Transtibial Amputation
Conditions
Keywords
sweat biomarker, prosthetic socket, pressure ulcer, residual limb health
Brief summary
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.
Interventions
PROCEDUREWalk
Treadmill walking
PROCEDUREYuga post
Participants conduct a yuga post which involves their efforts but not load on their residual limbs
DEVICEE-SWEAT Sensor
Mounting the E\_SWEAT sensor to monitor the lactic density, pressure, and temperature inside the socket
Sponsors
University of North Carolina, Chapel Hill
North Carolina State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
The participants are exposed to the two tasks in randomly decided sequence.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 * Have used the current socket for at least 6 months without a significant skin issue or major modification * Be able to comfortably walk 6 mins (with prosthetic legs) without pausing to rest * Be willing to come to North Carolina State University's Centennial Campus to participate in research and be photographed while doing research activities
Exclusion criteria
* 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 * Do not want to take photos * Are pregnant or plan to get pregnant * Are allergic to latex, which is often contained in medical tapes. * If you are using medication to control sweat on your residual limb, and your medical provider does not think that it is OK to avoid these medications for 48 hours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lactic acid density | periprocedural in the first visit | amount of lactic acid in sweat |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Socket environment - temperature | periprocedural in the first visit | temperature at the location where the E-SWEAT is mounted |
| Socket environment - pressure | periprocedural in the first visit | Pressure measured at the location where the E-SWAET is mounted |
Other
| Measure | Time frame | Description |
|---|---|---|
| Body weight | At the beginning of the first visit | Participants' body weight |
Countries
United States
Contacts
Primary ContactAmay Bandodkar, PhD
Backup ContactMing Liu, PhD
Outcome results
None listed