Auto Control of Volume Management for Limb Loss

Completed · Not applicable

Conditions studied: Lower Limb Amputation Below Knee (Injury)

In brief

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.

Key facts

Study ID

NCT03550118

Run by

University of Washington

People needed

104

Starts

2015-08-07

Expected to finish

2022-01-01

Last updated by the study team

2023-05-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of Washington Bioengineering — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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