Multicentric investigation on the safety, feasibility and usability of the ABLE lower-limb robotic exoskeleton for individuals with spinal cord injury

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 inco...

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Autores: Wright, Mark Andrew, Herzog, Franziska, Mas-Vinyals, Anna, Carnicero-Carmona, Alfons, Lobo-Prat, Joan, Hensel, Cornelia, Franz, Steffen, Weidner, Norbert, Vidal, Joan|||0000-0002-3952-2442, Opisso, Eloy|||0000-0002-6868-6737, Rupp, Rüdiger
Tipo de documento: artigo
Data de publicação:2023
País:España
Recursos:Universitat Autònoma de Barcelona
Repositório:Dipòsit Digital de Documents de la UAB
Idioma:inglês
OAI Identifier:oai:ddd.uab.cat:281280
Acesso em linha:https://ddd.uab.cat/record/281280
https://dx.doi.org/urn:doi:10.1186/s12984-023-01165-0
Access Level:Acceso aberto
Palavra-chave:Exoskeleton
Feasibility
Gait
Rehabilitation
Robotics
Safety
Spinal cord injury
Spinal cord disorder
Study protocol
Standardisation
Usability
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spelling Multicentric investigation on the safety, feasibility and usability of the ABLE lower-limb robotic exoskeleton for individuals with spinal cord injurya framework towards the standardisation of clinical evaluationsWright, Mark AndrewHerzog, FranziskaMas-Vinyals, AnnaCarnicero-Carmona, AlfonsLobo-Prat, JoanHensel, CorneliaFranz, SteffenWeidner, NorbertVidal, Joan|||0000-0002-3952-2442Opisso, Eloy|||0000-0002-6868-6737Rupp, RüdigerExoskeletonFeasibilityGaitRehabilitationRoboticsSafetySpinal cord injurySpinal cord disorderStudy protocolStandardisationUsabilityRobotic 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.Universitat Autònoma de Barcelona 22023-01-0120232023-01-01Articlehttp://purl.org/coar/resource_type/c_6501VoRhttp://purl.org/coar/version/c_970fb48d4fbd8a85info:eu-repo/semantics/articleapplication/pdfhttps://ddd.uab.cat/record/281280https://dx.doi.org/urn:doi:10.1186/s12984-023-01165-0reponame:Dipòsit Digital de Documents de la UABinstname:Universitat Autònoma de BarcelonaInglésengopen accesshttp://purl.org/coar/access_right/c_abf2Aquest 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.https://creativecommons.org/licenses/by/4.0/info:eu-repo/semantics/openAccessoai:ddd.uab.cat:2812802026-06-06T12:50:31Z
dc.title.none.fl_str_mv 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
title Multicentric investigation on the safety, feasibility and usability of the ABLE lower-limb robotic exoskeleton for individuals with spinal cord injury
spellingShingle Multicentric investigation on the safety, feasibility and usability of the ABLE lower-limb robotic exoskeleton for individuals with spinal cord injury
Wright, Mark Andrew
Exoskeleton
Feasibility
Gait
Rehabilitation
Robotics
Safety
Spinal cord injury
Spinal cord disorder
Study protocol
Standardisation
Usability
title_short Multicentric investigation on the safety, feasibility and usability of the ABLE lower-limb robotic exoskeleton for individuals with spinal cord injury
title_full Multicentric investigation on the safety, feasibility and usability of the ABLE lower-limb robotic exoskeleton for individuals with spinal cord injury
title_fullStr Multicentric investigation on the safety, feasibility and usability of the ABLE lower-limb robotic exoskeleton for individuals with spinal cord injury
title_full_unstemmed Multicentric investigation on the safety, feasibility and usability of the ABLE lower-limb robotic exoskeleton for individuals with spinal cord injury
title_sort Multicentric investigation on the safety, feasibility and usability of the ABLE lower-limb robotic exoskeleton for individuals with spinal cord injury
dc.creator.none.fl_str_mv Wright, Mark Andrew
Herzog, Franziska
Mas-Vinyals, Anna
Carnicero-Carmona, Alfons
Lobo-Prat, Joan
Hensel, Cornelia
Franz, Steffen
Weidner, Norbert
Vidal, Joan|||0000-0002-3952-2442
Opisso, Eloy|||0000-0002-6868-6737
Rupp, Rüdiger
author Wright, Mark Andrew
author_facet Wright, Mark Andrew
Herzog, Franziska
Mas-Vinyals, Anna
Carnicero-Carmona, Alfons
Lobo-Prat, Joan
Hensel, Cornelia
Franz, Steffen
Weidner, Norbert
Vidal, Joan|||0000-0002-3952-2442
Opisso, Eloy|||0000-0002-6868-6737
Rupp, Rüdiger
author_role author
author2 Herzog, Franziska
Mas-Vinyals, Anna
Carnicero-Carmona, Alfons
Lobo-Prat, Joan
Hensel, Cornelia
Franz, Steffen
Weidner, Norbert
Vidal, Joan|||0000-0002-3952-2442
Opisso, Eloy|||0000-0002-6868-6737
Rupp, Rüdiger
author2_role author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Universitat Autònoma de Barcelona
dc.subject.none.fl_str_mv Exoskeleton
Feasibility
Gait
Rehabilitation
Robotics
Safety
Spinal cord injury
Spinal cord disorder
Study protocol
Standardisation
Usability
topic Exoskeleton
Feasibility
Gait
Rehabilitation
Robotics
Safety
Spinal cord injury
Spinal cord disorder
Study protocol
Standardisation
Usability
description 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.
publishDate 2023
dc.date.none.fl_str_mv 2
2023-01-01
2023
2023-01-01
dc.type.none.fl_str_mv Article
http://purl.org/coar/resource_type/c_6501
VoR
http://purl.org/coar/version/c_970fb48d4fbd8a85
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://ddd.uab.cat/record/281280
https://dx.doi.org/urn:doi:10.1186/s12984-023-01165-0
url https://ddd.uab.cat/record/281280
https://dx.doi.org/urn:doi:10.1186/s12984-023-01165-0
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
https://creativecommons.org/licenses/by/4.0/
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
dc.source.none.fl_str_mv reponame:Dipòsit Digital de Documents de la UAB
instname:Universitat Autònoma de Barcelona
instname_str Universitat Autònoma de Barcelona
reponame_str Dipòsit Digital de Documents de la UAB
collection Dipòsit Digital de Documents de la UAB
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repository.mail.fl_str_mv
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