Exoskeleton-based training improves walking independence in incomplete spinal cord injury patients: results from a randomized controlled trial

Background: In recent years, ambulatory lower limb exoskeletons are being gradually introduced into the clinical practice to complement walking rehabilitation programs. However, the clinical evidence of the outcomes attained with these devices is still limited and nonconclusive. Furthermore, the use...

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Autores: Gil-Agudo, Á., Megía-García, Á., Pons Rovira, José Luis, Sinovas-Alonso, I., Comino-Suárez, Natalia, Lozano-Berrio, V., Del Ama Espinosa, Antonio José
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2023
País:España
Institución:Consejo Superior de Investigaciones Científicas (CSIC)
Repositorio:DIGITAL.CSIC. Repositorio Institucional del CSIC
OAI Identifier:oai:digital.csic.es:10261/344456
Acceso en línea:http://hdl.handle.net/10261/344456
Access Level:acceso abierto
Palabra clave:Neurological rehabilitation
Robotic exoskeleton
Spinal cord injury
Walking.
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spelling Exoskeleton-based training improves walking independence in incomplete spinal cord injury patients: results from a randomized controlled trialGil-Agudo, Á.Megía-García, Á.Pons Rovira, José LuisSinovas-Alonso, I.Comino-Suárez, NataliaLozano-Berrio, V.Del Ama Espinosa, Antonio JoséNeurological rehabilitationRobotic exoskeletonSpinal cord injuryWalking.Background: In recent years, ambulatory lower limb exoskeletons are being gradually introduced into the clinical practice to complement walking rehabilitation programs. However, the clinical evidence of the outcomes attained with these devices is still limited and nonconclusive. Furthermore, the user-to-robot adaptation mechanisms responsible for functional improvement are still not adequately unveiled. This study aimed to (1) assess the safety and feasibility of using the HANK exoskeleton for walking rehabilitation, and (2) investigate the effects on walking function after a training program with it. Methods: A randomized controlled trial was conducted including a cohort of 23 patients with less than 1 year since injury, neurological level of injury (C2-L4) and severity (American Spinal Cord Injury Association Impairment Scale [AIS] C or D). The intervention was comprised of 15 one-hour gait training sessions with lower limb exoskeleton HANK. Safety was assessed through monitoring of adverse events, and pain and fatigue through a Visual Analogue Scale. LEMS, WISCI-II, and SCIM-III scales were assessed, along with the 10MWT, 6MWT, and the TUG walking tests (see text for acronyms). Results: No major adverse events were reported. Participants in the intervention group (IG) reported 1.8 cm (SD 1.0) for pain and 3.8 (SD 1.7) for fatigue using the VAS. Statistically significant differences were observed for the WISCI-II for both the “group” factor (F = 16.75, p < 0.001) and “group-time” interactions (F = 8.87; p < 0.01). A post-hoc analysis revealed a statistically significant increase of 3.54 points (SD 2.65, p < 0.0001) after intervention for the IG but not in the CG (0.7 points, SD 1.49, p = 0.285). No statistical differences were observed between groups for the remaining variables. Conclusions: The use of HANK exoskeleton in clinical settings is safe and well-tolerated by the patients. Patients receiving treatment with the exoskeleton improved their walking independence as measured by the WISCI-II after the treatment.This work was partially supported by the Institute of Health Carlos III (Spain) and co-funded by FEDER (PI15/01437), as well as the Spanish Ministerio de Ciencia, Innovación y Universidades, under the Programa Estatal de Investigación, Desarrollo e Innovación Orientada a los Retos de la Sociedad (Ref.: RTI2018-097290-B-C31).BioMed CentralInstituto de Salud Carlos IIIEuropean CommissionMinisterio de Ciencia, Innovación y Universidades (España)Consejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]2024202420232024info:eu-repo/semantics/articlehttp://purl.org/coar/resource_type/c_6501Publisher's versioninfo:eu-repo/semantics/publishedVersionhttp://hdl.handle.net/10261/344456reponame:DIGITAL.CSIC. Repositorio Institucional del CSICinstname:Consejo Superior de Investigaciones Científicas (CSIC)Inglés#PLACEHOLDER_PARENT_METADATA_VALUE##PLACEHOLDER_PARENT_METADATA_VALUE#info:eu-repo/grantAgreement/AEI/Plan Estatal de Investigación Científica y Técnica y de Innovación 2017-2020/RTI2018-097290-B-C31info:eu-repo/grantAgreement/MINECO//PI15%2F01437http://dx.doi.org/10.1186/s12984-023-01158-zSíinfo:eu-repo/semantics/openAccessoai:digital.csic.es:10261/3444562026-05-22T06:33:51Z
dc.title.none.fl_str_mv Exoskeleton-based training improves walking independence in incomplete spinal cord injury patients: results from a randomized controlled trial
title Exoskeleton-based training improves walking independence in incomplete spinal cord injury patients: results from a randomized controlled trial
spellingShingle Exoskeleton-based training improves walking independence in incomplete spinal cord injury patients: results from a randomized controlled trial
Gil-Agudo, Á.
Neurological rehabilitation
Robotic exoskeleton
Spinal cord injury
Walking.
title_short Exoskeleton-based training improves walking independence in incomplete spinal cord injury patients: results from a randomized controlled trial
title_full Exoskeleton-based training improves walking independence in incomplete spinal cord injury patients: results from a randomized controlled trial
title_fullStr Exoskeleton-based training improves walking independence in incomplete spinal cord injury patients: results from a randomized controlled trial
title_full_unstemmed Exoskeleton-based training improves walking independence in incomplete spinal cord injury patients: results from a randomized controlled trial
title_sort Exoskeleton-based training improves walking independence in incomplete spinal cord injury patients: results from a randomized controlled trial
dc.creator.none.fl_str_mv Gil-Agudo, Á.
Megía-García, Á.
Pons Rovira, José Luis
Sinovas-Alonso, I.
Comino-Suárez, Natalia
Lozano-Berrio, V.
Del Ama Espinosa, Antonio José
author Gil-Agudo, Á.
author_facet Gil-Agudo, Á.
Megía-García, Á.
Pons Rovira, José Luis
Sinovas-Alonso, I.
Comino-Suárez, Natalia
Lozano-Berrio, V.
Del Ama Espinosa, Antonio José
author_role author
author2 Megía-García, Á.
Pons Rovira, José Luis
Sinovas-Alonso, I.
Comino-Suárez, Natalia
Lozano-Berrio, V.
Del Ama Espinosa, Antonio José
author2_role author
author
author
author
author
author
dc.contributor.none.fl_str_mv Instituto de Salud Carlos III
European Commission
Ministerio de Ciencia, Innovación y Universidades (España)
Consejo Superior de Investigaciones Científicas [https://ror.org/02gfc7t72]
dc.subject.none.fl_str_mv Neurological rehabilitation
Robotic exoskeleton
Spinal cord injury
Walking.
topic Neurological rehabilitation
Robotic exoskeleton
Spinal cord injury
Walking.
description Background: In recent years, ambulatory lower limb exoskeletons are being gradually introduced into the clinical practice to complement walking rehabilitation programs. However, the clinical evidence of the outcomes attained with these devices is still limited and nonconclusive. Furthermore, the user-to-robot adaptation mechanisms responsible for functional improvement are still not adequately unveiled. This study aimed to (1) assess the safety and feasibility of using the HANK exoskeleton for walking rehabilitation, and (2) investigate the effects on walking function after a training program with it. Methods: A randomized controlled trial was conducted including a cohort of 23 patients with less than 1 year since injury, neurological level of injury (C2-L4) and severity (American Spinal Cord Injury Association Impairment Scale [AIS] C or D). The intervention was comprised of 15 one-hour gait training sessions with lower limb exoskeleton HANK. Safety was assessed through monitoring of adverse events, and pain and fatigue through a Visual Analogue Scale. LEMS, WISCI-II, and SCIM-III scales were assessed, along with the 10MWT, 6MWT, and the TUG walking tests (see text for acronyms). Results: No major adverse events were reported. Participants in the intervention group (IG) reported 1.8 cm (SD 1.0) for pain and 3.8 (SD 1.7) for fatigue using the VAS. Statistically significant differences were observed for the WISCI-II for both the “group” factor (F = 16.75, p < 0.001) and “group-time” interactions (F = 8.87; p < 0.01). A post-hoc analysis revealed a statistically significant increase of 3.54 points (SD 2.65, p < 0.0001) after intervention for the IG but not in the CG (0.7 points, SD 1.49, p = 0.285). No statistical differences were observed between groups for the remaining variables. Conclusions: The use of HANK exoskeleton in clinical settings is safe and well-tolerated by the patients. Patients receiving treatment with the exoskeleton improved their walking independence as measured by the WISCI-II after the treatment.
publishDate 2023
dc.date.none.fl_str_mv 2023
2024
2024
2024
dc.type.none.fl_str_mv info:eu-repo/semantics/article
http://purl.org/coar/resource_type/c_6501
Publisher's version
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv http://hdl.handle.net/10261/344456
url http://hdl.handle.net/10261/344456
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv #PLACEHOLDER_PARENT_METADATA_VALUE#
#PLACEHOLDER_PARENT_METADATA_VALUE#
info:eu-repo/grantAgreement/AEI/Plan Estatal de Investigación Científica y Técnica y de Innovación 2017-2020/RTI2018-097290-B-C31
info:eu-repo/grantAgreement/MINECO//PI15%2F01437
http://dx.doi.org/10.1186/s12984-023-01158-z
Sí
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv BioMed Central
publisher.none.fl_str_mv BioMed Central
dc.source.none.fl_str_mv reponame:DIGITAL.CSIC. Repositorio Institucional del CSIC
instname:Consejo Superior de Investigaciones Científicas (CSIC)
instname_str Consejo Superior de Investigaciones Científicas (CSIC)
reponame_str DIGITAL.CSIC. Repositorio Institucional del CSIC
collection DIGITAL.CSIC. Repositorio Institucional del CSIC
repository.name.fl_str_mv
repository.mail.fl_str_mv
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