NCT05601869

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 1, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

July 30, 2025

Status Verified

July 1, 2025

Enrollment Period

2.6 years

First QC Date

October 27, 2022

Last Update Submit

July 29, 2025

Conditions

Amputation

Keywords

Artificial LimbsAmputationLeg ProsthesisBody ImageCommunity ParticipationSocial Participation

Outcome Measures

Primary Outcomes (2)

  • Amputation-Specific Body Image Scale-Revised (ABIS-R) Change

    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.

    Baseline, 1-month, 6-months

  • PROMIS Ability to Participate in Social Roles and Activities (PROMIS APSRA) Change

    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.

    Baseline, 1-month, 6-months

Study Arms (1)

Intervention

EXPERIMENTAL

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

Device: RECOVER Prosthetic Ankle-Feet System

Interventions

RECOVER Prosthetic Ankle-Feet SystemDEVICE

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.

Also known as: RECOVER AFS
Intervention

Eligibility Criteria

Age18 Years - 89 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsThis project focuses on Veterans identifying as women.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

RECRUITING

Study Officials

  • Andrew H Hansen, PhD

    Minneapolis VA Health Care System, Minneapolis, MN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Andrew H Hansen, PhD

CONTACT

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

Nicole Walker, MS

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Pretest-Posttest Design
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2022

First Posted

November 1, 2022

Study Start

September 1, 2023

Primary Completion

March 31, 2026

Study Completion

March 31, 2026

Last Updated

July 30, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)