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NCT02124915 Clinical Trial

Influence of Socket Volume on Prosthesis Performance

Lower Limb Amputation Below Knee (Injury) Clinical Trial

— CAD  

Official title:
Influence of Socket Volume on Prosthesis Performance

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02124915
Other study ID # STUDY00001507
Secondary ID R01HD069387
Status Completed
Phase N/A
First received April 24, 2014
Last updated August 22, 2017
Start date February 2013
Est. completion date December 2014

Study information
Verified date August 2017
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to investigate how residual limb fluid volume, gait, prosthesis use, perceived comfort, and satisfaction with the prosthesis are affected by size of the prosthetic socket. Subjects are tested after wearing a nominal socket for 1 month and again after wearing a slightly oversized socket for 1 month.

Recruitment information / eligibility
Status Completed
Enrollment 9
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- transtibial amputee

- at least 18 months post amputation

- over 18 years of age

- capable of treadmill walking and 90 seconds of continuous standing

Exclusion Criteria:

- skin breakdown on the residual limb

Study Design

Related Conditions & MeSH terms

  • Lower Limb Amputation Below Knee (Injury)

Locations
Country Name City State
United States University of Washington 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, 

Outcome
Type Measure Description Time frame Safety issue
Other Comfort and prosthesis satisfaction 1 month
Other Gait 1 month
Primary Residual limb fluid volume 1 month
Secondary Activity 1 month
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