Dataset Information

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.

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.

SUBMITTER: Chen S

PROVIDER: S-EPMC9133609 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature

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Publications

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.

Chen Sijing S Wang Zhanbin Z Li Yongqiang Y Tang Jiashuai J Wang Xue X Huang Liping L Fang Zhuangwei Z Xu Tao T Xu Jiang J Guo Feng F Wang Yizhao Y Long Jianjun J Wang Xiaodong X Liu Fang F Luo Jianfeng J Wang Yulong Y Huang Xiaolin X Jia Zishan Z Shuai Mei M Li Jianan J

Frontiers in neurorobotics 20220512

<h4>Objective</h4>To evaluate the safety, walking efficiency, physiological cost, don and doff time cost, and user satisfaction of Ai-robot.<h4>Design</h4>Prospective, multi-center, and cross-over trial.<h4>Subjects</h4>Paraplegic subjects (<i>n</i> = 40) with T6-L2 level spinal cord injury.<h4>Methods</h4>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 comple ...[more]

PMID: 35645758

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Project description:The closed-loop control of rehabilitative technologies by neural commands has shown a great potential to improve motor recovery in patients suffering from paralysis. Brain-machine interfaces (BMI) can be used as a natural control method for such technologies. BMI provides a continuous association between the brain activity and peripheral stimulation, with the potential to induce plastic changes in the nervous system. Paraplegic patients, and especially the ones with incomplete injuries, constitute a potential target population to be rehabilitated with brain-controlled robotic systems, as they may improve their gait function after the reinforcement of their spared intact neural pathways. This paper proposes a closed-loop BMI system to control an ambulatory exoskeleton-without any weight or balance support-for gait rehabilitation of incomplete spinal cord injury (SCI) patients. The integrated system was validated with three healthy subjects, and its viability in a clinical scenario was tested with four SCI patients. Using a cue-guided paradigm, the electroencephalographic signals of the subjects were used to decode their gait intention and to trigger the movements of the exoskeleton. We designed a protocol with a special emphasis on safety, as patients with poor balance were required to stand and walk. We continuously monitored their fatigue and exertion level, and conducted usability and user-satisfaction tests after the experiments. The results show that, for the three healthy subjects, 84.44 ± 14.56% of the trials were correctly decoded. Three out of four patients performed at least one successful BMI session, with an average performance of 77.6 1 ± 14.72%. The shared control strategy implemented (i.e., the exoskeleton could only move during specific periods of time) was effective in preventing unexpected movements during periods in which patients were asked to relax. On average, 55.22 ± 16.69% and 40.45 ± 16.98% of the trials (for healthy subjects and patients, respectively) would have suffered from unexpected activations (i.e., false positives) without the proposed control strategy. All the patients showed low exertion and fatigue levels during the performance of the experiments. This paper constitutes a proof-of-concept study to validate the feasibility of a BMI to control an ambulatory exoskeleton by patients with incomplete paraplegia (i.e., patients with good prognosis for gait rehabilitation).

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Project description:BackgroundEvidence is emerging for the use of overground lower limb robotic exoskeletons in the rehabilitation of people with spinal cord injury (SCI), with suggested benefits for gait speed, bladder and bowel function, pain management and spasticity. To date, research has focused on devices that require the user to support themselves with a walking aid. This often precludes use by those with severe trunk, postural or upper limb deficits and places the user in a suboptimal, flexed standing position. Free-standing exoskeletons enable people with higher level injuries to exercise in an upright position. This study aimed to evaluate the feasibility of therapy with a free-standing exoskeleton for those with SCI, and to determine the potential health-related benefits of this intervention.MethodsThis 12-week intervention study with 12-week waitlist control and 12-week follow up, provided people with SCI scoring < 5 on the mobility section of the spinal cord independence measure (SCIM-III) twice weekly therapy in the REX (Rex Bionics, Auckland, NZ), a free-standing lower limb robotic exoskeleton. The primary outcome measure of interest was function, as measured on the SCIM-III. A battery of secondary outcomes was included. Participants also completed a survey on their perceptions of this treatment modality, to determine acceptability.ResultsForty-one potential participants were screened for eligibility. Two females (one ASIA A, one ASIA C) and one male (ASIA B) completed all 24 intervention sessions, and the follow up assessment. One participant showed positive trends in function, fatigue, quality of life and mood during the intervention phase. Grip and quadriceps strength, and lower limb motor function improved in another. Two improved their percentage of lean body mass during the intervention phase. Remaining results were varied across patients, time points and outcomes. The intervention was highly acceptable to all participants.ConclusionWith three of 41 potential participants being eligible and completing this study, our results show that there are potential benefits of exercise in a free-standing exoskeleton for people with severe mobility impairment due to SCI, for a small subset of patients. Further research is warranted to determine those most likely to benefit, and the type of benefit depending on the patient characteristics. Trial registration The trial was registered prospectively on 20 April 2018 at www.anzctr.org.au/ (ACTRN12618000626268).

Dataset Information

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.

Objective

Design

Subjects

Methods

Results

Conclusion

Publications

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.

Similar Datasets

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