Multicentric investigation on the safety, feasibility and usability of the ABLE lower-limb robotic exoskeleton for individuals with spinal cord injury: a framework towards the standardisation of clinical evaluations

Journal of NeuroEngineering and Rehabilitation

Research

Anna Mas-Vinyals¹  Alfons Carnicero-Carmona¹  Joan Lobo-Prat¹  Eloy Opisso²  Joan Vidal²  Mark Andrew Wright²  Franziska Herzog³  Norbert Weidner³  Steffen Franz³  Rüdiger Rupp³  Cornelia Hensel³ 

[1] ABLE Human Motion S.L., Barcelona, Spain;Institut Guttmann, University Institute attached to the Universitat Autònoma de Barcelona, Badalona, Barcelona, Spain;Universitat Autònoma de Barcelona, Bellaterra, Cerdanyola del Vallès, Spain;Fundació Institut d’Investigació en Ciències de la Salut Germans Trias i Pujol, Badalona, Barcelona, Spain;Spinal Cord Injury Center, Heidelberg University Hospital, Schlierbacher Landstraße 200a, 69118, Heidelberg, Germany;

关键词: Spinal cord injury;    Spinal cord disorder;    Exoskeleton;    Rehabilitation;    Robotics;    Safety;    Feasibility;    Usability;    Gait;    Study protocol;    Standardisation;   

DOI  :  10.1186/s12984-023-01165-0

 received in 2022-06-07, accepted in 2023-03-30,  发布年份 2023

来源: Springer

【 摘 要 】

BackgroundRobotic lower-limb exoskeletons have the potential to provide additional clinical benefits for persons with spinal cord injury (SCI). However, high variability between protocols does not allow the comparison of study results on safety and feasibility between different exoskeletons. We therefore incorporated key aspects from previous studies into our study protocol and accordingly conducted a multicentre study investigating the safety, feasibility and usability of the ABLE Exoskeleton in clinical settings.MethodsIn this prospective pretest-posttest quasi-experimental study across two SCI centres in Germany and Spain, in- and outpatients with SCI were recruited into a 12-session training and assessment protocol, utilising the ABLE Exoskeleton. A follow-up visit after 4 weeks was included to assess after-training outcomes. Safety outcomes (device-related adverse events (AEs), number of drop-outs), feasibility and usability measures (level of assistance, donning/doffing-time) were recorded at every session together with changes in gait parameters and function. Patient-reported outcome measures including the rate of perceived exertion (RPE) and the psychosocial impact of the device were performed. Satisfaction with the device was evaluated in both participants and therapists.ResultsAll 24 participants (45 ± 12 years), with mainly subacute SCI (< 1 year after injury) from C5 to L3, (ASIA Impairment Scale A to D) completed the follow-up. In 242 training sessions, 8 device-related AEs (pain and skin lesions) were reported. Total time for don and doff was 6:50 ± 2:50 min. Improvements in level of assistance and gait parameters (time, steps, distance and speed, p < 0.05) were observed in all participants. Walking function and RPE improved in participants able to complete walking tests with (n = 9) and without (n = 6) the device at study start (p < 0.05). A positive psychosocial impact of the exoskeleton was reported and the satisfaction with the device was good, with best ratings in safety (participants), weight (therapists), durability and dimensions (both).ConclusionsOur study results prove the feasibility of safe gait training with the ABLE Exoskeleton in hospital settings for persons with SCI, with improved clinical outcomes after training. Our study protocol allowed for consistent comparison of the results with other exoskeleton trials and can serve as a future framework towards the standardisation of early clinical evaluations.Trial Registrationhttps://trialsearch.who.int/, DRKS00023503, retrospectively registered on November 18, 2020.

【 授权许可】

CC BY   
© The Author(s) 2023

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