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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women Veterans with Lower Limb Amputations | Questionnaire |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire | Other | This is a questionnaire developed by DoD and VA researchers specifically for this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Women
Women Veterans with Lower Limb Amputation (excluding Syme's and Hip Disarticulation)
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth Russell Esposito, PhD | Extremity Trauma and Amputation Center of Excellence | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Minneapolis VA Health Care System | Minneapolis | Minnesota | 55417 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18295618 | Background | 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. | |
| 23365003 | 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. |
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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.
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Starting 6 months after publication for up to 10 years.
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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| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| 21174254 | 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. |
| 25019666 | 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. |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |