Institut Guttmann, University Institute attached to the Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain.
Universitat Autònoma de Barcelona, Bellaterra, Cerdanyola del Vallès, Spain.
J Neuroeng Rehabil. 2023 Apr 12;20(1):45. doi: 10.1186/s12984-023-01165-0.
Robotic lower-limb exoskeletons have the potential to provide additional clinical benefits for persons with spinal cord injury (SCI). However, high variability between protocols does not allow the comparison of study results on safety and feasibility between different exoskeletons. We therefore incorporated key aspects from previous studies into our study protocol and accordingly conducted a multicentre study investigating the safety, feasibility and usability of the ABLE Exoskeleton in clinical settings.
In this prospective pretest-posttest quasi-experimental study across two SCI centres in Germany and Spain, in- and outpatients with SCI were recruited into a 12-session training and assessment protocol, utilising the ABLE Exoskeleton. A follow-up visit after 4 weeks was included to assess after-training outcomes. Safety outcomes (device-related adverse events (AEs), number of drop-outs), feasibility and usability measures (level of assistance, donning/doffing-time) were recorded at every session together with changes in gait parameters and function. Patient-reported outcome measures including the rate of perceived exertion (RPE) and the psychosocial impact of the device were performed. Satisfaction with the device was evaluated in both participants and therapists.
All 24 participants (45 ± 12 years), with mainly subacute SCI (< 1 year after injury) from C5 to L3, (ASIA Impairment Scale A to D) completed the follow-up. In 242 training sessions, 8 device-related AEs (pain and skin lesions) were reported. Total time for don and doff was 6:50 ± 2:50 min. Improvements in level of assistance and gait parameters (time, steps, distance and speed, p < 0.05) were observed in all participants. Walking function and RPE improved in participants able to complete walking tests with (n = 9) and without (n = 6) the device at study start (p < 0.05). A positive psychosocial impact of the exoskeleton was reported and the satisfaction with the device was good, with best ratings in safety (participants), weight (therapists), durability and dimensions (both).
Our study results prove the feasibility of safe gait training with the ABLE Exoskeleton in hospital settings for persons with SCI, with improved clinical outcomes after training. Our study protocol allowed for consistent comparison of the results with other exoskeleton trials and can serve as a future framework towards the standardisation of early clinical evaluations. Trial Registration https://trialsearch.who.int/ , DRKS00023503, retrospectively registered on November 18, 2020.
机器人下肢外骨骼有可能为脊髓损伤（SCI）患者提供额外的临床益处。然而，协议之间的高度差异不允许对不同外骨骼之间的安全性和可行性研究结果进行比较。因此，我们将之前研究中的关键方面纳入研究方案，并相应地进行了一项多中心研究，以调查 ABLE 外骨骼在临床环境中的安全性、可行性和可用性。
在德国和西班牙的两个 SCI 中心进行的这项前瞻性预测试后准实验研究中，招募了 SCI 的门诊和住院患者参加 12 节训练和评估方案，使用 ABLE 外骨骼。在 4 周后进行随访，以评估训练后的结果。安全性结果（与设备相关的不良事件（AE）、脱落人数）、可行性和可用性测量（辅助水平、穿衣/脱衣时间）以及步态参数和功能的变化一起在每次治疗中记录。进行了患者报告的结果测量，包括感知用力率（RPE）和设备的心理社会影响。参与者和治疗师都评估了对设备的满意度。
所有 24 名参与者（45±12 岁），主要为亚急性 SCI（损伤后<1 年），从 C5 到 L3，（ASIA 损伤量表 A 到 D）完成了随访。在 242 次训练课程中，报告了 8 起与设备相关的 AE（疼痛和皮肤损伤）。穿衣和脱衣总时间为 6:50±2:50 分钟。所有参与者的辅助水平和步态参数（时间、步数、距离和速度，p<0.05）均有改善。在研究开始时能够完成步行测试的参与者（n=9）和不能完成步行测试的参与者（n=6）中，步行功能和 RPE 均有改善（p<0.05）。报告了外骨骼的积极心理社会影响，对设备的满意度良好，参与者对安全性的评价最高，治疗师对重量的评价最高，耐用性和尺寸（两者）。
我们的研究结果证明了在 SCI 患者住院期间使用 ABLE 外骨骼进行安全步态训练的可行性，并在训练后获得了更好的临床结果。我们的研究方案允许与其他外骨骼试验进行一致的比较，并可以作为早期临床评估标准化的未来框架。试验注册https://trialsearch.who.int/，DRKS00023503，于 2020 年 11 月 18 日进行了回顾性注册。
