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Impact of Improving Footwear Options

RecruitingNAAges 18 Years - 89 YearsAllVA Office of Research and Development
NCT05601869 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 participa

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • RECOVER Prosthetic Ankle-Feet System
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Where

1 site
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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