Amputee Residual Limb Volume Fluctuation

Amputation Clinical Trial

Official title:

Measuring and Controlling In-Socket Residual Limb Volume Fluctuation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01161238
• Other study ID #: 30863-E/B
• Secondary ID: R01HD060585
• Status: Completed
• Phase: N/A
• First received: July 9, 2010
• Last updated: April 24, 2014
• Start date: May 2010
• Est. completion date: September 2011

Study information

• Verified date: April 2014
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Amputation

Intervention

Other:
• Monitored for limb volume
Subjects are monitored for limb volume change using bioimpedance analysis

Locations

Country	Name	City	State
United States	University of Washington, Bioengineering Department	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Sanders JE, Harrison DS, Allyn KJ, Myers TR. Clinical utility of in-socket residual limb volume change measurement: case study results. Prosthet Orthot Int. 2009 Dec;33(4):378-90. doi: 10.3109/03093640903214067. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Residual limb fluid volume		1 day	No