Actively Recruiting
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
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on lower limb amputees who rely on prosthetic legs to maintain an active and independent life. It aims to evaluate a new pressure sensing system designed to help prosthetists visually track pressure distribution on the residual limb, addressing challenges in creating well-fitted prosthetic sockets. The study tests the safety and effectiveness of this innovative sensing pad made with nanotube materials that change color based on pressure. Participants will undergo a series of procedures in three sets during 3-4 visits. The first set involves custom socket construction and fitting by certified prosthetists. The second set compares the new sensing pad's accuracy against a commercial sensor pad by mounting both on the residual limb and measuring pressure while walking. The third set tests how well the sensing pad helps prosthetists assess socket fit under different conditions using added small pads at specific limb locations. Throughout the study, participants will be monitored with high-resolution imaging and asked to complete a comfort survey about the sensing pad. Measurements include pressure distribution during walking and a discomfort chart after the final visit. Safety measures such as a fall prevention harness are available, and participants are encouraged to self-monitor and can end procedures early if needed. Total involvement includes multiple office visits and walking trials lasting about 4 hours in total.
CONDITIONS
Brief Title
R21: An Easy-to-use, iNtelligent, Affordable LinEr (ENABLE) System for Socket Fit Assessment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Unilateral transtibial amputees
- At least 1 year of experience using a prosthetic leg
- Current prosthetic socket used for at least 6 months without significant skin issues or major modifications
- Able to comfortably walk for 3 minutes without resting
- Fibula length on residual limb greater than half of the unaffected side
You will not qualify if you...
- Cognitive or visual impairment affecting ability to give informed consent or follow instructions
- Neuropathy observed on the residual limb
- Pregnant female
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
3 to 4 visits to a local prosthetic company for socket construction and fitting
Duration - Several sessions over a few days
Participants will test the ENABLE sensing pad integrated into their prosthetic liner to measure pressure distribution during walking, compared to a commercial sensor pad. This includes mounting sensors and walking trials to stabilize measurements.
Multiple visits involving mounting sensors and walking trials with the ENABLE system
Duration - Multiple trials within a session
Participants will undergo testing under five different socket fit conditions using small pads to change pressure distribution. They will complete walking trials to evaluate fit and comfort while pressure patterns are recorded and assessed by prosthetists.
3 to 4 visits with walking trials and evaluations under different fit conditions
Duration - 1 visit
After completing all experimental procedures, participants will fill out a survey to provide feedback on the comfort of the ENABLE system.
1 survey visit immediately following testing
Trial Site Locations
Total: 1 location
1
NC State University
Raleigh, North Carolina, United States, 27695
Actively Recruiting
Research Team
M
Ming Liu, PhD
H
He Huang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here