Auto Control of Volume Management for Limb Loss



Status:Recruiting
Healthy:No
Age Range:18 - Any
Updated:6/10/2018
Start Date:August 7, 2015
End Date:January 2021
Contact:Joan E Sanders, PhD
Email:jsanders@u.washington.edu
Phone:(206)221-5872

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The aim of this research is to create a prosthetic 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.

People with lower limb 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 health problems including skin breakdown and injury to deeper tissues. Prosthetic
socket systems that accommodate limb volume changes can help address these issues, but they
require users to make adjustments throughout the day.

The objective of this research is to develop and test an automatically-adjusting prosthetic
socket system for prosthesis users. The system integrates with a range of adjustable socket
technologies, including those that are commercially available. The system allows small size
adjustments for both tightening and loosening the socket. In early aims of the study, the
prosthesis will be adjusted manually, but can be controlled remotely, eliminating the need to
remove the prosthesis or bend down to make adjustments. The system will later be enhanced to
automatically change the fit of an adjustable socket at the appropriate times, without
distracting the user. We hypothesize that this system will help to maintain consistent limb
fluid volume while the prosthesis user is wearing the socket and that socket fit will be
improved. The system functions by continuously collecting measurements from sensors within
the socket and uses small motors to control adjustable panels in the socket wall.

Inclusion Criteria:

- 18 years of age or older

- Unilateral transtibial amputee

- At least 6 months post-amputation

- Wear prosthesis at least 3 hours per day

- Use an elastomeric (i.e. gel) liner

- K3 or higher Medicare Functional Classification Level

- Able to walk continuously with prosthesis for at least 5 minutes at a time, sit,
stand, and step up a height of 5.0 cm.

- Residual limb of 9.0 cm or longer

- Experience problems with volume fluctuations that affect their prosthetic socket fit

Exclusion Criteria:

- Participants experiencing skin breakdown on enrollment will be excluded, but can enter
after having been free of clinically visually-apparent skin breakdown for two weeks.
We found this trial at
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Seattle, Washington 98105
Phone: 206-221-5872
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