Clinical Trials Directory

Trials / Completed

CompletedNCT03673371

Women's-Specific Footwear With Prosthetic Feet

Status
Completed
Phase
Study type
Observational
Enrollment
100 (actual)
Sponsor
Minneapolis Veterans Affairs Medical Center · Federal
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

Summary

The purpose of this study is to address footwear challenges unique to women prosthesis users. Comparing the effectiveness of different footwear and prosthesis combinations will help guide clinical decision making regarding the prescription of prosthetic devices, while keeping what the patient wants in mind. It is expected that these results will be used to generate new knowledge for the development of versatile prosthetic devices that accommodate a user's unique lifestyle while helping the patient to make good progress in rehabilitation. Investigators will characterize perceived limitations in footwear among women prosthesis users. Investigators think that women prosthesis users will be restricted in footwear choices and clothing choices due to the use of a prosthetic device. Specifically, investigators expect perceived limitations in footwear will be greater for shoes with higher heels than shoes without heels.

Detailed description

The project involves development, distribution, and analysis of a questionnaire designed to address footwear use among women lower limb prosthesis users. Responses from sixty women with a lower extremity amputation will be targeted. VA participants will be identified by the MVAHCS. These potential participants will receive the IRB-approved survey via mail. Eligible participants include women with unilateral or bilateral lower extremity amputations. The questionnaire will target the types of footwear worn by prosthesis users and the types of footwear desired to be worn. It will also capture the various types of prosthetic feet worn in each footwear category, amputation type, time spent walking in a prosthetic device, and general satisfaction with the prosthesis function during daily living when worn with shoes.

Conditions

Interventions

TypeNameDescription
OTHERQuestionnaireThis is a questionnaire developed by DoD and VA researchers specifically for this study.

Timeline

Start date
2019-03-04
Primary completion
2020-07-22
Completion
2023-01-06
First posted
2018-09-17
Last updated
2023-03-22

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03673371. Inclusion in this directory is not an endorsement.