Hong EunKyoung, Gorman Peter H, Forrest Gail F, Asselin Pierre K, Knezevic Steven, Scott William, Wojciehowski Sandra Buffy, Kornfeld Stephen, Spungen Ann M
Spinal Cord Damage Research Center, James J. Peters VA Medical Center, Bronx, NY, United States.
Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai, New York, NY, United States.
Front Robot AI. 2020 Aug 4;7:93. doi: 10.3389/frobt.2020.00093. eCollection 2020.
Clinical exoskeletal-assisted walking (EAW) programs for individuals with spinal cord injury (SCI) have been established, but many unknown variables remain. These include addressing staffing needs, determining the number of sessions needed to achieve a successful walking velocity milestone for ambulation, distinguishing potential achievement goals according to level of injury, and deciding the number of sessions participants need to perform in order to meet the Food and Drug Administration (FDA) criteria for personal use prescription in the home and community. The primary aim of this study was to determine the number of sessions necessary to achieve adequate EAW skills and velocity milestones, and the percentage of participants able to achieve these skills by 12 sessions and to determine the skill progression over the course of 36 sessions. A randomized clinical trial (RCT) was conducted across three sites, in persons with chronic (≥6 months) non-ambulatory SCI. Eligible participants were randomized (within site) to either the EAW arm first (Group 1), three times per week for 36 sessions, striving to be completed in 12 weeks or the usual activity arm (UA) first (Group 2), followed by a crossover to the other arm for both groups. The 10-meter walk test seconds (s) (10MWT), 6-min walk test meters (m) (6MWT), and the Timed-Up-and-Go (s) (TUG) were performed at 12, 24, and 36 sessions. To test walking performance in the exoskeletal devices, nominal velocities and distance milestones were chosen prior to study initiation, and were used for the 10MWT (≤ 40s), 6MWT (≥80m), and TUG (≤ 90s). All walking tests were performed with the exoskeletons. A total of 50 participants completed 36 sessions of EAW training. At 12 sessions, 31 (62%), 35 (70%), and 36 (72%) participants achieved the 10MWT, 6MWT, and TUG milestones, respectively. By 36 sessions, 40 (80%), 41 (82%), and 42 (84%) achieved the 10MWT, 6MWT, and TUG criteria, respectively. It is feasible to train chronic non-ambulatory individuals with SCI in performance of EAW sufficiently to achieve reasonable mobility skill outcome milestones.
针对脊髓损伤（SCI）患者的临床外骨骼辅助行走（EAW）项目已经建立，但仍存在许多未知变量。这些变量包括满足人员配备需求、确定实现成功行走速度里程碑以进行步行所需的训练次数、根据损伤程度区分潜在的成就目标，以及确定参与者为满足美国食品药品监督管理局（FDA）关于家庭和社区个人使用处方的标准需要进行的训练次数。本研究的主要目的是确定实现足够的EAW技能和速度里程碑所需的训练次数，以及在12次训练时能够实现这些技能的参与者百分比，并确定在36次训练过程中的技能进展情况。在三个地点对患有慢性（≥6个月）非步行性SCI的患者进行了一项随机临床试验（RCT）。符合条件的参与者（在各地点内）被随机分为先接受EAW训练组（第1组），每周三次，共36次训练，力争在12周内完成；或先接受常规活动组（UA）（第2组），然后两组交叉到另一组。在第12、24和36次训练时进行10米步行测试秒数（s）（10MWT）、6分钟步行测试米数（m）（6MWT）和定时起立行走测试秒数（s）（TUG）。为了测试外骨骼设备中的行走性能，在研究开始前选择了名义速度和距离里程碑，并用于10MWT（≤40s）、6MWT（≥80m）和TUG（≤90s）。所有步行测试均使用外骨骼进行。共有50名参与者完成了36次EAW训练。在12次训练时，分别有31名（62%）、35名（70%）和36名（72%）参与者达到了10MWT、6MWT和TUG里程碑。到36次训练时，分别有40名（80%）、41名（82%）和42名（84%）达到了10MWT、6MWT和TUG标准。对患有慢性非步行性SCI的个体进行EAW训练，使其充分实现合理的移动技能成果里程碑是可行的。
