In a recent issue of Pharma Tech Outlook, Protokinetics was listed as a one of the Top 10 Enterprise Software Solutions Providers. COO Michael Rowling appeared on the cover of the magazine.
The article discusses Protokinetics’ two offerings, the Zeno Walkway and PKMAS software, its uses in the pharma industry and its benefits for clients. It extensively quotes Rowling on the advancement of his company’s technology, the contextualization of collected gait data, their products’ effective uses in clinical trials to develop predictive tools, the future of wearables in gait measurement, and much more.
“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.
“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 gold standard for temporal-spatial gait assessment
“The [ZENO] 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.
“ProtoKinetics’ offerings can significantly benefit research projects, clinical trials, educational programs, hospitals, sports medicine, and rehabilitation clinics... ProtoKinetics’ solutions have served numerous health systems, universities, and 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’ use in clinical trials and expert analysis
“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.
Validated gait measurements are crucial
“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 postmarketing safety, supporting clinical trial designs, observational studies to generate innovative treatment approaches, and more. 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.”