Skip to main content
OpenTrials
Completed

NCT Number: NCT05001867

Comparing Conventional Abdominal Ultrasound Scanning Versus a Robotic Assisted Ultrasonography System (ROBUST)

Work-related musculoskeletal disorders (WRMSD) among sonographers/radiographers are prevalent in the healthcare industry. This pilot study will evaluate the use of a robotic assisted ultrasonography system (ROBUST) against the conventional abdominal ultrasound scanning procedure. The ROBUST will be developed to provide 6 degrees of freedom to allow radiographers to perform abdominal scanning without having to reach over patients.

10 sonographers with at least 5 years of experience will be recruited from SGH and SKH, to perform abdominal ultrasound scans on healthy volunteers. Each sonographer will be randomly assigned to scan a volunteer using conventional abdominal ultrasound scanning procedure and with ROBUST respectively. The study will be done in 2 phases, separated by at least a 1-month interval between scans.

Phase 1: Scanning of volunteer using conventional abdominal ultrasound scanning procedure.

Phase 2: Scanning of volunteer using ROBUST. Outcome measures will include ultrasound image quality, sonographer feedback and comfort level as well as satisfaction feedback from healthy volunteers. A panel of 4 reviewers, consisting of 2 radiologists and 2 senior radiographers will be invited to grade the images, using a 3-point Likert scale. The duration of each scanning will be recorded. The comfort level reported by sonographers will be assessed using the SGH Comfort Level Survey. In addition, the comfort level of healthy volunteers will also be assessed using a satisfaction questionnaire.

Completed

Looking for future studies?

Notify Me

Key information

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sengkang General Hospital, Singapore

Loading trial locations.

About this study

  • 10 participating sonographers will be recruited from SGH and SKH to perform abdominal ultrasound scanning.
  • 10 healthy volunteers of average body habitus with BMI <30, abdominal circumference <102cm will be recruited.
  • Each sonographer will be randomly assigned to scan 1 healthy volunteer. The same volunteer will be scanned twice with an interval of at least 1 month between two scans: once using conventional abdominal ultrasound scanning procedure and once using ROBUST.
  • During the session, markers coated with a retroreflective material to reflect light to the motion capture camera will be pasted on participating sonographers on various parts of the upper limb.
  • Surface electromyography (sEMG) electrodes will be affixed on sonographers' upper trapezius, deltoid, biceps, triceps, wrist extensors and flexors to monitor muscle activities.
  • The healthy volunteer will lie on a plinth with the participating sonographer seated next to him/her. The sonographer will then perform scanning on various abdominal organs following the point of reference and scanning approach as indicated.
  • The same ultrasound scanner and probe type will be used on all volunteers by all sonographers.
  • Static bilateral grip strength of participating sonographers will be measured using a dynamometer before and after each scan.
  • At the end of both scans, participating sonographers will be required to complete a survey on comfort level.
  • At the end of both scans, healthy volunteers will be required to complete a survey on satisfaction level.
  • The quality of the images from both scans will be rated by 4 readers: 2 consultant radiologists and 2 senior radiographers. A photometer will be used to ensure all readers interpret images directly from a designated monitor under consistent lighting condition.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Sonographer:

-Experienced sonographers/ radiographers with more than 5 years of experience

Healthy volunteer:

  • Inclusion criteria: - BMI <30
  • Abdominal circumference <102cm

Exclusion criteria

Sonographer:

-Participating sonographers with previously reported work-related or non-work related musculoskeletal discomfort or injury

Healthy volunteer:

-Pregnancy

Treatment and study plan

Primary outcomes

  1. Comparison of quality of ultrasound image for manual scanning and robot scanning

    Time frame: During the scan

  2. Kinematic data, Range of Motion from motion capture system

    Time frame: During the scan

  3. Muscle activation from EMG data

    Time frame: During the scan

  4. Static bilateral grip strength

    Time frame: Immediately before the scan and immediately after the scan

  5. Questionnaire on comfort level from sonographers

    Time frame: immediately after the scan

  6. Questionnaire on Satisfaction level from healthy volunteers

    Time frame: immediately after the scan

Sponsors and collaborators

Lead sponsor

Singapore General Hospital

Other

Collaborators

  • Sengkang General Hospital
  • Servo Dynamics

Registry information

Official study title

Comparing Conventional Abdominal Ultrasound Scanning Versus a Robotic Assisted Ultrasonography System (ROBUST): a Pilot Study

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 12, 2021
Registry last updated
Aug 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.