Neck Posturing in Surgeons During Microsurgery Procedures Using Upright Go 2 Device

December 14, 2023 updated by: Royal College of Surgeons, Ireland

Assessment of the Effects of Maladaptive Neck Posturing in Surgeons During Microsurgery Procedures Using Upright Go 2 Device

Consultant and senior registrars performing microsurgery will be invited to participate in this Study. The study will take place at single site (Beaumont Hospital). A questionnaire to collect demographic information (age, height, sex, year of training, prior neck trauma or know neck issues) will be given to the consented surgeons. Additionally, surgery characteristics will be recorded (procedure, surgeon role (i.e lead or assisting), table height, frequency of adjustment of table height, and use of sitting or step stool, headlight, and/or loupes for >50% of the procedure).

A postural training device, Upright Go 2 will be positioned at the spinous process of the cervical vertebrae of each surgeon and used to measure neck positions during microsurgical procedures. The device will be calibrated to an ideal neutral cervical spine position, so that excessive flexion and extension of the neck can be recorded.

The device contains built-in sensors that provide bio-feedback in the form of gentle vibrations if posture has deviated from neutral position.

During the first stage of the study the device will be set to record cervical spine positioning without bio-feedback signals. This will be used to record duration of time surgeons held maladaptation postures.

The second stage will involve real-time feedback through the device. For surgeons who consent, bio-feedback signals will be given once deviated from a neutral posture for >1 minute. Response of surgeons to bio-feedback signals will also be recorded.

The Neck Disability index score will be used to assess for neck pain and the functional implications in relation to reported neck pain. This will be completed following study completion.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Plastic and reconstructive surgeons performing microsurgery
  • Consultants, Registrars, and Senior House Officers with no prior cervical spine surgery or cervical degeneration

Exclusion Criteria:

  • Surgeons not performing microsurgery on a regular basis (at least once a month)
  • Plastic and reconstructive surgery trainees with <1 years experience in microsurgery.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Neck posture monitoring device without feedback option
Real-time feedback through the device. For surgeons who consent, bio-feedback signals will be given once deviated from a neutral posture for >1 minute.
Device: Real-time feedback through the device. Bio-feedback signals will be given once deviated from a neutral posture for >1 minute. Response of surgeons to bio-feedback signals will be recorded

During the first stage of the study the device will be set to record cervical spine positioning without bio-feedback signals. This will be used to record duration of time surgeons held maladaptation postures.

The second stage will involve real-time feedback through the device. For surgeons who consent, bio-feedback signals will be given once deviated from a neutral posture for >1 minute. Response of surgeons to bio-feedback signals will also be recorded.

The Neck Disability index score will be used to assess for neck pain and the functional implications in relation to reported neck pain. This will be completed following study completion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Measuring neck positioning using upright go 2 device during microsurgery procedures and adjustments in neck positioning after receiving bio-feedback signals.
Time Frame: 3 months
  1. The Upright go 2 device has sensors that are used to detect neck posture in real-time. This device will be used to measure surgeon's postural maladaptation. This measure will be degree angle of cervical spine flexion (>30 degrees is considered maladaptive)
  2. Neck Disability Index to assess neck pain and condition-specific functional status which will be compared to neck posture data obtained from neck measuring device. Score of 10-28% (i.e., 5-14 points) is considered by the authors to constitute mild disability; 30-48% is moderate; 50-68% is severe; 72% or more is complete.

Measure of change will be baseline (i.e no bio-feeback) and bio-feeback through device. Time between baseline and bio-feedback will depend on when each participant has a microsurgical case.
3 months
Time and rate spent in maladaptive neck positions in surgeons during as measured by the upright go 2 device.
Time Frame: 3 months

1. Feedback from device will be recorded (amount of times feedback is required and whether surgeons react to biofeedback). Again measure in degree angles of cervical flexion and adjustment angle.

This information will indicate the amount of times adjustments are made in neck positioning by the participants and if responses to bio-feeback are continuous and sustained.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Royal College of Surgeons, Ireland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 18, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 10, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 15, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 14, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RCSI sponsorship ref: 23-161

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study aims have been described so that data relevant to the aims of the study is collected by researchers. Data for all questionnaires will be stored in numerical value without context to their significance in the database.

Paper versions of the questionnaires will be used to collect the scores during in-person meeting with one of the project investigators. These paper sheets will be discarded in the hospital confidentiality bins in Beaumont Outpatients after the data is transferred to the database

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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