A new system to assess prosthetic socket fit for lower limb amputees
Official title: R21: An Easy-to-use, iNtelligent, Affordable LinEr (ENABLE) System for Socket Fit Assessment
Run by North Carolina State University · NCT05425810 · Data updated 2026-11-12
This study is testing a new pressure sensing pad to see if it can help lower limb amputees get a better and more comfortable fit for their prosthetic sockets.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | All |
| Enrollment | 3 (estimated) |
| Sponsor | North Carolina State University Academic / other |
| Locations | 1 site (Raleigh, North Carolina) |
| Status | Recruiting |
| Started | April 20, 2021 |
| Main results expected | January 30, 2026 |
| Study ends | February 27, 2026 |
| Registry record updated | May 20, 2025 |
| Trial ID | NCT05425810 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are unilateral transtibial amputees with at least one year of experience using a prosthetic leg and no significant skin issues.
✕Probably not a fit
Patients with cognitive or visual impairments, neuropathy on the residual limb, or who are pregnant may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to develop and test an innovative pressure sensing pad designed to improve the fit of prosthetic sockets for lower limb amputees. The pad utilizes embedded nanotubes filled with gallium alloys to measure pressure distribution on the residual limb, providing visual feedback to prosthetists. Participants will undergo a series of visits where a test socket will be constructed and fitted, followed by comparisons of the new sensing pad against a commercially available reference sensor. The goal is to enhance the comfort and effectiveness of prosthetic fittings.
Why it matters
Potential benefit: If successful, this system could significantly improve the comfort and fit of prosthetic sockets, reducing the risk of pressure ulcers and enhancing the quality of life for amputees.
How similar studies have gone: While the approach of using a pressure sensing pad is innovative, similar studies have shown promise in improving prosthetic fit and comfort.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Unilateral transtibial amputees * At least 1 year of experience using his/her prosthetic leg * Has used the current socket for at least 6 months without a significant skin issue or major modification * Can comfortably walk 3 mins without pausing to rest * The fibula length on the residual limb must be greater than half of the length of the fibula on the unaffected side Exclusion Criteria: * Cognitive or visual impairment that affects the participant's ability to provide informed consent or to follow simple instructions during the experiments * neuropathy observed on the residual limb * regnant female
Where it's running
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NC State University
Raleigh, North Carolina, United States Recruiting
Study contacts
- Study coordinator: Ming Liu, PhD
- Email: mliu10@ncsu.edu
- Phone: 9195158541
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.