RECRUITING

Impact of Improving Footwear Options

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Impact of Improving Footwear Options for Women Veterans With Amputations

Quick Facts

Study Start:2023-09-01
Study Completion:2025-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05601869

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * US military Veterans that identify as women
  2. * Transtibial (below-knee) amputation
  3. * Using a definitive prosthesis for at least 6 months (limb has accommodated to prosthesis use post-amputation)
  4. * Well fitting and well aligned prosthesis
  5. * Blessed Orientation-Memory-Concentration (Short Blessed) score between 0-6
  6. * Access to computer, tablet, or smart phone and internet for video conferencing and RedCap data collection
  1. * Residual limb skin problems
  2. * Residual limb too long to accommodate the RECOVER prosthetic ankle-feet system
  3. * Unable or unwilling to travel to Minneapolis
  4. * Not a regular prosthesis user
  5. * Mass over 125 kg
  6. * Documented neurocognitive disorder (e.g., dementia) with evidence of impact on activities of daily living and/or instrumental activities of daily living
  7. * Baseline ABIS-R or PROMIS-APSRA scores at the maximum levels (no room for improvement on primary outcomes)

Contacts and Locations

Study Contact

Andrew H Hansen, PhD
CONTACT
(612) 467-2910
andrew.hansen2@va.gov
Nicole Walker, MS
CONTACT
(612) 467-3229
nicole.walker6@va.gov

Principal Investigator

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

Study Locations (Sites)

Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-01
Study Completion Date2025-12-31

Study Record Updates

Study Start Date2023-09-01
Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

  • Amputation