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

PLoS One. 2024 Mar 21;19(3):e0299869. doi: 10.1371/journal.pone.0299869. eCollection 2024.

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).

Publication types

  • Clinical Trial Protocol

MeSH terms

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

Associated data

  • ClinicalTrials.gov/NCT05818410

Grants and funding

The funders did not and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript." And we would like to add that “The authors received no specific funding for this work.