Outcomes of a Multicenter Safety and Efficacy Study of the SuitX Phoenix Powered Exoskeleton for Ambulation by Patients With Spinal Cord Injury.

Autor:	Koljonen PA; Department of Orthopaedics and Traumatology, Maclehose Medical Rehabilitation Centre, Hong Kong West Cluster, Hospital Authority, Hong Kong, China.; Department of Orthopaedics and Traumatology, The University of Hong Kong Li Ka Shing Faculty of Medicine, Hong Kong, China., Virk AS; US Bionics at Emeryville, Emeryville, CA, United States., Jeong Y; US Bionics at Emeryville, Emeryville, CA, United States., McKinley M; US Bionics at Emeryville, Emeryville, CA, United States., Latorre J; St. David's Medical Center, Austin, TX, United States., Caballero A; University of Virginia School of Medicine, Charlottesville, VA, United States., Hu Y; Department of Orthopaedics and Traumatology, The University of Hong Kong Li Ka Shing Faculty of Medicine, Hong Kong, China., Wong YW; Department of Orthopaedics and Traumatology, The University of Hong Kong Li Ka Shing Faculty of Medicine, Hong Kong, China., Cheung K; Department of Orthopaedics and Traumatology, The University of Hong Kong Li Ka Shing Faculty of Medicine, Hong Kong, China., Kazerooni H; Department of Mechanical Engineering, University of California, Berkeley, Berkeley, CA, United States.
Jazyk:	angličtina
Zdroj:	Frontiers in neurology [Front Neurol] 2021 Jul 19; Vol. 12, pp. 689751. Date of Electronic Publication: 2021 Jul 19 (Print Publication: 2021).
DOI:	10.3389/fneur.2021.689751
Abstrakt:	Objective: To examine the safety and efficacy of ambulation utilizing a semi-passive and lightweight powered exoskeleton by spinal cord injury (SCI) patients. Methods: This is a multi-center, open-label, prospective cohort study across three facilities. A cohort of 40 individuals with SCI from T4-L5 was recruited into a 20-session training and assessment protocol, utilizing the SuitX Phoenix. All patients were tested using a 10-m-walk test (10 MWT), 6-min-walk test (6 MWT), and Timed up & Go test (TUG). Patient satisfaction, pain, exertion, changes in affect, as well as overall comfort and confidence were reported using a satisfaction survey, Rated Perceived Exertion (RPE) scale, and Positive and Negative Affect Schedule (PANAS). Safety outcomes, adverse events, and device malfunctions were reported. Results: Forty participants completed the study. There were no serious adverse events. All participants reported moderate to high levels of comfort and confidence using the device. All patients were able to achieve FIM of >4 on transitional movements and walking. The neurological level of injury had a statistically significant association with walking speed, WISCI-II, and FIM. Participants with an incomplete spinal cord injury had a higher FIM, faster speed, and higher WISCI-II in all outcome measures. Conclusion: This is the first study to examine the safety and efficacy of SuitX Phoenix for ambulation by SCI patients. We have shown that Phoenix is efficacious in allowing adults with SCI T4 to L5 perform walking and transitional movements. This study also reports the safety-profile of the device, user satisfaction, and psychological trends during training. Competing Interests: The study was supported, in part, by US Bionics (d.b.a. SuitX). The SuitX Phoenix devices used in this study were provided by the study sponsor US Bionics. YJ, MM, and HK own rights to the intellectual property and patent(s) of the SuitX Phoenix Medical Exoskeleton. The body of this manuscript was written and edited by authors AC and PK (corresponding author), and both authors declare no conflict of interest toward the results of the study. The results of this study were presented at the 2019 International Spinal Cord Society Annual Scientific Meeting (abstract). AV, YJ, and MM were employed by company US Bionics at Emeryville. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. (Copyright © 2021 Koljonen, Virk, Jeong, McKinley, Latorre, Caballero, Hu, Wong, Cheung and Kazerooni.)
Databáze:	MEDLINE
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