E-Socket, Diagnostic Monitoring
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Anterior-Distal Limb Motion
研究概览
简要总结
The long-term goal of this research is a socket-embedded prosthesis use and socket fit monitor (E-Socket) that facilitates clinical decision-making in the diagnosis and prognosis of health issues faced by people with transtibial amputation. The overall strategy is to enhance the E-socket to include additional metrics that we identified needed from studies to date (Aim #1). Then we conduct a randomized control trial testing the diagnostic utility of the E-socket data in clinical care (Aim #2). From the data collected in that study, we develop the prognostic capability of the system (Aim #3).
Aim 3 will not involve human subject testing as it will focus on the development of the system in preparation for a future aim involving participants' own clinicians.
Note: we use the term "diagnostic" throughout our application in a general sense. The device will not be diagnosing specific diseases or medical conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prosthesis Users:
- •Aims 1 and 2
- •Over 18 years of age
- •Unilateral or bilateral trans-tibial amputation at least 12 months prior
- •Have a limb of length 9 cm or greater
- •Are capable of at least 5 minutes of continuous walking
- •Regularly use a definitive prosthesis
- •Do not regularly use assistive devices (e.g., cane, walker) for ambulation
- •Do not have open wounds on their residual limb at the time of enrollment
- •Regularly visit their prosthetist at least twice a year,
排除标准
- •Prosthesis Users:
- •Aims 1 and 2
- •Reduced skin sensation
- •Presence of skin breakdown
- •Regular use of an assistive device
- •Persons with trans-femoral amputation
- •Vacuum suspension users
结局指标
主要结局
Anterior-Distal Limb Motion
时间窗: 12 months
Monitor anterior-distal limb motion in the prosthesis to determine if limb motions and activity changes precede changes in limb health. Interviews with the participants and questionnaires will be used to assess the outcome measure.
次要结局
未报告次要终点
研究者
Joan E Sanders
Associate Professor
University of Washington