Epidermal Sensors for Wireless and Enhanced Amputee Skin Tracking (E-SWEAT) Part 1

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNorth Carolina State University

About this trial

The goal of this clinical trial is to 1) demonstrate the feasibility of monitoring pressure, temperature, and lactic acid density of sweat inside the prosthetic socket, and 2) verify the relationship between mechanical pressure and Lactic acid density of sweat for lower limb amputees among transtibial amputees. The main questions it aims to answer are:

* Is it feasible to reliably monitor pressure, temperature, and lactic acid density inside the prosthetic sockets simultaneously? * Will the lactic acid density increase with higher pressure exposure? The participants are expected to wear the newly developed E-SWEAT system on their residual limb and are exposed to two activities, walk which generate mechanical load on the residual limb, and a yoga post - birddog, which does not generate mechanical loading on the residual limb. The E-SWEAT will measure pressure, temperature, and lactic acid density of sweat during these tasks.

Eligibility criteria

Qualifiers

Be 18 years or older

Have a unilateral lower limb amputee (below the knee). The tibial length on the residual limb must be greater than half of the length of the tibial on the unaffected side

Have an amputation that occurred over 2 years ago

Have at least 1 year of experience using your prosthetic leg

Disqualifiers

Have a cognitive or visual impairment that affects the participant's ability to provide informed consent or to follow simple instructions during the experiments

Have any neuropathy observed on the residual limb

Experience numbness, tingling, muscle weakness, and/or pain in your residual limb

Weigh more than 300lbs

Trial design

Treatments tested in this trial

  • Walk
  • Yuga post
  • E-SWEAT Sensor

Treatment groups

16 Participants
are divided into 2 treatment groups

Sponsors and collaborators

North Carolina State University

Lead sponsor

University of North Carolina, Chapel Hill

Collaborator