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Effectiveness of a Walking Program Involving the Hybrid Assistive Limb Robotic Exoskeleton Suit for Improving Walking Ability in Stroke Patients: Protocol for a Randomized Controlled Trial
BACKGROUND: Gait disturbance often occurs in stroke survivors. Recovery of walking function is challenging, as some gait disturbance due to hemiparesis often remains even after rehabilitation therapy, presenting a major obstacle towards regaining activities-of-daily-living performance and achieving...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
JMIR Publications
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6913690/ https://www.ncbi.nlm.nih.gov/pubmed/31605515 http://dx.doi.org/10.2196/14001 |
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author | Tsurushima, Hideo Mizukami, Masafumi Yoshikawa, Kenichi Ueno, Tomoyuki Hada, Yasushi Gosho, Masahiko Kohno, Yutaka Hashimoto, Koichi Iizumi, Yuichi Kikuchi, Toshihiro Matsumura, Akira |
author_facet | Tsurushima, Hideo Mizukami, Masafumi Yoshikawa, Kenichi Ueno, Tomoyuki Hada, Yasushi Gosho, Masahiko Kohno, Yutaka Hashimoto, Koichi Iizumi, Yuichi Kikuchi, Toshihiro Matsumura, Akira |
author_sort | Tsurushima, Hideo |
collection | PubMed |
description | BACKGROUND: Gait disturbance often occurs in stroke survivors. Recovery of walking function is challenging, as some gait disturbance due to hemiparesis often remains even after rehabilitation therapy, presenting a major obstacle towards regaining activities-of-daily-living performance and achieving social reintegration. OBJECTIVE: This study aims to clarify the effectiveness of a walking program involving the wearable Hybrid Assistive Limb (HAL-TS01) robotic exoskeleton for improving walking ability in stroke patients with hemiparesis and stagnant recovery despite ongoing rehabilitation. METHODS: This is a multicenter, randomized, parallel-group, controlled study (HAL group, n=27; control group, n=27). The study period includes preintervention observation (until stagnant recovery), intervention (HAL-based walking therapy or conventional rehabilitation; 5 weeks), and postintervention observation (2 weeks). Following provision of informed consent and primary registration, the patients undergo conventional rehabilitation for preintervention observation, during which the recovery of walking ability is monitored to identify patients with stagnant recovery (based on weekly assessments using the 10-meter maximum walking speed [MWS] test). Patients with an MWS of 30-60 m/minute and insufficient weekly improvement in MWS undergo secondary registration and are randomly assigned to undergo HAL-based walking therapy (HAL group) or conventional rehabilitation (control group). The primary outcome is the change in MWS from baseline to the end of the 5-week intervention. RESULTS: This study began in November 2016 and is being conducted at 15 participating facilities in Japan. CONCLUSIONS: Assessments of walking ability vary greatly and it is difficult to define the threshold for significant differences. To reduce such variability, our study involves conducting conventional rehabilitation to the point of saturation before starting the intervention. Stagnation in the recovery of walking ability despite conventional rehabilitation highlights the limits of current medical care. The present study may bring evidence that HAL-based therapy can overcome such limitations and induce added recovery of walking ability, which would promote the use of HAL technology in the clinical setting. TRIAL REGISTRATION: UMIN Clinical Trials Registry UMIN000024805; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028545 |
format | Online Article Text |
id | pubmed-6913690 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | JMIR Publications |
record_format | MEDLINE/PubMed |
spelling | pubmed-69136902020-01-02 Effectiveness of a Walking Program Involving the Hybrid Assistive Limb Robotic Exoskeleton Suit for Improving Walking Ability in Stroke Patients: Protocol for a Randomized Controlled Trial Tsurushima, Hideo Mizukami, Masafumi Yoshikawa, Kenichi Ueno, Tomoyuki Hada, Yasushi Gosho, Masahiko Kohno, Yutaka Hashimoto, Koichi Iizumi, Yuichi Kikuchi, Toshihiro Matsumura, Akira JMIR Res Protoc Protocol BACKGROUND: Gait disturbance often occurs in stroke survivors. Recovery of walking function is challenging, as some gait disturbance due to hemiparesis often remains even after rehabilitation therapy, presenting a major obstacle towards regaining activities-of-daily-living performance and achieving social reintegration. OBJECTIVE: This study aims to clarify the effectiveness of a walking program involving the wearable Hybrid Assistive Limb (HAL-TS01) robotic exoskeleton for improving walking ability in stroke patients with hemiparesis and stagnant recovery despite ongoing rehabilitation. METHODS: This is a multicenter, randomized, parallel-group, controlled study (HAL group, n=27; control group, n=27). The study period includes preintervention observation (until stagnant recovery), intervention (HAL-based walking therapy or conventional rehabilitation; 5 weeks), and postintervention observation (2 weeks). Following provision of informed consent and primary registration, the patients undergo conventional rehabilitation for preintervention observation, during which the recovery of walking ability is monitored to identify patients with stagnant recovery (based on weekly assessments using the 10-meter maximum walking speed [MWS] test). Patients with an MWS of 30-60 m/minute and insufficient weekly improvement in MWS undergo secondary registration and are randomly assigned to undergo HAL-based walking therapy (HAL group) or conventional rehabilitation (control group). The primary outcome is the change in MWS from baseline to the end of the 5-week intervention. RESULTS: This study began in November 2016 and is being conducted at 15 participating facilities in Japan. CONCLUSIONS: Assessments of walking ability vary greatly and it is difficult to define the threshold for significant differences. To reduce such variability, our study involves conducting conventional rehabilitation to the point of saturation before starting the intervention. Stagnation in the recovery of walking ability despite conventional rehabilitation highlights the limits of current medical care. The present study may bring evidence that HAL-based therapy can overcome such limitations and induce added recovery of walking ability, which would promote the use of HAL technology in the clinical setting. TRIAL REGISTRATION: UMIN Clinical Trials Registry UMIN000024805; https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028545 JMIR Publications 2019-10-11 /pmc/articles/PMC6913690/ /pubmed/31605515 http://dx.doi.org/10.2196/14001 Text en ©Hideo Tsurushima, Masafumi Mizukami, Kenichi Yoshikawa, Tomoyuki Ueno, Yasushi Hada, Masahiko Gosho, Yutaka Kohno, Koichi Hashimoto, Yuichi Iizumi, Toshihiro Kikuchi, Akira Matsumura, Hit2016 Study Group. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 11.10.2019. https://creativecommons.org/licenses/by/4.0/ This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included. |
spellingShingle | Protocol Tsurushima, Hideo Mizukami, Masafumi Yoshikawa, Kenichi Ueno, Tomoyuki Hada, Yasushi Gosho, Masahiko Kohno, Yutaka Hashimoto, Koichi Iizumi, Yuichi Kikuchi, Toshihiro Matsumura, Akira Effectiveness of a Walking Program Involving the Hybrid Assistive Limb Robotic Exoskeleton Suit for Improving Walking Ability in Stroke Patients: Protocol for a Randomized Controlled Trial |
title | Effectiveness of a Walking Program Involving the Hybrid Assistive Limb Robotic Exoskeleton Suit for Improving Walking Ability in Stroke Patients: Protocol for a Randomized Controlled Trial |
title_full | Effectiveness of a Walking Program Involving the Hybrid Assistive Limb Robotic Exoskeleton Suit for Improving Walking Ability in Stroke Patients: Protocol for a Randomized Controlled Trial |
title_fullStr | Effectiveness of a Walking Program Involving the Hybrid Assistive Limb Robotic Exoskeleton Suit for Improving Walking Ability in Stroke Patients: Protocol for a Randomized Controlled Trial |
title_full_unstemmed | Effectiveness of a Walking Program Involving the Hybrid Assistive Limb Robotic Exoskeleton Suit for Improving Walking Ability in Stroke Patients: Protocol for a Randomized Controlled Trial |
title_short | Effectiveness of a Walking Program Involving the Hybrid Assistive Limb Robotic Exoskeleton Suit for Improving Walking Ability in Stroke Patients: Protocol for a Randomized Controlled Trial |
title_sort | effectiveness of a walking program involving the hybrid assistive limb robotic exoskeleton suit for improving walking ability in stroke patients: protocol for a randomized controlled trial |
topic | Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6913690/ https://www.ncbi.nlm.nih.gov/pubmed/31605515 http://dx.doi.org/10.2196/14001 |
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