RecruitingNot Applicable

An Automatically Adjusting Prosthetic Socket for People With Transtibial Amputation

United States100 participantsStarted 2021-10-18

Plain-language 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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 18 years or older * Unilateral or bilateral trans-tibial amputation at least 12 months prior * Have a limb of length 9 cm or greater * Are capable of at least 5 minutes of continuous walking * Are capable of at least 1 hour of intermittent walking * Regularly use a definitive prosthesis with a pin-lock suspension system and no or few pads * Have adequate sensation to verbalize a socket that is too large or too small to be tolerated * Do not regularly use assistive devices (e.g., cane, walker) for ambulation * Do not have open wounds on their residual limb at the time of enrollment

What they're measuring

Socket Comfort Score

Timeframe: through study completion, an average of 1 year

Integral Absolute Error of Control System

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT05124652

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03

Contact for this trial

Katheryn Allen, CPO

206-390-0228 kate@allyn.org