Actively Recruiting
Epidermal Sensors for Wireless and Enhanced Amputee Skin Tracking (E-SWEAT) Part 1
Led by North Carolina State University · Updated on 2025-10-14
16
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
N
North Carolina State University
Lead Sponsor
U
University of North Carolina, Chapel Hill
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying transtibial amputees to see if it is possible to monitor pressure, temperature, and lactic acid density of sweat inside prosthetic sockets at the same time. The study also aims to understand if lactic acid density increases with higher pressure on the residual limb. This research focuses on people who use below-knee prosthetic legs and evaluates a new sensor system called E-SWEAT. Participants will wear the E-SWEAT device on their residual limb while performing two activities: walking on a treadmill at their preferred speed, which applies mechanical load to the limb, and holding a yoga pose called the birddog, which does not load the limb. The sensor records pressure, temperature, and lactic acid levels inside the socket during these tasks. During the study, participants will be monitored for lactic acid density, socket temperature, and pressure, particularly during their first visit. They will be asked to walk comfortably for six minutes without resting and agree to be photographed while participating in the research at North Carolina State University's Centennial Campus. The study collects data to verify the sensor's performance and the relationship between mechanical load and sweat composition in amputees.
CONDITIONS
Brief Title
Epidermal Sensors for Wireless and Enhanced Amputee Skin Tracking (E-SWEAT) Part 1
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Be 18 years or older
- Have a unilateral below-the-knee amputation with tibial length on the residual limb greater than half the unaffected side
- Amputation occurred over 2 years ago
- At least 1 year of experience using your prosthetic leg
- Have used the current prosthetic socket for at least 6 months without major skin issues or modifications
- Able to walk comfortably for 6 minutes with prosthetic legs without resting
- Willing to participate at North Carolina State University's Centennial Campus and be photographed during activities
You will not qualify if you...
- Have cognitive or visual impairments affecting consent or following instructions
- Have any neuropathy on the residual limb
- Experience numbness, tingling, muscle weakness, or pain in the residual limb
- Weigh more than 300 pounds
- Do not want to be photographed
- Are pregnant or planning to become pregnant
- Are allergic to latex often found in medical tapes
- Use medication to control sweat on your residual limb and cannot avoid it for 48 hours as advised by your medical provider
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.
1 visit (in-person)
Duration - 1 day
Participants have the E-SWEAT sensor mounted to monitor lactic acid density, pressure, and temperature inside the prosthetic socket during specified activities.
1 visit (in-person)
Duration - Single session
Participants perform treadmill walking at their preferred speed and conduct yuga post exercises which involve effort without load on the residual limb, with the E-SWEAT sensor monitoring the socket environment.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Engineering Build III
Raleigh, North Carolina, United States, 27695
Actively Recruiting
Research Team
A
Amay Bandodkar, PhD
M
Ming Liu, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
2
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