Spinal Cord Unit, Pisa University Hospital, Pisa, Italy.
The BioRobotics Institute, Scuola Superiore Sant'Anna, Pisa, Italy.
Spinal Cord. 2020 Sep;58(9):988-997. doi: 10.1038/s41393-020-0454-2. Epub 2020 Apr 6.
Prospective, quasi-experimental study, pre- and post-design, single arm study.
Investigate whether persons affected by SCI can safely experience walking function using Robotic Exoskeletons and Functional Electrical Stimulation (FES).
Inpatient METHODS: 52 persons with SCI were recruited (36 completed the protocol) and assigned to one of two groups based on their Lower Limb Motor Scores (LEMS): Group A: LEMS ≥ 10 and Group B: LEMS < 10. Participants in Group A (n = 19) underwent 20 sessions of Robot-Assisted Gait Training (RAGT) on a treadmill followed by 20 sessions of FES during Overground Gait (FES-OG). Participants in Group B (n = 17) received 20 sessions of FES-cycling followed by 20 sessions of overground RAGT. The main outcome measures were: WISCI-II, 10MWT, 6MWT, TUG and SCIM-II.
36 persons completed the study with no complications; only 4 of the 16 dropped out because of mild complications during the RAGT. Participants in Group A exhibited significant improvements in WISCI-II, 10MWT, 6MWT and TUG (p < 0.05), while those in Group B did not significantly improve their gait function but their walking velocity and resistance with the assistance of the robotic exoskeleton increased. SCIM-II scores increased followed therapy only in Group A.
Persons affected by SCI can safely experience their walking function with RAGT and FES therapy; only few mild complications were observed. Our data provides initial evidence of the potential value of these technologies, especially in persons with SCI having LEMS > 10.
前瞻性、准实验研究,前后设计,单臂研究。
研究使用机器人外骨骼和功能性电刺激(FES)是否能让 SCI 患者安全地体验行走功能。
住院患者
招募了 52 名 SCI 患者(36 名完成了方案),并根据他们的下肢运动评分(LEMS)分为两组:A 组:LEMS≥10;B 组:LEMS<10。A 组(n=19)患者在跑步机上接受 20 次机器人辅助步态训练(RAGT),然后在地面上接受 20 次 FES(FES-OG)。B 组(n=17)患者接受 20 次 FES 自行车运动,然后接受 20 次地面 RAGT。主要观察指标:WISCI-II、10MWT、6MWT、TUG 和 SCIM-II。
36 名患者完成了研究,没有并发症;只有 16 名患者中的 4 名因 RAGT 期间的轻度并发症而退出。A 组患者在 WISCI-II、10MWT、6MWT 和 TUG 方面均有显著改善(p<0.05),而 B 组患者的步态功能没有显著改善,但在机器人外骨骼的辅助下,他们的行走速度和阻力有所增加。仅 A 组患者的 SCIM-II 评分在治疗后增加。
SCI 患者可以安全地使用 RAGT 和 FES 治疗来体验行走功能;仅观察到少数轻度并发症。我们的数据提供了这些技术潜在价值的初步证据,特别是对 LEMS>10 的 SCI 患者。