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

Elke Lathouwers; Bruno Tassignon; Alexandre Maricot; Ahmed Radwan; Maarten Naeyaert; Hubert Raeymaekers; Peter Van Schuerbeek; Stefan Sunaert; Johan De Mey; Kevin De Pauw

doi:10.1371/journal.pone.0299869

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

Elke Lathouwers, Bruno Tassignon, Alexandre Maricot, Ahmed Radwan, Maarten Naeyaert, Hubert Raeymaekers, Peter Van Schuerbeek, Stefan Sunaert, Johan De Mey, Kevin De Pauw

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Abstract

BACKGROUND: 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.

OBJECTIVES: 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.

METHODS: 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.

CONCLUSION: 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.

TRIAL REGISTRATION: NCT05818410 (Clinicaltrials.gov).

Original language	English
Article number	e0299869
Journal	PLOS ONE
Volume	19
Issue number	3
DOIs	https://doi.org/10.1371/journal.pone.0299869
Publication status	Published - Mar 2024

Bibliographical note

Copyright: © 2024 Lathouwers et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

Keywords

Humans
Quality of Life
Lower Extremity
Amputees/rehabilitation
Gait
Walking
Artificial Limbs
Brain/diagnostic imaging
Physical Functional Performance
Biomechanical Phenomena
Prosthesis Design

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109715388Final published version, 1.06 MBLicence: CC BY

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Lathouwers, E., Tassignon, B., Maricot, A., Radwan, A., Naeyaert, M., Raeymaekers, H., Van Schuerbeek, P., Sunaert, S., De Mey, J., & De Pauw, K. (2024). Human-Prosthetic Interaction (HumanIT): A study protocol for a clinical trial evaluating brain neuroplasticity and functional performance after lower limb loss. PLOS ONE, 19(3), [e0299869]. https://doi.org/10.1371/journal.pone.0299869

Lathouwers, Elke ; Tassignon, Bruno ; Maricot, Alexandre ; Radwan, Ahmed ; Naeyaert, Maarten ; Raeymaekers, Hubert ; Van Schuerbeek, Peter ; Sunaert, Stefan ; De Mey, Johan ; De Pauw, Kevin. / Human-Prosthetic Interaction (HumanIT) : A study protocol for a clinical trial evaluating brain neuroplasticity and functional performance after lower limb loss. In: PLOS ONE. 2024 ; Vol. 19, No. 3.

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

abstract = "BACKGROUND: 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.OBJECTIVES: 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.METHODS: 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.CONCLUSION: 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.TRIAL REGISTRATION: NCT05818410 (Clinicaltrials.gov).",

keywords = "Humans, Quality of Life, Lower Extremity, Amputees/rehabilitation, Gait, Walking, Artificial Limbs, Brain/diagnostic imaging, Physical Functional Performance, Biomechanical Phenomena, Prosthesis Design",

author = "Elke Lathouwers and Bruno Tassignon and Alexandre Maricot and Ahmed Radwan and Maarten Naeyaert and Hubert Raeymaekers and {Van Schuerbeek}, Peter and Stefan Sunaert and {De Mey}, Johan and {De Pauw}, Kevin",

note = "Copyright: {\textcopyright} 2024 Lathouwers et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.",

year = "2024",

month = mar,

doi = "10.1371/journal.pone.0299869",

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Lathouwers, E , Tassignon, B , Maricot, A, Radwan, A, Naeyaert, M , Raeymaekers, H , Van Schuerbeek, P, Sunaert, S, De Mey, J & De Pauw, K 2024, 'Human-Prosthetic Interaction (HumanIT): A study protocol for a clinical trial evaluating brain neuroplasticity and functional performance after lower limb loss', PLOS ONE, vol. 19, no. 3, e0299869. https://doi.org/10.1371/journal.pone.0299869

Human-Prosthetic Interaction (HumanIT) : A study protocol for a clinical trial evaluating brain neuroplasticity and functional performance after lower limb loss. / Lathouwers, Elke ; Tassignon, Bruno ; Maricot, Alexandre; Radwan, Ahmed; Naeyaert, Maarten ; Raeymaekers, Hubert ; Van Schuerbeek, Peter; Sunaert, Stefan; De Mey, Johan ; De Pauw, Kevin.

In: PLOS ONE, Vol. 19, No. 3, e0299869, 03.2024.

Research output: Contribution to journal › Article › peer-review

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T1 - Human-Prosthetic Interaction (HumanIT)

T2 - A study protocol for a clinical trial evaluating brain neuroplasticity and functional performance after lower limb loss

AU - Lathouwers, Elke

AU - Tassignon, Bruno

AU - Maricot, Alexandre

AU - Radwan, Ahmed

AU - Naeyaert, Maarten

AU - Raeymaekers, Hubert

AU - Van Schuerbeek, Peter

AU - Sunaert, Stefan

AU - De Mey, Johan

AU - De Pauw, Kevin

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PY - 2024/3

Y1 - 2024/3

N2 - BACKGROUND: 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.OBJECTIVES: 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.METHODS: 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.CONCLUSION: 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.TRIAL REGISTRATION: NCT05818410 (Clinicaltrials.gov).

AB - BACKGROUND: 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.OBJECTIVES: 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.METHODS: 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.CONCLUSION: 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.TRIAL REGISTRATION: NCT05818410 (Clinicaltrials.gov).

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KW - Quality of Life

KW - Lower Extremity

KW - Amputees/rehabilitation

KW - Gait

KW - Walking

KW - Artificial Limbs

KW - Brain/diagnostic imaging

KW - Physical Functional Performance

KW - Biomechanical Phenomena

KW - Prosthesis Design

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DO - 10.1371/journal.pone.0299869

M3 - Article

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VL - 19

JO - PLoS ONE

JF - PLoS ONE

SN - 1932-6203

IS - 3

M1 - e0299869

ER -

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

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