Actively Recruiting

Phase Not Applicable
Age: 18Years - 99Years
All Genders
NCT05425810

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

Led by North Carolina State University · Updated on 2025-05-20

3

Participants Needed

1

Research Sites

253 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 99Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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
  • Pregnant female

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

NC State University

Raleigh, North Carolina, United States, 27695

Actively Recruiting

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Research Team

M

Ming Liu, PhD

CONTACT

H

He Huang, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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