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Amputee Residual Limb Volume Fluctuation

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ClinicalTrials.gov Identifier: NCT01161238
Recruitment Status : Completed
First Posted : July 13, 2010
Last Update Posted : April 25, 2014
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Amputation Other: Monitored for limb volume

Study Design

Study Type : Observational
Actual Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measuring and Controlling In-Socket Residual Limb Volume Fluctuation
Study Start Date : May 2010
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Limb Loss
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Lower-limb amputee
Subjects with at least one lower limb amputated at the trans-tibial level
Other: Monitored for limb volume
Subjects are monitored for limb volume change using bioimpedance analysis

Outcome Measures

Primary Outcome Measures :
  1. Residual limb fluid volume [ Time Frame: 1 day ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
people with lower limb amputation that are ambulatory

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01161238

United States, Washington
University of Washington, Bioengineering Department
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
More Information

Responsible Party: Joan Sanders, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01161238     History of Changes
Other Study ID Numbers: 30863-E/B
R01HD060585 ( U.S. NIH Grant/Contract )
First Posted: July 13, 2010    Key Record Dates
Last Update Posted: April 25, 2014
Last Verified: April 2014