Work-related Musculoskeletal DisordersNCT05001867
Comparing Conventional Abdominal Ultrasound Scanning Versus a Robotic Assisted Ultrasonography System (ROBUST)
An observational study of Work-related Musculoskeletal Disorders, run by Singapore General Hospital at 2 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Work-related Musculoskeletal Disorders
- How many people
- 20 participants
- Where
- 2 sitesSingapore
- Study dates
- 1 Jun 2018to 31 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 10 sonographers from SGH or SKH and 10 healthy volunteers.
Who may be able to join
- Sonographer:
- -Experienced sonographers/ radiographers with more than 5 years of experience
- Healthy volunteer:
- Abdominal circumference <102cm
Who cannot join
- Sonographer:
- -Participating sonographers with previously reported work-related or non-work related musculoskeletal discomfort or injury
- Healthy volunteer:
- -Pregnancy
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites
Singapore General Hospital
Singapore, 169608
Sengkang General Hospital
Singapore, 544886
About this study
Official title: Comparing Conventional Abdominal Ultrasound Scanning Versus a Robotic Assisted Ultrasonography System (ROBUST): a Pilot Study
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.
Read more
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.
Read the detailed description
- 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.
- Conditions
- Work-related Musculoskeletal Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of quality of ultrasound image for manual scanning and robot scanning
Measured: During the scan
Kinematic data, Range of Motion from motion capture system
Measured: During the scan
Muscle activation from EMG data
Measured: During the scan
Static bilateral grip strength
Measured: Immediately before the scan and immediately after the scan
Questionnaire on comfort level from sonographers
Measured: immediately after the scan
Questionnaire on Satisfaction level from healthy volunteers
Measured: immediately after the scan
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start1 Jun 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Work-related Musculoskeletal DisordersStudies of the same condition, open and under way.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sengkang General Hospital, Servo Dynamics
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05001867
- Sponsor's protocol ID
- 2017/3049
- Status last verified
- Aug 2021
- First submitted
- 25 Jul 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Conventional Abdominal Ultrasound Scanning Versus a Robotic Assisted Ultrasonography System (ROBUST): a Pilot Study
- ClinicalTrials.gov ID
- NCT05001867
- Acronym / sponsor ID
- 2017/3049
- Conditions
- Work-related Musculoskeletal Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Sengkang General Hospital, Servo Dynamics
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- 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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 10 sonographers from SGH or SKH and 10 healthy volunteers.
Key inclusion criteria (4 listed)
- -Experienced sonographers/ radiographers with more than 5 years of experience
- Abdominal circumference <102cm
Key exclusion criteria (4 listed)
- -Participating sonographers with previously reported work-related or non-work related musculoskeletal discomfort or injury
- -Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of quality of ultrasound image for manual scanning and robot scanning
Time frame: During the scan
Kinematic data, Range of Motion from motion capture system
Time frame: During the scan
Muscle activation from EMG data
Time frame: During the scan
Static bilateral grip strength
Time frame: Immediately before the scan and immediately after the scan
Questionnaire on comfort level from sonographers
Time frame: immediately after the scan
Questionnaire on Satisfaction level from healthy volunteers
Time frame: immediately after the scan
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Work-related Musculoskeletal Disorders, run by Singapore General Hospital at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of quality of ultrasound image for manual scanning and robot scanning (time frame: During the scan). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021.