Chen Sijing, Wang Zhanbin, Li Yongqiang, Tang Jiashuai, Wang Xue, Huang Liping, Fang Zhuangwei, Xu Tao, Xu Jiang, Guo Feng, Wang Yizhao, Long Jianjun, Wang Xiaodong, Liu Fang, Luo Jianfeng, Wang Yulong, Huang Xiaolin, Jia Zishan, Shuai Mei, Li Jianan
Center of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
Jiangsu Zhongshan Geriatric Rehabilitation Hospital, Nanjing, China.
Front Neurorobot. 2022 May 12;16:848443. doi: 10.3389/fnbot.2022.848443. eCollection 2022.
To evaluate the safety, walking efficiency, physiological cost, don and doff time cost, and user satisfaction of Ai-robot.
Prospective, multi-center, and cross-over trial.
Paraplegic subjects ( = 40) with T6-L2 level spinal cord injury.
Subjects who could walk independently using Aiwalker, Ailegs, and hip knee ankle foot orthosis (HKAFO) for 6 min within 30 days of training underwent 10 sets of tests. In each set, they completed three 6-min walk test (6MWT) sessions using the three aids in random order.
Skin lesions, pressure sores, and fractures, were the main adverse events, likely due to a lack of experience in using exoskeleton systems. The average 6MWT distances of the Aiwalker, Ailegs, and HKAFO groups were 134.20 ± 18.74, 79.71 ± 18.06, and 48.31 ± 19.87 m, respectively. The average heart rate increases in the Aiwalker (4.21 ± 8.20%) and Ailegs (41.81 ± 23.47%) groups were both significantly lower than that in the HKAFO group (62.33 ± 28.32%) (both < 0.001). The average donning/doffing time costs for Ailegs and Aiwalker were significantly shorter than that of HKAFO (both < 0.001). Satisfaction was higher in the Ailegs and Aiwalker groups (both < 0.001).
Subjects with paraplegia below T6 level were able to ambulate safely and efficiently with Ai-robot. The use of Ai-robot should be learned under the guidance of experienced medical personnel.
评估智能机器人的安全性、行走效率、生理成本、穿脱时间成本及用户满意度。
前瞻性、多中心、交叉试验。
40例T6-L2水平脊髓损伤的截瘫患者。
在训练30天内能够使用智能步行器、智能腿和髋膝踝足矫形器（HKAFO）独立行走6分钟的患者进行10组测试。每组中，他们以随机顺序使用这三种辅助器具完成三次6分钟步行测试（6MWT）。
皮肤损伤、压疮和骨折是主要不良事件，可能是由于缺乏使用外骨骼系统的经验所致。智能步行器、智能腿和HKAFO组的平均6MWT距离分别为134.20±18.74米、79.71±18.06米和48.31±19.87米。智能步行器组（4.21±8.20%）和智能腿组（41.81±23.47%）的平均心率增加均显著低于HKAFO组（62.33±28.32%）（均P<0.001）。智能腿和智能步行器的平均穿脱时间成本显著短于HKAFO（均P<0.001）。智能腿和智能步行器组的满意度更高（均P<0.001）。
T6水平以下的截瘫患者能够使用智能机器人安全、高效地行走。智能机器人的使用应在有经验的医务人员指导下学习。
