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Improving Footwear Options for Women Veterans with Amputations

This study is for women Veterans with a below-knee (transtibial) amputation who use a prosthetic leg. Researchers are testing a new device called the RECOVER Prosthetic Ankle-Feet System. This system includes a single prosthetic ankle joint that connects to 3D-printed feet, allowing you to wear different types of shoes. The goal is to see if having more footwear options improves your body image and your ability to participate in social activities. The study plans to enroll 18 participants, but its current status is unclear. Researchers will measure changes in your body image and social participation at the beginning of the study, after one month, and after six months.

Study design
This is an interventional study with a planned enrollment of 18 participants. It is designed to evaluate the effect of a new prosthetic system.
What's involved
You would use the RECOVER Prosthetic Ankle-Feet System for a 6-month period. Your body image and social participation will be measured at the start, at 1 month, and at 6 months.
Compensation
Not stated in the trial record.
Follow-up
Your progress will be followed for 6 months after starting the intervention.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05601869

Impact of Improving Footwear Options

Recruiting
NAAges 18–89InterventionalSupportive care
VA Office of Research and Development
~18 participants
Updated 2026-04-07 on ClinicalTrials.gov
What's tested:RECOVER Prosthetic Ankle-Feet System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Amputation-Specific Body Image Scale-Revised (ABIS-R) Change
Measured over Baseline, 1-month, 6-months
+1 more outcome measured

Conditions

Amputation

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Amputation

NCT05601869

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Minneapolis VA Health Care System, Minneapolis, MN

    Minneapolis, Minnesotastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Andrew H Hansen, PhD · PRINCIPAL_INVESTIGATOR · Minneapolis VA Health Care System, Minneapolis, MN

Who to contact

Andrew H Hansen, PhD
[email protected]
(612) 467-2910
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Amputation-Specific Body Image Scale-Revised (ABIS-R) ChangeBaseline, 1-month, 6-months

    The ABIS-R is a 14-item scale that assesses body image disturbance among individuals with amputations. Responses are reported on a 1 to 3 scale, with higher values representing greater body image disturbance.

  • PROMIS Ability to Participate in Social Roles and Activities (PROMIS APSRA) ChangeBaseline, 1-month, 6-months

    The PROMIS Ability to Participate in Social Roles and Activities (PROMIS-APSRA) specifically measures one's ability to participate in social roles and activities, including one's ability to do leisure activities and activities with friends and family. The PROMISAPSRA is an 8-item form that uses a 5-point scale, where higher values indicate a higher degree of ability to participate.