Abstract

A transtibial prosthetic interface typically comprises a compliant liner and an outer rigid socket. The preponderance of today’s conventional liners are mass produced in standard sizes, and conventional socket design is labor-intensive and artisanal, lacking clear scientific rationale. This work tests the clinical efficacy of a novel, physics-based digital design framework to create custom prosthetic liner-socket interfaces. In this investigation, we hypothesize that the novel digital approach will improve comfort outcomes compared to a conventional method of liner-socket design. The digital design framework generates custom transtibial prosthetic interfaces starting from MRI or CT image scans of the residual limb. The interface design employs FEA to simulate limb deformation under load. Interfaces are fabricated for 9 limbs from 8 amputees (1 bilateral). Testing compares novel and conventional interfaces across four assessments: 5-min walking trial, thermal imaging, 90-s standing pressure trial, and an evaluation questionnaire. Outcome measures include antalgic gait criterion, skin surface pressures, skin temperature changes, and direct questionnaire feedback. Antalgic gait is compared via a repeated measures linear mixed model while the other assessments are compared via a non-parametric Wilcoxon sign-rank test. A statistically significant () decrease in pain is demonstrated when walking on the novel interfaces compared to the conventional. Standing pressure data show a significant decrease in pressure on novel interfaces at the anterior distal tibia (), with no significant difference at other measured locations. Thermal results show no statistically significant difference related to skin temperature. Questionnaire feedback shows improved comfort on novel interfaces on posterior and medial sides while standing and the medial side while walking. Study results support the hypothesis that the novel digital approach improves comfort outcomes compared to the evaluated conventional method. The digital interface design methodology also has the potential to provide benefits in design time, repeatability, and cost.

Details

Title
A clinical comparison of a digital versus conventional design methodology for transtibial prosthetic interfaces
Author
Lee, Duncan R. C. 1 ; Yang, Xingbang 2 ; Riccio-Ackerman, Francesca 2 ; Alemón, Beatriz 3 ; Ballesteros-Escamilla, Mariana 4 ; Solav, Dana 5 ; Lipsitz, Stuart R. 6 ; Moerman, Kevin M. 5 ; Meyer, Christina I. 2 ; Jaeger, Aaron M. 5 ; Huegel, Joel C. 3 ; Herr, Hugh M. 2 

 Massachusetts Institute of Technology, Media Lab, Cambridge, USA (GRID:grid.116068.8) (ISNI:0000 0001 2341 2786); Massachusetts Institute of Technology, K. Lisa Yang Center for Bionics, Cambridge, USA (GRID:grid.116068.8) (ISNI:0000 0001 2341 2786); Massachusetts Institute of Technology, Mechanical Engineering, Cambridge, USA (GRID:grid.116068.8) (ISNI:0000 0001 2341 2786) 
 Massachusetts Institute of Technology, Media Lab, Cambridge, USA (GRID:grid.116068.8) (ISNI:0000 0001 2341 2786); Massachusetts Institute of Technology, K. Lisa Yang Center for Bionics, Cambridge, USA (GRID:grid.116068.8) (ISNI:0000 0001 2341 2786) 
 Tecnológico de Monterrey, Guadalajara, Mexico (GRID:grid.419886.a) (ISNI:0000 0001 2203 4701) 
 Tecnológico de Monterrey, Guadalajara, Mexico (GRID:grid.419886.a) (ISNI:0000 0001 2203 4701); Instituto Politécnico Nacional, Medical Robotics and Biosignal Laboratory and CIDETEC, Mexico City, Mexico (GRID:grid.418275.d) (ISNI:0000 0001 2165 8782) 
 Massachusetts Institute of Technology, Media Lab, Cambridge, USA (GRID:grid.116068.8) (ISNI:0000 0001 2341 2786) 
 Brigham and Women’s Hospital, Center for Surgery and Public Health, Boston, USA (GRID:grid.62560.37) (ISNI:0000 0004 0378 8294) 
Pages
25833
Publication year
2024
Publication date
2024
Publisher
Nature Publishing Group
e-ISSN
20452322
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
3121470578
Copyright
© The Author(s) 2024. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.