Women's-Specific Footwear With Prosthetic Feet

NCT03673371 | Completed

• 1 other identifier: OP160063
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lower Limb Amputation Below Knee (Injury); Lower Limb Amputation Above Knee (Injury)

Keywords

Limb Prosthesis; Shoe; Self Concepts

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Women Veterans with Lower Limb Amputations

Questionnaire

Other: Questionnaire

Interventions

Questionnaire OTHER

This is a questionnaire developed by DoD and VA researchers specifically for this study.

Also known as: "WSF Questionnaire"

Women Veterans with Lower Limb Amputations

Eligibility Criteria

• Age: 18 Years - 80 Years
• Gender Eligibility Details: Women
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Syme's Amputation
• Hip Disarticulation

Sponsors & Collaborators

• Minneapolis Veterans Affairs Medical Center: lead
• United States Department of Defense: collaborator

Study Sites (1)

Minneapolis VA Health Care System

Minneapolis, Minnesota, 55417, United States

Location

Related Publications (4)

• 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.

  PMID: 18295618 BACKGROUND

• 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.

  PMID: 23365003 BACKGROUND

• 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.

  PMID: 21174254 BACKGROUND

• 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.

  PMID: 25019666 BACKGROUND

MeSH Terms

Conditions

Wounds and Injuries

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Elizabeth Russell Esposito, PhD

  Extremity Trauma and Amputation Center of Excellence

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Site Principal Investigator

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: September 17, 2018
• Study Start: March 4, 2019
• Primary Completion: July 22, 2020
• Study Completion: January 6, 2023
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• 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.

Locations

US (1)