ABSTRACT

A multi-site study was conducted to evaluate the efficacy of the Keeogo™ exoskeleton as a mobility assist device for use in the clinic and at home in people with knee osteoarthritis (KOA). Twenty-four participants were randomized in a two-stage cross-over design that evaluated the immediate effects of using the exoskeleton in the clinic and the cumulative effects of training and home use. Immediate effects were quantified by comparing 1) physical performance with|without (W|WO) the device during a battery of mobility tests, and 2) physical activity levels at home (actigraphy) for one month, two weeks W|WO the device. Cumulative effects were quantified as change in physical performance W and WO over time. WOMAC and other self-report scales were measured and usability assessed. There were no immediate effects on physical performance or physical activity at home; however, there were cumulative effects as indicated by improved stair time (p = .001) as well as improved WOMAC pain (p = .004) and function (p = .003). There was a direct relationship between improved physical function and improved WOMAC pain (r = −.677, p < .001) and stiffness (r = .537, p = .007). Weight and battery life were identified as important to usability. A full-scale RCT with more participants, longer study period, and better usage monitoring is warranted.

摘要

进行了一项多站点研究，以评估 Keeogo™ 外骨骼作为膝骨关节炎 (KOA) 患者在诊所和家中使用的移动辅助设备的功效。24 名参与者被随机分配到一个两阶段交叉设计中，该设计评估了在诊所使用外骨骼的即时效果以及训练和家庭使用的累积效果。通过比较 1) 在一系列移动测试期间使用/不使用 (W|WO) 设备的身体表现，以及 2) 在家中一个月、两周 W|WO 设备的身体活动水平（体动记录仪）来量化直接影响。累积效应被量化为物理性能 W 和 WO 随时间的变化。测量了 WOMAC 和其他自我报告量表并评估了可用性。对在家的身体表现或身体活动没有立即影响；然而，楼梯时间的改善表明存在累积效应（p = .001) 以及改善 WOMAC 疼痛 ( p = .004) 和功能 ( p = .003)。改善身体机能与改善 WOMAC 疼痛 (r = −.677, p < .001) 和僵硬 (r = .537, p = .007)之间存在直接关系。重量和电池寿命被认为对可用性很重要。有必要进行具有更多参与者、更长研究周期和更好的使用监测的全面随机对照试验。