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RecruitingNot ApplicableNCT05425810

R21: An Easy-to-use, iNtelligent, Affordable LinEr (ENABLE) System for Socket Fit Assessment

Sponsor

North Carolina State University

Enrollment

3 participants

Start Date

Apr 20, 2021

Study Type

INTERVENTIONAL

Conditions

Lower Limb Amputation Below Knee (Injury)

Summary

Lower limb amputees (LLA) rely on their prosthetic legs 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 of accurate approaches to evaluate the pressure distribution on the residual limb accurately and effectively. To overcome this issue, the research team 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.

Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study tests a smart liner system (ENABLE) that can track how well a prosthetic socket fits for people with a below-knee (transtibial) amputation. Poor socket fit causes pain, skin breakdown, and reduced mobility. The ENABLE system is a sensor-equipped liner that monitors fit conditions, helping users and clinicians detect problems earlier. You may be eligible if... - You have a single (unilateral) below-knee amputation - You have at least 1 year of experience using your prosthetic leg - You have been using your current prosthetic socket for at least 6 months without major issues - You can walk for at least 3 minutes without pausing to rest - The fibula bone on your residual limb is more than half the length of the fibula on your unaffected leg You may NOT be eligible if... - You have cognitive or visual impairment that affects your ability to consent or follow instructions - You have neuropathy on your residual limb - You are a pregnant female Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEApply ENABLE sensing pad

The developed ENABLE system is integrated into the standard prosthetic liner and measures the pressure distribution during locomotion. Using the ENABLE system may lead temporary increase in the temperature inside the prosthetic socket and it is expected that the total exposition during the experimental procedure will be less than 10 min.

DEVICEInsert small pads at pressure tolerant locations

To change the pressure distribution inside the socket, four fitting conditions are introduced by adding small pads at patella tendon (PT), lateral tibial crest (LTC), medial tibial crest (MTC), and popliteal fossa (PF) respectively. Including the no pads scenario, totally of five fitting conditions are simulated.

Locations(1)

NC State University

Raleigh, North Carolina, United States

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NCT05425810

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