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A Pilot Study Testing a Novel 3D Printed Amphibious Lower Limb Prosthesis in a Recreational Pool Setting

INTRODUCTION: Adults with limb amputation and other physical disabilities are less likely to participate in physical activity than adults in the general population and have elevated risk of heart disease and stroke. Swimming is a physical activity often recommended for persons with limb amputation....

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Autores principales: Goldstein, Todd, Oreste, Anthony, Hutnick, Glenn, Chory, Ashley, Chehata, Veronica, Seldin, Joseph, Gallo, Michael D., Bloom, Ona
Formato: Online Artículo Texto
Lenguaje:English
Publicado: John Wiley & Sons, Inc. 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7496828/
https://www.ncbi.nlm.nih.gov/pubmed/31749329
http://dx.doi.org/10.1002/pmrj.12293
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author Goldstein, Todd
Oreste, Anthony
Hutnick, Glenn
Chory, Ashley
Chehata, Veronica
Seldin, Joseph
Gallo, Michael D.
Bloom, Ona
author_facet Goldstein, Todd
Oreste, Anthony
Hutnick, Glenn
Chory, Ashley
Chehata, Veronica
Seldin, Joseph
Gallo, Michael D.
Bloom, Ona
author_sort Goldstein, Todd
collection PubMed
description INTRODUCTION: Adults with limb amputation and other physical disabilities are less likely to participate in physical activity than adults in the general population and have elevated risk of heart disease and stroke. Swimming is a physical activity often recommended for persons with limb amputation. However, a standard economical swim prosthesis that facilitates easy transition from land to water does not exist. OBJECTIVE: The objectives were (1) to measure ease of first‐time use and likability of a novel U.S. Food and Drug Administration (FDA)–cleared 510(k) three‐dimensional (3D) printed device, the “FIN,” in a recreational pool; and (2) to determine differences in time to complete basic swim tasks using the novel 3D printed amphibious lower limb prosthesis or a standard Swim Ankle prosthesis. Our hypotheses were the following: (1) that the novel 3D printed amphibious lower limb prosthesis would be easy and likeable upon first use; and (2) that basic swim tasks would take comparable time to complete with either device. SETTING: Academic medical center and community pool in New York. PARTICIPANTS: Participants were (N = 10) English‐speaking adults with a transtibial amputation who self‐identified to swim comfortably in a recreational setting. INTERVENTIONS: Participants completed tasks typical of recreational swimming while wearing the novel 3D printed amphibious lower limb prosthesis or a Swim Ankle. MAIN OUTCOME MEASUREMENTS: Participants performed a series of recreational swim tasks at self‐selected speeds: entering/exiting pool, walking, swimming, and treading water, and completed a survey to assess the primary outcomes: likability, ease of use, and adverse events (feasibility). RESULTS: Participants found the novel 3D printed amphibious lower limb prosthesis more likable compared to the Swim Ankle and easy to use. Time to exit the pool was significantly reduced with the novel 3D printed amphibious lower limb prosthesis, while time to complete a 25‐m lap was comparable. Participants did not show significant changes in vital signs when using either prosthesis. CONCLUSIONS: The novel 3D printed amphibious lower limb prosthesis was likable and easy to use upon first use. This study supports conducting a larger clinical trial to determine if the data are broadly reproducible.
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spelling pubmed-74968282020-09-25 A Pilot Study Testing a Novel 3D Printed Amphibious Lower Limb Prosthesis in a Recreational Pool Setting Goldstein, Todd Oreste, Anthony Hutnick, Glenn Chory, Ashley Chehata, Veronica Seldin, Joseph Gallo, Michael D. Bloom, Ona PM R Original Research INTRODUCTION: Adults with limb amputation and other physical disabilities are less likely to participate in physical activity than adults in the general population and have elevated risk of heart disease and stroke. Swimming is a physical activity often recommended for persons with limb amputation. However, a standard economical swim prosthesis that facilitates easy transition from land to water does not exist. OBJECTIVE: The objectives were (1) to measure ease of first‐time use and likability of a novel U.S. Food and Drug Administration (FDA)–cleared 510(k) three‐dimensional (3D) printed device, the “FIN,” in a recreational pool; and (2) to determine differences in time to complete basic swim tasks using the novel 3D printed amphibious lower limb prosthesis or a standard Swim Ankle prosthesis. Our hypotheses were the following: (1) that the novel 3D printed amphibious lower limb prosthesis would be easy and likeable upon first use; and (2) that basic swim tasks would take comparable time to complete with either device. SETTING: Academic medical center and community pool in New York. PARTICIPANTS: Participants were (N = 10) English‐speaking adults with a transtibial amputation who self‐identified to swim comfortably in a recreational setting. INTERVENTIONS: Participants completed tasks typical of recreational swimming while wearing the novel 3D printed amphibious lower limb prosthesis or a Swim Ankle. MAIN OUTCOME MEASUREMENTS: Participants performed a series of recreational swim tasks at self‐selected speeds: entering/exiting pool, walking, swimming, and treading water, and completed a survey to assess the primary outcomes: likability, ease of use, and adverse events (feasibility). RESULTS: Participants found the novel 3D printed amphibious lower limb prosthesis more likable compared to the Swim Ankle and easy to use. Time to exit the pool was significantly reduced with the novel 3D printed amphibious lower limb prosthesis, while time to complete a 25‐m lap was comparable. Participants did not show significant changes in vital signs when using either prosthesis. CONCLUSIONS: The novel 3D printed amphibious lower limb prosthesis was likable and easy to use upon first use. This study supports conducting a larger clinical trial to determine if the data are broadly reproducible. John Wiley & Sons, Inc. 2020-01-18 2020-08 /pmc/articles/PMC7496828/ /pubmed/31749329 http://dx.doi.org/10.1002/pmrj.12293 Text en © 2019 The Authors. PM&R published by Wiley Periodicals, Inc. on behalf of American Academy of Physical Medicine and Rehabilitation This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc-nd/4.0/ License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.
spellingShingle Original Research
Goldstein, Todd
Oreste, Anthony
Hutnick, Glenn
Chory, Ashley
Chehata, Veronica
Seldin, Joseph
Gallo, Michael D.
Bloom, Ona
A Pilot Study Testing a Novel 3D Printed Amphibious Lower Limb Prosthesis in a Recreational Pool Setting
title A Pilot Study Testing a Novel 3D Printed Amphibious Lower Limb Prosthesis in a Recreational Pool Setting
title_full A Pilot Study Testing a Novel 3D Printed Amphibious Lower Limb Prosthesis in a Recreational Pool Setting
title_fullStr A Pilot Study Testing a Novel 3D Printed Amphibious Lower Limb Prosthesis in a Recreational Pool Setting
title_full_unstemmed A Pilot Study Testing a Novel 3D Printed Amphibious Lower Limb Prosthesis in a Recreational Pool Setting
title_short A Pilot Study Testing a Novel 3D Printed Amphibious Lower Limb Prosthesis in a Recreational Pool Setting
title_sort pilot study testing a novel 3d printed amphibious lower limb prosthesis in a recreational pool setting
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7496828/
https://www.ncbi.nlm.nih.gov/pubmed/31749329
http://dx.doi.org/10.1002/pmrj.12293
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