Women's-Specific Footwear With Prosthetic Feet

Women's-Specific Footwear With Prosthetic Feet

Sponsors

Lead sponsor: Minneapolis Veterans Affairs Medical Center

Collaborator: United States Department of Defense

Source Minneapolis Veterans Affairs Medical Center
Brief 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.

Overall Status Recruiting
Start Date March 4, 2019
Completion Date September 2020
Primary Completion Date October 2019
Study Type Observational
Primary Outcome
Measure Time Frame
Women's-Specific Footwear and Prosthetic Feet Questionnaire through data collection, an average of one year
Enrollment 60
Condition
Intervention

Intervention type: Other

Intervention name: Questionnaire

Description: This is a questionnaire developed by DoD and VA researchers specifically for this study.

Arm group label: Women Veterans with Lower Limb Amputations

Other name: "WSF Questionnaire"

Eligibility

Sampling method: Non-Probability Sample

Criteria:

Inclusion Criteria:

- Woman Veteran

- Age 18-80

- Lower Limb Amputation (transtibial, through the knee, transfemoral)

- Eligible to receive care through the VA Health Care System

- Ambulatory and currently using a prosthesis

Exclusion Criteria:

- Syme's Amputation

- Hip Disarticulation

Gender: All

Gender based: Yes

Gender description: Women

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Elizabeth Russell Esposito, PhD Principal Investigator Extremity Trauma and Amputation Center of Excellence
Overall Contact

Last name: Andrew H. Hansen, PhD

Phone: 612-467-2910

Email: [email protected]

Location
facility status contact contact_backup
Minneapolis VA Health Care System Recruiting Andrew H Hansen, PhD 612-467-2910 [email protected]
Location Countries

United States

Verification Date

March 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Minneapolis Veterans Affairs Medical Center

Investigator full name: Andrew H. Hansen

Investigator title: Site Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Arm group label: Women Veterans with Lower Limb Amputations

Description: Questionnaire

Acronym WSF
Patient Data Yes
Study Design Info

Observational model: Cohort

Time perspective: Prospective

Source: ClinicalTrials.gov