The study of LinEr (ENABLE) System for Socket Fit Assessment in lower limb amputees (LLA)

North Carolina State University is starting a new clinical trial of R21: An Easy-to-use, iNtelligent, Affordable LinEr (ENABLE) System for Socket Fit Assessment.

Lower limb amputees (LLA) rely on their prosthetic leg to remain active and lead an independent life. For most LLAs, a well-fitted prosthetic socket is the only option to interface with their prosthetic leg, however, it is a real challenge to make a prosthetic socket to interface with residual limbs accurately. One of the reasons is that there lack accurate approaches to evaluate the pressure distribution on the residual limb accurately and effectively. To overcome this issue, we will develop an innovative sensing system, which permits the prosthetists to track the pressure distribution on the residual limb visually. The capability of the new sensing system will be demonstrated on lower limb amputees.

A novel pressure sensing pad will be tested in the project. The purpose of these tests is to collect the safety and efficacy of the sensing pad. We would like to seek a Non-significant Risk claim from Institutional Review Board (IRB). The pad will be made of materials similar to the normal liner with embedded nanotubes. The nanotubes are filled with gallium alloys, of which resistance will change based on loaded pressure. When constant current passes these tubes, the change of pressure leads to a change in temperatures around, which will excite thermal-sensitive dyes to change color. So we could estimate the pressure at a given area based on the color around it.

The experimental procedure includes three sets and requires 3-4 visits from each subject.

The clinical trial started in April 20, 2021 and will continue throughout August 30, 2024.

For more details: https://ichgcp.net/clinical-trials-registry/NCT05425810 or https://clinicaltrials.gov/ct2/show/NCT05425810.

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