| NCT ID | NCT05601869 |
| Status | Recruiting |
| Phase | — |
| Sponsor | VA Office of Research and Development |
| Condition | Amputation |
| Study Type | INTERVENTIONAL |
| Enrollment | 18 participants |
| Start Date | 2023-09-01 |
| Primary Completion | 2027-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 18 participants in total. It began in 2023-09-01 with a primary completion date of 2027-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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)
Contact & Investigator
Andrew H Hansen, PhD
PRINCIPAL INVESTIGATOR
Minneapolis VA Health Care System, Minneapolis, MN
Frequently Asked Questions
Who can join the NCT05601869 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 89 Years, studying Amputation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05601869 currently recruiting?
Yes, NCT05601869 is actively recruiting participants. Contact the research team at andrew.hansen2@va.gov for enrollment information.
Where is the NCT05601869 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT05601869 clinical trial?
NCT05601869 is sponsored by VA Office of Research and Development. The principal investigator is Andrew H Hansen, PhD at Minneapolis VA Health Care System, Minneapolis, MN. The trial plans to enroll 18 participants.