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NCT05601869
Impact of Improving Footwear Options
Conditions: Amputation
Sex: All
Ages: 18 Years – 89 Years
Phase: NA
Enrollment: 18
Sponsor: VA Office of Research and Development
Location: United States
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 Criteria
Inclusion Criteria:US military Veterans that identify as womenTranstibial (below-knee) amputationUsing a definitive prosthesis for at least 6 months (limb has accommodated to prosthesis use post-amputation)Well fitting and well aligned prosthesisBlessed Orientation-Memory-Concentration (Short Blessed) score between 0-6Access to computer, tablet, or smart phone and internet for video conferencing and RedCap data collectionExclusion Criteria:Residual limb skin problemsResidual limb too long to accommodate the UNYQ systemUnable or unwilling to travel to MinneapolisNot a regular prosthesis userMass over 125 kgDocumented neurocognitive disorder (e.g., dementia) with evidence of impact on activities of daily living and/or instrumental activities of daily livingBaseline ABIS-R or PROMIS-APSRA scores at the maximum levels (no room for improvement on primary outcomes)
Source: ClinicalTrials.gov (NCT05601869). StuddyBuddy aggregates publicly available trial information.