The long-term goal of the proposed research is a paradigm shift towards limb size management rather than socket size management in prosthesis users experiencing socket fit changes during the day. The focus of this application is to implement and optimize a novel limb-volume management strategy, and then characterize its impact on prosthesis user clinical outcomes, health, and quality-of-life.
The specific aims of the proposed research are to monitor user activity and socket fit within prostheses equipped with novel socket release/relock mechanisms. Socket release is the relief of limb-socket pressures during sitting, and relock is the return to the normal socket configuration. Different release/relock operations conducted while sitting and their influence on subsequent ambulatory limb mechanics, socket fit, and functional outcomes are tested. The procedure most beneficial to patient outcomes is implemented in long-term testing. Participants wear prostheses with the socket release/relock mechanism in their free-living environments for four weeks. Outcome measures are compared with results from traditional sockets. To accomplish the aims, unobtrusive sensors that monitor prosthesis use and limb-socket distances indicative of socket fit are integrated into prostheses with motor-driven socket release/relock mechanisms. A repeated- measures study is conducted using a standardized protocol to determine if the ordering of pin relock and socket relock after socket release affects subsequent limb fluid volume retention, limb vertical and angular positions in the socket, user comfort, and functional performance. A crossover study is conducted to determine if use of release/relock sockets compared with traditional sockets for 4 weeks enhances participant activity, socket fit, self-reported outcomes, energy level, and residual limb health. The relevance of the proposed application to public health is better understanding how use of active release/relock affects users? experience with a prosthesis, clinically-important outcomes related to residual limb health, and users? performance in life activities. Currently, it is unknown to what degree active release/relock benefits prosthesis users? quality of life. Potentially, the efforts described here can be extended to other areas where devices require a secure and intimate fit with human tissues despite changes in soft tissue volume, including trans-fermoral prosthetics, upper-limb prosthetics, and orthotics.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project (R01)
Project #
5R01HD060585-09
Application #
10017274
Study Section
Musculoskeletal Rehabilitation Sciences Study Section (MRS)
Program Officer
Bonner, Joseph Francis
Project Start
2009-09-10
Project End
2024-06-30
Budget Start
2020-07-01
Budget End
2021-06-30
Support Year
9
Fiscal Year
2020
Total Cost
Indirect Cost
Name
University of Washington
Department
Biomedical Engineering
Type
Biomed Engr/Col Engr/Engr Sta
DUNS #
605799469
City
Seattle
State
WA
Country
United States
Zip Code
98195
Baran, U; Swanson, E; Sanders, J E et al. (2018) OCT-based microangiography for reactive hyperaemia assessment within residual limb skin of people with lower limb loss. Skin Res Technol 24:152-155
Goldstein, Mark D; Cagle, John C; Hafner, Brian J et al. (2018) Retracting Locking-Pin Mechanism That Allows Partial Prosthetic Socket Doffing during Sitting. J Prosthet Orthot 30:114-118
Sanders, Joan E; Hartley, Tyler L; Phillips, Reid H et al. (2016) Does temporary socket removal affect residual limb fluid volume of trans-tibial amputees? Prosthet Orthot Int 40:320-8
Sanders, Joan E; Moehring, Mark A; Rothlisberger, Travis M et al. (2016) A Bioimpedance Analysis Platform for Amputee Residual Limb Assessment. IEEE Trans Biomed Eng 63:1760-70
Sanders, Joan E; Cagle, John C; Allyn, Katheryn J et al. (2014) How do walking, standing, and resting influence transtibial amputee residual limb fluid volume? J Rehabil Res Dev 51:201-12
Sanders, Joan E; Cagle, John C; Harrison, Daniel S et al. (2013) How does adding and removing liquid from socket bladders affect residual-limb fluid volume? J Rehabil Res Dev 50:845-60
Sanders, Joan E; Harrison, Daniel S; Cagle, John C et al. (2012) Post-doffing residual limb fluid volume change in people with trans-tibial amputation. Prosthet Orthot Int 36:443-9
Sanders, Joan E; Harrison, Daniel S; Allyn, Katheryn J et al. (2012) How do sock ply changes affect residual-limb fluid volume in people with transtibial amputation? J Rehabil Res Dev 49:241-56
Sanders, Joan E; Allyn, Katheryn J; Harrison, Daniel S et al. (2012) Preliminary investigation of residual-limb fluid volume changes within one day. J Rehabil Res Dev 49:1467-78
Sanders, Joan E; Severance, Michael R (2011) Assessment technique for computer-aided manufactured sockets. J Rehabil Res Dev 48:763-74

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