PROTXX phybrata* measurements can potentially allow clinical neurology, orthopedics, and sports medicine providers and allied physical therapy, occupational therapy, and athletic training providers to more effectively monitor and quantify the onset and progression of injury, medical-treatment, and age-related sensory, neurological, musculoskeletal, cardiovascular, and central nervous system performance impairments by:
The PROTXX machine learning engine leverages unique features in phybrata signals to identify, quantify, and monitor the treatment of complex neurophysiological impairments throughout the body.
The Phybrata sensor* attaches with a disposable adhesive for ease of use in any clinical or remote setting.
The Clinic mobile app lets users configure tests and collect data in less than a minute. Results are presented instantly via simple and intuitive reports.
The Clinic PaaS system provides data to monitor progress over time and adjust treatments more frequently for better health outcomes.
Phybrata sensing*, pioneered by PROTXX, delivers an easy-to-use wearable solution to identify and quantify changes to balance and postural stability, and to monitor each patient’s unique response to treatment and rehabilitation.
The PROTXX physiological vibration acceleration (phybrata) sensor* ³ is an unobtrusive, non-invasive, wearable device that attaches behind the user’s ear using a disposable medical adhesive. Phybrata testing requires the patient to simply stand still for 20 seconds with their eyes open and again for 20 seconds with their eyes closed. During testing, the phybrata sensor* detects microscopic involuntary motions of the body, both normal motions characteristic of healthy individuals and pathological motions caused by physiological impairments that impact balance and postural stability.
Unique spatial-domain, time-domain, and frequency-domain features detected in the phybrata signals are used to derive digital biomarkers that identify and quantify the contributions made by different physiological systems in the body to the biomechanical stabilization of the head and eyes as the reference platform used by the body to enable balance and movement. This phenomenon allows impairments to major physiological systems in the body to be classified, quantified, and monitored using their unique vibrational signatures.¹⁻⁵
Phybrata sensing* delivers a powerful new solution that enables much easier to use precision neurophysiological assessments to be carried out in any doctor’s office or via remote patient care.
Conditions such as concussions, stroke, multiple sclerosis, and Parkinson’s disease lead to disruptions that are widespread throughout the brain. Each patient can suffer from a unique combination of impairments to multiple physiological systems throughout the body, and symptoms can fluctuate significantly over time, making diagnoses difficult and treatments challenging.
Current solutions for diagnosing these multiple impairments, and monitoring the effectiveness of treatments and rehabilitation, either:
(i) require multiple time-consuming tests carried out by multiple clinical specialists using expensive lab equipment; or
(ii) they’re limited to subjective observations and reliance on patient self-reporting.
PROTXX Clinic* is used by clinical neurology, rehabilitation medicine, and sports medicine specialists and researchers to monitor and quantify changes in balance and postural stability that can reflect overall physical health, as well as the onset and progression of impairments to the central nervous system (CNS), peripheral nervous system (PNS), sensory systems (visual, vestibular, somatosensory), and musculoskeletal system. These changes can have many different causes, including participation in sports, lifestyle changes, fatigue, injuries, disease, age-related disorders, prescription medications, rehabilitation therapies, and surgical procedures. PROTXX Clinic* enables easy to use, quantitative, and more frequent monitoring of changes to balance and postural stability by benchmarking user performance vs. relevant individual and group performance metrics and target ranges and tracking individual variations over time.
Athletes
monitoring & limiting effects of head impact exposure; stratifying performance, monitoring recovery from fatigue and injury.
Elderly
stratifying balance performance, fall risks, and response to balance therapy; aging in place support.
Physiological performance testing, training
Neurosensory, neuromotor contributions
Individual and group/team target ranges
Recovery from fatigue and injury
PROTXX Health Fairs provide free balance / fall risk assessments, determine neurosensory and neuromotor contributions, and provide recommendations as a service to the community
Residents preemptively assigned to balance and strength classes offered in their fitness center, PROTXX used to set individual and group targets, monitor improvements.
Stroke leads to a wide range of occlusion/hemorrhage-induced lesion locations (brain, cerebral arteries), volumes, topologies, and affected CNS, PNS, sensory, vascular, and musculoskeletal structures and functions.
The phybrata sensor* provides stroke researchers, clinicians, and rehabilitation providers with a powerful new tool that can help to
identify and quantify occlusion/hemorrhage-induced physiological impairments
prepare personalized plans to manage, treat, and rehabilitate stroke patients
accelerate return to functional independence
reduce the incidence, severity, and duration of longer-term physical disabilities and cognitive impairments.
Concussions lead to a wide range of impact-induced damage locations (brain, vestibular system, visual system, cervical spine), volumes, topologies, and affected CNS, PNS, sensory, vascular, and musculoskeletal structures and functions.
The phybrata sensor* provides concussion researchers, clinicians, and rehabilitation providers with a powerful new tool that can help to
identify and quantify impact-induced physiological impairments
prepare personalized plans to manage, treat, and rehabilitate concussion patients
accelerate return to functional independence
reduce the incidence, severity, and duration of longer-term physical disabilities and cognitive impairments.
Multiple sclerosis (MS) is an auto-immune disease that causes demyelination of neurons in the brain and nerves in the spinal cord. MS currently has no cure and leads to debilitating impairments to multiple physiological systems throughout the body. Patients have highly individual impairment profiles, and their symptoms can fluctuate significantly. Available disease modifying therapies are expensive, have severe side effects, and patients have widely varying responses.
The phybrata sensor* provides MS researchers, clinicians, and physical therapy providers with a powerful new tool that can help to
Quantify each patient’s unique MS impairment profile.
Continuously monitor each patient’s unique response to pharmaceutical or non-pharmaceutical treatments to enable real-time adjustments.
Slow the progression of longer-term physical disabilities and cognitive impairments.
Parkinson’s Disease (PD) leads to degenerative loss of dopaminergic neurons in the midbrain (substantia nigra) that impairs the function of many other regions of the brain. PD currently has no cure and leads to debilitating impairments to multiple physiological systems throughout the body. Patients have highly individual impairment profiles, and their symptoms can fluctuate significantly. Available disease modifying therapies are expensive, have severe side effects, and patients have widely varying responses.
The phybrata sensor* provides PD researchers, clinicians, and physical therapy providers with a powerful new tool that can help to
Quantify each patient’s unique PD impairment profile.
Continuously monitor each patient’s unique response to pharmaceutical or non-pharmaceutical treatments to enable real-time adjustments.
Slow the progression of longer-term physical disabilities and cognitive impairments.
Clinical studies and pilot deployments with clinical neurology, rehabilitation medicine, and sports medicine customers and R&D partners have demonstrated that digital biomarkers derived from phybrata sensor* data show well-defined normative values over a very wide age range, allowing rapid determination of “healthy” vs. “impaired” status with no previous baseline measurement required. Furthermore, for “impaired” individuals, phybrata biomarkers* allow impairments to specific physiological systems to be identified with sensitivity, specificity, and area-under the curve all above 90%. In the case of concussions, for example, the diagnostic performance of the phybrata sensor* has been shown to match the performance of current gold standard solutions that generate more complex multimodal concussion biomarkers by combining data from multiple time consuming and expensive tests (computerized dynamic posturography, eye tracking, neurocognitive assessments).
PROTXX Clinic* is intended to assess body motion during quiet standing as an indicator of balance/postural stability performance and related physiological impairments. PROTXX Clinic* testing should be administered as directed by a qualified individual such as a certified athletic trainer or coach, physical therapist, nurse, physician, or medical researcher. Interpretation of PROTXX Clinic* results should be made by a healthcare professional as part of a multifaceted assessment of balance/postural stability. Conditions affecting balance/postural stability include fatigue, dehydration, nausea, headache, ear infection, medications, orthopedic injury, head impact injuries, stroke, multiple sclerosis, Parkinson’s disease, and peripheral neuropathies. PROTXX Clinic* may be used together with mobile devices running the iOS operating system. PROTXX Clinic* is not an FDA-cleared device.
Phybrata sensors* & charging case
Intuitive mobile app
Cloud-based data services
The PROTXX Clinic* Platform-as-a-Service (PaaS) solution integrates phybrata sensors* and charging case, mobile app to configure and run tests, and a powerful set of cloud-based signal processing, data analytics, machine learning, and reporting services to enable easy-to-use phybrata testing in any doctor’s office or via remote patient care.
The Clinic platform can replace expensive computerized posturography and balance assessment equipment used to assess neurological, sensory, or musculoskeletal impairments.
The first screen of the report shows the visit notes that were entered prior to the test. The second screen shows the patient identifier, the date of the test and a summary of the test results, which are described further below.
The third screen of the report shows a plot of the patient’s Eyes-Open and Eyes-Closed phybrata power aligned to their age, against the backdrop of a graph of the average power of healthy individuals across a range of ages. This chart allows the patient and their caregiver to see how the results from the current test relate to the average of healthy people the same age.
Three phybrata measures are derived from the raw sensor data:
The Phybrata Power and L/R Asymmetry are present for both the Eyes-Open and Eyes-Closed tests. Each measure is compared to a normative threshold (0.5 for Eyes-Open, 0.6 for Eyes-Closed), above which the patient’s result is flagged for further assessment. For quick identification, results below the threshold appear in green and results above the threshold appear in red.
The Phybrata Power represents the aggregate power (in Watts) of the movement of the body measured at the head. A higher than threshold Phybrata Power indicates a potential neurological impairment that should be investigated further.
The Left/Right Ratio measures any asymmetry present in the patient’s phybrata measurement. An asymmetry of zero indicates that the patient is centered. An asymmetry less than or above zero indicates that the patient leans preferentially to either the left or right side, respectively. Favoring one side beyond the normative threshold (+/- 0.5) indicates a potential orthopedic impairment that should be investigated further.
The Eyes-Closed/Eyes-Open Ratio quantifies vestibular performance. An EC/EO Ratio above the normative threshold (2.0) means the Phybrata Power is much higher with the eyes closed, indicating a potential vestibular impairment that should be investigated further.
Sample of good phybrata data
Sample of bad phybrata data
Phybrata Sensors* and Machine Learning for Enhanced Neurophysiological Diagnosis and Treatment
Investigating the validity of a single tri-axial accelerometer mounted on the head for monitoring the activities of daily living and the timed-up and go test
Physiological Vibration Acceleration (Phybrata)Sensor Assessment of Multi-System Physiological Impairments and Sensory Reweighting Following Concussion
Monitoring of postural sway with a head-mounted wearable device: effects of gender, participant state, and concussion
Hope A, Vashisth U, Parker M, Ralston AB, Roper JM, Ralston JD. Phybrata Sensors and Machine Learning for Enhanced Neurophysiological Diagnosis and Treatment. Sensors 2021: 21: 7417.
Abdollah V, Dief TN, Ralston JD, Ho C, Rouhani H. Investigating the Validity of A Single Tri-axial Accelerometer Mounted on the head for Monitoring the Activities of Daily Living and the Timed-Up and Go Test. Gait & Posture. 2021; 90: 137–140.
Ralston JD, Raina A, Benson BW, Peters RM, Roper JM, Ralston AB. Physiological Vibration Acceleration (Phybrata) Sensor Assessment of Multi-System Physiological Impairments and Sensory Reweighting Following Concussion. Medical Devices: Evidence & Research. 2020; 13: 411–438.
Grafton ST, Ralston AB, Ralston JD. Monitoring of postural sway with a head-mounted wearable device: Effects of gender, participant state, and concussion. Medical Devices: Evidence & Research. 2019; 12: 151-164.
Hauenstein A, Roper JM, Ralston AB, Ralston JD. Signal classification of wearable inertial motion sensor data using a convolutional neural network. Proc IEEE-EMBS 2019 Intnl Conf Biomed & Health Informatics, May 19-22, Chicago, IL
Items marked with* are investigational devices and for research use only. CAUTION - Investigational Device. Limited by Federal (or United States) law to investigational use.
PROTXX Clinic is not an FDA-cleared device.
