12 Participants Needed

Biofeedback Device for Postural Strain

NK
CS
Overseen ByChristian Sanderfer, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

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

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.12345

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.36789

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.56101112

Who Is on the Research Team?

WS

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

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 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?
1Treatment groups
Experimental Treatment
Group I: ResidentsExperimental Treatment1 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:

๐Ÿ‡บ๐Ÿ‡ธ
Approved in United States as Posture Biofeedback Device for:
  • Prevention of musculoskeletal disorders in surgeons
  • Improvement of surgical ergonomics
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Approved in European Union as Vibrotactile Biofeedback Device for:
  • Reduction of ergonomic risk during surgery
  • Prevention of musculoskeletal disorders in surgeons

Find a Clinic Near You

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

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.
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.
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.
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]

Citations

A Portable Sensory Augmentation Device for Balance Rehabilitation Using Fingertip Skin Stretch Feedback. [2017]
Can a plantar pressure-based tongue-placed electrotactile biofeedback improve postural control under altered vestibular and neck proprioceptive conditions? [2022]
Salient and placebo vibrotactile feedback are equally effective in reducing sway in bilateral vestibular loss patients. [2022]
A novel balance training system using multimodal biofeedback. [2018]
Effects of Vibrotactile Biofeedback Providing Real-Time Pressure Information on Static Balance Ability and Weight Distribution Symmetry Index in Patients with Chronic Stroke. [2022]
Reducing postural load in order picking through a smart workwear system using real-time vibrotactile feedback. [2021]
7.Czech Republicpubmed.ncbi.nlm.nih.gov
Compensation effect of visual biofeedback in upright posture control. [2009]
A smart pressure-sensitive insole that reminds you to walk correctly: an orthotic-less treatment for over pronation. [2020]
Sitting Posture during Prolonged Computer Typing with and without a Wearable Biofeedback Sensor. [2021]
Energetic assessment of trunk postural modifications induced by a wearable audio-biofeedback system. [2013]
Clinical evaluation of a new biofeedback standing balance training device. [2022]
Evaluating the Effects of Kinesthetic Biofeedback Delivered Using Reaction Wheels on Standing Balance. [2019]
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