Feature Inventional Thinking These PTs saw needs and literally created solutions. You can, too, they advise. By Danielle Bullen Love | August 2017 Inspiration for new inventions has many sources. Scott Rogoff, PT, DPT, ATC, with St Jude Medical Center in Fullerton, California, was prompted by personal experiences with rehabilitation. "I was a soccer player and had ankle injuries, but no one ever taught me ankle rehab," he says. As a result, Rogoff—now a board-certified clinical specialist in orthopaedic physical therapy and a certified strength and conditioning specialist—kept getting reinjured. "A lot of details and precision are missed when the ankle is being strengthened," Rogoff says. He wondered what could be done to make the process more efficient. Most PTs use elastic bands or isometric machines for lower limb exercises. Those can create an imbalance by strengthening calf muscles at expense of the ankle. As a PT focusing on sports medicine and orthopedics, Rogoff saw the struggles of patients with ankle injuries. They often developed compensatory mechanisms. Traditional exercises did not adequately isolate the ankle. Rogoff knew that a device that worked the muscles on the front side of the ankle—one that was fairly small, and appropriate to use in the clinic or at home—would benefit patients with ankle injuries, since the joint is only as strong as the surrounding muscles. Unlike what had happened to him, patients benefiting from such a device would be less at risk for reinjury. His research revealed that no such product existed. He talked with a patent lawyer to confirm those findings, then partnered with a friend who fabricates metal. That friend made the first prototype of the dynamic ankle rehabilitation trainer (DART), which positions patients to perform isometric ankle strengthening exercises. Rogoff first tested the model on himself, family members, and friends. The prototype worked well, but it was deemed too "clunky." Knowing he needed more feedback, he brought his idea to the chief executive officer of St Jude, who referred him to the Innovation Institute in La Palma, California. Executives there saw value in the device and connected Rogoff to engineers to help improve the concept. Since 2013, there have been 4 iterations of DART, each reflecting a refinement of the previous version. The Innovation Institute provided the resources to have them tested at various health care centers and clinics. Rogoff praises the entity, saying, "They have been the main hub that's carried this thing." While developing each version, Rogoff and the institute's engineers have incorporated user suggestions. For example, DART now includes biofeedback testing so that PTs can determine if the right muscles are working. "The feedback has been overwhelmingly positive," says Rogoff. He's succeeded in creating an ankle rehabilitation device that's easy for patients to use correctly at home. Refining an Existing Tool Bryce Taylor, PT, MSPT, owner of Downtown Physical Therapy and Wellness in Indianapolis, also drew on his sports medicine knowledge to create a better rehabilitation experience. Working with patients who were using stability balls to modernize lumbar stabilization protocols, Taylor wondered if attaching a frame-like device with handlebars to the ball would lessen some of the instability users often experienced. Thus, the idea for the Halo Trainer was born. Taylor started with a racquetball and flexible aluminum wire often used in floral design to make a small-scale but manageable-sized prototype. He then experimented with different angles and arcs of the handlebars. When it came time to scale up to the size of a stability ball, he made a rough prototype of what would become the Halo Trainer, using soft copper filled with sand wrapped around a basketball hoop. He found that if the frame of the device was slightly smaller than the ball's circumference, it would snugly fit around most stability balls on the market. Taylor shared the prototype with local engineers, who helped him refine it. "The first model with copper, foam, and vinyl tape didn't hold up very well," he admits, and its utility was fairly limited. A local manufacturer then created a type of sturdy aluminum alloy that could be tested with patients. Later, Taylor connected with marketers who helped him secure funding to make the molds needed to fashion additional units. The product launched in late 2011 at the Team Concept Conference of APTA's Sports Physical Therapy Section. Taylor sold 22 Halo Trainers at that time, even though he hadn't brought any order forms with him. He was better prepared at a fitness industry show in March 2012, where he sold more than 100. "It was an overwhelmingly positive reaction," Taylor says. He began incorporating the trainer into his own work with patients. Their response was encouraging, and Taylor notes that the device "created new properties for the stability ball," combining core strengthening with strengthening of the shoulders, hips, and knees for more-integrated training. Taylor also developed proprietary educational materials to better enable patients to properly use the Halo Trainer with their stability balls at home. "The education is just as important as the actual tool," he notes. Concerned about a potential conflict of interest were he to sell his product while acting as a PT, Taylor does not offer the device at his clinic. It is licensed for sale via third-party distributors. Encouraging Mobility Other PT inventors were inspired by the desire to make even basic tasks such as walking easier for their patients. At the Henry Ford Health System in Detroit, PTs started an early-rehab program in the medical intensive care unit (MICU). As beneficial as movement can be for patients while they still are on ventilation, sometimes mobility is easier said than done. It can take 4 or 5 clinicians to manage the lines and vents to help a single patient in the MICU walk. PTs at Henry Ford wanted to use a walker designed for high-acuity patients to better accommodate those on ventilation. Some PTs saw such walkers demonstrated at APTA's 2015 Combined Sections Meeting, but none of the walkers met all their needs, so they decided to construct their own. A team of 2 PTs and 2 occupational therapists did the planning. They drew together elements they deemed important and combined their ideas to create what, in their minds, was the ideal walker. "We knew that we needed weight requirements and easy maneuverability," says Romina Bello, PT, DPT, the team's lead PT. She and her colleagues shared their ideas with product designers at the Henry Ford Innovation Institute, who then created a model from PVC pipe. The PTs themselves then tested the prototype. Of course, testing with patients who were on ventilators was paramount. The institute provided funding, and Henry Ford's clinical engineering department built a stronger model out of industrial-grade materials. The health system now is testing the walker, with a goal of having 50 to 100 patients use it during this phase. Patients in the MICU are attached to many different lines. Keeping those lines safe and intact is crucial. The high-acuity-patient walker therefore features flexible tubing—if a patient needs to sit quickly, all of the attached lines can accommodate the movement. "There's no fear that the patient will lose a crucial line during therapy," Bello says. The incorporation of a seat into the walker gives patients an added sense of security, she notes. The main goal of the walker is increased patient walking speed. "The reaction from the other health disciplines has been really good," Bello says. "We have doctors and nurses gathering around to watch patients walk around the unit with the walker's assistance, and cheering for them." A secondary goal is to require only 2 clinicians—a PT and a respiratory therapist—to accompany each patient, which would give PTs additional time to treat other patients. "We haven't had to make a lot of adjustments yet," Bello says. "The walker's been working quite well." Exploring Their Environment Better mobility also was the inspiration for 2 other PTs—albeit with a vastly different patient population in mind. Early mobility is critical to the progress of babies born with developmental impairments such as cerebral palsy. In her clinic at the University of Oklahoma Health Sciences Center in Norman, H. Thubi Kolobe, PT, PhD, had seen such infants become progressively delayed in their mobility. Most 4- and 5-month-old babies explore their environment by crawling, looking around, and reaching for objects. Exploring on the belly is associated with cognitive and social development, Kolobe notes, but because of the physical limitations of their diagnoses, some infants lack the ability to develop those skills. Babies with cerebral palsy and other developmental delays do, however, make spontaneous movements. Kolobe wondered how those spontaneous movements might be harnessed to encourage the valuable skills. "There was nothing out there to help teach these skills to 4-month-olds," she says, "so my mind turned to technology." She envisioned a skateboard-like device that could be propelled by babies' arm and leg movements. Kolobe took her drawings to Peter Pidcoe, who in addition to being an inventor is director of the engineering and biomechanics lab at Virginia Commonwealth University in Richmond. Pidcoe, who had worked as a biomedical engineer before becoming a PT, straddled both worlds in developing the new product. Kolobe and Pidcoe tested multiple versions of what came to be known as the Self-Initiated Progressive Prone Crawler (SIPPC). "Everything about it is data-driven—you build it and you test it," Pidcoe says. "Over the years, all the elements we used were made smaller and lighter and yet more complicated." The device is in its fourth iteration since 2004. It has been tested with 70 babies across 3 studies. The babies remain in the study for 12 weeks. "We want these kids to explore," Pidcoe says. "Anything you can do to facilitate that is a positive." Crawling is an important developmental step. For babies with cerebral palsy, it could be their only form of locomotion for 24 months. Assisting them with earlier mobility allows them to benefit cognitively from exploration. "What makes the SIPPC different is that we capture the dynamism of movement," Kolobe says. The babies wear suits outfitted with sensors to track their head and limb movements as they operate the device. Sensors are wirelessly connected to laptops at which researchers monitor changes in the babies' brains as they learn to use the SIPPC. "We saw that they did improve as they learned to drive it," Kolobe says. That is a key aspect of the invention. Fellow PTs initially expressed concern about using robotics with babies, Kolobe recalls, worrying that the technology would do the work rather than the infants themselves. The device is self-initiated, however, meaning that it responds to the babies' movements, helping them along. Developers later added a sensor that moves the SIPPC when babies shift weight in their trunks. Although the babies are the primary drivers of the crawler, the software can provide facilitated movement. Algorithms determine where the locomotion came from—for instance, from moving the arms or the legs. When computerized assistance is deployed, the babies' exploration areas increase. Kolobe and Pidcoe no longer work together on the SIPPC, with Kolobe having taken ownership of the project. She sees value in releasing the SIPPC for wider use, but she first wants to conduct a clinical trial. A long-term goal is to create an affordable, portable version for clinic or home use that could be controlled by PTs or parents with a tablet. Kolobe encourages other PTs to think beyond current uses of technology in developing their ideas. "Technology is more advanced than we have yet tapped into for patients," she observes. A Fitting Solution Daniel J. Lee, PT, DPT, an assistant professor in the Department of Rehabilitation Sciences at the University of Hartford in Connecticut, believed that technology could benefit his patients with amputated lower limbs. His experiences with patients with new prostheses had exposed some unexpected issues. "The ostensibly simple task of donning a prosthetic limb and achieving a comfortable fit was a stumbling block for many new prosthesis users," Lee says. The process of comfortably fitting the prosthetic leg is difficult for some patients, especially older ones. The series of steps involved—adjusting lanyard straps, inspecting the suspension sleeve, and more—often leaves patients frustrated and depressed, notes Lee, who is a board-certified clinical specialist in geriatric physical therapy. This translates into more time spent fitting and adjusting the prosthesis, and less time spent improving the patients' functional mobility. Lee felt that a new and better approach to patient education was needed. The existing educational materials—booklets and DVDs—did not have the specificity needed to optimally aid the patient. But a mobile app, Lee believed, could offer multitudes of scenarios to guide patients through their specific prosthetic challenges. He created decision trees for common suspension types among individuals with transtibial and transfemoral amputations. Users could answer various prompts, which then would instruct them either to self-correct the problem or to see a prosthetist for additional help. "This process empowers the user to self-manage complicated yet common fit issues without needing outside assistance," Lee says. "Users can avoid secondary complications associated with improper wearing." Lee reached out to the Connecticut Center for Advanced Technology (CCAT). "I wanted the app to be as simple and user-friendly as possible, so that all the user had to do was press a button on the screen to advance," he explains. CCAT helped him refine the concept and create the first prototype of limbWISE. They tested the app among prosthesis users, recording the number of errors made using the app and the time spent completing common scenarios. "The results were nearly unanimously favorable, with acceptability and usability scoring very high," Lee says. He is preparing for the second phase of development, to expand the app's interactivity. Lee plans to make limbWISE free to download. "I want to get this out there without finances being a barrier to its adoption," he says. Of course, funding is key to any invention's development. Lee has set up a GoFundMe page for contributions. He also has developed a potential revenue model for the app, which he isn't yet ready to reveal. "Ultimately, I would like to see the app be in the hands of every prosthesis user on day one," Lee says, "as part of standard care to help ease this arduous process." Developing a Support System Whether an invention is designed for the smartphone or the clinic, teamwork is vital to its development. Collaboration across disciplines and communication among people with different perspectives is important. Inventing a product "takes over your life," Taylor warns. "Be sure you have support around you, because otherwise things can get overwhelming." He was fortunate, he says, in that each person he worked with in his product's development led him to someone else who helped in a different way. "Partner with people who can work with you to develop your idea," Kolobe counsels other PTs. She suggests working with graduate students and professors. Lee echoes that. Among other collaborators, he credits students in the University of Hartford's master's program in prosthetics and orthotics for helping to develop his app as part of a research project. Before the collaborative stage, though, prospective inventors should see if there's anything similar already on the market. If there's not, the next step is to determine whether a need truly exists. "We didn't realize how beneficial our perspective was until we went for it," Bello says. From a practical standpoint, Pidcoe and Taylor advise PTs to protect their ideas as intellectual property by filing for patents if necessary. There are 2 types of patents, they note. A utility patent means that no other product on the market makes the same functional claim. A design patent protects the look of the product. Taylor also recommends creating a nondisclosure agreement to protect proprietary ideas, especially when dealing with resellers. And, of course, retaining legal counsel is highly advisable. Following the Money As all these PTs have discovered, developing and testing an invention requires funding. The Foundation for Physical Therapy recognizes the need to foster innovation by funding new physical therapy inventions. Seed funding is especially important in this field, as there are relatively few research funds specifically available to facilitate new physical therapy-related products. Barbara Malm, MBA and CEO of the Foundation, says, "There are special subpopulations of people who receive physical therapy who could greatly benefit from such inventions." In fact, the SIPPC was partially funded by the Foundation. The Academy of Pediatric Physical Therapy has established a fund with the Foundation to support emerging research. "The SIPPC highlights the importance of being able to acquire seed funds to develop a prototype of a new invention and, subsequently, to be able to capitalize on that success," Malm says. Kolobe, like many PTs in academia, received initial funding from her university. Later, the National Institutes of Health and the National Science Foundation awarded grants to further develop the SIPPC. She encourages PTs to apply for monetary awards to support their inventions. Private partners such as the Innovation Institute also can provide funding for inventors. "Another option," Lee adds, "is a GoFundMe page, which can collect donations for your project." "While the Foundation does not currently offer any research funding opportunities that are designed specifically to help investigators take a new invention to market, any of the Foundation's research funding opportunities, in theory, can be used to do so," Malm notes. She also recommends the New England Pediatric Device Consortium as a source of research grants. The inspiration for a new product can strike at any time. "I think anyone can be an inventor," Rogoff says—the only requirement is a desire to analyze current products and look for ways to improve them. "Let existing practice continue to drive your thinking," Kolobe advises. Danielle Bullen Love, based in the Philadelphia area, has been writing about health care since 2010.