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

Part of paid clinical trials in Raleigh, North Carolina.

Sponsor
North Carolina State University
Study ID
NCT05425810
Status
Recruiting
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Conditions

  • Lower Limb Amputation Below Knee (Injury)

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Apply ENABLE sensing pad — DEVICE
    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.
  • Insert small pads at pressure tolerant locations — DEVICE
    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.

Study Details

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 Dates

Start date
Apr 20, 2021
Status verified
May 2025
Primary completion
Jan 30, 2026
Completion
Feb 27, 2026

Study Design

Enrollment
3 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY

Arms

  • Experimental: Transtibial patient
    All the recruited participants will be included in this arm and will go through the socket manufacturing, fitting, and testing procedure.

Primary Outcome Measure

Discomfort chart [ Time Frame: The outcome is to evaluate the comfort of the final visit for the project (4 hours). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
NC State UniversityRaleighNorth Carolina27695
Ming Liu
[email protected]
919-515-8541
He Huang
[email protected]
9195158541
Ming Liu, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
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