Clinic for Spinal Cord Injuries, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
Swiss Paraplegic Centre (SPC), Nottwil, Switzerland.
Spinal Cord. 2018 Feb;56(2):106-116. doi: 10.1038/s41393-017-0013-7. Epub 2017 Nov 6.
Prospective quasi-experimental study, pre- and post-design.
Assess safety, feasibility, training characteristics and changes in gait function for persons with spinal cord injury (SCI) using the robotic exoskeletons from Ekso Bionics.
Nine European rehabilitation centres.
Robotic exoskeleton gait training, three times weekly over 8 weeks. Time upright, time walking and steps in the device (training characteristics) were recorded longitudinally. Gait and neurological function were measured by 10 Metre Walk Test (10 MWT), Timed Up and Go (TUG), Berg Balance Scale (BBS), Walking Index for Spinal Cord Injury (WISCI) II and Lower Extremity Motor Score (LEMS).
Fifty-two participants completed the training protocol. Median age: 35.8 years (IQR 27.5-52.5), men/women: N = 36/16, neurological level of injury: C1-L2 and severity: AIS A-D (American Spinal Injury Association Impairment Scale). Time since injury (TSI) < 1 year, N = 25; > 1 year, N = 27. No serious adverse events occurred. Three participants dropped out following ankle swelling (overuse injury). Four participants sustained a Category II pressure ulcer at contact points with the device but completed the study and skin normalized. Training characteristics increased significantly for all subgroups. The number of participants with TSI < 1 year and gait function increased from 20 to 56% (P = 0.004) and 10MWT, TUG, BBS and LEMS results improved (P < 0.05). The number of participants with TSI > 1 year and gait function, increased from 41 to 44% and TUG and BBS results improved (P < 0.05).
Exoskeleton training was generally safe and feasible in a heterogeneous sample of persons with SCI. Results indicate potential benefits on gait function and balance.
前瞻性准实验研究，前后设计。
评估使用 Ekso Bionics 机器人外骨骼对脊髓损伤（SCI）患者的安全性、可行性、训练特点和步态功能变化。
欧洲 9 个康复中心。
机器人外骨骼步态训练，每周 3 次，共 8 周。记录纵向时间站立、时间行走和设备中的步数（训练特点）。步态和神经功能通过 10 米步行测试（10 MWT）、计时起立行走测试（TUG）、伯格平衡量表（BBS）、脊髓损伤步行指数（WISCI） II 和下肢运动评分（LEMS）进行测量。
52 名参与者完成了训练方案。中位数年龄：35.8 岁（IQR 27.5-52.5），男性/女性：N=36/16，损伤神经水平：C1-L2 和严重程度：AIS A-D（美国脊髓损伤协会损伤量表）。受伤时间（TSI）<1 年，N=25；>1 年，N=27。无严重不良事件发生。3 名参与者因踝关节肿胀（过度使用损伤）退出。4 名参与者在与设备接触点处出现 2 级压力性溃疡，但完成了研究，皮肤恢复正常。所有亚组的训练特征均显著增加。TSI<1 年和步态功能的参与者人数从 20%增加到 56%（P=0.004），10 MWT、TUG、BBS 和 LEMS 结果改善（P<0.05）。TSI>1 年和步态功能的参与者人数从 41%增加到 44%，TUG 和 BBS 结果改善（P<0.05）。
外骨骼训练在异质的 SCI 患者中通常是安全和可行的。结果表明对步态功能和平衡有潜在益处。
