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Improving Walker Device Safety Keeps Patients Moving Forward

Innovation is an act of defiance against the status quo. Anthony Pompliano

By Laura Fonda Hochnadel

Aluminum frame walkers have been helping people get around since the late 1940’s. Did you ever wonder if they could do more?

Inspiration comes to us in many forms. For Tim Visos-Ely, his inspiration came from personal experience with his grandmother. Not quite 10 years ago, Grandma Chris had a series of strokes that left her with impaired mobility, and she began using a walker, said Visos-Ely. The family assumed that using a walker would improve her mobility and help prevent falls. However, “nothing really changed. Her mobility continued to decline, and she continued to have issues with walking,” he said, including suffering a fall.

Her continued decline in mobility, independence, and confidence prompted Visos-Ely to question how her walker use might be affecting her health. As a mechanical engineering student at the University of Colorado, Boulder, he had already gained experience working with a medical device manufacturer to redesign a walker, for which a patent was received. He also learned about the process of getting US Food and Drug Administration (FDA) approval for a medical device, which will eventually help in navigating their path toward reimbursement.* In the meantime, Visos-Ely sought another route, one that brought technology and walkers together–walker attachment technology (see inset photo).

“The idea was that I would create an attachment to a walker so I wouldn’t need to go through the same barriers and hurdles” as is required to get FDA approval for a Class I medical device, he said. Visos-Ely put together a team to start a company, StrideTech Medical (Boulder, CO), to develop a device, called StrideTech Go, which integrates sensors and biofeedback onto existing walkers to correct unsafe use in real-time. “If you’re not using the walker correctly, you can actually cause more harm than good and cause falls,” he said. Key challenges that lead to falls with walkers include excessive weight on the walker handles and/or excessive distance between the user and the walker.

The StrideTech Go kit (see page 41) includes the smart unit with rechargeable battery and grip covers embedded with force sensors that attach to the walker handles with Velcro. The force sensors vibrate when excessive weight is placed on the handles while left- and right-hand force measurements can determine asymmetrical gait. An additional sensor, mounted to the frame, measures the distance from the user’s hips to the walker frame. A red LED flashes visibly when these sensors detect excessive distance between the frame of the walker and the user.

Healthcare professionals using StrideTech Go with patients will be able to see improved compliance with correct walker use, explained Visos-Ely. “They will have access to critical data that showcases the progress a patient is making with their mobility.”

He explained: Utilizing an app, healthcare professionals can set up patient profiles in a way that biofeedback warnings are customized to each individual. Feedback thresholds, the point at which the patient is cued to correct their body position or weight bearing, is automatically suggested after having a patient walk with the technology for 30 seconds. The feedback level is then set to the appropriate setting for the individual. As the patient progresses through their rehabilitation, the healthcare professional can adjust these feedback thresholds as progress is made. Several patient profiles can be created on 1 device so each StrideTech Go unit can be used across multiple patients.

For those patients who have the accessory placed on their walker full time, progress reports can be sent from the app and utilized for documentation, assessment, patient training, and family member peace of mind. In the future, it might be possible that data driven analysis of a user could enable the device to become more than a training tool, but also a diagnostic measuring device. “Imagine being able to detect slight variations in weight distribution on the left and right side of a patient’s walker,” said Visos-Ely. “Or the time-of-day usage to note an increase in activity at nighttime. These data could help detect asymmetry and changes in gait over time, which could alert providers to underlying issues such as pain, or the nighttime usage might indicate a urinary tract infection or changes in cognition. Abnormal low activity or long response time to feedback cues can also indicate unsafe mobility or cognitive decline.” These are only a few examples of the potential insights this technology could provide, he said.

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“Three years of R&D has gone into the patented StrideTech Go technology,” said Visos-Ely. “To inform product direction and business strategy, StrideTech Medical (the company he cofounded) has brought on a team of highly experienced advisors and partners.” These advisors shared critical details on how StrideTech Go will be implemented to decrease falls in various healthcare settings.

Included in the R&D Visos-Ely mentioned was quantifying walker use. “Physical therapists will verbally explain how to use your walker,” he said, but that instruction does not include how far away to stand from the walker and how much weight to place on the handles. “A huge part of the last 3 years has been collecting data in order to validate that part of our technology. We’ve worked with Denver University’s biomechanical lab, and we’ve done our own testing,” he said, through volunteer recruitment at free walker repair workshops the company hosted.

The results are promising, as evidenced by several White Papers, which have been published to the company’s website, discussing the short- and long-term efficacy of StrideTech Go. The long-term case study followed the progress of a user, Barbara, over the course of 11 weeks. On a weekly basis, the StrideTech team would meet with Barbara to download the previous week’s data from the device, display walker use data, and get feedback on how well the device was functioning.

Looking at the average of her hip distance comparing Week 1 to Week 11 showed a decrease from 10.2 inches to 7.5 inches, and collected data showed a more than 30% decrease in walker misuse—defined as the daily number of hip distance and force misuses as a percentage of daily activity—from her starting week. The data was also able to establish Barbara’s patterns of daily activity.

The next steps, according to Visos-Ely, include producing 100 units to validate the manufacturing process of StrideTech Go, completing partnerships to further test with multiple users, and raising funds to facilitate and further the mission of preventing falls.

To learn more about this product, visit stridetechmedical.com.

Laura Fonda Hochnadel is Associate Editor at Lower Extremity Review.

*The new CPT code 98975 covers: remote therapeutic monitoring (eg, respiratory system status, musculoskeletal system status, therapy adherence, therapy response), initial set-up, and patient education on use of equipment.

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