AUTHOR=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 TITLE=Safety and Feasibility of a Novel Exoskeleton for Locomotor Rehabilitation of Subjects With Spinal Cord Injury: A Prospective, Multi-Center, and Cross-Over Clinical Trial JOURNAL=Frontiers in Neurorobotics VOLUME=16 YEAR=2022 URL=https://www.frontiersin.org/journals/neurorobotics/articles/10.3389/fnbot.2022.848443 DOI=10.3389/fnbot.2022.848443 ISSN=1662-5218 ABSTRACT=Objective

To evaluate the safety, walking efficiency, physiological cost, don and doff time cost, and user satisfaction of Ai-robot.

Design

Prospective, multi-center, and cross-over trial.

Subjects

Paraplegic subjects (n = 40) with T6–L2 level spinal cord injury.

Methods

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.

Results

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 p < 0.001). The average donning/doffing time costs for Ailegs and Aiwalker were significantly shorter than that of HKAFO (both p < 0.001). Satisfaction was higher in the Ailegs and Aiwalker groups (both p < 0.001).

Conclusion

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.