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 user...

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Autores: Gil Agudo, Ángel, Megía García-Carpintero, Álvaro, Pons , José Luis, Sinovas Alonso, Isabel, Comino Suárez, Natalia, Lozano Berrio, Vicente, Del-Ama , Antonio José
Tipo de recurso: artículo
Fecha de publicación:2023
País:España
Institución:Universidad de Castilla-La Mancha
Repositorio:RUIdeRA. Repositorio Institucional de la UCLM
OAI Identifier:oai:ruidera.uclm.es:10578/44052
Acceso en línea:https://doi.org/10.1186/s12984-023-01158-z
https://link.springer.com/article/10.1186/s12984-023-01158-z
https://hdl.handle.net/10578/44052
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, ÁngelMegía García-Carpintero, ÁlvaroPons , José LuisSinovas Alonso, IsabelComino Suárez, NataliaLozano Berrio, VicenteDel-Ama , Antonio JoséNeurological rehabilitationRobotic exoskeletonSpinal cord injuryWalkingBackground 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.La investigación aborda la efectividad del entrenamiento con exoesqueletos para mejorar la independencia al caminar en pacientes con lesión medular incompleta. Este estudio utilizó un diseño aleatorizado y controlado para comparar la terapia con el exoesqueleto HANK frente a la terapia de marcha convencional. Se destacó una mejora significativa en el índice de marcha WISCI-II en el grupo de intervención, mientras que no se registraron diferencias relevantes en otras variables funcionales. Además, se evidenció la seguridad y tolerancia del dispositivo en un entorno clínico.Springer Nature202520252023info:eu-repo/semantics/articleapplication/pdfapplication/pdfhttps://doi.org/10.1186/s12984-023-01158-zhttps://link.springer.com/article/10.1186/s12984-023-01158-zhttps://hdl.handle.net/10578/44052reponame:RUIdeRA. Repositorio Institucional de la UCLMinstname:Universidad de Castilla-La ManchaInglésPI15/01437RTI2018-097290-B-C31info:eu-repo/semantics/openAccessoai:ruidera.uclm.es:10578/440522026-05-27T07:36:41Z
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, Ángel
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, Ángel
Megía García-Carpintero, Álvaro
Pons , José Luis
Sinovas Alonso, Isabel
Comino Suárez, Natalia
Lozano Berrio, Vicente
Del-Ama , Antonio José
author Gil Agudo, Ángel
author_facet Gil Agudo, Ángel
Megía García-Carpintero, Álvaro
Pons , José Luis
Sinovas Alonso, Isabel
Comino Suárez, Natalia
Lozano Berrio, Vicente
Del-Ama , Antonio José
author_role author
author2 Megía García-Carpintero, Álvaro
Pons , José Luis
Sinovas Alonso, Isabel
Comino Suárez, Natalia
Lozano Berrio, Vicente
Del-Ama , Antonio José
author2_role author
author
author
author
author
author
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
2025
2025
dc.type.none.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://doi.org/10.1186/s12984-023-01158-z
https://link.springer.com/article/10.1186/s12984-023-01158-z
https://hdl.handle.net/10578/44052
url https://doi.org/10.1186/s12984-023-01158-z
https://link.springer.com/article/10.1186/s12984-023-01158-z
https://hdl.handle.net/10578/44052
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv PI15/01437
RTI2018-097290-B-C31
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Springer Nature
publisher.none.fl_str_mv Springer Nature
dc.source.none.fl_str_mv reponame:RUIdeRA. Repositorio Institucional de la UCLM
instname:Universidad de Castilla-La Mancha
instname_str Universidad de Castilla-La Mancha
reponame_str RUIdeRA. Repositorio Institucional de la UCLM
collection RUIdeRA. Repositorio Institucional de la UCLM
repository.name.fl_str_mv
repository.mail.fl_str_mv
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