Riding a Tailwind to Success
by Caelie M. Haines
Republished with permission from University of Maryland, Baltimore
View original story in Proficio, Fall 2009, Issue 18
In lifeand in science especiallythere are sometimes happy accidents, turns in the road you don’t expect but which lead in exciting directions. Such was the case with Jill Whitall, PhD, professor, and Sandra McCombe-Waller, PT, PhD, associate professor, whose research into a bilateral arm rehabilitation device unexpectedly brought them a patented product and a whirlwind of attention.
They never set out to create such a stir when they first started this research in the late 1990s. Their primary concern was the stroke patients coming through their doors, who were traditionally offered rehabilitative options to improve leg function and gait but did not get the same attention paid to their affected upper extremities. Utilizing their past experience with rhythmic cueing devices and motor-learning principles, McCombe-Waller and Whitall came up with the idea for the BATRAC (Bilateral Arm Training with Rhythmic Auditory Cueing) device. They worked with a physical therapy student, David Grant, to build their first prototype. This first device was made of wood, and was used in the initial research study, which investigated the response to six weeks of training in individuals with chronic hemiparesis.
"Our initial intent was never to make a device and sell it," says McCombe-Waller. "Our motivation has been studying the use of the device and how to help people with stroke regain arm function. Initially, it was targeted for lower-functioning people, for whom there really was nothing. They had no options; they didn’t even qualify for studies at that time."
It was a colleague, Dr. Gad Alon, who suggested McCombe-Waller and Whitall might want to patent BATRAC, which had progressed from a wooden device to a Plexiglass one, thanks to a grant from the University of Maryland, Claude D. Pepper Older Americans Independent Center. This change made the device more conducive to magnetic tracking and other assessment measures. Meanwhile, the University of Maryland’s research and development team helped walk the two women through the patent process.
The university was also instrumental in later pairing Whitall and McCombe-Waller with Kris Appel, a student in a program for women entrepreneurs at the University of Maryland Baltimore County, who was looking for technologies to license. "The inventors were inspiring," said Appel of Whitall and McCombe-Waller in an interview in The Daily Record about her company, Encore Path, which was honored as an Innovator of the Year. "After I met them, I thought, ‘Somebody has to do this.’ It was a great innovation, and there is such a tremendous need for stroke rehabilitation that I felt this needed to be out on the market."
With input from McCombe-Waller and Whitall, Appel tweaked the BATRAC device, which she decided to market under the name Tailwind. Tailwind was designed to be the home version of BATRAC. "We specified the new features that are in the Tailwind based on our experience working with the original BATRAC design," says McCombe-Waller. "For example we wanted it to be one-hand adjustable and lightweight, with independently adjustable arms." Now "it’s a little bit more patient-friendly," adds Whitall.
Although the Tailwind device is being marketed to individual patients for home use, it can be used in the clinical practice setting as well. "We want to get physical therapists interested and thinking about this kind of approach," says Whitall. "It does have value, if you think about the concepts," adds McCombe-Waller. "It’s easy to utilize it in the clinic, and it could be cost-effective for them."
Whitall and McCombe-Waller have plenty of good things to say about Tailwind, but they have nothing to do officially with marketing the device. Their focus remains only on researching what BATRAC/Tailwind can do for stroke patients. "What we’re trying to study is who does it work for, when does it work, who should be using it?" explains McCombe-Waller. "The principles behind the device are strong and sound, and that’s what we’re trying to prove through the current and planned studies. We do not believe ‘BATRAC training is the only way.’ Already, one of our studies is combining BATRAC with another approach to see if we can build off the functional benefits achieved with this kind of bilateral arm training."
Brain imaging research has shown that BATRAC is associated with cortical reorganization, reveals Whitall. "Using fMRI, you see how the activation of the brain during paretic elbow movement changes after BATRAC training. There is new activation, mostly in the unaffected hemisphere, after BATRAC, which was not seen after a unilateral training approach, even though both approaches improved function." Full return to arm function is a challenge in these patients, most of whom are months, even years, out from their initial injury. The goals of BATRAC training are to improve bilateral arm function as well as use of the paretic arm. These gains do not, however, include fine motor skills. "The training really targets neural control of the proximal muscles," Whitall explains. "You might get a little benefit from gripping the handles, but it’s not going to do much for finger function or hand function beyond that."
However, for patients who previously had no use of an arm, even being able to straighten it away from their body can make a big difference. "These are the outcomes we’ve been seeing with our patients," says McCombe-Waller. For example, they say, ‘I can put my hand on a table, I can steady a cup, I can put my arm on something to stabilize while I use my good hand.’ It’s important to the patients, because they don’t need assistance, they can do something independently now. They’re taking the all-important step from being dependent on someone else to doing it on their own."
Unfortunately, not all patients have had success with the device. "There are people who really benefit from using this device. However there are people who do not benefit from the device, for example patients who have flaccid arms." admits McCombe-Waller. "In our current research we are testing variations on the training and trying to determine who is likely to respond optimally to this training approach. Our primary interest is in helping patients, and I don’t want patients to think this training will do more than it can. Now that the device is on the market, we want to be clear about how the device should be used and for whom it is recommended. We don’t want consumers to be disappointed. It’s a great product, and the science behind it is sound, but I don’t think we know everything about its capabilities and limitations at this time."
A new grant, funded by NIH, will allow Whitall and McCombe-Waller – along with colleague Dr. Leslie Glickman – to test the Tailwind in a new population: patients who are only weeks post-stroke. This study will be conducted in collaboration with Encore Path and therapists at Good Samaritan Hospital, including alumnus Anneliese Massey. "We are interested in seeing the response in a subacute population." says McCombe-Waller.
For the most part, Whitall and McCombe-Waller’s current research involving BATRAC/Tailwind – funded through NIH and the Claude D. Pepper Center – is less about the device and more about their research questions. "The device is one way of getting answers to questions," says McCombe-Waller. "For instance, what does unilateral versus bilateral therapy do, what happens in the brain, what happens if we start with proximal training verses more whole-arm, distal training? So we use the device, but we’re not testing the device and all its possibilities, we’re testing research questions about movement control post-stroke and trying to get conceptual answers beyond just what this one device will do. "
Neither Whitall nor McCombe-Waller are currently reaping financial benefits from Tailwind device. "That’s really important to us, because we really have an interest in pursuing the research and not compounding our conflict of interest as inventors," McCombe-Waller says. "The university has been working with us on the issue of reducing our conflict of interest. This research is important work to us; for us it is not about selling the devices and making money. It’s about the patients and finding better interventions for them."