An Overground Robotic Gait Training Program for People With Multiple Sclerosis: A Protocol for a Randomized Clinical Trial

Maintaining the ability to walk is one of the significant challenges in people with multiple sclerosis (MS) for keeping a good quality of life as the disease and the aging process progresses. Overground robotic (OR) wearable exoskeletons are promising tools for gait rehabilitation, but currently the...

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Autores: Berriozabalgoitia Etxaniz, Rakel, Sanz Echevarría, María Begoña, Fraile Bermúdez, Ana Belén, Otxoa, Erika, Yeregui Prieto, Izaskun, Bidaurrazaga López de Letona, Iraia, Duñabeitia Usategui, Iratxe, Rodríguez-Antigüedad Zarranz, Alfredo, Domercq García, María, Irazusta Astiazaran, Jon, Rodríguez Larrad, Ana
Tipo de recurso: artículo
Fecha de publicación:2020
País:España
Institución:Universidad del País Vasco
Repositorio:Addi. Archivo Digital para la Docencia y la Investigación
OAI Identifier:oai:addi.ehu.eus:10810/44762
Acceso en línea:http://hdl.handle.net/10810/44762
Access Level:acceso abierto
Palabra clave:exoskeleton
gait speed
inflammation biomarkers
multiple sclerosis
quality of life
rehabilitation
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spelling An Overground Robotic Gait Training Program for People With Multiple Sclerosis: A Protocol for a Randomized Clinical TrialBerriozabalgoitia Etxaniz, RakelSanz Echevarría, María BegoñaFraile Bermúdez, Ana BelénOtxoa, ErikaYeregui Prieto, IzaskunBidaurrazaga López de Letona, IraiaDuñabeitia Usategui, IratxeRodríguez-Antigüedad Zarranz, AlfredoDomercq García, MaríaIrazusta Astiazaran, JonRodríguez Larrad, Anaexoskeletongait speedinflammation biomarkersmultiple sclerosisquality of liferehabilitationMaintaining the ability to walk is one of the significant challenges in people with multiple sclerosis (MS) for keeping a good quality of life as the disease and the aging process progresses. Overground robotic (OR) wearable exoskeletons are promising tools for gait rehabilitation, but currently there is no evidence of their clinical effects on patients with MS. The present study aims to determine the effects of an OR intervention in people with MS and moderate to severe walking disabilities and ascertain if benefits are maintained over a follow-up period of 3 months. This randomized controlled trial will include 36 participants with MS. Inclusion criteria are: older than 18 years, definitive diagnosis of MS, 4.5-7 points on the EDSS (Expanded Disability Status Scale), and needing one or two canes or crutches for walking outdoors. Subjects in the control group will receive conventional physiotherapy sessions at ADEMBI (Asociacion de Esclerosis Multiple de Bizkaia) provided to control spasticity, maintain articular range and exercise balance. Subjects in the intervention group will receive the same physiotherapy but also participate in a progressive OR gait training program assisted by the EksoTM exoskeleton. The program consists of twice a week individually supervised sessions in two setting modalities: PreGait and ProStepPlus. The training parameters (duration, speed, cadence, length of steps) will be set during the first session and the progression and intensity of the intervention will be adapted to the tolerance of each participant. The primary outcome of this study is gait speed. Secondary outcomes will include physical and cognitive performance tests, clinical, fatigue and quality of life assessments, and changes in the plasma levels of inflammatory cytokines. The present trial is the first analyzing the effectiveness of an OR intervention for gait training in patients with MS. It will help clarify the applicability of robotic technologies to clinical practice, extending the functionality and quality of life of people with MS to face a successful aging process. (ACTRN12619000014156; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376548).This research was partially supported by Bilbao Bizkaia Kutxa Bank Foundation, Euskampus Fundazioa Foundation and by the Ministry of Science of Spain under Grant No. DPI2017-82694-R (AEI/FEDER, UE).Frontiers Media202020202020info:eu-repo/semantics/articleapplication/pdfhttp://hdl.handle.net/10810/44762reponame:Addi. Archivo Digital para la Docencia y la Investigacióninstname:Universidad del País VascoIngléshttps://www.frontiersin.org/articles/10.3389/fmed.2020.00238/fullinfo:eu-repo/semantics/openAccesshttp://creativecommons.org/licenses/by/3.0/es/2020 Berriozabalgoitia, Sanz, Fraile-Bermúdez, Otxoa, Yeregui, Bidaurrazaga-Letona, Duñabeitia, Antigüedad, Domercq, Irazusta and Rodriguez-Larrad. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.Atribución 3.0 Españaoai:addi.ehu.eus:10810/447622026-06-18T09:23:17Z
dc.title.none.fl_str_mv An Overground Robotic Gait Training Program for People With Multiple Sclerosis: A Protocol for a Randomized Clinical Trial
title An Overground Robotic Gait Training Program for People With Multiple Sclerosis: A Protocol for a Randomized Clinical Trial
spellingShingle An Overground Robotic Gait Training Program for People With Multiple Sclerosis: A Protocol for a Randomized Clinical Trial
Berriozabalgoitia Etxaniz, Rakel
exoskeleton
gait speed
inflammation biomarkers
multiple sclerosis
quality of life
rehabilitation
title_short An Overground Robotic Gait Training Program for People With Multiple Sclerosis: A Protocol for a Randomized Clinical Trial
title_full An Overground Robotic Gait Training Program for People With Multiple Sclerosis: A Protocol for a Randomized Clinical Trial
title_fullStr An Overground Robotic Gait Training Program for People With Multiple Sclerosis: A Protocol for a Randomized Clinical Trial
title_full_unstemmed An Overground Robotic Gait Training Program for People With Multiple Sclerosis: A Protocol for a Randomized Clinical Trial
title_sort An Overground Robotic Gait Training Program for People With Multiple Sclerosis: A Protocol for a Randomized Clinical Trial
dc.creator.none.fl_str_mv Berriozabalgoitia Etxaniz, Rakel
Sanz Echevarría, María Begoña
Fraile Bermúdez, Ana Belén
Otxoa, Erika
Yeregui Prieto, Izaskun
Bidaurrazaga López de Letona, Iraia
Duñabeitia Usategui, Iratxe
Rodríguez-Antigüedad Zarranz, Alfredo
Domercq García, María
Irazusta Astiazaran, Jon
Rodríguez Larrad, Ana
author Berriozabalgoitia Etxaniz, Rakel
author_facet Berriozabalgoitia Etxaniz, Rakel
Sanz Echevarría, María Begoña
Fraile Bermúdez, Ana Belén
Otxoa, Erika
Yeregui Prieto, Izaskun
Bidaurrazaga López de Letona, Iraia
Duñabeitia Usategui, Iratxe
Rodríguez-Antigüedad Zarranz, Alfredo
Domercq García, María
Irazusta Astiazaran, Jon
Rodríguez Larrad, Ana
author_role author
author2 Sanz Echevarría, María Begoña
Fraile Bermúdez, Ana Belén
Otxoa, Erika
Yeregui Prieto, Izaskun
Bidaurrazaga López de Letona, Iraia
Duñabeitia Usategui, Iratxe
Rodríguez-Antigüedad Zarranz, Alfredo
Domercq García, María
Irazusta Astiazaran, Jon
Rodríguez Larrad, Ana
author2_role author
author
author
author
author
author
author
author
author
author
dc.subject.none.fl_str_mv exoskeleton
gait speed
inflammation biomarkers
multiple sclerosis
quality of life
rehabilitation
topic exoskeleton
gait speed
inflammation biomarkers
multiple sclerosis
quality of life
rehabilitation
description Maintaining the ability to walk is one of the significant challenges in people with multiple sclerosis (MS) for keeping a good quality of life as the disease and the aging process progresses. Overground robotic (OR) wearable exoskeletons are promising tools for gait rehabilitation, but currently there is no evidence of their clinical effects on patients with MS. The present study aims to determine the effects of an OR intervention in people with MS and moderate to severe walking disabilities and ascertain if benefits are maintained over a follow-up period of 3 months. This randomized controlled trial will include 36 participants with MS. Inclusion criteria are: older than 18 years, definitive diagnosis of MS, 4.5-7 points on the EDSS (Expanded Disability Status Scale), and needing one or two canes or crutches for walking outdoors. Subjects in the control group will receive conventional physiotherapy sessions at ADEMBI (Asociacion de Esclerosis Multiple de Bizkaia) provided to control spasticity, maintain articular range and exercise balance. Subjects in the intervention group will receive the same physiotherapy but also participate in a progressive OR gait training program assisted by the EksoTM exoskeleton. The program consists of twice a week individually supervised sessions in two setting modalities: PreGait and ProStepPlus. The training parameters (duration, speed, cadence, length of steps) will be set during the first session and the progression and intensity of the intervention will be adapted to the tolerance of each participant. The primary outcome of this study is gait speed. Secondary outcomes will include physical and cognitive performance tests, clinical, fatigue and quality of life assessments, and changes in the plasma levels of inflammatory cytokines. The present trial is the first analyzing the effectiveness of an OR intervention for gait training in patients with MS. It will help clarify the applicability of robotic technologies to clinical practice, extending the functionality and quality of life of people with MS to face a successful aging process. (ACTRN12619000014156; https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376548).
publishDate 2020
dc.date.none.fl_str_mv 2020
2020
2020
dc.type.none.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv http://hdl.handle.net/10810/44762
url http://hdl.handle.net/10810/44762
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv https://www.frontiersin.org/articles/10.3389/fmed.2020.00238/full
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
http://creativecommons.org/licenses/by/3.0/es/
Atribución 3.0 España
eu_rights_str_mv openAccess
rights_invalid_str_mv http://creativecommons.org/licenses/by/3.0/es/
Atribución 3.0 España
dc.format.none.fl_str_mv application/pdf
dc.publisher.none.fl_str_mv Frontiers Media
publisher.none.fl_str_mv Frontiers Media
dc.source.none.fl_str_mv reponame:Addi. Archivo Digital para la Docencia y la Investigación
instname:Universidad del País Vasco
instname_str Universidad del País Vasco
reponame_str Addi. Archivo Digital para la Docencia y la Investigación
collection Addi. Archivo Digital para la Docencia y la Investigación
repository.name.fl_str_mv
repository.mail.fl_str_mv
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