Improving the Health Status of Dysvascular Amputees by Deploying Digital Prosthetic Interface Technology in Combination With an Exercise Intervention
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Difference in step counts between the two groups
研究概览
简要总结
The study will test a new approach to the design and implementation of socket and liner technology in individuals who lost a lower limb secondary to diabetes mellitus type II (herein referred to as dysvascular amputees). The technology-based intervention will be combined with an exercise program designed to improve the health status of dysvascular amputees.
详细描述
The study will test the hypothesis that the use of a digital approach to the design and implementation of socket and liner technology (herein referred to as "digital prosthetic interface technology") leads to better health of the residuum (compared to traditional socket and liner technology). This hypothesis will be tested by recruiting a group of dysvascular amputees (herein meant to refer to individuals who lost a lower limb secondary diabetes mellitus type II) and by randomizing them to either receiving a digital prosthetic interface technology or a traditional socket and liner system. Furthermore, the study will assess if the digital prosthetic interface technology improves adherence to an exercise program and results in better clinical outcomes. To test this hypothesis, an exercise intervention will be deployed by relying on coaching and mobile health technology to encourage adherence to a walking program targeting dysvascular transtibial amputees. This exercise intervention is an extension of pilot work that demonstrated the suitability of mobile health technology to implement an exercise-based intervention program in dysvascular amputees.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral transtibial amputation within the past 6 years
- •Etiology secondary to complications of Diabetes Mellitus (DM) type II
- •Current use of a prosthesis, with at least 2 months prior use
- •K2 or K3 level (as determined using the Amputee Mobility Predictor assessment tool)
- •Own a smartphone
排除标准
- •Amputation due to cancer or macrotrauma or acute hemorrhage
- •Bilateral amputation
- •Medically or surgically unstable contralateral lower extremity as determined by medical criteria (e.g., critical limb ischemia)
- •Severe residual limb pain that limits function preventing participation in an exercise-based program
- •Medical conditions that would interfere with subject's participation in regular sustained exercise
- •Anthropometric characteristics that are not compatible with the technology used to scan the residuum and manufacture the liner and socket (e.g., a residuum circumference greater than 32 inches would not be compatible with the device used to scan the residuum)
- •Current pregnancy
研究组 & 干预措施
digital prosthetic interface technology group
Study participants randomized to this group will use the digital prosthetic interface technology developed by Bionic Skins.
干预措施: digital prosthetic interface technology (Device)
traditional socket and liner technology group
Study participants randomized to this group will use a traditional socket-liner technology (i.e., study participants will use their own liner and socket system).
结局指标
主要结局
Difference in step counts between the two groups
时间窗: 12 months
The average number of steps over a period of 2 weeks will be provided by a wearable sensor (Oura ring). The data will be expressed in number of steps per day.
Difference in intra-socket interface pressure between the two groups
时间窗: Baseline
Pressure sensors inserted in the socket will be used to measure the pressure on the residuum when study participants are weight bearing. The pressure is measured in kilopascals (kPa). 1 kPa is approximately the pressure exerted by a 10-g mass resting on a 1-cm2 area.
次要结局
- Difference in thermal imaging measures of the temperature of the residuum in the two groups(Baseline)
- Difference in Prosthesis Evaluation Questionnaire (PEQ) scores in the two groups(Baseline)
- Difference in Socket Evaluation Questionnaire (SEQ) scores in the two groups(Baseline)
研究者
Paolo Bonato
Director, Motion Analysis Laboratory
Spaulding Rehabilitation Hospital