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

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

Plain Language Summary

Simplified for easier understanding

This study tests an automatically adjusting prosthetic socket for people who have had a below-the-knee (transtibial) amputation. Residual limb volume can change throughout the day, causing discomfort or poor fit. The new socket adjusts automatically to maintain a comfortable fit. The study involves both prosthetists evaluating the device and amputee participants wearing it. You may be eligible if... - You are 18 years or older - For amputees: you had a transtibial amputation at least 12 months ago and regularly use a prosthesis with pin-lock suspension - You have experienced limb volume fluctuation in the past - Your residual limb is at least 9 cm long - You can walk continuously for at least 5 minutes You may NOT be eligible if... - You have neuropathy or reduced skin sensation in your residual limb - You regularly use an assisted walking device - You have sores or skin breakdown on your residual limb Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

William H. Foege Hall

Seattle, Washington, United States

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NCT05124652


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