Amputee Residual Limb Volume Fluctuation

The goal of this project is a useful clinical instrument for diagnosis and treatment of residual limb volume fluctuation in individuals who use prosthetic limbs. One hypothesis to be tested is that the instrument effectively measures short and long term volume fluctuations in individuals with trans-tibial amputation. Another hypothesis to be tested is that when subjects add a sock or insert to the prosthesis residual limb volume decreases, and when they remove the sock or insert residual limb volume increases.

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Key information

Conditions

Amputation

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Washington, Bioengineering Department

Seattle, Washington, 98195, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

trans-tibial amputees who have a regular prosthetist and who wear the prosthesis at least five hours per day.

Exclusion criteria

Inability to ambulate continuously with a prosthesis (with or without the use of an assistive device such as a cane or walker) for 10 minutes indoors on a level walkway. 2. Inability to shift from horizontal to vertical posture in 30 seconds.

Treatment and study plan

Monitored for limb volume

Other

Subjects are monitored for limb volume change using bioimpedance analysis

Primary outcomes

Residual limb fluid volume

Time frame: 1 day

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study title

Measuring and Controlling In-Socket Residual Limb Volume Fluctuation

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Jul 13, 2010
Registry last updated: Apr 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed