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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to aid concussion recovery using wearable sensors that provide real-time feedback during physical therapy. The goal is to determine if this biofeedback (instant sound and visual cues) can enhance balance and movement more effectively than traditional therapy. Participants will receive either standard therapy or therapy with added feedback. Individuals who have experienced a mild concussion, continue to experience symptoms, and can stand unassisted for 10 minutes may be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve recovery methods for future patients.

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 prior data suggests that this biofeedback-based rehabilitation method is safe for concussion patients?

Research shows that using wearable technology for biofeedback in concussion treatment is generally safe. Studies have found that devices like accelerometers and heart monitors can be used safely in many situations. These devices track movements and provide real-time feedback without major safety concerns.

In past studies, using wearable sensors for concussions did not lead to serious side effects. Some risks exist, such as increased symptoms or a small chance of falling, but these are rare. The treatment is well-tolerated when aiding balance and movement during physical therapy.

Overall, wearable sensors for biofeedback have proven safe for people recovering from concussions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new way to enhance recovery from concussions using wearable technology. Unlike traditional vestibular therapy, which relies solely on physical exercises, this approach integrates real-time audio and visual biofeedback. This innovation allows patients to receive instant feedback on their movements, potentially speeding up recovery and improving balance more effectively. By providing immediate corrections during therapy sessions, the biofeedback system aims to make rehabilitation more interactive and adaptive, offering a personalized treatment experience that could lead to better outcomes for those with mild traumatic brain injuries.

What evidence suggests that wearable technology is effective for mTBI?

Research shows that wearable technology providing real-time feedback can aid recovery from mild traumatic brain injuries, such as concussions. In this trial, one group will receive vestibular therapy enhanced with visual and audio real-time biofeedback through wearable technology. Studies suggest that instant visual and audio feedback on movements can enhance the effectiveness of physical therapy exercises, improving balance and walking skills. This method targets crucial body movements needed for a safe return to daily activities. Early findings indicate that wearable sensors can track progress and ensure exercises are performed correctly, potentially leading to better recovery. Although direct evidence remains limited, this approach appears promising due to its immediate feedback during therapy. ^{1 2 6 7 8}

Who Is on the Research Team?

Laurie A King, PhD, DPT

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06381674

Wearable Technology to Characterize and Treat mTBI ... In this study, the investigators will use wearable sensors to both assess and treat people with mTBI. Specifically, the investigators will provide immediate ...

2. health.utah.edu health.utah.edu/news/2023/10/concussion-game-changer-wearable-device-research-redefines-rehabilitation-outcomes

A Concussion Game Changer: Wearable Device Research ... Wearable devices can track your sleep, your heartrate and your exercise. Beyond their basic use, these gadgets can also help patients better rehabilitate after ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8493665/

The Sensor Technology and Rehabilitative Timing (START ... Additionally, using wearable sensors to monitor performance and adherence may improve home exercise outcomes. There is currently limited evidence supporting ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/74/NCT06381674/Prot_SAP_ICF_002.pdf

Wearable Technology to Characterize and Treat mTBI ... We hypothesize that augmenting rehabilitation with wearable sensors to simultaneously measure and provide feedback on head, trunk and balance/gait will improve.

5. formative.jmir.org formative.jmir.org/2025/1/e54630

Feasibility of Data Collection Via Consumer-Grade Wearable ... Results: The study demonstrated high participant adherence to wearing the device. The orthopedic injury cohort exhibited a median adherence rate ...

6. ctv.veeva.com ctv.veeva.com/study/wearable-technology-to-characterize-and-treat-mtbi-subtypes-biofeedback-based-precision-rehabilitat

Wearable Technology to Characterize and Treat mTBI Subtypes In this study, the investigators will use wearable sensors to both assess and treat people with mTBI. Specifically, the investigators will ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12074312/

Potential for Wearable Sensor-Based Field-Deployable ... Studies have shown that wearable commercial off-the-shelf sensors, such as accelerometers, inertial measurement units, and heart monitors, can distinguish ...

8. attheu.utah.edu attheu.utah.edu/facultystaff/wearable-tech-helps-concussion-patients/

Wearable tech helps concussion patients - @theU The results will reveal if real-time biofeedback using wearable sensors improves outcomes after rehabilitation. The research team includes ...