Validation Study of an Assistive Pulse Data Collection Device

NCT06974227 | Recruiting Phase 1

• 1 other identifier: PRM
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Male and Female Subjects

Keywords

machine; pulse; wave form; TCM

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Secondary Outcomes (1)

• Subjects feedback on the device

  Baseline

Study Arms (1)

Assistive Pulse Data Collection (APDC) Device

EXPERIMENTAL

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.

Device: Assistive Pulse Data Collection (APDC) Device

Interventions

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.

Assistive Pulse Data Collection (APDC) Device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-65 years
• BMI 18.5-22.5 kg/m2
• Willing to give informed consent

You may not qualify if:

• \. dorsally located radial artery

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead
• Logistics and Supply Chain MultiTech R&D Centre, Hong Kong: collaborator

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

Central Study Contacts

WF Yeung, Ph.D

CONTACT

852-27664151; jerry-wf.yeung@polyu.edu.hik

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2025
• First Posted: May 15, 2025
• Study Start: March 20, 2025
• Primary Completion: June 30, 2025
• Study Completion: July 31, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)