Women's-Specific Footwear With Prosthetic Feet (WSF)
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|ClinicalTrials.gov Identifier: NCT03673371|
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : March 11, 2019
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.
|Condition or disease||Intervention/treatment|
|Lower Limb Amputation Below Knee (Injury) Lower Limb Amputation Above Knee (Injury)||Other: Questionnaire|
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|
|Estimated Enrollment :||60 participants|
|Official Title:||Women's-Specific Footwear With Prosthetic Feet|
|Actual Study Start Date :||March 4, 2019|
|Estimated Primary Completion Date :||October 2019|
|Estimated Study Completion Date :||September 2020|
Women Veterans with Lower Limb Amputations
This is a questionnaire developed by DoD and VA researchers specifically for this study.
Other Name: "WSF Questionnaire"
- Women's-Specific Footwear and Prosthetic Feet Questionnaire [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03673371
|Contact: Andrew H. Hansen, PhDfirstname.lastname@example.org|
|Contact: Billie Slater, MAEdemail@example.com|
|United States, Minnesota|
|Minneapolis VA Health Care System||Recruiting|
|Minneapolis, Minnesota, United States, 55417|
|Contact: Andrew H Hansen, PhD 612-467-2910 firstname.lastname@example.org|
|Contact: Billie Slater, MAEd 612-629-7830 email@example.com|
|Principal Investigator:||Elizabeth Russell Esposito, PhD||Extremity Trauma and Amputation Center of Excellence|