CompletedNot Applicable

Auto Control of Volume Management for Limb Loss

United States104 participantsStarted 2015-08-07

Plain-language summary

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.

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.

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.

What they're measuring

Change in Limb Volume

Timeframe: Change from baseline period (non-adjustment) to test period (adjustment), commonly each 1 hour long and separated by a seated period of approximately 30 minutes.

Change in Limb Movement

Timeframe: Change from baseline period (non-adjustment) to test period (adjustment), commonly each 1 hour long and separated by a seated period of approximately 30 minutes.

Number of Participants With Increase in Limb Fluid Volume After Panel Pull

Timeframe: Change from baseline period (non-adjustment) to test period (adjustment), commonly each 1 hour long and separated by a seated period of approximately 30 minutes.

Integral of Absolute Error to Maintain Set Point

Timeframe: Over 30 minutes of controlled use of the auto-adjusting socket

Trial details

NCT IDNCT03550118

SponsorUniversity of Washington

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-09

Results submitted2022-09-23

View on ClinicalTrials.gov More Lower Limb Amputation Below Knee (Injury) trials

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.

What they're measuring

Change in Limb Volume

Timeframe: Change from baseline period (non-adjustment) to test period (adjustment), commonly each 1 hour long and separated by a seated period of approximately 30 minutes.

Change in Limb Movement

Timeframe: Change from baseline period (non-adjustment) to test period (adjustment), commonly each 1 hour long and separated by a seated period of approximately 30 minutes.

Number of Participants With Increase in Limb Fluid Volume After Panel Pull

Timeframe: Change from baseline period (non-adjustment) to test period (adjustment), commonly each 1 hour long and separated by a seated period of approximately 30 minutes.

Integral of Absolute Error to Maintain Set Point

Timeframe: Over 30 minutes of controlled use of the auto-adjusting socket