Department of Rehabilitation and Human Performance, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.
The Graduate School, Icahn School of Medicine at Mount Sinai, New York City, New York, USA.
J Spinal Cord Med. 2020 Sep;43(5):657-666. doi: 10.1080/10790268.2019.1671076. Epub 2019 Oct 11.
Information on the safety and feasibility of lower extremity powered exoskeletons for persons with acute/sub-acute spinal cord injury (SCI) is limited. Understanding the safety and feasibility of employing powered exoskeletons in acute/sub-acute (<6 months post injury) at a SCI acute inpatient rehabilitation (SCI-AIR) facility could guide clinical practice and provide a basis for larger clinical trials on efficacy and effectiveness. Single group observational study. SCI-AIR. Participants ( = 12; age: 28-71 years; 58% AIS D; 58% male) with neurological levels of injuries ranging from C2 to L3. Up to 90 min of exoskeleton-assisted locomotor training was provided up to three times per week during SCI-AIR. Safety of device use during inpatient locomotor training was quantified as the number of adverse events (AE) per device exposure hour. Feasibility of device use was defined in terms of protocol compliance, intensity, and proficiency. Concerning safety, symptomatic hypotension was the most common AE reported at 111-events/exoskeleton-hours. Protocol compliance had a mean (SD) of 54% (30%). For intensity, 77% of participants incorporated variable assistance into at least 1 walking session; 70% of participants' sessions were completed with a higher RPE than the physical therapist. In proficiency, 58% achieved at least minimal assistance when walking with the device. Exoskeleton training in SCI-AIR can be safe and feasible for newly injured individuals with SCI who have clinically defined ambulatory goals. Nonetheless, sufficient controls to minimize risks for AEs, such as hypotensive events, are required.
关于下肢动力外骨骼在急性/亚急性脊髓损伤(SCI)患者中的安全性和可行性的信息有限。了解在 SCI 急性住院康复(SCI-AIR)机构中对急性/亚急性(损伤后 <6 个月)患者使用动力外骨骼的安全性和可行性,可以为临床实践提供指导,并为更大规模的关于疗效和有效性的临床试验提供依据。
单组观察性研究。
SCI-AIR。
参与者(n=12;年龄:28-71 岁;58% AIS D;58%男性)的神经损伤水平从 C2 到 L3。
在 SCI-AIR 期间,每周最多进行三次,每次最多 90 分钟的外骨骼辅助步行训练。
通过设备暴露小时数来量化住院步行训练期间设备使用的安全性,即不良事件(AE)的数量/设备暴露小时数。设备使用的可行性是根据方案依从性、强度和熟练度来定义的。
就安全性而言,症状性低血压是报告最多的 AE,发生率为 111 次/外骨骼小时。方案依从性的平均值(SD)为 54%(30%)。就强度而言,77%的参与者在至少一次行走中加入了变量辅助;70%的参与者的行走 sessions 完成时的 RPE 高于物理治疗师。在熟练度方面,58%的参与者在使用设备行走时至少能获得最低限度的辅助。
对于具有临床定义的步行目标的新损伤 SCI 患者,SCI-AIR 中的外骨骼训练是安全且可行的。然而,需要足够的对照措施来最小化 AE 风险,如低血压事件。