Recruiting

Footwear Options

Sponsor:

VA Office of Research and Development

Code:

NCT05601869

Conditions

Amputation

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

RECOVER Prosthetic Ankle-Feet System

Study Details

Brief 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.

Conditions

Amputation

Study ID

NCT05601869

Start date

Sep 1, 2023

Status verified date

Apr, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention

Participants in this arm receive a new prosthesis system designed to improve footwear options.

Interventions

RECOVER 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.

Primary outcome measure

  • Amputation-Specific Body Image Scale-Revised (ABIS-R) Change [ Time Frame: Baseline, 1-month, 6-months ]
  • PROMIS Ability to Participate in Social Roles and Activities (PROMIS APSRA) Change [ Time Frame: Baseline, 1-month, 6-months ]

Central Contacts and Locations

Central contacts

Andrew H Hansen, PhD

(612) 467-2910andrew.hansen2@va.gov

Nicole Walker, MS

(612) 467-3229nicole.walker6@va.gov

Locations

Minneapolis VA Health Care System, Minneapolis, MN

Recruiting

Minneapolis, Minnesota, United States, 55417-2309

Contacts

Andrew H Hansen, PhD

612-467-2910andrew.hansen2@va.gov

Nicole Walker, MS

(612) 467-3229nicole.walker6@va.gov

Principal Investigator:

Andrew H Hansen, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Apr 7, 2026

Last verified

Apr, 2026

Keywords

  • Artificial Limbs
  • Amputation
  • Leg Prosthesis
  • Body Image
  • Community Participation
  • Social Participation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-04-07.