Seattle, Washington 98195

  • Lower Limb Amputation Below Knee (Injury)

Purpose:

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.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT03550118


Primary Contact:

Principal Investigator
Joan E Sanders, PhD
University of Washington

Joan E Sanders, PhD
Phone: (206)221-5872
Email: jsanders@u.washington.edu


Backup Contact:

N/A


Location Contact:

Seattle, Washington 98195
United States

Joan E Sanders, PhD
Phone: 206-221-5872
Email: jsanders@u.washington.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: June 24, 2021

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