Evidence map›Paper›PMID 38512879›Full record

ArticlePloS one2024

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

Erratum issued Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT05818410 (Human-Prosthetic Interaction), which is not on this map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.7field-weighted citation impact, top 34% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05818410 narecruitingnot on this map

Human-Prosthetic Interaction: Brain & Technology After Lower-Limb Loss

TypeinterventionalSponsorVrije Universiteit BrusselRan2024 to 2028Enrolled60ConditionsLower Limb Amputation Below Knee (Injury)ArmsProsthetic device (Lunaris), No prosthetic device, Prosthetic device (Sach foot)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

10 authors at 3 institutions in 1 country.

Elke LathouwersHuman Physiology and Sports Physiotherapy research group, Vrije Universiteit Brussel, Brussels, Belgium.ORCID 0000-0003-0117-8356
Bruno TassignonHuman Physiology and Sports Physiotherapy research group, Vrije Universiteit Brussel, Brussels, Belgium.ORCID 0000-0003-3216-4045
Alexandre MaricotHuman Physiology and Sports Physiotherapy research group, Vrije Universiteit Brussel, Brussels, Belgium.ORCID 0000-0002-3280-368X
Ahmed RadwanKU Leuven, Department of Imaging and pathology, Translational MRI, Leuven, Belgium.
Maarten NaeyaertDepartment of Radiology and Magnetic Resonance, UZ Brussel, Jette, Belgium.
Hubert RaeymaekersDepartment of Radiology and Magnetic Resonance, UZ Brussel, Jette, Belgium.ORCID 0000-0003-0041-6359
Peter Van SchuerbeekDepartment of Radiology and Magnetic Resonance, UZ Brussel, Jette, Belgium.
Stefan SunaertKU Leuven, Department of Imaging and pathology, Translational MRI, Leuven, Belgium.
Johan De MeyDepartment of Radiology and Magnetic Resonance, UZ Brussel, Jette, Belgium.
Kevin De PauwHuman Physiology and Sports Physiotherapy research group, Vrije Universiteit Brussel, Brussels, Belgium.ORCID 0000-0001-7553-9957
Vrije Universiteit Brussel · BEKU Leuven · BEUniversitair Ziekenhuis Leuven · BE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundLower 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.

objectivesThe 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.

methodsParticipants 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.

conclusionThis 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 registrationNCT05818410 (Clinicaltrials.gov).

Indexed as

AmputeesArtificial LimbsBiomechanical PhenomenaBrainGaitHumansLower ExtremityPhysical Functional PerformanceProsthesis DesignQuality of LifeWalking

Identifiers

PMID38512879
PMCPMC10956762
OpenAlexW4393062991

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.