Women's-Specific Footwear With Prosthetic Feet

Lower Limb Amputation Above Knee (Injury) Clinical Trial

— WSF  

Official title:

Women's-Specific Footwear With Prosthetic Feet

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03673371
• Other study ID #: OP160063
• Status: Completed
• Start date: March 4, 2019
• Est. completion date: January 6, 2023

Study information

• Verified date: March 2023
• Source: Minneapolis Veterans Affairs Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 6, 2023
• Est. primary completion date: July 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lower Limb Amputation Above Knee (Injury)
• Lower Limb Amputation Below Knee (Injury)
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
United States	Minneapolis VA Health Care System	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Minneapolis Veterans Affairs Medical Center	United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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