Amputee Residual Limb Volume Fluctuation

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Joan Sanders, University of Washington
ClinicalTrials.gov Identifier:
NCT01161238
First received: July 9, 2010
Last updated: April 24, 2014
Last verified: April 2014
  Purpose

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 Intervention
Amputation
Other: Monitored for limb volume

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measuring and Controlling In-Socket Residual Limb Volume Fluctuation

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Residual limb fluid volume [ Time Frame: 1 day ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: May 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

people with lower limb amputation that are ambulatory

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. 2. Inability to shift from horizontal to vertical posture in 30 seconds.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01161238

Locations
United States, Washington
University of Washington, Bioengineering Department
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
  More Information

Publications:
Responsible Party: Joan Sanders, Professor, University of Washington
ClinicalTrials.gov Identifier: NCT01161238     History of Changes
Other Study ID Numbers: 30863-E/B, R01HD060585
Study First Received: July 9, 2010
Last Updated: April 24, 2014
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on October 20, 2014