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

12 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Posture Biofeedback Device, Vibrotactile Biofeedback Device, Posture Monitor, Upright GO2?

Research shows that biofeedback devices, like those providing vibrotactile feedback, can help improve balance and posture by giving real-time information about body position. For example, studies have found that such devices can reduce body sway in patients with balance issues and improve static balance ability in stroke patients. ^{1 2 3 4 5}

Is the biofeedback device for postural strain safe for humans?

The studies suggest that wearable biofeedback devices, including those providing vibrotactile feedback, are generally safe for humans. Users found these devices comfortable and supportive, with no reported adverse effects during use in various settings. ^{5 6 7 8 9}

How does the Posture Biofeedback Device treatment differ from other treatments for postural strain?

The Posture Biofeedback Device is unique because it uses vibrotactile feedback to help users correct their posture in real-time, unlike traditional methods that may rely on passive support or exercises. This device actively engages the user's own muscles to improve posture, making it a more interactive and potentially effective approach. ^{4 8 10 11 12}

What is the purpose of this trial?

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.

Research Team

William Sherrill, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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

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

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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 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]

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 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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Portable Sensory Augmentation Device for Balance Rehabilitation Using Fingertip Skin Stretch Feedback. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Can a plantar pressure-based tongue-placed electrotactile biofeedback improve postural control under altered vestibular and neck proprioceptive conditions? [2022]

3. England pubmed.ncbi.nlm.nih.gov

Salient and placebo vibrotactile feedback are equally effective in reducing sway in bilateral vestibular loss patients. [2022]

4. England pubmed.ncbi.nlm.nih.gov

A novel balance training system using multimodal biofeedback. [2018]

5. Switzerland 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. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Reducing postural load in order picking through a smart workwear system using real-time vibrotactile feedback. [2021]

7. Czech Republic pubmed.ncbi.nlm.nih.gov

Compensation effect of visual biofeedback in upright posture control. [2009]

8. United States pubmed.ncbi.nlm.nih.gov

A smart pressure-sensitive insole that reminds you to walk correctly: an orthotic-less treatment for over pronation. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Sitting Posture during Prolonged Computer Typing with and without a Wearable Biofeedback Sensor. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Energetic assessment of trunk postural modifications induced by a wearable audio-biofeedback system. [2013]

11. England pubmed.ncbi.nlm.nih.gov

Clinical evaluation of a new biofeedback standing balance training device. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Evaluating the Effects of Kinesthetic Biofeedback Delivered Using Reaction Wheels on Standing Balance. [2019]