A new system to assess prosthetic socket fit for lower limb amputees
R21: An Easy-to-use, iNtelligent, Affordable LinEr (ENABLE) System for Socket Fit Assessment
NA · North Carolina State University · NCT05425810
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 3 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | All |
| Sponsor | North Carolina State University (other) |
| Locations | 1 site (Raleigh, North Carolina) |
| Trial ID | NCT05425810 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with cognitive or visual impairments, neuropathy on the residual limb, or who are pregnant may not benefit from this study.
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 performed: While the approach of using a pressure sensing pad is innovative, similar studies have shown promise in improving prosthetic fit and comfort.
Eligibility criteria
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 this trial is running
Raleigh, North Carolina
- NC State University — Raleigh, North Carolina, United States (RECRUITING)
Study contacts
- Study coordinator: Ming Liu, PhD
- Email: mliu10@ncsu.edu
- Phone: 9195158541
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lower Limb Amputation Below Knee, amputee, prosthetic socket, residual skin, pressure ulcer