Recruiting

Observational Study

Sponsor:

North Carolina State University

Code:

NCT05425810

Conditions

Lower Limb Amputation Below Knee (Injury)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Apply ENABLE sensing pad

Insert small pads at pressure tolerant locations

Study Details

Brief 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.

Conditions

Lower Limb Amputation Below Knee (Injury)

Study ID

NCT05425810

Start date

Apr 20, 2021

Status verified date

May, 2025

Completion date

Feb 27, 2026

Anticipated

Primary completion date

Jan 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

3 participants

Anticipated

Intervention Model

Single group

Primary purpose

Device Feasibility

Interventions and Outcome Measures

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.

Interventions

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.

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.

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 and Locations

Central contacts

Ming Liu, PhD

9195158541mliu10@ncsu.edu

He Huang, PhD

9195158541hhuang11@ncsu.edu

Locations

NC State University

Recruiting

Raleigh, North Carolina, United States, 27695

Contacts

Ming Liu

919-515-8541mliu10@ncsu.edu

He Huang

9195158541hhuang11@ncsu.edu

Principal Investigator:

Ming Liu, PhD

More Information

Sponsor

North Carolina State University

Last update posted

May 20, 2025

Last verified

May, 2025

Keywords

  • amputee
  • prosthetic socket
  • residual skin
  • pressure ulcer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by North Carolina State University on 2025-05-20.