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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03673371
Recruitment Status : Recruiting
First Posted : September 17, 2018
Last Update Posted : March 11, 2019
United States Department of Defense
Information provided by (Responsible Party):
Andrew H. Hansen, 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.

Condition or disease Intervention/treatment
Lower Limb Amputation Below Knee (Injury) Lower Limb Amputation Above Knee (Injury) 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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health

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

Primary Outcome Measures :
  1. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women Veterans with Lower Limb Amputation (excluding Syme's and Hip Disarticulation)

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT03673371

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Contact: Andrew H. Hansen, PhD 612-467-2910
Contact: Billie Slater, MAEd 612-629-7830

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United States, Minnesota
Minneapolis VA Health Care System Recruiting
Minneapolis, Minnesota, United States, 55417
Contact: Andrew H Hansen, PhD    612-467-2910   
Contact: Billie Slater, MAEd    612-629-7830   
Sponsors and Collaborators
Minneapolis Veterans Affairs Medical Center
United States Department of Defense
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Principal Investigator: Elizabeth Russell Esposito, PhD Extremity Trauma and Amputation Center of Excellence
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Responsible Party: Andrew H. Hansen, Site Principal Investigator, Minneapolis Veterans Affairs Medical Center Identifier: NCT03673371    
Other Study ID Numbers: OP160063
First Posted: September 17, 2018    Key Record Dates
Last Update Posted: March 11, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Time Frame: Starting 6 months after publication for up to 10 years.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrew H. Hansen, Minneapolis Veterans Affairs Medical Center:
Limb Prosthesis
Self Concepts
Additional relevant MeSH terms:
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Wounds and Injuries