Women's-Specific Footwear With Prosthetic Feet

Completed

• Conditions: Lower Limb Amputation Above Knee (Injury); Lower Limb Amputation Below Knee (Injury)
• Interventions: Other: Questionnaire

• Registration Number: NCT03673371
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-09-13
• Study First Posted: 2018-09-17
• Study Start: 2019-03-04
• Primary Completion: 2020-07-22
• Study Completion: 2023-01-06
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-20
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women Veterans with Lower Limb Amputations	Questionnaire	Questionnaire

Primary Outcome Measures

Name	Time	Method
Women's-Specific Footwear and Prosthetic Feet Questionnaire	through data collection, an average of one year	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

Trial Locations

Locations (1)

Minneapolis VA Health Care System; 🇺🇸 Minneapolis, Minnesota, United States