TY  - JOUR
PY  - 2022//
TI  - 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
JO  - Frontiers in neurorobotics
A1  - Chen, Sijing
A1  - Wang, Zhanbin
A1  - Li, Yongqiang
A1  - Tang, Jiashuai
A1  - Wang, Xue
A1  - Huang, Liping
A1  - Fang, Zhuangwei
A1  - Xu, Tao
A1  - Xu, Jiang
A1  - Guo, Feng
A1  - Wang, Yizhao
A1  - Long, Jianjun
A1  - Wang, Xiaodong
A1  - Liu, Fang
A1  - Luo, Jianfeng
A1  - Wang, Yulong
A1  - Huang, Xiaolin
A1  - Jia, Zishan
A1  - Shuai, Mei
A1  - Li, Jianan
SP  - e848443
EP  - e848443
VL  - 16
IS  - 
N2  - OBJECTIVE: To evaluate the safety, walking efficiency, physiological cost, don and doff time cost, and user satisfaction of Ai-robot. <br><br>DESIGN: Prospective, multi-center, and cross-over trial. SUBJECTS: Paraplegic subjects (n = 40) with T6-L2 level spinal cord injury. <br><br>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. <br><br>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). <br><br>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.<p />  <p>Language: en</p>
LA  - en
SN  - 1662-5218
UR  - http://dx.doi.org/10.3389/fnbot.2022.848443
ID  - ref1
ER  -