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
Wright, Mark Andrew (Institut Germans Trias i Pujol. Institut Guttmann)
Herzog, Franziska (Heidelberg University Hospital (Alemanya))
Mas-Vinyals, Anna (ABLE Human Motion S.L.)
Carnicero-Carmona, Alfons (ABLE Human Motion S.L.)
Lobo-Prat, Joan (ABLE Human Motion S.L.)
Hensel, Cornelia (Heidelberg University Hospital (Alemanya))
Franz, Steffen (Heidelberg University Hospital (Alemanya))
Weidner, Norbert (Heidelberg University Hospital (Alemanya))
Vidal, Joan (Institut Germans Trias i Pujol. Institut Guttmann)
Opisso, Eloy (Institut Germans Trias i Pujol. Institut Guttmann)
Rupp, Rüdiger (Heidelberg University Hospital (Alemanya))
Universitat Autònoma de Barcelona

Data:	2023
Resum:	Robotic 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. In 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. All 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). Our 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 Registration , DRKS00023503, retrospectively registered on November 18, 2020. The online version contains supplementary material available at 10. 1186/s12984-023-01165-0.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Exoskeleton ; Feasibility ; Gait ; Rehabilitation ; Robotics ; Safety ; Spinal cord injury ; Spinal cord disorder ; Study protocol ; Standardisation ; Usability
Publicat a:	Journal of neuroengineering and rehabilitation, Vol. 20 (april 2023) , ISSN 1743-0003

DOI: 10.1186/s12984-023-01165-0
PMID: 37046307

18 p, 1.2 MB

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Documents de recerca > Documents dels grups de recerca de la UAB > Centres i grups de recerca (producció científica) > Ciències de la salut i biociències > Institut d'Investigació en Ciencies de la Salut Germans Trias i Pujol (IGTP)
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