Women's-Specific Footwear With Prosthetic Feet (WSF)

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.

Study Overview

• Status: Completed
• Conditions: Lower Limb Amputation Below Knee (Injury); Lower Limb Amputation Above Knee (Injury)
• Intervention / Treatment: Other: Questionnaire

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Minneapolis VA Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Women Veterans with Lower Limb Amputation (excluding Syme's and Hip Disarticulation)

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women Veterans with Lower Limb Amputations; Questionnaire	Other: Questionnaire; This is a questionnaire developed by DoD and VA researchers specifically for this study.; Other Names: "WSF Questionnaire"

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Women's-Specific Footwear and Prosthetic Feet Questionnaire	Questionnaire regarding Women Veterans and their use of different types of footwear with prosthetic feet. The subscales are derived from the following scales:Patient Reported Outcome System (PROMIS) Anxiety - 4 Patient Reported Outcome System (PROMIS) Depression - 4 Patient Reported Outcome System - Ability to Participate in Social Roles and Activities Patient Reported Outcome System - Satisfaction with Social Roles and Activities - 4a Amputee Body Image Scale - Revised Prosthetic Limb Users Survey of Mobility Community Participation Index - Importance subscale Community Participation Index - Control subscale Community Participation Index - Frequency index Activities-Specific Balance Confidence Scale Prosthesis Evaluation Questionnaire - Appearance Prosthesis Evaluation Questionnaire - Utility	through data collection, an average of one year

Collaborators and Investigators

• Sponsor: Minneapolis Veterans Affairs Medical Center
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Elizabeth Russell Esposito, PhD, Extremity Trauma and Amputation Center of Excellence

Publications and helpful links

General Publications

• Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.
• Elnitsky CA, Latlief GA, Andrews EE, Adams-Koss LB, Phillips SL. Preferences for rehabilitation services among women with major limb amputations. Rehabil Nurs. 2013 Jan-Feb;38(1):32-6. doi: 10.1002/rnj.62.
• Klodd E, Hansen A, Fatone S, Edwards M. Effects of prosthetic foot forefoot flexibility on gait of unilateral transtibial prosthesis users. J Rehabil Res Dev. 2010;47(9):899-910. doi: 10.1682/jrrd.2009.10.0166.
• Meier MR, Tucker KA, Hansen AH. Development of inexpensive prosthetic feet for high-heeled shoes using simple shoe insole model. J Rehabil Res Dev. 2014;51(3):439-50. doi: 10.1682/JRRD.2013.01.0010.

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2019
• Primary Completion (Actual): July 22, 2020
• Study Completion (Actual): January 6, 2023

Study Registration Dates

• First Submitted: August 23, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 20, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Limb Prosthesis; Shoe; Self Concepts
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: OP160063

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A de-identified, anonymized data set will be created and shared under a written agreement that prohibits the recipient from identifying or attempting to re-identify any individual whose data are included in the data set.
• IPD Sharing Time Frame: Starting 6 months after publication for up to 10 years.
• IPD Sharing Access Criteria: The Principal Investigator and Site Principal Investigator will review requests for the de-identified final data set. It is possible that the de-identified final data set will be available through PubMed Central.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No