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RECRUITING
NCT05425810
NA

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

Sponsor: North Carolina State University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 99 Years

Study Type

INTERVENTIONAL

Enrollment

3

Start Date

2021-04-20

Completion Date

2026-02-27

Last Updated

2025-05-20

Healthy Volunteers

No

Interventions

DEVICE

Apply 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.

DEVICE

Insert 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