Validation Study of an Assistive Pulse Data Collection Device

ConditionHealthy Male and Female Subjects

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18-65

SponsorThe Hong Kong Polytechnic University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age 18-65 years

BMI 18.5-22.5 kg/m2

Willing to give informed consent

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

Assistive Pulse Data Collection (APDC) Device
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.

Treatment groups

30 Participants

are divided into 1 treatment group

Group A: Assistive Pulse Data Collection (APDC) DeviceExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Rating on the Agreement in pulse feature

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.

Time frame

Baseline

Secondary outcomes

Subjects feedback on the device

Subjects' feedback on their experience with the pulse measurement process was collected. Subjects will indicate their level of agreement with various statements using a 5-point scale (1 "Not at all" to 5 "Very Much"). The questionnaire is 4-item, each focused on four key areas: comfort during the measurement process, ease of understanding and using the machine, the efficiency of the measurement process, and overall satisfaction with the experience. It aims to assess the user-friendliness and effectiveness of the machine from the subjects ' perspective.

Time frame

Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Hong Kong Polytechnic University

Lead sponsor

Logistics and Supply Chain MultiTech R&D Centre, Hong Kong

Collaborator

Source ClinicalTrials.gov

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