From the Max Nader Lab for Rehabilitation Technologies and Outcomes Research (A.J., M.K.O., C.K.M., K.H.), Shirley Ryan AbilityLab (H.R.R., K.H., A.T., K.B., W.Z.R.); Departments of Physical Medicine and Rehabilitation (A.J., M.K.O., W.Z.R.) and Preventative Medicine (M.K.), Northwestern University; Department of Physical Therapy (S.M.), University of Illinois at Chicago; and Honda R&D Americas, Inc. (K.J.W., H.T.), Raymond, OH.
Neurology. 2019 Jan 15;92(3):e263-e273. doi: 10.1212/WNL.0000000000006782. Epub 2018 Dec 19.
To test the hypothesis that gait training with a hip-assistive robotic exoskeleton improves clinical outcomes and strengthens the descending corticospinal drive to the lower limb muscles in persons with chronic stroke.
Fifty participants completed the randomized, single-blind, parallel study. Participants received over-ground gait training with the Honda Stride Management Assist (SMA) exoskeleton or intensity-matched functional gait training, delivered in 18 sessions over 6-8 weeks. Performance-based and self-reported clinical outcomes were measured at baseline, midpoint, and completion, and at a 3-month follow-up. Corticomotor excitability (CME) of 3 bilateral leg muscles was measured using transcranial magnetic stimulation.
The primary outcome, walking speed, improved for the SMA group by completion of the program (0.24 ± 0.14 m/s difference, < 0.001). Compared to the functional group, SMA users had greater improvement in walking endurance (46.0% ± 27.4% vs 35.7% ± 20.8%, = 0.033), took more steps during therapy days (4,366 ± 2,426 vs 3,028 ± 1,510; = 0.013), and demonstrated larger changes in CME of the paretic rectus femoris (178% ± 75% vs 33% ± 32%, = 0.010). Participants with hemorrhagic stroke demonstrated greater improvement in balance when using the SMA (24.7% ± 20% vs 6.8% ± 6.7%, = 0.029).
Gait training with the SMA improved walking speed in persons with chronic stroke, and may promote greater walking endurance, balance, and CME than functional gait training.
NCT01994395.
This study provides Class I evidence that gait training with a hip-assistive exoskeleton increases clinical outcomes and CME in persons with chronic stroke, but does not significantly improve walking speeds compared to intensity-matched functional gait training.
验证假说，即使用髋关节辅助机器人外骨骼进行步态训练可以改善慢性脑卒中患者的临床结果，并增强对下肢肌肉的下行皮质脊髓驱动。
50 名参与者完成了这项随机、单盲、平行研究。参与者接受了为期 6-8 周、共 18 次的地面步态训练，使用本田 Stride Management Assist（SMA）外骨骼或强度匹配的功能性步态训练。在基线、中点和完成时以及 3 个月随访时测量基于表现的和自我报告的临床结果。使用经颅磁刺激测量 3 对双侧腿部肌肉的皮质运动兴奋性（CME）。
主要结果是 SMA 组在完成方案时的步行速度提高（0.24±0.14m/s 差异，<0.001）。与功能组相比，SMA 用户在步行耐力方面有更大的改善（46.0%±27.4%对 35.7%±20.8%，=0.033），在治疗日中走更多的步数（4366±2426 对 3028±1510；=0.013），并且在患侧股直肌的 CME 变化更大（178%±75%对 33%±32%，=0.010）。使用 SMA 的出血性脑卒中患者在平衡方面的改善更大（24.7%±20%对 6.8%±6.7%，=0.029）。
使用 SMA 进行步态训练可提高慢性脑卒中患者的步行速度，并且可能比功能性步态训练更能促进更大的步行耐力、平衡和 CME。
临床试验.gov 标识符：NCT01994395。
这项研究提供了 I 级证据，表明使用髋关节辅助外骨骼进行步态训练可以增加慢性脑卒中患者的临床结果，并增强对下肢肌肉的皮质脊髓驱动，但与强度匹配的功能性步态训练相比，步行速度的改善并不显著。
