Biofeedback-Based Rehabilitation for Concussions

(SuBTyPE Trial)

Recruiting at 2 trial locations

Overseen By Laurie A King, PhD, PT, MCR

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Oregon Health and Science University

Disqualifiers: Stroke, Severe brain injury, Pregnancy, others

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

Compensation: Varies

Number of Visits: 12

Duration: 6 weeks

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Current clinical assessment tools are often not sensitive enough to detect and treat some subtle (yet troubling) problems after mTBI. In this study, the investigators will use wearable sensors to both assess and treat people with mTBI. Specifically, the investigators will provide immediate feedback, with visual and/or auditory, on movement quality during physical therapy. This immediate feedback on performance may improve outcomes as the investigators will measure multiple body segments including head movements simultaneously with balance and walking exercises. Such complex movements are needed for safe return to high level activity and military duty. The investigators will test this approach against a standard vestibular rehabilitation program. There are few potential risks to this study such as increasing symptoms and a small fall risk. Benefits include physical therapy for balance problems regardless of therapy with or without biofeedback. An indirect benefit is to have data on correct dosage of physical therapy. The investigators will also distinguish which concussion subtype profiles benefit most from physical therapy. This will help healthcare providers and patients by providing more information to help establish clinical guidelines and new tools for physical therapy.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Wearable Technology, Wearable Sensors, Biofeedback-Based Precision Rehabilitation, Wearable Technology for mTBI?

Research shows that using wearable sensors and biofeedback can help improve balance in people with mild traumatic brain injuries (mTBI). A study found that adding audio biofeedback to traditional rehabilitation improved motor activation and reduced time delays in balance control, suggesting that these technologies can enhance recovery outcomes. ^{1 2 3 4 5}

Is biofeedback-based rehabilitation using wearable technology safe for humans?

Wearable technology, including biofeedback systems, has been used in various rehabilitation settings and is generally considered safe for humans. These devices are designed to monitor and provide feedback on physical activities, and while they are not specifically tested for concussions, they have been used safely in other conditions like stroke rehabilitation. ^{2 3 5 6 7}

How is the biofeedback-based rehabilitation treatment for concussions different from other treatments?

This treatment uses wearable technology to provide real-time biofeedback, helping patients improve their motor function by giving them immediate information about their movements. Unlike traditional therapies, it focuses on task-oriented training and uses advanced sensors to enhance rehabilitation through personalized feedback. ^{1 8 9 10 11}

Research Team

Laurie A King, PhD, DPT

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

This trial is for individuals with mild Traumatic Brain Injury (mTBI), including balance disorders and concussions. Participants should be seeking treatment for these conditions and are willing to undergo physical therapy with wearable technology that provides real-time feedback.

Inclusion Criteria

I can stand by myself for at least 10 minutes.

Participants may be either civilians, active duty military, or Veterans

Participants must have at least some measurable deficit in Vestibular/Ocular categories based on Concussion Profile Screen

Exclusion Criteria

I don't have joint pain or injuries that stop me from walking or moving around.

Participants must not meet criteria for moderate to severe substance-use disorder within the past month, as defined by DSM-V

Participants must not display behavior that would significantly interfere with validity of data collection or safety during study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive vestibular physical therapy with or without real-time biofeedback for 6 weeks

6 weeks

12 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Daily Life Mobility Monitoring

Participants' daily life mobility is monitored using wearable sensors over 7 days

1 week

Treatment Details

Interventions

• Wearable Technology

Trial Overview The study compares standard vestibular therapy for mTBI against the same therapy augmented with audiovisual biofeedback provided by wearable sensors. The goal is to see if immediate feedback during exercises can improve recovery of movement quality, balance, and walking.

Participant Groups

Group I: Vestibular Therapy Augmented with Audio and Visual Real-Time Biofeedback Experimental Treatment 1 Intervention

This arm will receive 12 sessions over 6-weeks of vestibular therapy for mTBI (concussion) based on clinical practice guidelines augmented with visual and audio real-time biofeedback.

Group II: Vestibular Therapy-Standard of Care Active Control 1 Intervention

This arm will receive 12 sessions of vestibular physical therapy over 6-weeks based on clinical practice guidelines for mTBI (concussion).

Who Is Running the Clinical Trial?

Oregon Health and Science University

Lead Sponsor

Trials

1,024

Recruited

7,420,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Findings from Research

Innovative technologies using biofeedback for sensorimotor retraining show promise in the rehabilitation of patients who have suffered a cerebral stroke, as supported by high-level evidence from various clinical studies and guidelines.

Multisensory training that engages visual, auditory, vestibular, and kinesthetic systems enhances cognitive-motor training and motivation, suggesting that combining digital technologies with biofeedback and virtual reality can significantly improve rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Innovative technologies and multimodal correction in medical rehabilitation of motor and neuropsychological disturbances due to stroke]. Kostenko, EV., Petrova, LV., Pogonchenkova, IV., et al.[2022]

Mild traumatic brain injuries (mTBIs) are common and can lead to serious long-term effects if not diagnosed promptly, highlighting the need for better diagnostic tools.

Recent advancements in wearable technology and machine learning are paving the way for more accurate and sensitive diagnostic methods for mTBI, which could significantly improve clinical decision-making and patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Review of wearable technologies and machine learning methodologies for systematic detection of mild traumatic brain injuries. Schmid, W., Fan, Y., Chi, T., et al.[2021]

Recent advancements in wearable technology are enhancing the assessment of rehabilitation interventions by providing real-time data on patients' activity levels and exercise compliance outside of clinical settings.

These wearable sensors allow healthcare providers to monitor patients' progress more effectively, facilitating better medication management and evaluation of motor activity performance in daily life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical applications of wearable technology. Bonato, P.[2020]

In a study of 31 participants with chronic mild traumatic brain injury (mTBI), vestibular rehabilitation therapy significantly improved balance, with both groups showing medium effect-sized decreases in symptoms and large increases in balance scores after 6 weeks of treatment.

The group receiving auditory biofeedback (ABF) showed trends towards better outcomes in motor activation and reduced time delay compared to the group without ABF, suggesting that incorporating ABF may enhance rehabilitation effectiveness for balance control in mTBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of augmenting traditional rehabilitation with audio biofeedback in people with persistent imbalance following mild traumatic brain injury. Campbell, KR., Peterka, RJ., Fino, PC., et al.[2022]

The phybrata sensor, used in a study of 175 patients over 12 months, effectively distinguishes between individuals with concussions and those without, showing over 90% accuracy in diagnosing neurological and vestibular impairments associated with concussions.

This technology not only aids in the objective diagnosis of concussions but also helps track recovery and tailor rehabilitation strategies, making it a valuable tool alongside traditional assessment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physiological Vibration Acceleration (Phybrata) Sensor Assessment of Multi-System Physiological Impairments and Sensory Reweighting Following Concussion. Ralston, JD., Raina, A., Benson, BW., et al.[2022]

A review of 8567 publications identified nine studies that provided original data on technologies for diagnosing and managing sports-related concussions, focusing on quantitative EEG (qEEG) and functional MRI (fMRI).

While qEEG and fMRI show potential as tools for concussion diagnosis and management, their effectiveness and clinical utility are not yet fully established, indicating a need for further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What evidence exists for new strategies or technologies in the diagnosis of sports concussion and assessment of recovery? Kutcher, JS., McCrory, P., Davis, G., et al.[2017]

The SQUID smart shirt, which uses electromyography (EMG) and heart rate monitoring, offers a promising low-cost solution for remote rehabilitation of stroke patients, allowing for home-based therapy with real-time feedback.

Initial testing with a healthy subject demonstrated the system's ability to provide audiovisual and haptic feedback during exercises, indicating its potential for automated monitoring and support in physical therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SQUID: sensorized shirt with smartphone interface for exercise monitoring and home rehabilitation. Farjadian, AB., Sivak, ML., Mavroidis, C.[2017]

Biofeedback has been increasingly integrated into physical therapy over the past 20 years, showing promise in treating various conditions, including stroke.

Modern biofeedback technology provides advanced movement data that can enhance treatment effectiveness and is crucial for justifying reimbursement for physical therapy services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relationship of technology assessment and utilization. Electromyographic feedback instrumentation as a model. Wolf, SL.[2019]

Traditional biofeedback methods focused on static muscle activity have not effectively improved motor function in patients with central nervous system injuries.

Recent advancements in biofeedback technology allow for task-oriented training during dynamic movements, which may enhance motor function recovery and provide a new framework for neuromotor rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent developments in biofeedback for neuromotor rehabilitation. Huang, H., Wolf, SL., He, J.[2022]

Neurofeedback (NFB) shows promise as a complementary therapy for motor rehabilitation in chronic stroke patients, potentially enhancing traditional rehabilitation methods by adapting to individual patient needs based on brain imaging and clinical context.

The review emphasizes the importance of integrating engineering advancements with medical expertise to improve NFB technologies, aiming to better understand brain recovery mechanisms and promote cerebral plasticity after stroke.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toward an Adapted Neurofeedback for Post-stroke Motor Rehabilitation: State of the Art and Perspectives. Le Franc, S., Herrera Altamira, G., Guillen, M., et al.[2022]

The gesture recognition biofeedback (GRB) device significantly improved fine motor function in 12 participants with brain injuries, reducing their completion time on the nine-hole peg test by an average of 15.5%.

The GRB training was more effective than standard repetitive training without feedback, indicating that real-time visual biofeedback can enhance rehabilitation outcomes for individuals with motor impairments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improving fine motor function after brain injury using gesture recognition biofeedback. Yungher, D., Craelius, W.[2012]

References

1. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Innovative technologies and multimodal correction in medical rehabilitation of motor and neuropsychological disturbances due to stroke]. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Review of wearable technologies and machine learning methodologies for systematic detection of mild traumatic brain injuries. [2021]

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

Clinical applications of wearable technology. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

The effects of augmenting traditional rehabilitation with audio biofeedback in people with persistent imbalance following mild traumatic brain injury. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Physiological Vibration Acceleration (Phybrata) Sensor Assessment of Multi-System Physiological Impairments and Sensory Reweighting Following Concussion. [2022]

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

What evidence exists for new strategies or technologies in the diagnosis of sports concussion and assessment of recovery? [2017]

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

SQUID: sensorized shirt with smartphone interface for exercise monitoring and home rehabilitation. [2017]

8. England pubmed.ncbi.nlm.nih.gov

The relationship of technology assessment and utilization. Electromyographic feedback instrumentation as a model. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Recent developments in biofeedback for neuromotor rehabilitation. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Toward an Adapted Neurofeedback for Post-stroke Motor Rehabilitation: State of the Art and Perspectives. [2022]

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

Improving fine motor function after brain injury using gesture recognition biofeedback. [2012]