Clinical trial NCT03673371: Women's-Specific Footwear With Prosthetic Feet
Official title: Women's-Specific Footwear With Prosthetic Feet
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Limb Amputation Below Knee (Injury)
Lower Limb Amputation Above Knee (Injury)
Keywords: Limb Prosthesis
Shoe
Self Concepts
Lead sponsor: Minneapolis Veterans Affairs Medical Center
Sponsor class: FED
Collaborators: name: United States Department of Defense
First posted: 2018-09-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women Veterans with Lower Limb Amputation (excluding Syme's and Hip Disarticulation)

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.

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

Primary outcomes:
measure: Women's-Specific Footwear and Prosthetic Feet Questionnaire
timeFrame: through data collection, an average of one year
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System
state: Minnesota
Study officials:
affiliation: Extremity Trauma and Amputation Center of Excellence
name: Elizabeth Russell Esposito, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.