Neuropathy Evaluation Using the Vibration Function of a Mobile Phone - the NERVE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 328
- 试验地点
- 1
- 主要终点
- Vibration Perception Threshold (volts) as measured by Health Care Professionals
研究概览
简要总结
A single centre validation/method comparison study of the experimental NERVE device for the measurement of vibration perception threshold against the established 'Neurothesiometer' device, evaluating agreement and reliability. It will also include collecting feedback from patients, carers and clinicians on the usability of the device
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Formally Diagnosed With Diabetes
排除标准
- •Un- willing or un-able to provide free informed consent (no time limit)
- •Un-willing or un-able to comply with all protocol requirements including study assessments;
- •Bilateral foot ulcers
研究组 & 干预措施
Person With Diabetes
A health care professional will conduct the vibration perception threshold testing using both the Neurothesiometer and NERVE diagnostic testing on the person with diabetes. The person with diabetes will conduct the vibration perception threshold testing using the NERVE device. There is an option for a carer/buddy to conduct the vibration perception threshold testing with the NERVE device on the person with diabetes.
干预措施: Neurothesiometer (Diagnostic Test)
Person With Diabetes
A health care professional will conduct the vibration perception threshold testing using both the Neurothesiometer and NERVE diagnostic testing on the person with diabetes. The person with diabetes will conduct the vibration perception threshold testing using the NERVE device. There is an option for a carer/buddy to conduct the vibration perception threshold testing with the NERVE device on the person with diabetes.
干预措施: NERVE (Diagnostic Test)
结局指标
主要结局
Vibration Perception Threshold (volts) as measured by Health Care Professionals
时间窗: Follow up within baseline visit
Measured using Neurothesiometer and NERVE device
Vibration Perception Threshold (volts) as measured by person with diabetes
时间窗: Follow up within baseline visit
Measured using NERVE device
Vibration Perception Threshold (volts) as measured by Health Care Professionals
时间窗: Baseline
Measured using Neurothesiometer and NERVE device
Vibration Perception Threshold (volts) as measured by person with diabetes
时间窗: Baseline
Measured using NERVE device
次要结局
未报告次要终点