Postural; StrainNCT06564519
Resident Posture Biofeedback Study
A study testing Posture Biofeedback Device in people with Postural; Strain and Healthy, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
While a majority of surgical ergonomic studies have been evaluating attending surgeons, few have evaluated surgical ergonomics within the surgical resident. Biofeedback devices can be partnered with education and geared towards surgical residents to decrease current and future musculoskeletal disorders, which may in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postural; Strain, Healthy
- What is being tested?
- Posture Biofeedback Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Sep 2024to 2 Nov 2025
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgical residents with surgical experience of at least one year (Postgraduate year 2-5)
- Completing a one-month rotation at the study sites within the general surgery department during the study period
Who cannot join
- Clinically diagnosed inflammatory musculoskeletal disorders per self-report
- History of orthopedic surgery in the last six months per self-report
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: Check Yourself Before You Wreck Yourself: A Wearable Biofeedback Device to Decrease Surgical Resident's Time in a Non-upright Posture and Work-related Musculoskeletal Pain
While a majority of surgical ergonomic studies have been evaluating attending surgeons, few have evaluated surgical ergonomics within the surgical resident. Biofeedback devices can be partnered with education and geared towards surgical residents to decrease current and future musculoskeletal disorders, which may in turn lead to longer and more fulfilling careers.
Read the detailed description
This study aims to use a commercially-available posture training device for surgical residents that sends biofeedback in the form of a gentle vibration if posture has deviated from the upright (neutral) position for a long period of time. For residents performing minimally-invasive procedures with a laparoscopic approach, our overarching hypothesis is that the time spent in a non-upright position will be less after using the posture biofeedback device compared with before. The study hypothesizes that residents will report fewer complaints related to musculoskeletal pain after wearing the posture training device.
Residents completing general surgery rotations will be recruited and wear a biofeedback device for about four weeks while performing laparoscopic procedures. Posture data from the device and survey data in the form of the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) will be collected and analyzed.
- Conditions
- Postural; Strain, Healthy
- Being tested
- Posture Biofeedback Device
- Keywords
- Biofeedback, Surgery, Surgical Resident
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Posture Biofeedback DeviceDevice
Participants will wear a commercially available posture training device for a two-week tracking period and a two-week training period while performing laparoscopic procedures.
| Study group | Role | What they receive |
|---|---|---|
| Residents | Other | This is a single arm study. All Resident participants will use the posture biofeedback device. Receives: Device: Posture Biofeedback Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent in upright vs non-upright position
proportion (percentage) of time (minutes) in the upright position relative to the non-upright position during laparoscopic procedures
Measured: week 1 to week 4]
Secondary outcomes (1)
Change in Self-reported musculoskeletal pain score
Complaints related to musculoskeletal pain assessed using the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) - measures self-reported musculoskeletal discomfort for all body segments. 1 = low (score 1-2) 2 = moderate (score 3-4) 3 = high (score 5-7) 4 = very high (score 8-10 - higher scores meaning more discomfort
Measured: baseline to week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2024
- Study start26 Sep 2024
- Primary completion2 Nov 2025
- Study completion2 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural; StrainStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- William Sherrill, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06564519
- Sponsor's protocol ID
- IRB00115419
- Status last verified
- Nov 2025
- First submitted
- 19 Aug 2024
- Last updated
- 2 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Check Yourself Before You Wreck Yourself: A Wearable Biofeedback Device to Decrease Surgical Resident's Time in a Non-upright Posture and Work-related Musculoskeletal Pain
- ClinicalTrials.gov ID
- NCT06564519
- Acronym / sponsor ID
- IRB00115419
- Conditions
- Postural; Strain, Healthy
- Keywords
- Biofeedback, Surgery, Surgical Resident
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 26 Sep 2024 (actual)
- Primary completion
- 2 Nov 2025 (actual)
- Study completion
- 2 Nov 2025 (actual)
- First posted
- 21 Aug 2024 (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.
While a majority of surgical ergonomic studies have been evaluating attending surgeons, few have evaluated surgical ergonomics within the surgical resident. Biofeedback devices can be partnered with education and geared towards surgical residents to decrease current and future musculoskeletal disorders, which may in turn lead to longer and more fulfilling careers.
Detailed description
This study aims to use a commercially-available posture training device for surgical residents that sends biofeedback in the form of a gentle vibration if posture has deviated from the upright (neutral) position for a long period of time. For residents performing minimally-invasive procedures with a laparoscopic approach, our overarching hypothesis is that the time spent in a non-upright position will be less after using the posture biofeedback device compared with before. The study hypothesizes that residents will report fewer complaints related to musculoskeletal pain after wearing the posture training device.
Residents completing general surgery rotations will be recruited and wear a biofeedback device for about four weeks while performing laparoscopic procedures. Posture data from the device and survey data in the form of the Cornell Musculoskeletal Discomfort Questionnaire (CMDQ) will be collected and analyzed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Residents | Other | Device: Posture Biofeedback DeviceThis is a single arm study. All Resident participants will use the posture biofeedback device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Surgical residents with surgical experience of at least one year (Postgraduate year 2-5)
- Completing a one-month rotation at the study sites within the general surgery department during the study period
Key exclusion criteria (2 listed)
- Clinically diagnosed inflammatory musculoskeletal disorders per self-report
- History of orthopedic surgery in the last six months per self-report
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 |
|---|---|---|
| Posture Biofeedback DeviceParticipants will wear a commercially available posture training device for a two-week tracking period and a two-week training period while performing laparoscopic procedures. | Device | Residents |
Primary outcome
Time spent in upright vs non-upright position
Time frame: week 1 to week 4]
proportion (percentage) of time (minutes) in the upright position relative to the non-upright position during laparoscopic procedures
1 secondary outcome
Change in Self-reported musculoskeletal pain score
Time frame: baseline to week 4
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 2 Jul 2026.
- Individual participant dataSharing planned: No
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.
William Sherrill, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Posture Biofeedback Device in people with Postural; Strain and Healthy, run by Wake Forest University Health Sciences at 1 site in United States.
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 2 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 2 Jul 2026. 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 United States. 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?
Time spent in upright vs non-upright position (time frame: week 1 to week 4]). 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 2 Jul 2026; AzTrials last refreshed its copy on 28 Oct 2026.