Amputee Residual Limb Volume Fluctuation
Sponsor
University of Washington (Other)
Overall Status
Completed
CT.gov ID
NCT01161238
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) (NIH)
28
1
16
1.7
Study Details
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 | Phase |
|---|---|---|
|
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 1, 2010
Actual Primary Completion Date
:
Sep 1, 2011
Actual Study Completion Date
:
Sep 1, 2011
Arms and Interventions
| Arm | 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
- Residual limb fluid volume [1 day]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
Responsible Party:
Joan Sanders,
Professor,
University of Washington
ClinicalTrials.gov Identifier:
NCT01161238
Other Study ID Numbers:
- 30863-E/B
- R01HD060585
First Posted:
Jul 13, 2010
Last Update Posted:
Apr 25, 2014
Last Verified:
Apr 1, 2014