A Randomized and Controlled Crossover Study Investigating the Improvement of Walking and Posture Functions in Chronic Stroke Patients Using HAL Exoskeleton – The HALESTRO Study (HAL-Exoskeleton STROke Study)

Background: The exoskeleton HAL (hybrid assistive limb) has proven to improve walking functions in spinal cord injury and chronic stroke patients when using it for body-weight supported treadmill training (BWSTT). Compared with other robotic devices, it offers the possibility to initiate movements a...

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Main Authors: Matthias Sczesny-Kaiser, Rebecca Trost, Mirko Aach, Thomas A. Schildhauer, Peter Schwenkreis, Martin Tegenthoff
Format: Article
Language:English
Published: Frontiers Media S.A. 2019-03-01
Series:Frontiers in Neuroscience
Subjects:
Online Access:https://www.frontiersin.org/article/10.3389/fnins.2019.00259/full
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author Matthias Sczesny-Kaiser
Rebecca Trost
Mirko Aach
Thomas A. Schildhauer
Peter Schwenkreis
Martin Tegenthoff
author_facet Matthias Sczesny-Kaiser
Rebecca Trost
Mirko Aach
Thomas A. Schildhauer
Peter Schwenkreis
Martin Tegenthoff
author_sort Matthias Sczesny-Kaiser
collection DOAJ
description Background: The exoskeleton HAL (hybrid assistive limb) has proven to improve walking functions in spinal cord injury and chronic stroke patients when using it for body-weight supported treadmill training (BWSTT). Compared with other robotic devices, it offers the possibility to initiate movements actively. Previous studies on stroke patients did not compare HAL-BWSTT with conventional physiotherapy (CPT). Therefore, we performed a crossover clinical trial comparing CPT and HAL-BWSTT in chronic stroke patients with hemiparesis, the HALESTRO study. Our hypothesis was that HAL-training would have greater effects on walking and posture functions compared to a mixed-approach CPT.Methods: A total of 18 chronic stroke patients participated in this study. Treatment consisted of 30 CPT sessions and of 30 sessions of BWSTT with a double leg type HAL exoskeleton successively in a randomized, crossover study design. Primary outcome parameters were walking time and speed in 10-meter walk test (10MWT), time in timed-up-and-go test (TUG) and distance in 6-min walk test (6MWT). Secondary outcome parameters were the functional ambulatory categories (FAC) and the Berg-Balance Scale (BBS). Data were assessed at baseline, at crossover and at the end of the study, all without using and wearing HAL.Results: Our study demonstrate neither a significant difference in walking parameters nor in functional and balance parameters. When HAL-BWSTT was applied to naïve patients, it led to an improvement in walking parameters and in balance abilities. Pooling all data, we could show a significant effect in 10MWT, 6MWT, FAC and BBS, both therapies sequentially applied over 12 weeks. Thereby, FAC improve from dependent to independent category (3 to 4). One patient dropped out of the study due to intensive fatigue after each training session.Conclusion: HAL-BWSTT and mixed-approach CPT were effective therapies in chronic stroke patients. However, compared with CPT, HAL training with 30 sessions over 6 weeks was not more effective. The combination of both therapies led to an improvement of walking and balance functions. Robotic rehabilitation of walking disorders alone still lacks the proof of superiority in chronic stroke. Robotic treatment therapies and classical CPT rehabilitation concepts should be applied in an individualized therapy program.
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spelling doaj.art-65ba9ade820143a68fb2757c6b6696c42022-12-22T01:24:41ZengFrontiers Media S.A.Frontiers in Neuroscience1662-453X2019-03-011310.3389/fnins.2019.00259436027A Randomized and Controlled Crossover Study Investigating the Improvement of Walking and Posture Functions in Chronic Stroke Patients Using HAL Exoskeleton – The HALESTRO Study (HAL-Exoskeleton STROke Study)Matthias Sczesny-Kaiser0Rebecca Trost1Mirko Aach2Thomas A. Schildhauer3Peter Schwenkreis4Martin Tegenthoff5Department of Neurology, BG University Hospital Bergmannsheil Bochum, Bochum, GermanyDepartment of Neurology, BG University Hospital Bergmannsheil Bochum, Bochum, GermanyDepartment of Spinal Cord Injury, BG University Hospital Bergmannsheil Bochum, Bochum, GermanyDepartment of General and Trauma Surgery, BG University Hospital Bergmannsheil Bochum, Bochum, GermanyDepartment of Neurology, BG University Hospital Bergmannsheil Bochum, Bochum, GermanyDepartment of Neurology, BG University Hospital Bergmannsheil Bochum, Bochum, GermanyBackground: The exoskeleton HAL (hybrid assistive limb) has proven to improve walking functions in spinal cord injury and chronic stroke patients when using it for body-weight supported treadmill training (BWSTT). Compared with other robotic devices, it offers the possibility to initiate movements actively. Previous studies on stroke patients did not compare HAL-BWSTT with conventional physiotherapy (CPT). Therefore, we performed a crossover clinical trial comparing CPT and HAL-BWSTT in chronic stroke patients with hemiparesis, the HALESTRO study. Our hypothesis was that HAL-training would have greater effects on walking and posture functions compared to a mixed-approach CPT.Methods: A total of 18 chronic stroke patients participated in this study. Treatment consisted of 30 CPT sessions and of 30 sessions of BWSTT with a double leg type HAL exoskeleton successively in a randomized, crossover study design. Primary outcome parameters were walking time and speed in 10-meter walk test (10MWT), time in timed-up-and-go test (TUG) and distance in 6-min walk test (6MWT). Secondary outcome parameters were the functional ambulatory categories (FAC) and the Berg-Balance Scale (BBS). Data were assessed at baseline, at crossover and at the end of the study, all without using and wearing HAL.Results: Our study demonstrate neither a significant difference in walking parameters nor in functional and balance parameters. When HAL-BWSTT was applied to naïve patients, it led to an improvement in walking parameters and in balance abilities. Pooling all data, we could show a significant effect in 10MWT, 6MWT, FAC and BBS, both therapies sequentially applied over 12 weeks. Thereby, FAC improve from dependent to independent category (3 to 4). One patient dropped out of the study due to intensive fatigue after each training session.Conclusion: HAL-BWSTT and mixed-approach CPT were effective therapies in chronic stroke patients. However, compared with CPT, HAL training with 30 sessions over 6 weeks was not more effective. The combination of both therapies led to an improvement of walking and balance functions. Robotic rehabilitation of walking disorders alone still lacks the proof of superiority in chronic stroke. Robotic treatment therapies and classical CPT rehabilitation concepts should be applied in an individualized therapy program.https://www.frontiersin.org/article/10.3389/fnins.2019.00259/fullstroke rehabilitationexoskeletonhybrid assistive limbphysiotherapeutic approachlocomotor training
spellingShingle Matthias Sczesny-Kaiser
Rebecca Trost
Mirko Aach
Thomas A. Schildhauer
Peter Schwenkreis
Martin Tegenthoff
A Randomized and Controlled Crossover Study Investigating the Improvement of Walking and Posture Functions in Chronic Stroke Patients Using HAL Exoskeleton – The HALESTRO Study (HAL-Exoskeleton STROke Study)
Frontiers in Neuroscience
stroke rehabilitation
exoskeleton
hybrid assistive limb
physiotherapeutic approach
locomotor training
title A Randomized and Controlled Crossover Study Investigating the Improvement of Walking and Posture Functions in Chronic Stroke Patients Using HAL Exoskeleton – The HALESTRO Study (HAL-Exoskeleton STROke Study)
title_full A Randomized and Controlled Crossover Study Investigating the Improvement of Walking and Posture Functions in Chronic Stroke Patients Using HAL Exoskeleton – The HALESTRO Study (HAL-Exoskeleton STROke Study)
title_fullStr A Randomized and Controlled Crossover Study Investigating the Improvement of Walking and Posture Functions in Chronic Stroke Patients Using HAL Exoskeleton – The HALESTRO Study (HAL-Exoskeleton STROke Study)
title_full_unstemmed A Randomized and Controlled Crossover Study Investigating the Improvement of Walking and Posture Functions in Chronic Stroke Patients Using HAL Exoskeleton – The HALESTRO Study (HAL-Exoskeleton STROke Study)
title_short A Randomized and Controlled Crossover Study Investigating the Improvement of Walking and Posture Functions in Chronic Stroke Patients Using HAL Exoskeleton – The HALESTRO Study (HAL-Exoskeleton STROke Study)
title_sort randomized and controlled crossover study investigating the improvement of walking and posture functions in chronic stroke patients using hal exoskeleton the halestro study hal exoskeleton stroke study
topic stroke rehabilitation
exoskeleton
hybrid assistive limb
physiotherapeutic approach
locomotor training
url https://www.frontiersin.org/article/10.3389/fnins.2019.00259/full
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