Validation Study of an Assistive Pulse Data Collection Device

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.

NCT Number	NCT06974227
Lead Sponsor	The Hong Kong Polytechnic University Collaborators: Logistics and Supply Chain MultiTech R&D Centre, Hong Kong
Conditions	Healthy Male and Female Subjects
Enrollment	30 participants
Start Date	2025-03-20
Primary Completion	2025-06-30 (estimated)
Study Completion	2025-07-31 (estimated)
Updated on ClinicalTrials.gov	2025-05-15