RecruitingNot ApplicableNCT05601869

Impact of Improving Footwear Options

Impact of Improving Footwear Options for Women Veterans With Amputations

Sponsor

VA Office of Research and Development

Enrollment

18 participants

Start Date

Sep 1, 2023

Study Type

INTERVENTIONAL

Conditions

Amputation

Summary

Veterans with leg amputations have limited footwear options because their artificial feet do not change shapes for different shoes. Studies have shown that women with amputations receive more frequent prosthetics care than men, but are less satisfied with the fit, comfort, and appearance of their prostheses. The investigators' previous research indicates that women Veterans would like to be able to wear a broader variety of footwear, and those who perceive more footwear limitations tend to have poorer body image and community participation. A new prosthesis designed by the investigators' group allows Veterans with amputations to use their footwear of choice using 3D-printed artificial feet with a single ankle. The novel prosthesis will be tested in this project with women Veterans with amputations to determine the impact of improving footwear options on body image and community participation.

Eligibility

Min Age: 18 YearsMax Age: 89 Years

Inclusion Criteria6

US military Veterans that identify as women
Transtibial (below-knee) amputation
Using a definitive prosthesis for at least 6 months (limb has accommodated to prosthesis use post-amputation)
Well fitting and well aligned prosthesis
Blessed Orientation-Memory-Concentration (Short Blessed) score between 0-6
Access to computer, tablet, or smart phone and internet for video conferencing and RedCap data collection

Exclusion Criteria7

Residual limb skin problems
Residual limb too long to accommodate the RECOVER prosthetic ankle-feet system
Unable or unwilling to travel to Minneapolis
Not a regular prosthesis user
Mass over 125 kg
Documented neurocognitive disorder (e.g., dementia) with evidence of impact on activities of daily living and/or instrumental activities of daily living
Baseline ABIS-R or PROMIS-APSRA scores at the maximum levels (no room for improvement on primary outcomes)

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Interventions

DEVICERECOVER Prosthetic Ankle-Feet System

The RECOVER prosthetic ankle-feet system includes a single prosthetic ankle joint that can be easily attached to 3D printed feet. The feet are designed to fit specifically within different footwear.