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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
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Andrew H. Hansen, Minneapolis Veterans Affairs Medical Center

Tracking Information
First Submitted Date August 23, 2018
First Posted Date September 17, 2018
Last Update Posted Date March 11, 2019
Actual Study Start Date March 4, 2019
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 13, 2018)
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
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03673371 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Women's-Specific Footwear With Prosthetic Feet
Official Title Women's-Specific Footwear With Prosthetic Feet
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Women Veterans with Lower Limb Amputation (excluding Syme's and Hip Disarticulation)
Condition
  • Lower Limb Amputation Below Knee (Injury)
  • Lower Limb Amputation Above Knee (Injury)
Intervention Other: Questionnaire
This is a questionnaire developed by DoD and VA researchers specifically for this study.
Other Name: "WSF Questionnaire"
Study Groups/Cohorts Women Veterans with Lower Limb Amputations
Questionnaire
Intervention: Other: Questionnaire
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 13, 2018)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2020
Estimated Primary Completion Date October 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Gender Based Eligibility: Yes
Gender Eligibility Description: Women
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Andrew H. Hansen, PhD 612-467-2910 andrew.hansen2@va.gov
Contact: Billie Slater, MAEd 612-629-7830 billie.slater@va.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03673371
Other Study ID Numbers OP160063
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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.
Responsible Party Andrew H. Hansen, Minneapolis Veterans Affairs Medical Center
Study Sponsor Minneapolis Veterans Affairs Medical Center
Collaborators United States Department of Defense
Investigators
Principal Investigator: Elizabeth Russell Esposito, PhD Extremity Trauma and Amputation Center of Excellence
PRS Account Minneapolis Veterans Affairs Medical Center
Verification Date March 2019