Clinical trial NCT06974227: Validation Study of an Assistive Pulse Data Collection Device
Official title: Validation Study of an Assistive Pulse Data Collection Device
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Healthy Male and Female Subjects
Keywords: machine
pulse
wave form
TCM
Lead sponsor: The Hong Kong Polytechnic University
Sponsor class: OTHER
Collaborators: name: Logistics and Supply Chain MultiTech R&D Centre, Hong Kong
First posted: 2025-05-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

Detailed description: 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

1. A subject's pulse features will be recorded by the APDC Device;
2. Three CMPs will assess the subject's pulse of both hands and then the regeneration pulse from the APDC Device;
3. 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")
4. Subjects' user experience will be assessed by a questionnaire (appendix 2);
5. 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.

Pilot Phase In the Pilot Phase, the above procedure will be repeated until 12 CMPs' and 35 subjects' feedback have been collected.

Blinding the practitioners is not feasible due to the inherent differences between the simulator and a real subject. In this case, the study design focuses on the practitioners' ability to match the pulse features from the simulator to those of the patients using categorical responses.

Procedure

1. Three CMPs will take turns to assess five subjects' pulses;
2. The CMPs will categorize each subject's pulse, in the respects of frequency, rhythm, wideness, and force at three places of the wrist, which are known as cun, guan, and chi;
3. The CMPs will then assess the five regenerated pulses from the APDC Device in random order. They will be informed that the pulses are generated from the five subjects they have just assessed in random order;
4. The CMPs will categorize and the APDC-regenerated pulse, using the same approach; they will be asked to match the PTSE-regenerated pulse with the subjects.
5. The above procedure will repeat until thirty subjects are assessed.

Subject recruitment Subjects will be recruited via social media and posters at the University. All subjects will be required to sign a consent form indicating their voluntary participation. Their socio-demographic characteristics will be recruited. The Pulse Taking System Device will digitalize the pulse feature in waveform data. Registered CMPs with at least 5 years of clinical experience will be recruited to assess the pulse from both participants and the device; afterward, they will fill out a predefined record form to rate the pulse characteristics. A HK$100 supermarket coupon will be given to the subject as an incentive upon completion of either phase 1 or 2.

Subjects

* Inclusion criteria

  1. Age 18-65 years
  2. BMI 18.5-22.5 kg/m2
  3. Willing to give informed consent
* Exclusion criteria 1. dorsally located radial artery

Pulse taking setting The CMPs will assess the subjects' pulse as if they were in clinical practice. Subjects will sit on a chair, put their arm on a table, and position their wrist on a pulse pillow. The CMP will assess the subjects' pulse for up to one minute each.

Outcome assessment Agreement in pulse feature between the CMPs and the pulse regeneration device will be assessed using a self-developed questionnaire. The questionnaire will cover the pulse features including frequency, rhythm, wideness, and force.

Users' experience As the APDC Device consists of three parts, namely artery viewing device, pulse collection device, and pulse re-generation device. Device will be assessed separately.

Quantitative feedback from the subjects and CMPs will be collected via a self-developed questionnaire using 5-point Likert items to assess their view on the Pulse Taking System Device, in terms of the satisfaction, ease to use, and comfortability etc.

Qualitative feedback from the subjects and CMPs will be collected using open end questions by a self-completed questionnaire. The ease of use and further suggestions for the pulse taking system device will be collected.

Eligibility criteria: Inclusion Criteria:

1. Age 18-65 years
2. BMI 18.5-22.5 kg/m2
3. Willing to give informed consent

Exclusion Criteria:

1. dorsally located radial artery

Primary outcomes:
measure: Rating on the Agreement in pulse feature
timeFrame: Baseline
Secondary outcomes:
measure: Subjects feedback on the device
timeFrame: Baseline
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Hong Kong Polytechnic University
Study officials:
References: