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临床试验/NCT07216183
NCT07216183招募中1 期

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

North Carolina State University2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2025年9月16日最近更新:

试验速览

阶段
1 期
状态
招募中
入组人数
16
试验地点
2
主要终点
Lactic acid density

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

结局指标

主要结局

Lactic acid density

时间窗: periprocedural in the first visit

amount of lactic acid in sweat

次要结局

  • Socket environment - temperature(periprocedural in the first visit)
  • Socket environment - pressure(periprocedural in the first visit)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amay Bandodkar

Assistant Professor

North Carolina State University

研究点 (2)

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