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

Sijing Chen; Zhanbin Wang; Yongqiang Li; Jiashuai Tang; Xue Wang; Liping Huang; Zhuangwei Fang; Tao Xu; Jiang Xu; Feng Guo; Yizhao Wang; Jianjun Long; Xiaodong Wang; Fang Liu; Jianfeng Luo; Yulong Wang; Xiaolin Huang; Zishan Jia; Mei Shuai; Jianan Li

doi:10.3389/fnbot.2022.848443

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

Front Neurorobot. 2022 May 12:16:848443. doi: 10.3389/fnbot.2022.848443. eCollection 2022.

Authors

Sijing Chen^{1

2}, Zhanbin Wang³, Yongqiang Li^{1

2}, Jiashuai Tang², Xue Wang^{1

2}, Liping Huang⁴, Zhuangwei Fang⁴, Tao Xu⁵, Jiang Xu⁵, Feng Guo⁵, Yizhao Wang⁵, Jianjun Long^{6

7}, Xiaodong Wang^{6

7}, Fang Liu^{6

7}, Jianfeng Luo^{8

9

10}, Yulong Wang^{6

7}, Xiaolin Huang⁵, Zishan Jia⁴, Mei Shuai¹¹, Jianan Li^{1

2}

Affiliations

¹ Center of Rehabilitation Medicine, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
² Jiangsu Zhongshan Geriatric Rehabilitation Hospital, Nanjing, China.
³ School of Automation Science and Electrical Engineering, Beihang University, Beijing, China.
⁴ Department of Rehabilitation, The First Medical Center, Chinese PLA General Hospital, Beijing, China.
⁵ Department of Rehabilitation Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
⁶ Department of Rehabilitation, Shenzhen Second People's Hospital, Shenzhen, China.
⁷ Department of Rehabilitation, The First Affiliated Hospital of Shenzhen University, Shenzhen, China.
⁸ Department of Biostatistics, School of Public Health, Fudan University, Shanghai, China.
⁹ NHC Key Laboratory of Health Technology Assessment, Fudan University, Shanghai, China.
¹⁰ Key Laboratory of Public Health Safety of Ministry of Education, Fudan University, Shanghai, China.
¹¹ School of Biological Science and Medical Engineering, Beijing Advanced Innovation Centre for Biomedical Engineering, Beihang University, Beijing, China.

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.

Keywords: exoskeleton; orthosis; paraplegia; rehabilitation; spinal cord injury (SCI); walking aid.