Rodríguez-Fernández Antonio, Lobo-Prat Joan, Tolrà-Campanyà Mariona, Pérez-Cañabate Florentina, Font-Llagunes Josep M, Guirao-Cano Lluis
Biomechanical Engineering Lab, Department of Mechanical Engineering and Research Center for Biomedical Engineering, Universitat Politècnica de Catalunya, Barcelona, Spain.
Institut de Recerca Sant Joan de Déu, Esplugues de Llobregat, Spain.
PLoS One. 2025 May 27;20(5):e0318039. doi: 10.1371/journal.pone.0318039. eCollection 2025.
Wearable exoskeletons are emerging as a new tool for gait training. However, comparisons between exoskeletons and conventional orthoses in terms of safety and feasibility are scarce. This study assessed the safety, feasibility, usability, and learning process of using the ABLE Exoskeleton in people with spinal cord injury (SCI) while comparing it with knee-ankle-foot orthoses (KAFOs). In this randomized, crossover clinical trial, 10 patients with chronic complete SCI (T4-T12) conducted a 10-session training and assessment protocol with each device: KAFOs and the ABLE Exoskeleton. Outcomes on safety (adverse events), and feasibility and usability (level of assistance, donning/doffing, therapy activities) were recorded for both devices. Evaluation sessions included standard clinical tests (Timed Up and Go, 10-Meter Walk Test, and 6-Minute Walk Test) to assess gait performance. The therapy metrics (number of steps, distance, gait speed, and standing and walking time) were recorded at each session for the robotic device. Participants quickly learned how to use the ABLE Exoskeleton, showing improvements in all therapy metrics (p<0.05) and the 6-Minute Walk Test (p<0.05). Participants reported less adverse events with the robotic device than KAFOs (17 and 31, respectively). Total donning and doffing time was 43 s faster with the robotic device using comparable levels of assistance. The time to complete the therapy activities was very similar between devices. Overall, participants needed 1 to 4 training sessions to perform essential therapy activities (sit/stand transitions, walking 10 meters, turning around) with both devices using minimum assistance or less. The results of this study show that it is feasible and safe for people with motor complete paraplegia due to SCI (T4-T12) to use the ABLE Exoskeleton for gait training in a rehabilitation hospital setting. The ABLE Exoskeleton proved to be as practical and easy to use as conventional orthoses, with fewer AEs reported when using the exoskeleton versus the KAFOs.
可穿戴外骨骼正逐渐成为步态训练的一种新工具。然而，在外骨骼与传统矫形器的安全性和可行性方面的比较却很少。本研究评估了脊髓损伤（SCI）患者使用ABLE外骨骼的安全性、可行性、易用性和学习过程，并将其与膝踝足矫形器（KAFO）进行比较。在这项随机交叉临床试验中，10例慢性完全性SCI（T4 - T12）患者对每种设备进行了为期10节的训练和评估方案：KAFO和ABLE外骨骼。记录了两种设备的安全性（不良事件）以及可行性和易用性（辅助水平、穿脱、治疗活动）结果。评估环节包括标准临床测试（定时起立行走测试、10米步行测试和6分钟步行测试）以评估步态表现。每次训练时记录机器人设备的治疗指标（步数、距离、步态速度以及站立和行走时间）。参与者很快学会了如何使用ABLE外骨骼，所有治疗指标（p<0.05）和6分钟步行测试（p<0.05）均有改善。参与者报告机器人设备的不良事件比KAFO少（分别为17起和31起）。在使用相当辅助水平的情况下，机器人设备的总穿脱时间快43秒。两种设备完成治疗活动的时间非常相似。总体而言，参与者需要1至4次训练课程，以在最少或更少辅助的情况下使用两种设备进行基本治疗活动（坐/站转换、行走10米、转身）。本研究结果表明，对于因SCI（T4 - T12）导致运动完全性截瘫的患者，在康复医院环境中使用ABLE外骨骼进行步态训练是可行且安全的。ABLE外骨骼被证明与传统矫形器一样实用且易于使用，使用外骨骼时报告的不良事件比KAFO少。
