Continuation of the Development of Moisture Management Liner and Active Cooling System for Improving Residual Limb Skin Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Residual Limb Temperature
研究概览
简要总结
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm and ultimately moist environment.
To address this, Liberating Technologies, Inc. (LTI) and Vivonics, Inc. have developed a thermo-electric cooling (TEC)-based module called the Intrasocket Cooling Element (ICE), that can be embedded into the prosthesis in order to cool the residual limb. A technology that can provide thermal control while retaining adequate suspension, weight and other prosthetic characteristics would benefit many prosthesis wearers.
详细描述
The comfort and fit of the residual limb within a prosthetic socket are of primary concern for many amputees. The residual limb is typically covered by non-breathable and non- thermally conductive materials that can create a warm and ultimately moist environment. Studies found increases in socket temperature after the prosthesis was donned (0.8 degrees C) and after 30 minutes of walking (2.5 degrees C). Temperatures were found to remain elevated long after activity cessation and even a rest period of double the duration of the preceding activity period is insufficient to return the limb to its initial temperature. A study suggested that a modest temperature increase of only 2 degrees C may be responsible for reports of thermal discomfort by amputees. Therefore, a small amount of activity can cause the socket temperature to elevate and remain at an uncomfortable level for an extended period of time, which can lead to decreased wear times. In summary, an uncomfortable socket/residual limb interface decreases prosthesis use among amputees who want to remain active in their lives.
To address this, Liberating Technologies, Inc. (LTI) and Vivonics, Inc. have developed a thermo-electric cooling (TEC)-based module called the Intrasocket Cooling Element (ICE), that can be embedded into the prosthesis in order to cool the residual limb. A technology that can provide thermal control while retaining adequate suspension, weight and other prosthetic characteristics would benefit many prosthesis wearers.
This study will focus on investigating the efficacy of this novel socket cooling technology.
The rationale for this study is to determine how well the new technology can cool the residual limb not only in a controlled laboratory environment, but also in a home environment where the device would ultimately be utilized.
The primary objective of this study is to measure the effects of cooling the residual limb on quality of life (QoL) and functional outcomes. Cooling the residual limb inside the prosthetic socket would result in less sweating and greater comfort while wearing the prosthesis, and ultimately greater function and better quality of life as measured by standard functional and QoL outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must have a lower limb absence
- •Willing and able to complete outlined tasks
- •Must complete and pass our Semmes-Weinstein monofilament test
- •Must understand English in order to be properly consented and provide feedback to the study personnel
排除标准
- •The risks to pregnant women and fetuses are unknown and therefore pregnant women should not participate in the study
- •No symptoms consistent with peripheral neuropathy or other sensory diagnosis that could prevent them from feeling the temperature of their limb
研究组 & 干预措施
ICE Unit
The subject wears the experimental socket with an ICE Unit, which includes a TEC and will be actively cooling the leg whenever the device is powered on. An ambient temperature sensor and step counter is attached to the socket. The subject is only informed that each condition is a "different level of cooling" to reduce bias. This condition should last approximately one month.
干预措施: ICE Condition (Device)
Sham Unit
The subject wears the experimental socket with a Sham Unit, which excludes a TEC and will not be actively cooling the leg when the device is powered on. An ambient temperature sensor and step counter is attached to the socket. The subject is only informed that each condition is a "different level of cooling" to reduce bias. This condition should last approximately one month.
干预措施: Sham Condition (Device)
结局指标
主要结局
Residual Limb Temperature
时间窗: 4 hours
This will be tested only during in-lab visits. An intervention of the experimental socket with the ICE cooling unit should yield at least a 2 degree Celsius decrease in temperature compared with no intervention. This will be tested in-lab with 6 thermocouples taped to the residual limb while the subject is sitting and walking on a treadmill. The reported result is the temperature difference of the residual limb from the baseline temperature (before activity) to the end of the sitting period (after activity). The ICE or Sham unit is turned on 5 minutes before the 15 minute walking period. After the 15 minute walking period, the participant sits with the unit ON for 45 minutes. The baseline temperature reading is taken directly before the unit is turned on, and the end temperature reading is taken after the 45 minutes of sitting.
次要结局
未报告次要终点
研究者
Todd Farrell
Director of Research
Liberating Technologies, Inc.