By Deborah Conn

    Just as their young patients develop and mature, pediatric orthotists see their profession changing and growing.  
    Factors that influence the field are wide-ranging, from innovative materials to advances in computer-aided design to the chilling effect of Medicaid cuts.
    This month, the O&P Almanac takes a look at some of what’s happening in the field of pediatric orthotics.

Cranial remolding helmets
    For Lisa Schoonmaker, CPO, FAAOP, of Tandem O&P in Sartell, Minnesota, the most dramatic expansion in the field has been the demand for cranial orthotic devices to treat infant plagiocephaly.
    Thanks to the “Back to Sleep” movement, parents are placing their babies on their backs while sleeping in order to prevent Sudden Infant Death Syndrome, or SIDS. The result, said Schoonmaker, is that the number of head deformities has skyrocketed.
    “Unfortunately,” said Schoonmaker, “many parents are afraid to place their babies in any other position, even when they’re awake. If they’re not in a crib, they’re in an infant seat. And while infant carriers that move from car to stroller are convenient, babies are developing these head deformities—and they are not developing any muscle strength.”
    Schoonmaker encourages parents to place their babies on their tummies for play and exploration. “If your baby is awake, he or she needs to be in other positions than on his or her back or sitting in an infant seat,” she said.
    The good news is that cranial remolding helmets are effective. “Our outcomes are very positive,” said Schoonmaker. And helmets are improving. She said, “Helmets are regulated by the FDA, and more manufacturers are getting approved, so there is more competition in the marketplace.”

CAD/CAM
    Orthomerica Products Inc. in Orlando, Fl., for one, has extended its line of cranial remolding orthoses, said Marketing Director William Gustavson, noting that 1 in 60 infants develops plagiocephaly. The company has also enhanced its STARscanner™ laser data acquisition system, which uses a combination of lasers and cameras to measure the infant’s head.
    “This eliminates the casting process, which can be traumatic for children, and it is the fastest, most accurate means of collecting 3-D head shape data that provides superior outcome-measurement tools,” said Gustavson.
The image produced by the scanner is sent to Orthomerica’s fabrication facility, where modifications are made and the helmet is produced.
    Hanger Prosthetics and Orthotics, headquartered in Bethesda, Md., has developed its own system, called Insignia, which uses a hand-held laser scanner and motion-tracking device, for pediatric cranial and spinal orthoses, ankle-foot orthoses, and knee-ankle-foot orthoses.
    Much of the time, the practitioner can use special software to make modifications or, in the case of more complicated devices or FDA-regulated cranial helmets, will provide specifications to Hanger’s central design center in Tempe, Az.  Then Hanger’s central fabrication network or a local fabrication facility will construct the device.
    “We are only scratching the surface of where we can take this technology in the future,” said Kaia Busch, CPO, director of orthotics at Hanger. “There are a significant number of Insignia applications we are beginning to explore that will have a great impact on patient care.”
    The use of computer-aided design and manufacturing for pediatric orthotics is just beginning, said Stephen Fletcher, CPO, of Virginia Prosthetics in Roanoke, Va. “I think it will be much more widespread in a few years,” he predicted.
    “Software is the big change. My company has had a computer system for about 10 years, but we used it only for prosthetics. Now software upgrades are making it possible to use CAD/CAM for orthotics. It’s already happening in two areas: cranial remolding helmets and spinal orthotics.”
    More difficult, according to Tom DiBello, CO, FAAOP, of Dynamic O&P in Houston, is using CAD/CAM for pediatric ankle-foot orthoses. “While some manufacturers say they have good methods for computer-aided design of AFOs, I’ve seen really significant accommodation to the technology that has diminished the effectiveness of fit right now. More work needs to be done in this area,” he said.
    Fletcher agreed. “There are some technical limitations because the change of angles in ankle orthoses. The limits are in fabrication, not in capturing the shape. The hard part is carving the mold with a computer-driven carver.”
Carol Hentges, CO, of Custom Care Orthotics, in Minneapolis, takes the best of both worlds, combining CAD with plaster molds. “Our CAD system has made us 100 percent more efficient,” she said.
    “We can do twice as many spinal orthoses in the same amount of time, even though we are still pulling molds and hand-modifying them. We can take molds of two or three [children] in one day and fit them the same day, with no compromise to the quality of fit.”

Carbon fiber braces
    A significant breakthrough in orthotic materials for children is carbon fiber composite, which combines rigidity with ultra-light weight. When used in lower extremity orthosis designs, it can provide dynamic response and energy return.
    Many suppliers manufacture prefabricated dynamic lower-extremity orthoses, including Ossur North America, Aliso Viejo, Calif. (which introduced the technology in its Flex-foot®); Otto Bock HealthCare, Minneapolis, and Trulife Seattle Systems, Poulsbo, Wash.
    “One purely cosmetic advantage is that kids can choose their own fabric that can be laminated on to the orthosis,” noted Keith M. Smith, CO, LO, of O&P Labs Inc. in St. Louis. “It can be tough for kids to wear a brace at school, and this allows them to make it a little cooler. It makes it easier for them to wear it.”
    Noel Chladek, CO, of Chladek O&P, in Des Moines, became fascinated with the technology over a decade ago. He experimented with various curing methods and then developed designs that would accommodate the material’s forces and transfer them to pediatric patients effectively.
    He tested his Dynamic Response Orthosis (marketed under the name Phatbraces) through 2003 and 2004 and introduced it at the Academy’s 2005 Annual Meeting & Scientific Symposium. Today, he said, “a growing number of facilities are using our designs,” which are produced by his fabrication facility, Biomechanical Composites, based in Des Moines.
    Cascade DAFO, Ferndale, Wash., also produces dynamic orthoses for adults and children. The firm has kindled a certain amount of controversy among orthotists. At issue is Cascade’s willingness to market its orthoses to physical therapists in addition to certified orthotists.
    “Cascade DAFO helped revolutionize orthotic management for kids,” said William Beiswenger, CPO, FAAOP, of Abilities Unlimited, Inc., in Colorado Springs. “But it started marketing to PTs in rural areas who didn’t have orthotists to provide pediatric care. It aggravated a lot of orthotists.”
    Beiswenger does his own in-house fabrication unless physicians specify the Cascade DAFO by name. “But right now, many physicians are requesting it, so I took the course,” he said.
    “The issue is that COs have spent enormous time and energy in the field, with a strong emphasis on education making sure our people fit orthoses properly,” said Keith Smith. “PTs are well trained in their discipline, but their orthotics training might consist of only a two-day course.”
    Smith currently uses the DAFOs in his practice, but emphasizes the need for better attention to who is qualified to fit these pediatric custom molded orthoses.
    Diane Hodgkins, director of marketing for Cascade DAFO, is aware of the controversy. She said that direct sales to physical therapists account for a smaller portion of the company’s business, and stems from Cascade’s origins.
    Twenty-five years ago, Don Buethorn, CPO and founder, developed the Cascade DAFO to help solve a problem for a colleague. Nancy Hylton, PT, CO, LO, needed a more durable material for an orthosis she had designed for therapy sessions.
    The plastic AFO was a success, requests from therapists grew, and eventually the company was split into two: Cascade P&O, which sells locally and nationwide to therapists, and Cascade DAFO, which sells almost exclusively to orthotists. “Business is growing faster on the DAFO side,” said Hodgkins.
    “We are working on a program, the Cascade Care Provider Network, that encourages therapists and orthotists to work together,” said Hodgkins. “We want to leverage our knowledge and relationship with therapists and orthotists to provide better services for patients.”
    The Cascade DAFO Web site states, “If you are a physical therapist or other non-orthotist medical practitioner, please call us for information on providers in your area who can network with you.”
    Gustavson says that the orthotist has always been the customer for Orthomerica’s TC Flex Lower Extremity System. The company is planning workshops to bring therapists and orthotists together to promote the best outcomes for children. Recent marketing efforts have targeted therapists and physicians as a way to educate them about the availability of TC Flex proprioceptive and orthopedic designs through their orthotist.
    “The response has been very favorable,” said Gustavson. “The system has designs that incorporate total contact foot plate modifications and dorsal wraps into a variety of combination AFOs, SMOs, and even KAFOs.”
    Fletcher takes a slightly different perspective of the inroads made by other professions into the pediatric orthotics field. “Many times, a prefab orthosis is what’s called for,” he said. “Now anyone—athletic trainers, PTs, orthopedic surgeons, nurses—can purchase a prefab brace in three sizes, put it in the closet, and just grab it and put it on a patient.
    “This has really changed things. Many orthotists see pre-made devices as bad for business, but it’s not a bad thing. All the easy ones can be done by someone else, and orthotists will get the difficult, custom cases.”

Other Developments
    Another growing area is the use of botulinum toxin for spasticity. “Botulinum injections relax spastic or hypertonic muscles, which gives us a three- to six-month window to try to dynamically stretch them,” explained Smith.
    “It has been a revolution in our field. We can use orthoses that allow for more function and an increased range of motion like the Ultraflex system.” Manufactured by Ultraflex Systems Inc., Pottstown, Pa., the Ultraflex device “takes advantage of this window of time by giving a force in the direction opposite the push,” explained Smith. “For instance, a plantarflexed ankle would be treated with a dorsiflexion force.”
    Another development is the stance-control knee-ankle-foot orthosis. “In the past,” said Smith, “these devices were always locked at the knees. Now they only lock when the foot is on the ground. During the swing phase, the foot can clear the ground without brushing it.”
    Smith has pioneered the use of stance-control KAFOs with reciprocating gait orthoses, and he just made a presentation on the stance-control RGO at the Academy’s 2006 Annual Meeting & Scientific Symposium.
    “We provided gait analysis results showing a dramatic improvement to walking speed and kinematics,” Smith said. “By leaning [to the posterior], the patient can advance one leg forward with flexion while the other extends. By combining this new technology with an RGO, it opens up a whole new ease of walking with an RGO.”
    A number of manufacturers produce stance-control KAFOs, including Otto Bock, Minneapolis; Fillauer Inc., Chattanooga, Tenn.; Horton’s Technology Inc., Little Rock, Ark.; and Becker Orthopedic, Troy, Mich. Smith uses a Fillauer IRGO with a Horton’s stance-control KAFO.
    David Hensley, CPO, educational manager at Trulife Seattle Systems, points to the development of a knee hinge that can be used efficiently with small children. “We can make a full-blown custom knee orthosis from a cast, digital flash scan, or digitized shape files,” he said. “The result is a completely custom, functional knee orthosis for pediatric sizes.”

Paying for it
    One of the most troubling trends for many orthotists and manufacturers is the reduction in Medicaid funding.
    The demands on the program are certainly growing: economists and actuaries from the National Health Statistics Group at the Centers for Medicare and Medicaid Services predict that Medicaid spending will grow from $293 billion in 2004 to $670 billion in 2015 (Health Affairs, vol. 25, no. 2).
    Orthomerica’s Gustavson said, “Since the pediatric population is served by Medicaid programs, we have to be cognizant of demands in the marketplace, of pressure to reduce reimbursement levels on Capitol Hill.”
    For example, in many states Medicaid does not cover cranial remolding orthoses. “The California Orthotics & Prosthetics Association was successful in getting coverage for CROs,” said Gustavson. “We helped with that effort, and Orthomerica is working diligently to get coverage for these medically necessary devices in other states.”
    John Wall, PT, CPO, FAAOP, of Wall Prosthetics & Orthotics, in Salem, Massachusetts, said, “My biggest issue is cuts in Medicaid. I am a pediatric specialist, and I see a lot of very involved children who, because of Medicaid cuts in Massachusetts, are limited to one pair of AFOs or one body jacket per year.”
    “Because children outgrow these devices so quickly,” said Wall, “this limits our ability to provide the kind of care we want.”
    In Missouri, said Smith, “a bill was passed that eliminated Medicaid coverage for orthotics. There is no coverage after age 20 for orthoses. While these cuts don’t affect children yet, the Medicaid budget is definitely something to watch with a fearful eye.”
    DiBello feels deeply about this subject, both as a practitioner and as a citizen. “As a political conservative, I am deeply troubled that the wealthiest country in world is turning its back on its most needy constituents,” he said.
    “Children…exist in certain socioeconomic conditions through no fault of their own. The reality is that a fraction of the number of dollars we currently designate to assist large corporations through a variety of tax advantages could be used to support and sustain the needs of indigent children throughout the United States.”

Proving it
    As funding gets tighter, it will be incumbent on practitioners to provide evidence of their success.
    “Payers want to know why you’re doing what you’re doing and what the outcome will be,” said Fletcher. “If we can’t show a positive outcome, it will be more difficult to get reimbursement for services.
    “Orthotists will have to have an evidence-based practice—clinical, scientifically based evidence that a device works and the outcome is measurable. It may be a difficult transition, but there may be a silver lining in that when we can consistently show outcomes and the evidence to back up what we are doing, we will have an easier time getting reimbursement.”
    This type of accountability, according to Chladek, is particularly vital in the pediatric arena. “The tools are lacking in evaluating whether AFOs are actually doing their job for that pediatric pathology,” he said.
    “With adults, you can try something else if a device doesn’t work. But with children, they are developing and we could lose that window of opportunity. The wrong brace could have a lifelong effect.”
Chladek believes manufacturers have a responsibility to help raise the level of orthotic care by tying performance to certification in a particular system.
    “I propose that after providers take a class to learn how an orthosis works, they set functional goals for five patients and evaluate whether the goals are met at the fitting or follow-up, and send that information back to the company. This is how I certify practitioners to use my orthoses.”
    “That way I know they have shown their ability to be successful with the orthosis. If other manufacturers required that level of skill in using their products, it would help raise the standard of care we provide in the field.”

What’s next
    Looking ahead, one might predict a continuing flow of new materials and refinements in devices. But for DiBello, what is more important in pediatric orthotics is the growth of research.
    “More than any specific device or component, what’s most exciting is a movement to change the way we manage children with a whole variety of physical challenges, from lower-extremity issues to idiopathic scoliosis,” he said.
    Research at the University of Strathclyde in Scotland, at Northwestern University in Chicago, and at Texas Scottish Rite Hospital for Children in Dallas, among other places, he said, “will change the way we think about children with disabilities and we will see those concepts turn into solid principles, based on good science.”
    For now, DiBello said, this research must undergo assessment and evaluation by the scientific community but “for the first time in over 25 years I feel there will be dramatic and genuine changes in the field.”

Deborah Conn is a freelance writer in Falls Church, Va.