Impact of Improving Footwear Options

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
VA Office of Research and Development
Study ID
NCT05601869
Status
Recruiting
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Conditions

  • Amputation

Eligibility Criteria

Sex
ALL
Age
18 Years - 89 Years
Healthy Volunteers
Not accepted

Interventions

  • RECOVER Prosthetic Ankle-Feet System — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Sep 1, 2023
Status verified
Apr 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention
    Participants in this arm receive a new prosthesis system designed to improve footwear options.

Primary Outcome Measure

Amputation-Specific Body Image Scale-Revised (ABIS-R) Change [ Time Frame: Baseline, 1-month, 6-months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Minneapolis VA Health Care System, Minneapolis, MNMinneapolisMinnesota55417-2309
Andrew H Hansen, PhD
[email protected]
612-467-2910
Nicole Walker, MS
[email protected]
(612) 467-3229
Andrew H Hansen, PhD (PRINCIPAL_INVESTIGATOR)

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