Biofeedback Device for Postural Strain

Overseen By Christian Sanderfer, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Disqualifiers: Inflammatory musculoskeletal disorders, recent orthopedic surgery

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the Posture Biofeedback Device can help surgical residents reduce postural strain and prevent future musculoskeletal issues. The device is intended to enable residents to enjoy longer, more fulfilling careers without the discomfort of strain. The trial targets surgical residents with at least one year of experience who are completing a one-month rotation in general surgery. Participants should not have any recent orthopedic surgeries or inflammatory musculoskeletal disorders. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance their career longevity and well-being.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this biofeedback device is safe for surgical residents?

Research has shown that posture biofeedback devices are safe for use. These devices emit gentle vibrations to help correct posture, reducing the risk of strain for surgeons. They assist users in maintaining better posture without causing harm.

The device improves posture and strengthens core muscles. Studies have not reported any major negative effects. The device's feedback is gentle, ensuring user comfort.

Overall, evidence suggests that posture biofeedback devices are safe and effective for improving posture and reducing strain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the posture biofeedback device because it offers a unique approach to addressing postural strain. Unlike traditional treatments such as physical therapy exercises or ergonomic adjustments, this device provides real-time feedback to the user, helping them correct their posture instantly. This immediate feedback loop encourages users to develop better posture habits more effectively. Additionally, the device's non-invasive nature makes it a convenient option for daily use, potentially leading to quicker and more sustainable improvements in posture.

What evidence suggests that this biofeedback device is effective for reducing postural strain?

Research has shown that posture biofeedback devices can effectively improve posture. One study found that a device using gentle vibrations reduced the time people spent in poor posture by 30%. These devices monitor posture and provide a gentle reminder, such as a vibration, to help correct it. This feedback can prevent muscle and joint problems, especially for those who sit or stand in the same position for long periods, like surgical residents. Overall, early findings suggest these devices can significantly reduce postural strain and improve long-term health. In this trial, all participants will use the posture biofeedback device to assess its effectiveness in reducing postural strain among residents. ^{1 3 4 6 7}

Who Is on the Research Team?

William Sherrill, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

This trial is for surgical residents who are in good health but may experience postural strain. The goal is to see if using a posture biofeedback device can reduce musculoskeletal disorders.

Inclusion Criteria

I am a surgical resident with at least one year of experience.

Completing a one-month rotation at the study sites within the general surgery department during the study period

Exclusion Criteria

I have had orthopedic surgery within the last six months.

I have been told I have an inflammatory joint or muscle condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Residents wear a biofeedback device for posture training during laparoscopic procedures

4 weeks

Continuous monitoring during procedures

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Posture Biofeedback Device

Trial Overview The study tests whether a posture biofeedback device, along with education, helps surgical residents improve their posture and potentially prevent future musculoskeletal issues.

How Is the Trial Designed?

Group I: Residents Experimental Treatment 1 Intervention

This is a single arm study. All Resident participants will use the posture biofeedback device.

Posture Biofeedback Device is already approved in United States, European Union for the following indications:

Approved in United States as Posture Biofeedback Device for:

• Prevention of musculoskeletal disorders in surgeons
• Improvement of surgical ergonomics

Approved in European Union as Vibrotactile Biofeedback Device for:

• Reduction of ergonomic risk during surgery
• Prevention of musculoskeletal disorders in surgeons

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

Published Research Related to This Trial

In a study involving 10 patients with severe bilateral vestibular loss, vibrotactile biofeedback improved body sway in 4 patients, particularly when the tilt sensor was placed on the head, indicating potential efficacy in enhancing balance.

However, the improvements were not solely due to the biofeedback; factors like training, increased self-confidence, and alertness also contributed, suggesting that the biofeedback system's effectiveness may vary among individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Salient and placebo vibrotactile feedback are equally effective in reducing sway in bilateral vestibular loss patients. Janssen, M., Stokroos, R., Aarts, J., et al.[2022]

A study involving 21 healthy young adults showed that using a wearable biofeedback sensor significantly improved sitting posture during a 1-hour typing task, reducing neck flexion, thoracic kyphosis, and pelvic tilt.

The results suggest that wearable biofeedback devices can effectively help computer users maintain an upright posture, potentially reducing the risk of spinal pain associated with prolonged sitting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sitting Posture during Prolonged Computer Typing with and without a Wearable Biofeedback Sensor. Kuo, YL., Huang, KY., Kao, CY., et al.[2021]

Visual biofeedback can effectively help stabilize upright posture when a person's body weight is artificially increased, but it has little effect on stability when standing on a soft surface.

The effectiveness of visual biofeedback in improving posture relies on the proper functioning of the body's postural control system, indicating that it may not be a one-size-fits-all solution for balance issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Compensation effect of visual biofeedback in upright posture control. Hlavacka, F., Saling, M.[2009]

The study involved 14 young healthy adults and examined how a tongue-placed electrotactile biofeedback system affected their postural control while standing under different head postures and sensory conditions.

Results indicated that the biofeedback significantly helped participants maintain stability in an extended head posture, counteracting the destabilizing effects of altered vestibular and neck proprioceptive inputs, suggesting its potential for improving balance in challenging conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can a plantar pressure-based tongue-placed electrotactile biofeedback improve postural control under altered vestibular and neck proprioceptive conditions? Vuillerme, N., Chenu, O., Pinsault, N., et al.[2022]

The study evaluated a low-cost multimodal biofeedback system that combines visual and haptic feedback to improve balance in healthy young participants, showing significant reductions in body sway during balance tasks.

Results indicated that the combination of visual and haptic feedback was most effective in minimizing body sway, suggesting that this system could be a valuable tool for therapists working with patients who have balance issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel balance training system using multimodal biofeedback. Afzal, MR., Oh, MK., Choi, HY., et al.[2018]

A smart insole equipped with a force sensor effectively detects over pronation in real time and provides vibrotactile feedback to help users correct their posture using their own muscles.

Over a two-week evaluation period, this method reduced over pronation by 30% to 50% in the first week, demonstrating its efficacy compared to traditional passive orthotics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A smart pressure-sensitive insole that reminds you to walk correctly: an orthotic-less treatment for over pronation. Berengueres, J., Fritschi, M., McClanahan, R.[2020]

A new biofeedback training device using pressure sensors significantly improved static balance ability and weight distribution symmetry in 24 patients with chronic stroke, compared to traditional methods.

The study found that vibrotactile biofeedback was more effective than visual biofeedback and standing without feedback, suggesting it could be a better intervention for preventing falls in stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Vibrotactile Biofeedback Providing Real-Time Pressure Information on Static Balance Ability and Weight Distribution Symmetry Index in Patients with Chronic Stroke. Kim, H., Kim, H., Shin, WS.[2022]

The wearable biofeedback device effectively helped nine healthy subjects reduce trunk sway during quiet stance by providing real-time feedback on their trunk movements, indicating its potential for improving postural control.

Subjects demonstrated a significant reduction in rotational kinetic energy when using the device, especially under conditions of sensory limitation, suggesting that the device can enhance balance and stability in challenging environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Energetic assessment of trunk postural modifications induced by a wearable audio-biofeedback system. Giansanti, D., Dozza, M., Chiari, L., et al.[2013]

A portable sensory augmentation device (SAD) using skin stretch feedback was developed to help improve balance in individuals with sensory deficits, showing promise for rehabilitation.

In a study with 15 healthy young adults, the SAD significantly aided in correcting posture and balance, particularly under conditions of increased sensory deficits, indicating its potential effectiveness in balance rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Portable Sensory Augmentation Device for Balance Rehabilitation Using Fingertip Skin Stretch Feedback. Pan, YT., Yoon, HU., Hur, P.[2017]

In a study involving 15 workers in an industrial setting, real-time vibrotactile feedback significantly reduced harmful postures during order-picking tasks, indicating its effectiveness in promoting better work techniques.

Workers found the vibrotactile feedback system to be usable and comfortable, suggesting it could be a supportive tool for short-term training to improve posture and reduce injury risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reducing postural load in order picking through a smart workwear system using real-time vibrotactile feedback. Lind, CM., Yang, L., Abtahi, F., et al.[2021]

A new biofeedback training device was developed to improve standing balance in patients with neurological damage, specifically targeting postural steadiness before advancing to walking and self-care training.

In a clinical evaluation involving 60 patients with hemiplegia from acute stroke over four weeks, the device effectively enhanced static standing steadiness through weight-bearing biofeedback and visual correction, making it suitable for both clinical and home use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a new biofeedback standing balance training device. Lee, MY., Wong, MK., Tang, FT.[2022]

A wearable system that provides light touch-based balance biofeedback significantly improves balance control in healthy young individuals, reducing trunk tilt and acceleration during balance tasks.

The study involved 7 participants and demonstrated that the device's effectiveness varies based on the type of stance and surface, suggesting potential for broader applications in virtual reality and rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Effects of Kinesthetic Biofeedback Delivered Using Reaction Wheels on Standing Balance. Afzal, MR., Eizad, A., Palo Peña, CE., et al.[2019]

Citations

1. store.uprightpose.com store.uprightpose.com/products/upright-go2?srsltid=AfmBOopYPVdNCh2uN9T4zcNeNYmfhGaOk-98YyJ210DrLCeZNFPsJDET

UPRIGHT GO 2™ – Upright Technologies Ltd GO 2 includes two built in sensors with gyroscope for more precise training and accuracy. Use while sitting, walking and physical activity.

2. amazon.com amazon.com/Upright-GO-Corrector-Strapless-Confidence/dp/B07SRW2D38

Upright GO 2 Premium | Posture Corrector Trainer & ... Actively tracks your posture and sends a gentle vibration when you slouch reminding you to correct your posture.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10064280/

Association of Vibrotactile Biofeedback With Reduced ... The vibrotactile biofeedback device was also associated with reduced time spent in an at-risk posture as measured on the posture monitor by 30% ...

4. withpower.com withpower.com/trial/phase-healthy-subjects-hs-8-2024-e8342

Biofeedback Device for Postural Strain This trial is for surgical residents who are in good health but may experience postural strain. The goal is to see if using a posture biofeedback device can ...

5. jamanetwork.com jamanetwork.com/journals/jamaotolaryngology/fullarticle/2802786

Association of Vibrotactile Biofeedback With Reduced ... The vibrotactile biofeedback device was also associated with reduced time spent in an at-risk posture as measured on the posture monitor by 30% ...

6. store.uprightpose.com store.uprightpose.com/products/upright-go2?srsltid=ARcRdnojAADTKdbl3cBwlN1KQv1yjuWTJ40GinrcrAVgUhOQ1bHiXhYZ

UPRIGHT GO 2™ – Upright Technologies Ltd The UPRIGHT GO 2 is a smart wearable posture trainer with built-in sensors, 9 feedback plans, and 30-day auto app syncing. It uses gentle vibration to correct ...

7. wired.com wired.com/gallery/posture-correctors/

The Best Posture Correctors to Straighten You Out Posture correctors can train you to sit taller, stand straighter, and develop the kind of muscle memory that sticks, even after you've taken the device off.