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Clinical Trials/NCT01161238
NCT01161238
Completed
Not Applicable

Measuring and Controlling In-Socket Residual Limb Volume Fluctuation

University of Washington1 site in 1 country28 target enrollmentMay 2010
ConditionsAmputation

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Amputation
Sponsor
University of Washington
Enrollment
28
Locations
1
Primary Endpoint
Residual limb fluid volume
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2010
End Date
September 2011
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joan Sanders

Professor

University of Washington

Eligibility Criteria

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.
  • Inability to shift from horizontal to vertical posture in 30 seconds.

Outcomes

Primary Outcomes

Residual limb fluid volume

Time Frame: 1 day

Study Sites (1)

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