Validation Study of an Assistive Pulse Data Collection Device

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

Qualifiers

Age 18-65 years

BMI 18.5-22.5 kg/m2

Willing to give informed consent

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Assistive Pulse Data Collection (APDC) Device

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators

The Hong Kong Polytechnic University

Lead sponsor

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

Collaborator