Validation Study of an Assistive Pulse Data Collection Device
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Rating on the Agreement in pulse feature
研究概览
简要总结
Background: Traditional Chinese Medicine (TCM) relies on pulse diagnosis, a subjective and complex method that is crucial for assessing patients' health status. The COVID-19 pandemic has disrupted healthcare delivery, highlighting the need for remote diagnostic tools. To address this, an Assistive Pulse Data Collection Device (APDC) has been developed to capture and regenerate pulse features for remote pulse assessment in TCM.
Objective: This study aims to validate the accuracy and reliability of the APDC by assessing its agreement with Chinese Medicine Practitioners (CMPs) and collecting users' feedback.
Intervention: The APDC consists of a radial artery viewing device, pulse collection device, and pulse regeneration device.
Methods: Subjects will be recruited via social media and posters at the University. Inclusion criteria include age 18-65 years and BMI 18.5-22.5 kg/m2, while exclusion criteria include a dorsally located radial artery. Registered CMPs with at least 5 years of clinical experience will assess the pulse from both participants and the regenerated pulse by the device.
Outcome Assessment: Agreement in pulse features between the subjects' real pulse and the pulse regeneration device will be assessed using a self-developed questionnaire, covering frequency, rhythm, wideness, and force. Quantitative and qualitative feedback from subjects and CMPs will be collected to assess their views on the APDC Device in terms of satisfaction, ease of use, and comfortability.
详细描述
This study aims to assess whether the CMP can correctly recognize the pulse feature generated from the APDC Device and match it with the subjects. Its purpose is to ensure that the device-regenerated pulse resembles the subjects' pulse.
Feasibility Phase During the Feasibility Phase, users' experience from both CMPs and subjects will be collected for the team to refine the setting of the APDC Device.
Procedure
- A subject's pulse features will be recorded by the APDC Device;
- Three CMPs will assess the subject's pulse of both hands and then the regeneration pulse from the APDC Device;
- The CMPs will rate the agreement, using a predefined record form (appendix 1), on the likeliness between the subjects' pulse and PTSE-regenerated pulse, in the respects of frequency, rhythm, wideness, and force (5-point Likert for each domain, from "Strongly disagree" to "strongly agree")
- Subjects' user experience will be assessed by a questionnaire (appendix 2);
- The above steps repeat until 10 subjects' pulses have been assessed.
The engineer team will then adjust and improve the machine based on the user feedback.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 years
- •BMI 18.5-22.5 kg/m2
- •Willing to give informed consent
排除标准
- •1. dorsally located radial artery
研究组 & 干预措施
Assistive Pulse Data Collection (APDC) Device
An Assistive Pulse Data Collection Device prototype has been designed and manufactured by the Logistics and Supply Chain MultiTech R&D Centre, Hong Kong. The device comprises a pulse sensor to record the patient's pulse and digitalize the pulse feature into waveform data. The digitalized waveform data is then converted the electronic signal into mechanical vibration that responds to the patient's pulse.
干预措施: Assistive Pulse Data Collection (APDC) Device (Device)
结局指标
主要结局
Rating on the Agreement in pulse feature
时间窗: Baseline
CMPs will rate their level of agreement with statements regarding the similarity between the machine-generated pulse and the actual pulse of subjects. Responses will be recorded using a 5-point Likert scale, ranging from 1 (Strongly Disagree) to 5 (Strongly Agree). The questionnaire (4-item) evaluated four key pulse attributes: frequency, rhythm, wideness, and force. CMPs will assess the extent to which they agreed that the frequency of the machine-regenerated pulse accurately resembled that of a real person's pulse. Similarly, they evaluated the rhythm, wideness, and force of the machine-generated pulse in comparison to the actual pulse.
次要结局
- Subjects feedback on the device(Baseline)