Human-Prosthetic Interaction (HumanIT): A study protocol for a clinical trial evaluating brain neuroplasticity and functional performance after lower limb loss.

<h4>Background</h4>Lower limb amputation contributes to structural and functional brain alterations, adversely affecting gait, balance, and overall quality of life. Therefore, selecting an appropriate prosthetic ankle is critical in enhancing the well-being of these individuals. Despite...

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Main Authors: Elke Lathouwers, Bruno Tassignon, Alexandre Maricot, Ahmed Radwan, Maarten Naeyaert, Hubert Raeymaekers, Peter Van Schuerbeek, Stefan Sunaert, Johan De Mey, Kevin De Pauw
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2024-01-01
Series:PLoS ONE
Online Access:https://doi.org/10.1371/journal.pone.0299869
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author Elke Lathouwers
Bruno Tassignon
Alexandre Maricot
Ahmed Radwan
Maarten Naeyaert
Hubert Raeymaekers
Peter Van Schuerbeek
Stefan Sunaert
Johan De Mey
Kevin De Pauw
Kevin De Pauw
author_facet Elke Lathouwers
Bruno Tassignon
Alexandre Maricot
Ahmed Radwan
Maarten Naeyaert
Hubert Raeymaekers
Peter Van Schuerbeek
Stefan Sunaert
Johan De Mey
Kevin De Pauw
Kevin De Pauw
author_sort Elke Lathouwers
collection DOAJ
description <h4>Background</h4>Lower limb amputation contributes to structural and functional brain alterations, adversely affecting gait, balance, and overall quality of life. Therefore, selecting an appropriate prosthetic ankle is critical in enhancing the well-being of these individuals. Despite the availability of various prostheses, their impact on brain neuroplasticity remains poorly understood.<h4>Objectives</h4>The primary objective is to examine differences in the degree of brain neuroplasticity using magnetic resonance imaging (MRI) between individuals wearing a new passive ankle prosthesis with an articulated ankle joint and a standard passive prosthesis, and to examine changes in brain neuroplasticity within these two prosthetic groups. The second objective is to investigate the influence of prosthetic type on walking performance and quality of life. The final objective is to determine whether the type of prosthesis induces differences in the walking movement pattern.<h4>Methods</h4>Participants with a unilateral transtibial amputation will follow a 24-week protocol. Prior to rehabilitation, baseline MRI scans will be performed, followed by allocation to the intervention arms and commencement of rehabilitation. After 12 weeks, baseline functional performance tests and a quality of life questionnaire will be administered. At the end of the 24-week period, participants will undergo the same MRI scans, functional performance tests and questionnaire to evaluate any changes. A control group of able-bodied individuals will be included for comparative analysis.<h4>Conclusion</h4>This study aims to unravel the differences in brain neuroplasticity and prosthesis type in patients with a unilateral transtibial amputation and provide insights into the therapeutic benefits of prosthetic devices. The findings could validate the therapeutic benefits of more advanced lower limb prostheses, potentially leading to a societal impact ultimately improving the quality of life for individuals with lower limb amputation.<h4>Trial registration</h4>NCT05818410 (Clinicaltrials.gov).
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spelling doaj-art-7769f5e810b649d2a3302adec173d6832025-01-26T05:31:24ZengPublic Library of Science (PLoS)PLoS ONE1932-62032024-01-01193e029986910.1371/journal.pone.0299869Human-Prosthetic Interaction (HumanIT): A study protocol for a clinical trial evaluating brain neuroplasticity and functional performance after lower limb loss.Elke LathouwersBruno TassignonAlexandre MaricotAhmed RadwanMaarten NaeyaertHubert RaeymaekersPeter Van SchuerbeekStefan SunaertJohan De MeyKevin De PauwKevin De Pauw<h4>Background</h4>Lower limb amputation contributes to structural and functional brain alterations, adversely affecting gait, balance, and overall quality of life. Therefore, selecting an appropriate prosthetic ankle is critical in enhancing the well-being of these individuals. Despite the availability of various prostheses, their impact on brain neuroplasticity remains poorly understood.<h4>Objectives</h4>The primary objective is to examine differences in the degree of brain neuroplasticity using magnetic resonance imaging (MRI) between individuals wearing a new passive ankle prosthesis with an articulated ankle joint and a standard passive prosthesis, and to examine changes in brain neuroplasticity within these two prosthetic groups. The second objective is to investigate the influence of prosthetic type on walking performance and quality of life. The final objective is to determine whether the type of prosthesis induces differences in the walking movement pattern.<h4>Methods</h4>Participants with a unilateral transtibial amputation will follow a 24-week protocol. Prior to rehabilitation, baseline MRI scans will be performed, followed by allocation to the intervention arms and commencement of rehabilitation. After 12 weeks, baseline functional performance tests and a quality of life questionnaire will be administered. At the end of the 24-week period, participants will undergo the same MRI scans, functional performance tests and questionnaire to evaluate any changes. A control group of able-bodied individuals will be included for comparative analysis.<h4>Conclusion</h4>This study aims to unravel the differences in brain neuroplasticity and prosthesis type in patients with a unilateral transtibial amputation and provide insights into the therapeutic benefits of prosthetic devices. The findings could validate the therapeutic benefits of more advanced lower limb prostheses, potentially leading to a societal impact ultimately improving the quality of life for individuals with lower limb amputation.<h4>Trial registration</h4>NCT05818410 (Clinicaltrials.gov).https://doi.org/10.1371/journal.pone.0299869
spellingShingle Elke Lathouwers
Bruno Tassignon
Alexandre Maricot
Ahmed Radwan
Maarten Naeyaert
Hubert Raeymaekers
Peter Van Schuerbeek
Stefan Sunaert
Johan De Mey
Kevin De Pauw
Kevin De Pauw
Human-Prosthetic Interaction (HumanIT): A study protocol for a clinical trial evaluating brain neuroplasticity and functional performance after lower limb loss.
PLoS ONE
title Human-Prosthetic Interaction (HumanIT): A study protocol for a clinical trial evaluating brain neuroplasticity and functional performance after lower limb loss.
title_full Human-Prosthetic Interaction (HumanIT): A study protocol for a clinical trial evaluating brain neuroplasticity and functional performance after lower limb loss.
title_fullStr Human-Prosthetic Interaction (HumanIT): A study protocol for a clinical trial evaluating brain neuroplasticity and functional performance after lower limb loss.
title_full_unstemmed Human-Prosthetic Interaction (HumanIT): A study protocol for a clinical trial evaluating brain neuroplasticity and functional performance after lower limb loss.
title_short Human-Prosthetic Interaction (HumanIT): A study protocol for a clinical trial evaluating brain neuroplasticity and functional performance after lower limb loss.
title_sort human prosthetic interaction humanit a study protocol for a clinical trial evaluating brain neuroplasticity and functional performance after lower limb loss
url https://doi.org/10.1371/journal.pone.0299869
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