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

RecruitingNAAges 18 Years - 99 YearsAllNorth Carolina State University
NCT05425810 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Apply ENABLE sensing pad
  • Insert small pads at pressure tolerant locations
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Where

1 site
NC State University
Raleigh, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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