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
This trial does not accept healthy volunteersQualifiers
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
Crossover
Treatments tested in this trial
Walk
Procedure/SurgeryTreadmill walking
Yuga post
Procedure/SurgeryParticipants conduct a yuga post which involves their efforts but not load on their residual limbs
E-SWEAT Sensor
DeviceMounting the E\_SWEAT sensor to monitor the lactic density, pressure, and temperature inside the socket
Treatment groups
Trial outcomes
Primary outcomes
Lactic acid density
amount of lactic acid in sweat
Secondary outcomes
Socket environment - temperature
temperature at the location where the E-SWEAT is mounted
Socket environment - pressure
Pressure measured at the location where the E-SWAET is mounted
Other outcomes
Body weight
Participants' body weight
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
North Carolina State University
Lead sponsor
University of North Carolina, Chapel Hill
Collaborator