HealthyNCT04646304
Motion Capture as a Tool for the Assessment of Laparoscopic Performance
A study testing Objective Feedback (Motion Capture) in people with Healthy and Adult ALL, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The goal of this study is to 1) identify motion capture variables that can be used to differentiate surgical experience level and 2) evaluate if these variables can be used in a surgical education setting to improve resident performance. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- Objective Feedback (Motion Capture)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2021to 31 Dec 2024
- Phase
- Interventional
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- staff surgeons, surgical fellows and residents
- primary affiliation with the departments of Obstetrics and Gynecology, Urology, General Surgery, and Thoracics at the University of Ottawa and The Ottawa Hospital
Who cannot join
- current injury/condition that in the opinion or the participant and/or research team will affect performance
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this study is to 1) identify motion capture variables that can be used to differentiate surgical experience level and 2) evaluate if these variables can be used in a surgical education setting to improve resident performance.
Read the detailed description
This will be a two-phase study that will take 2 years to complete.
Phase 1 will recruit staff surgeons, surgical fellows, and residents from the departments of Obstetrics and Gynecology, Urology, General Surgery, and Thoracics at The University of Ottawa and The Ottawa Hospital to complete a set of FLS tasks. Logistic regressions will be used to identify significant factors that differentiate surgical experience level (junior residents, senior residents, fellows, and staff). Classification of residents will depend on their current cohort in the CDB or traditional time-based system: A target interval will be computed for each significant factor based on the staff surgeons' average performance. This target interval will be used to assess resident performance in Phase 2.
Phase 2 will recruit Transition to Discipline residents from each department to complete 3 sets of FLS tasks. Participants will be randomized into an "objective feedback" group or a "no feedback" group. Participants randomized to the objective feedback group will receive a report that compares their performance in Set 1 to that of the staff surgeons' using the target interval as a reference. Participants receiving objective feedback will then complete Sets 2 and 3 knowing what factors to improve upon. Participants receiving no feedback will complete all sets with no intervention. Phase 2 data collection will start once Phase 1 is completed.
Trajectories of retro-reflective markers will be recorded using a 6-camera motion analysis system (40MXF-40 Vicon cameras, Oxford Metrics, Oxford, UK) sampling at 100 Hz with supporting Nexus software (v2, Oxford Metrics, Oxford, UK). Retro-reflective markers will be placed on various anatomical landmarks on the participant's body based on a cluster marker set. Laparoscopic surgical tools (grasper, scissors, or dissector) will have a marker triad fixed to the upper shaft while a laparoscopic trainer (FLS Trainer System, Limbs \& Things, Savannah GA) will have markers placed at its corners. Using Vicon Nexus software, raw marker trajectories will be filtered and used to compute local coordinate systems of the upper body, joint centers, and subsequent joint angles while filtered marker trajectories on the laparoscopic tools will compute the tool tip's motion and orientation relative to the box trainer's workspace. Inertial measurement units (IMUs) will also be used to capture motion of the upper body and compare to motion capture outcomes (Secondary Objective). Wireless IMUs will be placed along the long axis of the forearm, upper arm, upper spine and lower spine.
Surface electromyography (EMG) signals of the biceps, triceps, anterior deltoid, upper trapezius, wrist extensors and flexors will also be recorded using a wireless EMG system (Trigno, Delsys Inc., Natick MA) and recorded using Nexus. Sensors will be placed over the muscle bellies following SENIAM guidelines [34] and signals will be sample data 100Hz with a 20-450Hz bandpass. All experimental EMG signals will be appropriately conditioned and normalized to maximum EMG value elicited during maximum voluntary isometric contraction (MVIC) exercises. Three repetitions of each MVIC exercise will be performed before the experimental task and will include elbow flexion and extension, arm abduction, arm flexion, and wrist flexion and extension. A minimum of 30 seconds rest will be given between each exercise to mitigate effects of fatigue.
Motion and EMG data will be exported to a custom MatLab (2019, Mathworks, Natick, MA) application to compute objective measures of laparoscopic performance: instrument tip pathlength, average (±1 stdev) excursion velocity, average (±1 stdev) excursion error, average (±1 stdev) upper body kinematics (shoulder, elbow, wrist, neck and trunk) in all three planes of motion, and integrated EMG.
Video of the surgical tasks will be recorded and synced to marker trajectory data using an external trigger. Videos will be de-identified, and the last repetition assessed by three staff surgeons. First, the raters will categorize each video as Transition to Discipline resident, Foundation of Discipline resident, Core Discipline resident, Transition to Practice resident, fellow, or staff surgeon based other their general perception of the performer's experience level. The raters will then score each video following the FLS scoring system (based on timing and penalty scores), and the OSATS evaluation grid.
- Being tested
- Objective Feedback (Motion Capture)
- Keywords
- surgical trainees, surgical staff
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Objective Feedback (Motion Capture)Other
Participants assigned to the objective feedback group will be given a report after completing Set 1 and Set 2. This report will outline their performance for each significant factor (identified in Phase 1) relative to a target interval, derived from the staff surgeon group average (± one standard deviation). Participants assigned to the objective feedback group will then be able to repeat the tasks knowing which variables to improve.
| Study group | Role | What they receive |
|---|---|---|
| Objective Feedback (Motion Capture) | Other | Participants in the objective feedback group will receive a report that compares their performance in Set 1 to that of the staff surgeons' using the target interval as a reference. Participants receiving objective feedback will then complete Sets 2 and 3 knowing what factors to improve upon. Receives: Other: Objective Feedback (Motion Capture) |
| No Feedback | No intervention | Participants receiving no feedback will complete all sets with no intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion time
Time to complete each task measured in seconds
Measured: 1 year
Instrument pathlength
Pathlength of surgical instrument tip measured in cm
Measured: 1 year
Motion smoothness
Motion smoothness of surgical instrument tip measured by the number of changes in acceleration (m/s^2)
Measured: 1 year
Instrument orientation
Orientation of surgical instrument tip measured in the three planes of motion (depth, pitch, roll, yaw), quantified in degrees relative to the surgical trainer box's local coordinate system.
Measured: 1 year
Fundamentals of Laparoscopy Skill (FLS) score
- A numbered score is calculated following procedures outlined in the Fundamentals of Laparoscopy Skills (FLS) modules
Measured: 1 year
Objective Structured Assessment of Technical Skills (OSATS) score
- A numbered score is computed from a global rating system based evaluation grid.
Measured: 1 year
Participant classification
Blinded reviews will classify participants as junior residents, senior residents, fellows/staff based on their perception of participant skill level.
Measured: 1 year
Secondary outcomes (3)
Muscle Electromyography
- Muscles: erector spinae, biceps, triceps, anterior deltoid, upper trapezius, wrist extensors, wrist flexors
- Amplitude quantified as %maximum measured during maximal effort trials
Measured: 1 year
Muscle activation symmetry
- Muscles: erector spinae, biceps, triceps, anterior deltoid, upper trapezius, wrist extensors, wrist flexors
- Symmetry indices will be quantified as non-dominant side/dominant side.
Measured: 1 year
Upper body kinematics
- Body orientation will be measured in degrees for the shoulder, elbow, wrist, neck, trunk
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2020
- Study start1 May 2021
- Primary completion11 Oct 2023
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Phase 1 will recruit 4 groups of participants that vary in surgical experience (junior residents, senior residents, surgical fellows, and staff surgeons). Significant differences in objective measures of surgical performance will be identified. A target interval will be computed for each significant factor based on the staff surgeons' average performance. Phase 2 will recruit junior residents to complete the same sets of surgical tasks. Half of the participants will receive objective feedback comparing their performance in Set 1 to the staff surgeons' target interval while the other half will receive no feedback. Differences in performance between Sets 1 and 3 will be quantified and compared between groups.
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sukhbir Singh, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646304
- Sponsor's protocol ID
- 20200631-01H
- Status last verified
- Mar 2025
- First submitted
- 3 Nov 2020
- Last updated
- 25 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanchez A, Rodriguez O, Sanchez R, Benitez G, Pena R, Salamo O, Baez V. Laparoscopic surgery skills evaluation: analysis based on accelerometers. JSLS. 2014 Oct-Dec;18(4):e2014.00234. doi: 10.4293/JSLS.2014.00234.
PubMed 25489218Moorthy, Munz, Dosis, Bello, Darzi. Motion analysis in the training and assessment of minimally invasive surgery. Minim Invasive Ther Allied Technol. 2003 Jul;12(3):137-42. doi: 10.1080/13645700310011233.
PubMed 16754092Farcas MA, Trudeau MO, Nasr A, Gerstle JT, Carrillo B, Azzie G. Analysis of motion in laparoscopy: the deconstruction of an intra-corporeal suturing task. Surg Endosc. 2017 Aug;31(8):3130-3139. doi: 10.1007/s00464-016-5337-4. Epub 2016 Dec 7.
PubMed 27928669Gray RJ, Kahol K, Islam G, Smith M, Chapital A, Ferrara J. High-fidelity, low-cost, automated method to assess laparoscopic skills objectively. J Surg Educ. 2012 May-Jun;69(3):335-9. doi: 10.1016/j.jsurg.2011.10.014.
PubMed 22483134Ganni S, Botden SMBI, Chmarra M, Li M, Goossens RHM, Jakimowicz JJ. Validation of Motion Tracking Software for Evaluation of Surgical Performance in Laparoscopic Cholecystectomy. J Med Syst. 2020 Jan 24;44(3):56. doi: 10.1007/s10916-020-1525-9.
PubMed 31980955Gallagher AG, McClure N, McGuigan J, Ritchie K, Sheehy NP. An ergonomic analysis of the fulcrum effect in the acquisition of endoscopic skills. Endoscopy. 1998 Sep;30(7):617-20. doi: 10.1055/s-2007-1001366.
PubMed 9826140
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motion Capture as a Tool for the Assessment of Laparoscopic Performance
- ClinicalTrials.gov ID
- NCT04646304
- Acronym / sponsor ID
- 20200631-01H
- Keywords
- surgical trainees, surgical staff
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 1 May 2021 (actual)
- Primary completion
- 11 Oct 2023 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 27 Nov 2020 (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.
The goal of this study is to 1) identify motion capture variables that can be used to differentiate surgical experience level and 2) evaluate if these variables can be used in a surgical education setting to improve resident performance.
Detailed description
This will be a two-phase study that will take 2 years to complete.
Phase 1 will recruit staff surgeons, surgical fellows, and residents from the departments of Obstetrics and Gynecology, Urology, General Surgery, and Thoracics at The University of Ottawa and The Ottawa Hospital to complete a set of FLS tasks. Logistic regressions will be used to identify significant factors that differentiate surgical experience level (junior residents, senior residents, fellows, and staff). Classification of residents will depend on their current cohort in the CDB or traditional time-based system: A target interval will be computed for each significant factor based on the staff surgeons' average performance. This target interval will be used to assess resident performance in Phase 2.
Phase 2 will recruit Transition to Discipline residents from each department to complete 3 sets of FLS tasks. Participants will be randomized into an "objective feedback" group or a "no feedback" group. Participants randomized to the objective feedback group will receive a report that compares their performance in Set 1 to that of the staff surgeons' using the target interval as a reference. Participants receiving objective feedback will then complete Sets 2 and 3 knowing what factors to improve upon. Participants receiving no feedback will complete all sets with no intervention. Phase 2 data collection will start once Phase 1 is completed.
Trajectories of retro-reflective markers will be recorded using a 6-camera motion analysis system (40MXF-40 Vicon cameras, Oxford Metrics, Oxford, UK) sampling at 100 Hz with supporting Nexus software (v2, Oxford Metrics, Oxford, UK). Retro-reflective markers will be placed on various anatomical landmarks on the participant's body based on a cluster marker set. Laparoscopic surgical tools (grasper, scissors, or dissector) will have a marker triad fixed to the upper shaft while a laparoscopic trainer (FLS Trainer System, Limbs \& Things, Savannah GA) will have markers placed at its corners. Using Vicon Nexus software, raw marker trajectories will be filtered and used to compute local coordinate systems of the upper body, joint centers, and subsequent joint angles while filtered marker trajectories on the laparoscopic tools will compute the tool tip's motion and orientation relative to the box trainer's workspace. Inertial measurement units (IMUs) will also be used to capture motion of the upper body and compare to motion capture outcomes (Secondary Objective). Wireless IMUs will be placed along the long axis of the forearm, upper arm, upper spine and lower spine.
Surface electromyography (EMG) signals of the biceps, triceps, anterior deltoid, upper trapezius, wrist extensors and flexors will also be recorded using a wireless EMG system (Trigno, Delsys Inc., Natick MA) and recorded using Nexus. Sensors will be placed over the muscle bellies following SENIAM guidelines [34] and signals will be sample data 100Hz with a 20-450Hz bandpass. All experimental EMG signals will be appropriately conditioned and normalized to maximum EMG value elicited during maximum voluntary isometric contraction (MVIC) exercises. Three repetitions of each MVIC exercise will be performed before the experimental task and will include elbow flexion and extension, arm abduction, arm flexion, and wrist flexion and extension. A minimum of 30 seconds rest will be given between each exercise to mitigate effects of fatigue.
Motion and EMG data will be exported to a custom MatLab (2019, Mathworks, Natick, MA) application to compute objective measures of laparoscopic performance: instrument tip pathlength, average (±1 stdev) excursion velocity, average (±1 stdev) excursion error, average (±1 stdev) upper body kinematics (shoulder, elbow, wrist, neck and trunk) in all three planes of motion, and integrated EMG.
Video of the surgical tasks will be recorded and synced to marker trajectory data using an external trigger. Videos will be de-identified, and the last repetition assessed by three staff surgeons. First, the raters will categorize each video as Transition to Discipline resident, Foundation of Discipline resident, Core Discipline resident, Transition to Practice resident, fellow, or staff surgeon based other their general perception of the performer's experience level. The raters will then score each video following the FLS scoring system (based on timing and penalty scores), and the OSATS evaluation grid.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase 1 will recruit 4 groups of participants that vary in surgical experience (junior residents, senior residents, surgical fellows, and staff surgeons). Significant differences in objective measures of surgical performance will be identified. A target interval will be computed for each significant factor based on the staff surgeons' average performance. Phase 2 will recruit junior residents to complete the same sets of surgical tasks. Half of the participants will receive objective feedback comparing their performance in Set 1 to the staff surgeons' target interval while the other half will receive no feedback. Differences in performance between Sets 1 and 3 will be quantified and compared between groups.
| Arm | Type | Receives |
|---|---|---|
| Objective Feedback (Motion Capture) | Other | Other: Objective Feedback (Motion Capture)Participants in the objective feedback group will receive a report that compares their performance in Set 1 to that of the staff surgeons' using the target interval as a reference. Participants receiving objective feedback will then complete Sets 2 and 3 knowing what factors to improve upon. |
| No Feedback | No intervention | –Participants receiving no feedback will complete all sets with no intervention. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- staff surgeons, surgical fellows and residents
- primary affiliation with the departments of Obstetrics and Gynecology, Urology, General Surgery, and Thoracics at the University of Ottawa and The Ottawa Hospital
Key exclusion criteria (1 listed)
- current injury/condition that in the opinion or the participant and/or research team will affect performance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Objective Feedback (Motion Capture)Participants assigned to the objective feedback group will be given a report after completing Set 1 and Set 2. This report will outline their performance for each significant factor (identified in Phase 1) relative to a target interval, derived from the staff surgeon group average (± one standard deviation). Participants assigned to the objective feedback group will then be able to repeat the tasks knowing which variables to improve. | Other | Objective Feedback (Motion Capture) |
Primary outcome
Completion time
Time frame: 1 year
Time to complete each task measured in seconds
Instrument pathlength
Time frame: 1 year
Pathlength of surgical instrument tip measured in cm
Motion smoothness
Time frame: 1 year
Motion smoothness of surgical instrument tip measured by the number of changes in acceleration (m/s^2)
Instrument orientation
Time frame: 1 year
Orientation of surgical instrument tip measured in the three planes of motion (depth, pitch, roll, yaw), quantified in degrees relative to the surgical trainer box's local coordinate system.
Fundamentals of Laparoscopy Skill (FLS) score
Time frame: 1 year
- A numbered score is calculated following procedures outlined in the Fundamentals of Laparoscopy Skills (FLS) modules
Objective Structured Assessment of Technical Skills (OSATS) score
Time frame: 1 year
- A numbered score is computed from a global rating system based evaluation grid.
Participant classification
Time frame: 1 year
Blinded reviews will classify participants as junior residents, senior residents, fellows/staff based on their perception of participant skill level.
3 secondary outcomes
Muscle Electromyography
Time frame: 1 year
Muscle activation symmetry
Time frame: 1 year
Upper body kinematics
Time frame: 1 year
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 25 Mar 2025.
- Background: PubMed 25489218Sanchez A, Rodriguez O, Sanchez R, Benitez G, Pena R, Salamo O, Baez V. Laparoscopic surgery skills evaluation: analysis based on accelerometers. JSLS. 2014 Oct-Dec;18(4):e2014.00234. doi: 10.4293/JSLS.2014.00234.
- Background: PubMed 16754092Moorthy, Munz, Dosis, Bello, Darzi. Motion analysis in the training and assessment of minimally invasive surgery. Minim Invasive Ther Allied Technol. 2003 Jul;12(3):137-42. doi: 10.1080/13645700310011233.
- Background: PubMed 27928669Farcas MA, Trudeau MO, Nasr A, Gerstle JT, Carrillo B, Azzie G. Analysis of motion in laparoscopy: the deconstruction of an intra-corporeal suturing task. Surg Endosc. 2017 Aug;31(8):3130-3139. doi: 10.1007/s00464-016-5337-4. Epub 2016 Dec 7.
- Background: PubMed 22483134Gray RJ, Kahol K, Islam G, Smith M, Chapital A, Ferrara J. High-fidelity, low-cost, automated method to assess laparoscopic skills objectively. J Surg Educ. 2012 May-Jun;69(3):335-9. doi: 10.1016/j.jsurg.2011.10.014.
- Background: PubMed 31980955Ganni S, Botden SMBI, Chmarra M, Li M, Goossens RHM, Jakimowicz JJ. Validation of Motion Tracking Software for Evaluation of Surgical Performance in Laparoscopic Cholecystectomy. J Med Syst. 2020 Jan 24;44(3):56. doi: 10.1007/s10916-020-1525-9.
- Background: PubMed 9826140Gallagher AG, McClure N, McGuigan J, Ritchie K, Sheehy NP. An ergonomic analysis of the fulcrum effect in the acquisition of endoscopic skills. Endoscopy. 1998 Sep;30(7):617-20. doi: 10.1055/s-2007-1001366.
- 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.
Sukhbir Singh principal investigator
Ottawa Hospital Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Objective Feedback (Motion Capture) in people with Healthy and Adult ALL, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 2 inclusion and 1 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 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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?
Completion time (time frame: 1 year). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04646304, which also lists 6 linked publications.
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 25 Mar 2025.