ProtoKinetics: Improving Clinical Trial Results with Digital Gait Analysis
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ProtoKinetics: Improving Clinical Trial Results with Digital Gait Analysis

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Michael Rowling, COO & Director of Business Development, ProtoKineticsMichael Rowling, COO & Director of Business Development It is no secret that the digital transformation that businesses have undergone over the past decade has empowered consumers. The transformation—still ongoing—has driven most, if not all, companies to adopt consumer-centric strategies in their go-to-market approaches. Consumer service and satisfaction has never been more critical. This is especially true of the healthcare sector, where patient care is paramount. And what often lead to better patient healthcare outcomes are data and data-driven insights that improve clinical trial endpoints, resulting in the development of new devices, drugs, therapies, and other techniques. A patient-oriented system based on robust data sets and data sharing among various key actors in the industry can lead to improved healthcare delivery.

The pharmaceutical industry has already initiated the adoption of various digital data collection technologies to advance medical research initiatives and improve clinical trial results. “The convenient and relatively inexpensive deployment of tablets, smartphones and wearables for remote or virtual trials is gaining tremendous traction in the field of healthcare information technology, however, these devices require contextualization,” says Michael Rowling, COO and director of business development, ProtoKinetics. As a leading developer of gait analysis and assessment systems, ProtoKinetics has delivered clinicians and researchers a number of innovative solutions for their studies. Those solutions cover a wide range of services, from the development of protocols to analytical reports that describe patients’ functional performance results with granular detail.

Zeno: Providing Enhanced Measurement and Analytical Capabilities

Since its start in April 2012, ProtoKinetics’ core product, the Zeno Walkway System, has provided data and meaningful insights for clinicians and researchers to better understand gait function during clinical interventions at major hospitals and key research institutions. The Zeno Walkway can be deployed in minutes on any flat, hard surface. ProtoKinetics has put maximum effort into creating an optimal user experience. Once the system is set up, testing and other data collection procedures can be conducted in a few clicks, which is almost as easy as using a stopwatch.

The walkway houses a highly accurate, scientifically-validated technology, which constitutes the current gold standard for temporal-spatial gait assessment and validation of new devices. When patients walk or stand on the Zeno mat, their feet activate pressure sensors, providing information about the way they move and transfer their weight from one side to the other. The proprietary software— ProtoKinetics Movement Analysis Software (PKMAS)—calculates and displays valuable, actionable insights based on the technical, objective data captured.

Mission Critical: Improving Patients’ Quality of Life

ProtoKinetics’ offerings can significantly benefit research projects, clinical trials, educational programs, hospitals, sports medicine, and rehabilitation clinics. The company’s mission is to improve patients’ quality of life by providing researchers and clinicians with accurate gait and balance measurement, which can be used to verify and validate interventions to increase and maintain mobility and independence. ProtoKinetics’ solutions have served numerous health systems, universities, government agencies including the Food and Drug Administration (FDA) and the National Institute on Aging (NIA), pharmaceutical companies for 21 CFR Part 11 clinical trials, and medical device manufacturers in both commercial and consumer markets.

Rowling and his team fulfill all kinds of client requirements and provide exactly what they need—from the raw signals of sensors to a fully customized clinical report. “As we enter our eighth year, we have added personnel with several years of research and clinical experience. Not only are we focused on understanding how healthcare is driven and scientific research processes work, but we also stay updated on all the relevant research publications and new commercial products. Thus, we can propose current, valid, and meaningful measurements, but more importantly, it enables us to develop new protocols that will help define the future of healthcare,” explains Rowling.

ProtoKinetics’ core product, the Zeno Walkway System, has provided data and meaningful insights for clinicians and researchers to better understand gait function during clinical interventions



Playing an Integral Role in Clinical Trials

Over the past several years, ProtoKinetics has established a presence in the pharma market by successfully introducing the Zeno Walkway system into clinical trials. The ProtoKinetics team has provided hardware and software for clinical protocols, appropriate standard operating procedures for these protocols, on-site training, data audits, data management services through automatic backups to its HIPAA compliant server as well as advanced analytics services to accurately interpret clinical trial findings.

“While instrumented, quantitative gait measures provide a multitude of data, it is important to have the expertise to sort through these data and to create the appropriate protocols for use in clinical trials. Our team of researchers has that expertise and clinical experience, which enables us to set up the testing protocols and outcome measures to answer the necessary clinical research questions,” states Rowling.

However, increased data also poses additional data management hurdles. PKMAS software overcomes these by efficiently exporting data into digestible formats for data storage and analysis. This flexibility enables ProtoKinetics to be the gait experts during clinical trials or provide the necessary training for sites to function in a self-sufficient manner.

Importantly, the ProtoKinetics solution provides objective measurements that are based on metrics designed and programmed into PKMAS. This objective approach minimizes the risk of producing skewed readings that can be the result of trials using subjective scales to analyze data.

Helping Clients Better Navigate the Path to Patient Wellness

Most of ProtoKinetics’ clients use the Zeno Walkway as their default system to evaluate the functional mobility of their patients. The dynamic software package enables clients to continue building a robust database as they monitor patient progress and develop and assess therapeutic programs throughout a patient’s wellness journey. After decades of studies on gait and balance impairments in pathological populations, many disease driven phenomena are well characterized at the different stages, and are easily compared to the normative values and limits of healthy peers. Researchers, on the other hand, are extremely interested and eager to learn more about the changing biomechanical conditions that may trigger or lead to disease—the main idea being the development of predictive tools and preemptive treatment.

Studies have flagged motor abnormalities as potentially the most sensitive and specific clinical features for predicting future progression to disease. Meanwhile, certain scientific articles have highlighted how this prodromal approach might benefit healthcare. In one longitudinal study, higher step time variability and asymmetry of all gait characteristics were associated with a shorter time to Parkinson’s disease (PD) diagnosis, and the first gait deviations start as early as four years prior to diagnosis.1 In another study, persons with an idiopathic rapid eye movement sleep behavior disorder (iRBD), a clinical feature often observed in people who will develop PD, were evaluated on a Zeno Walkway at normal paced walking while counting backward by 7s from 100.Results demonstrated that healthy controls widened their step width without changing step width variability, whereas iRBD patients did not widen their step width, but rather significantly increased their step width variability.2 The accurate collection of these sensitive measures is imperative as parameters that depend on the spatial relation of both feet—step length and width—are more complex to calculate, and, therefore, there is a paucity of literature on this problem for wearable sensors. 3 In contrast, temporal-spatial gait measures from the Zeno Walkway system have been well established in the literature.

Optimizing Patient-Centered Mobility Performance Requires Validated Devices

“Identifying the subtle changes in gait and balance before the onset of prominent motor or cognitive symptoms requires validated measurements and trustworthy protocols. In light of the increasing use of multiple wearable sensors, non-specialists may find it difficult to identify which device constitutes an appropriate tool for clinical assessments and trials from the one that falls into the gadget category,” says Rowling. According to the FDA, validated measures are necessary because real-world data (RWD) and real-world evidence (RWE) play an increasingly important role in healthcare decision-making. Examples include: monitoring post-marketing safety, supporting clinical trial designs, observational studies to generate innovative treatment approaches, and more.4 Rowling asserts, “facilitating and optimizing patient-centered mobility performance is a win-win for all stakeholders: industry, payers, providers, and patients— thus making validated measures extremely crucial.”

Preliminary results suggest that wearables have the potential to alter the course of drug and device development, and, eventually, they may become part of routine clinical care. However, most algorithms used in today’s inertial measurement units (IMUs) have not yet achieved reliable levels, except in a few select variables. According to a recent panoramic review, “only 6 percent of sensors (including IMU’s and magnetometers) used to assess Parkinson’s disease are precise and efficient enough for clinical testing.”5 The specificity and sensitivity of these algorithms may provide false positives/negatives for different populations characterized by altered gait patterns because they have not been validated during walking or other transitional movements such as turning. Also, from a clinician’s point of view, “protocols designed to assess gait using IMU’s are many and the plethora of quantified outcomes is an obstacle for a comprehensive overview of pathological gaits, which can be highly confusing.”6 ProtoKinetics overcomes these challenges by relying on the industry gold standard to deliver validated and accurate measurements of gait events.

Ground Truth for Temporal-Spatial Measurements

Today, even as healthcare organizations consider “real-world walking” more important than episodic/periodic assessments in the clinic, ProtoKinetics believes both of these environments are necessary to gain insights into patient performance for tracking purposes. “A recent study by Hillel et al. reveals that data captured by wearables during real-world walking looks more like dual-task walking than usual walking.7 But all dual-tasking activities are not equal; walking while talking versus texting on a cell phone while walking can affect gait differently,” mentions Rowling. In a laboratory setting, dual-task gait is standardized using the same activity, such as counting backward by 7s from 100 or reciting animal names, making the gait outcomes directly comparable. In this regard, ProtoKinetics’ Zeno and PKMAS is becoming the reference system for the next decade and beyond to provide consistent, standardized measures that can be relied upon and compared to as new wearable technologies emerge.

“Essentially, ProtoKinetics is the calibration station—the ground truth for temporal-spatial measurements. We are able to collect and accurately analyze aberrant gaits and pathological gaits, whereas wearable technologies can be limited by their AI/machine learning algorithms that are in place at the time of assessments,” remarks Rowling. “As more data from ProtoKinetics is used to optimize wearable sensors’ algorithms, these devices can be deployed more confidently.”

Managing and synthesizing accurate gait and balance data are vital to understanding the effectiveness of interventions that portray patients’ mobility in, and capacity for, daily activities. To this end, ProtoKinetics is focused on continued innovation that delivers unique products and analytical services that empower researchers, clinicians and the pharmaceutical industry to most effectively answer these critical performance-based questions.

- Stacey Smith
    September 16, 2019
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Company
ProtoKinetics

Headquarters
Havertown, PA

Management
Michael Rowling, COO & Director of Business Development

Description
As a leading developer of gait analysis and assessment systems, ProtoKinetics has delivered clinicians and researchers a number of innovative solutions for their studies. Those solutions cover a wide range of services, from the development of protocols to analytical reports that describe functional performance results with granular detail. Since its start in April 2012, ProtoKinetics’ core product, the Zeno Walkway System, has provided data and meaningful insights to help better understand gait function during clinical interventions at major hospitals and key research institutions. The Zeno Walkway can be deployed in minutes on any flat, hard surface

ProtoKinetics