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

NCT05001867 | Completed

• 1 other identifier: 2017/3049
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Work-related Musculoskeletal Disorders

Outcome Measures

Primary Outcomes (6)

• Comparison of quality of ultrasound image for manual scanning and robot scanning

  During the scan

• Kinematic data, Range of Motion from motion capture system

  During the scan

• Muscle activation from EMG data

  During the scan

• Static bilateral grip strength

  Immediately before the scan and immediately after the scan

• Questionnaire on comfort level from sonographers

  immediately after the scan

• Questionnaire on Satisfaction level from healthy volunteers

  immediately after the scan

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

10 sonographers from SGH or SKH and 10 healthy volunteers.

You may qualify if:

• Sonographer:
• Experienced sonographers/ radiographers with more than 5 years of experience
• Healthy volunteer:
• Abdominal circumference \<102cm

You may not qualify if:

• Sonographer:
• Participating sonographers with previously reported work-related or non-work related musculoskeletal discomfort or injury
• Healthy volunteer:
• Pregnancy

Sponsors & Collaborators

• Singapore General Hospital: lead
• Sengkang General Hospital: collaborator
• Servo Dynamics: collaborator

Study Sites (2)

Singapore General Hospital

Singapore, 169608, Singapore

Location

Sengkang General Hospital

Singapore, 544886, Singapore

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2021
• First Posted: August 12, 2021
• Study Start: June 1, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: August 12, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)