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User-centred assistive SystEm for arm Functions in neUromuscuLar subjects (USEFUL): a randomized controlled study

BACKGROUND: Upper limb assistive devices can compensate for muscular weakness and empower the user in the execution of daily activities. Multiple devices have been recently proposed but there is still a lack in the scientific comparison of their efficacy. METHODS: We conducted a cross-over multi-cen...

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Autores principales: Longatelli, Valeria, Antonietti, Alberto, Biffi, Emilia, Diella, Eleonora, D’Angelo, Maria Grazia, Rossini, Mauro, Molteni, Franco, Bocciolone, Marco, Pedrocchi, Alessandra, Gandolla, Marta
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7789525/
https://www.ncbi.nlm.nih.gov/pubmed/33407580
http://dx.doi.org/10.1186/s12984-020-00794-z
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author Longatelli, Valeria
Antonietti, Alberto
Biffi, Emilia
Diella, Eleonora
D’Angelo, Maria Grazia
Rossini, Mauro
Molteni, Franco
Bocciolone, Marco
Pedrocchi, Alessandra
Gandolla, Marta
author_facet Longatelli, Valeria
Antonietti, Alberto
Biffi, Emilia
Diella, Eleonora
D’Angelo, Maria Grazia
Rossini, Mauro
Molteni, Franco
Bocciolone, Marco
Pedrocchi, Alessandra
Gandolla, Marta
author_sort Longatelli, Valeria
collection PubMed
description BACKGROUND: Upper limb assistive devices can compensate for muscular weakness and empower the user in the execution of daily activities. Multiple devices have been recently proposed but there is still a lack in the scientific comparison of their efficacy. METHODS: We conducted a cross-over multi-centric randomized controlled trial to assess the functional improvement at the upper limb level of two arms supports on 36 patients with muscular dystrophy. Participants tested a passive device (i.e., Wrex by Jaeco) and a semi-active solution for gravity compensation (i.e., Armon Ayura). We evaluated devices’ effectiveness with an externally-assessed scale (i.e., Performance of the Upper Limb-PUL-module), a self-perceived scale (i.e., Abilhand questionnaire), and a usability scale (i.e., System Usability Scale). Friedman’s test was used to assess significant functional gain for PUL module and Abilhand questionnaire. Moreover, PUL changes were compared by means of the Friedman’s test. RESULTS: Most of the patients improved upper limb function with the use of arm supports (median PUL scores increase of 1–3 points). However, the effectiveness of each device was related to the level of residual ability of the end-user. Slightly impaired patients maintained the same independence without and with assistive devices, even if they reported reduced muscular fatigue for both devices. Moderately impaired patients enhanced their arm functionality with both devices, and they obtained higher improvements with the semi-active one (median PUL scores increase of 9 points). Finally, severely impaired subjects benefited only from the semi-active device (median PUL scores increase of 12 points). Inadequate strength was recognized as a barrier to passive devices. The usability, measured by the System Usability Scale, was evaluated by end-users “good” (70/100 points) for the passive, and “excellent” (80/100 points) for the semi-active device. CONCLUSIONS: This study demonstrated that assistive devices can improve the quality of life of people suffering from muscular dystrophy. The use of passive devices, despite being low cost and easy to use, shows limitations in the efficacy of the assistance to daily tasks, limiting the assistance to a predefined horizontal plane. The addition of one active degree of freedom improves efficacy and usability especially for medium to severe patients. Further investigations are needed to increase the evidence on the effect of arm supports on quality of life and diseases’ progression in subjects with degenerative disorders. Trial registration clinicaltrials.gov, NCT03127241, Registered 25th April 2017. The clinical trial was also registered as a post-market study at the Italian Ministry of Health.
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spelling pubmed-77895252021-01-07 User-centred assistive SystEm for arm Functions in neUromuscuLar subjects (USEFUL): a randomized controlled study Longatelli, Valeria Antonietti, Alberto Biffi, Emilia Diella, Eleonora D’Angelo, Maria Grazia Rossini, Mauro Molteni, Franco Bocciolone, Marco Pedrocchi, Alessandra Gandolla, Marta J Neuroeng Rehabil Research BACKGROUND: Upper limb assistive devices can compensate for muscular weakness and empower the user in the execution of daily activities. Multiple devices have been recently proposed but there is still a lack in the scientific comparison of their efficacy. METHODS: We conducted a cross-over multi-centric randomized controlled trial to assess the functional improvement at the upper limb level of two arms supports on 36 patients with muscular dystrophy. Participants tested a passive device (i.e., Wrex by Jaeco) and a semi-active solution for gravity compensation (i.e., Armon Ayura). We evaluated devices’ effectiveness with an externally-assessed scale (i.e., Performance of the Upper Limb-PUL-module), a self-perceived scale (i.e., Abilhand questionnaire), and a usability scale (i.e., System Usability Scale). Friedman’s test was used to assess significant functional gain for PUL module and Abilhand questionnaire. Moreover, PUL changes were compared by means of the Friedman’s test. RESULTS: Most of the patients improved upper limb function with the use of arm supports (median PUL scores increase of 1–3 points). However, the effectiveness of each device was related to the level of residual ability of the end-user. Slightly impaired patients maintained the same independence without and with assistive devices, even if they reported reduced muscular fatigue for both devices. Moderately impaired patients enhanced their arm functionality with both devices, and they obtained higher improvements with the semi-active one (median PUL scores increase of 9 points). Finally, severely impaired subjects benefited only from the semi-active device (median PUL scores increase of 12 points). Inadequate strength was recognized as a barrier to passive devices. The usability, measured by the System Usability Scale, was evaluated by end-users “good” (70/100 points) for the passive, and “excellent” (80/100 points) for the semi-active device. CONCLUSIONS: This study demonstrated that assistive devices can improve the quality of life of people suffering from muscular dystrophy. The use of passive devices, despite being low cost and easy to use, shows limitations in the efficacy of the assistance to daily tasks, limiting the assistance to a predefined horizontal plane. The addition of one active degree of freedom improves efficacy and usability especially for medium to severe patients. Further investigations are needed to increase the evidence on the effect of arm supports on quality of life and diseases’ progression in subjects with degenerative disorders. Trial registration clinicaltrials.gov, NCT03127241, Registered 25th April 2017. The clinical trial was also registered as a post-market study at the Italian Ministry of Health. BioMed Central 2021-01-06 /pmc/articles/PMC7789525/ /pubmed/33407580 http://dx.doi.org/10.1186/s12984-020-00794-z Text en © The Author(s) 2021 Open AccessThis article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.
spellingShingle Research
Longatelli, Valeria
Antonietti, Alberto
Biffi, Emilia
Diella, Eleonora
D’Angelo, Maria Grazia
Rossini, Mauro
Molteni, Franco
Bocciolone, Marco
Pedrocchi, Alessandra
Gandolla, Marta
User-centred assistive SystEm for arm Functions in neUromuscuLar subjects (USEFUL): a randomized controlled study
title User-centred assistive SystEm for arm Functions in neUromuscuLar subjects (USEFUL): a randomized controlled study
title_full User-centred assistive SystEm for arm Functions in neUromuscuLar subjects (USEFUL): a randomized controlled study
title_fullStr User-centred assistive SystEm for arm Functions in neUromuscuLar subjects (USEFUL): a randomized controlled study
title_full_unstemmed User-centred assistive SystEm for arm Functions in neUromuscuLar subjects (USEFUL): a randomized controlled study
title_short User-centred assistive SystEm for arm Functions in neUromuscuLar subjects (USEFUL): a randomized controlled study
title_sort user-centred assistive system for arm functions in neuromuscular subjects (useful): a randomized controlled study
topic Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7789525/
https://www.ncbi.nlm.nih.gov/pubmed/33407580
http://dx.doi.org/10.1186/s12984-020-00794-z
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