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临床试验/NCT06458426
NCT06458426Enrolling By Invitation不适用

Thermoregulation in Individuals With a Leg Amputation: Mechanics and Vascular Physiology Factors to Understand Risks for Tissue Complications

University of Utah2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年5月7日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
60
试验地点
2
主要终点
Comfort

研究概览

简要总结

The goal of this project is to understand the factors that affect skin temperature (e.g., tissue above amputation site, and opposite foot) in people with amputation and diabetes. This project will also test the effects of 'shock-absorbing' prosthesis on skin temperature responses.

详细描述

The overall goal of this project is to understand the factors that affect impaired temperature control in individuals with a leg amputation for areas vulnerable to damage, such as the tissue above the amputation site and the opposite intact foot. Abnormal tissue temperature is associated with risks for tissue damage, such as ulcers and pressure sores, especially in people with diabetes. In this study, we aim to study the effects of biomechanics and vascular physiology on tissue temperature responses. We will also determine the effectiveness of prosthetic shock-absorbing components in protecting the tissue from damage.

It is hypothesized that the temperatures of tissues above the amputation site and in the opposite intact foot are associated with mechanical factors during walking, such as shear forces and work (i.e., energy). It is also hypothesized that impaired temperature regulation, especially in people with diabetes, is associated with poor vascular function that inhibits effective blood circulation and oxygen delivery to affected tissues. Lastly, it is hypothesized that walking with a shock-absorbing prosthetic component can improve comfort and improve temperature regulation of tissues above the amputation site.

This project will recruit 40 individuals with a unilateral transtibial (below-knee) amputation, divided into two groups: with and without diabetes. All individuals will be given two sets of prostheses: with and without a shock-absorbing pylon (SAP). SAP is a modular prosthetic component that connects the socket and the foot components and allows added compression and twisting along the pylon. In both sets of prostheses conditions, the participants will wear the same foot component provided by the research team. For each of the two sets of prostheses (with and without SAP), the participants will make up to 5 visits to the laboratory (i.e., up to 10 total visits for the entire protocol). Each visit will involve data collections under a variety of walking tasks, such as walking on various slopes and turning. The same data collections will be repeated with the other set of prostheses.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Individuals with a unilateral transtibial amputation, divided into two groups (with and without diabetes)
  • Participants must classify as Medicare class K2 or higher (who can traverse low-level environmental barriers such as curbs, stairs or uneven surfaces).
  • Participants must have undergone amputation at least 6 months prior.
  • They must have the ability to walk for at least 10 continuous minutes without undue fatigue.

排除标准

  • Neurological impairment that may affect walking function, such as stroke, severe traumatic brain injury, Parkinson's disease, and multiple sclerosis.
  • History of inflammatory diseases, such as Raynaud's syndrome or rheumatoid arthritis.

研究组 & 干预措施

Rigid Pylon

Experimental

The prosthesis will be given a commercial prosthetic foot and a rigid pylon that connects the prosthetic foot to the socket.

干预措施: shock-absorbing prosthesis (Device)

Shock-absorbing Pylon

Experimental

The prosthesis will be given a commercial prosthetic foot and a compressive 'shock-absorbing' pylon that connects the prosthetic foot to the socket.

干预措施: shock-absorbing prosthesis (Device)

结局指标

主要结局

Comfort

时间窗: during the intervention/procedure/surgery

Participants will complete a self-reported questionnaire to indicate comfort while walking with a prosthesis.

Temperature in lower limb

时间窗: during the intervention/procedure/surgery

Temperatures of the skin above the amputation site and the opposite intact foot will be recorded using thermistors and a thermal imaging camera.

Walking mechanics

时间窗: during the intervention/procedure/surgery

Mechanics of walking will be collected using a high-speed motion capture system and force-sensing platforms, which will quantify the motion of the legs and forces acting on the legs, respectively.

Vascular physiology - macrocirculation

时间窗: during the intervention/procedure/surgery

Macrocirculation of the legs (i.e.,blood flow) will be recorded using a Doppler ultrasound probe secured over the thigh during walking

Vascular physiology - microcirculation

时间窗: during the intervention/procedure/surgery

Microcirculation of the legs (i.e.,oxygen utility) will be recorded using near-infrared spectroscopy sensors placed on the thighs, calf, and top surface of the foot.

次要结局

未报告次要终点

研究者

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

Kota Takahashi

Assistant Professor

University of Utah

研究点 (2)

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