The goal of the proposed research is to determine to what degree too large a socket impacts the health and quality of life of individuals with transtibial amputation using prosthetic limbs. The clinical relevance of this research is to promote quantitative standards for socket replacement based on prosthetic fit rather than duration of prosthesis use, as is current practice.
The specific aims are to characterize volume changes typically made to transtibial sockets replaced because of residual limb volume reduction and to characterize differences in the daily residual limb volume change, gait stability, comfort, and satisfaction with the prosthesis, and activity level for individuals with transtibial amputation using enlarged sockets as opposed to their original as-prescribed sockets. To accomplish the aims, the volume differences between replacement and original sockets typically made for patients having their socket replaced because of residual limb volume reduction are determined. Automated fabrication methods are then used to make prosthetic test sockets that have known and quantified socket volume differences (relative to the original as-prescribed sockets) for a population of transtibial amputee subjects. After one-month wear periods, outcomes are assessed for each study participant. Bioimpedance analysis is used to assess daily residual limb fluid volume change, gait analysis to assess variability in walking patterns, subjective survey instruments to evaluate satisfaction and comfort with the prosthesis, a sock monitor to assess sock ply changes, and a portable gait monitor to assess overall activity. Hypotheses are evaluated to determine if the outcome variables are significantly different when patients wear the enlarged test sockets compared with the original as-prescribed sockets. The relevance of the proposed application to public health is better understanding of how socket fit impacts user experience with a prosthesis, clinically-important outcomes related to residual limb health, and performance measures traditionally measured in prosthetics research. Currently, it is unknown how poorly fitting sockets impact daily limb volume change, functional performance, satisfaction with the prosthesis, comfort, sock ply change, and activity level of individuals with limb amputation. Beyond the grant period, it is anticipated the proposed research will be extended into clinical tools that allow practitioners to isolate socket design problems from other issues such as improper componentry or alignment. Potentially, the efforts described here can be extended to other areas including trans-femoral prosthetics, upper-limb prosthetics, and orthotics.

Public Health Relevance

The long-term goal of this project is a paradigm shift to quantitative guidelines and standards for socket replacement based on prosthetic fit rather than duration of prosthesis use, as is current practice.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
1R01HD069387-01
Application #
8158819
Study Section
Special Emphasis Panel (ZRG1-MOSS-F (15))
Program Officer
Nitkin, Ralph M
Project Start
2011-07-15
Project End
2015-05-31
Budget Start
2011-07-15
Budget End
2012-05-31
Support Year
1
Fiscal Year
2011
Total Cost
$311,185
Indirect Cost
Name
University of Washington
Department
Biomedical Engineering
Type
Schools of Engineering
DUNS #
605799469
City
Seattle
State
WA
Country
United States
Zip Code
98195
Swanson, Eric C; McLean, Jake B; Allyn, Katheryn J et al. (2018) Instrumented socket inserts for sensing interaction at the limb-socket interface. Med Eng Phys 51:111-118
Sanders, Joan E; Youngblood, Robert T; Hafner, Brian J et al. (2017) Effects of socket size on metrics of socket fit in trans-tibial prosthesis users. Med Eng Phys 44:32-43
Cagle, John C; D'Silva, Krittika J; Hafner, Brian J et al. (2016) Amputee socks: Sock thickness changes with normal use. Prosthet Orthot Int 40:329-35
Sanders, Joan E; McLean, Jake B; Cagle, John C et al. (2016) Technical note: Computer-manufactured inserts for prosthetic sockets. Med Eng Phys 38:801-6
D'Silva, Krittika; Hafner, Brian J; Allyn, Katheryn J et al. (2014) Self-reported prosthetic sock use among persons with transtibial amputation. Prosthet Orthot Int 38:321-31
Hafner, Brian J; Sanders, Joan E (2014) Considerations for development of sensing and monitoring tools to facilitate treatment and care of persons with lower-limb loss: a review. J Rehabil Res Dev 51:1-14
Sanders, Joan E; Severance, Michael R; Swartzendruber, David L et al. (2013) Influence of prior activity on residual limb volume and shape measured using plaster casting: results from individuals with transtibial limb loss. J Rehabil Res Dev 50:1007-16
Sander, Joan E (2013) Commentary on Troedsson's 1964 article ""Stump arterial circulation and its relationship to the prescription of a prosthesis for the geriatric patient"". J Rehabil Res Dev 50:ix
Redfield, Morgan T; Cagle, John C; Hafner, Brian J et al. (2013) Classifying prosthetic use via accelerometry in persons with transtibial amputations. J Rehabil Res Dev 50:1201-12
Sanders, Joan E; Murthy, Revathi; Cagle, John C et al. (2012) Device to monitor sock use in people using prosthetic limbs: technical report. J Rehabil Res Dev 49:1229-38

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