RecruitingNot ApplicableNCT05124652

An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation

An Automatically-adjusting Prosthetic Socket for People With Transtibial Amputation

Sponsor

University of Washington

Enrollment

100 participants

Start Date

Oct 18, 2021

Study Type

INTERVENTIONAL

Conditions

Lower Limb Amputation Below Knee (Injury)Diurnal Residual Limb Fluid Volume Fluctuation

Summary

People with leg amputations often experience daily changes in the size (volume) of their residual limb. These daily changes can cause a prosthesis to fit poorly. They can also cause limb problems like pain or skin breakdown. Prosthetic socket systems that accommodate limb volume changes can help address these issues, but they require users to make adjustments throughout the day. The aim of this research is to create a system that will automatically adjust the fit of the socket and create a well-fitting prosthesis for people with leg amputations who experience volume fluctuations when using their prosthesis.

Eligibility

Min Age: 18 Years

Inclusion Criteria8

or older (Prosthetists and Prosthesis Users)
must have certification and regularly treat patients with trans-tibial limb loss in a clinical setting (Prosthetists only)
had a trans-tibial amputation at least 12 months prior (prosthesis users only)
regularly use a definitive prosthesis with pin lock suspension and few or no pads (prosthesis users only)
self-report experiencing limb volume fluctuation in the past (prosthesis users only)
have residual limb length of at least 9 cm (prosthesis users, Aim 2 and Aim 3 only)
walk at least 5 continuous minutes and intermittently at least 1 hour (prosthesis users, Aim 2 and Aim 3 only)
capable of distinguishing socket sizes too large and too small to be tolerated (Prosthetists and Prosthesis Users)

Exclusion Criteria5

Are not certified prosthetists (prosthetists only)
neuropathy (prosthesis users only)
reduced skin sensation (prosthesis users only)
regular use of an assisted device (prosthesis users only)
sores or skin breakdown on their residual limb (prosthesis users, Aim 2 and Aim 3 only)

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Interventions

DEVICEAuto Adjusting Prosthesis

Participants will test the auto adjusting prosthesis. The prosthesis will be able to move up to 3 panels built into the socket walls to expand or tighten the socket's fit. The auto adjustments will take place during periods of sitting, standing, or walking. Manual adjustments will also be possible either via the researcher controlling the prosthesis or via the key fob developed in the first aim.