 评估步行训练对主观结果的影响。
10 名参与者完成了 30 次训练，可以独立行走。研究期间未报告严重不良事件。训练后，6MWT 中行走的平均距离（49.13 米）明显高于基线（20.65 米）。TUGT 的结果也表明，站立、行走 3 米和坐下所需的时间有统计学意义上的改善。尽管没有统计学意义，但一些参与者报告了一些次要生理结果和/或生活质量的临床有意义的变化。
总之，本研究表明，新开发的可穿戴外骨骼 H-MEX 对非步行性 SCI 患者是安全且可行的，并且通过辅助双足步行，可能有改善患者生活质量的潜力。这些结果表明，H-MEX 可以被认为是慢性非步行性 SCI 患者的有益设备。
ClinicalTrials.gov 标识符：NCT04055610。
