Amputee Residual Limb Volume Fluctuation

Completed

• Conditions: Amputation
• Interventions: Other: Monitored for limb volume

• Registration Number: NCT01161238
• Lead Sponsor: University of Washington

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-07-09
• Study First Submitted QC: 2010-07-09
• Study First Posted: 2010-07-13
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-24
• Last Update Posted: 2014-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lower-limb amputee	Monitored for limb volume	Subjects with at least one lower limb amputated at the trans-tibial level

Primary Outcome Measures

Name	Time	Method
Residual limb fluid volume	1 day

Trial Locations

Locations (1)

University of Washington, Bioengineering Department; 🇺🇸 Seattle, Washington, United States