Future Innovation in Pediatric Care

The needs of pediatric O&P patients can be dramatically different than those of adults. This also holds true for the types of innovations that specialists look to for the future of pediatric care. Innovations making their way into clinical care and on the horizon for the future include technology that allows for growth and development, monitoring wear times, optimizing developmental dynamic gait, visualization, and microprocessor controls, as well as technology that can involve parents, therapists, teachers, coaches, and other caretakers. The following discussion among pediatric specialists shows us some of the devices and strategies that may impact the future of pediatric O&P care. Monitoring Wear and Dosage Bryan Malas, MPH, CO/L, director of Children’s Hospital, Chicago, looks to real-time electronic monitoring of orthotic devices to help define dosage and refine the understanding of orthotic device effectiveness. He says, “In the not-too-distant past, we really had no idea of how long the patient was wearing their devices, so we were estimating the efficacy on compromised information. We could advocate for a type of spinal or lower-limb orthosis, but if the patient didn’t wear it or the caregiver did not reinforce use, it may have been judged ineffective by the rehabilitation team. [A monitoring device] also can confirm that the child is adhering to the prescribed wearing schedule and the actual problem may be with the design itself.” Malas says he and others look to new sensors that can monitor tension, pressure, or number of steps. “With this new technology, I can dial in and refine what I am seeing with the orthosis so I can understand how it is being used. I can tell the parents that more time is needed, or pressure is needed, or conversely, to reduce the force application if adherence is at risk. This also helps me develop a better internal correlation of the outcomes for the different devices rather than relying on an estimation of wear…. For our department, this has expanded beyond just spinal, but now for the lower limb.” Microprocessor Control Kinsey Herrin, MSPO, FAAOP, CPO/L, is a senior clinical research scientist at Georgia Tech who has been working with Aaron Young, PhD, to develop microprocessor-controlled mechatronic exoskeletal systems and prostheses to help patients, including children, control movement and ambulate. “One of the challenges that comes to mind is that for itty-bitty kids, we need to miniaturize actuators, batteries, and the human interface if you want an autonomous system that allows a child to walk around freely,” says Herrin. “We need the exoskeleton to fit well to translate the torque patterns that our controller is commanding. We don’t want weight, bulk, or a poor fit to negatively affect the data and outcomes we are gathering.” That can be a challenge for research, she says. “Our youngest subject was eight years old and getting the child to have an attention span long enough to walk in a straight line on the gait mat can be difficult.” Herrin also adds that the nature of their engagement was different. “With children, their attention spans are limited so the sessions have to be short and fun. We are starting to look at how we can gamify the outcomes testing with biofeedback so we can keep them involved like what might happen in a virtual-reality experience.” Herrin sees greater possibilities in the future for applications in rehabilitation. “I really see the use of exoskeletons evolving as rehabilitation tools. For children, durability and longevity may always be a challenge, but if we used [exoskeletons] as a rehabilitation tool for therapy in a clinical setting, the child would go in for periodic ‘tune-ups’ to see how they are developing in their mobility patterns.” She adds, “I would like to see the profession move from being device makers to managing rehabilitation and more rehab focus. These devices can allow us to analyze gait deviations and make small adjustments. If we can make small adjustments guiding movement, we can encourage change in mobility and development outside of the exoskeleton for the patient.” Elastic and MPK Control Suits New designs are looking toward movement guidance rather than locking motion. During the 1960s the Soviet space program intensively investigated how to maintain musculoskeletal, circulatory, and respiratory strength for cosmonauts and astronauts while in space. In the 1990s, Inessa Kozlovskaya, MD, PhD, and Professor Xenia Semenova created a system of elastic rubber bands to create tension on the body, called the “Penguin.” This same technology was used to create the LK-92 Adeli Suit to rehabilitate children and adults with cerebral palsy. The custom orientation of the elastic portions of the suit was used to mimic the physiologic placement of the patient’s flexors, extensors, adductors, and rotators of the lower limb. The Adeli suit did not function to restrict or lock movement, but rather to guide it and optimize movement to provide resistance to develop muscular control with active therapy. This helps the brain to recognize and initiate the corrective movement. Another form of movement guidance suit includes the Neurosuit that also uses bungee-type bands to provide corrective alignment and compression to provide attenuation of spasticity and dampening of overcorrection. These types of devices are also referred to as adaptive clothing to provide increased motor control used as a tool for therapy and can incorporate a two-day training for parents. This same principle is used in the application of microprocessor control in the Exopulse Mollii suit (also known as Eketrodress) originally from Sweden and currently only used on a limited basis in Sweden and the United Kingdom. The suit, which has not received approval by the US Food and Drug Administration and is not yet available in the United States, is a functional garment of lower leg and torso sections with a control unit.It uses surface-mounted electrodes within the garment that transmit electrical signals to reduce intermittent reflexes and spasticity and improve range of motion, posture, and functional ability. It can also be used to address pain and improve sleep patterns. Using 58 electrodes activated with low-level electrical stimulation similar to a transcutaneous electrical nerve stimulation (TENS) unit with a computer algorithm, the control suit can be programmed for each user. The clinician uses a program to calibrate the system with respect to intensity and timing. The muscle stimulates that antagonistic muscle group to counteract the spastic compartment and relax the affected group in a physiological process called reciprocal inhibition. The devices can be used for children with cerebral palsy, upper-motor neuron involvement, spinal cord injury, and other neurological conditions. The garment is custom tailored to each child, with 26 sizes available, and the control is programmed based on the individual presentation to help in the rehabilitation process for efficiency and optimization of mobility, upper-limb function, postural control, and balance 3D Printing Any discussion of pediatric technology would be remiss if it did not mention 3D scanning and printing and its potential to provide mass customization for the unique needs of pediatric patients. While questions remain as to the durability of these devices, the potential to fit pediatric patients with custom devices designed specifically for their needs in terms of presentation, size, and color cannot be denied. One area where 3D technology is being used is in custom imaging and orthotic management. Digital 3D scanning, modification, and printing can be used to compensate for growth and development. Direct Scan to Print Cranial Remolding Orthoses Ottobock’s new cranial remolding process, MyCro Band, from its French subsidiary Chabloz, uses 3D-scanned digital images that are processed by the programmed algorithm to account for growth of the child’s head. Ted Friedmann, CO/L, senior clinical orthotic specialist with Ottobock, says, “Using this advanced FDA-approved technology gives us the chance to reduce manufacturing inaccuracies from standard manufacturing processes. In the past there were always discrepancies as the mold was replicated and modified from the impression to positive, to formed helmet. With this new direct scanning to printing technology we can create a more intimate cranial remolding device. This means we can reduce the size and thickness of the device. However, we don’t have the margin of error that others do so the scan must be accurate.” Friedmann speaks to the confidence clinicians have regarding this technology. “I have found that clinicians aren’t afraid of technology necessarily, but maybe if they have been dissatisfied with results and haven’t been getting good outcomes, they are looking for better results. With a few small modifications to eliminate extraneous shape anomalies and the trimlines, we can move to print a 3D-printed deposition MyCRO Band that is very thin yet effective. We can get the correct amount of adjustment with just one custom band rather than approximating the process with grinding thick foam found with other processes.” Regarding digital tools, Friedmann says, “The principles of contact, volume, and growth are the same. However, people aren’t fond of the guesswork of creating the foam shape in cranial remolding helmets. They really want it to be more accurate especially when molding the minds of the future generation.” When asked if this involves more skill, he adds, “I’ll tell people to take three to four scans, so you get the confidence with the tool and get the best scan. Some achieve this easily, others take more time, but like anything, with persistence and practice they can usually achieve what they desire clinically.” Printing Custom AFOs This same level of design found in upper-limb prostheses and cranial remolding orthoses can also be found in lower-limb orthoses. John Izak, CPO, owner, Orthologix, headquartered in Trevose, Pennsylvania, says, “Creating custom shapes through 3D printing and composites helps address the changing nature of pediatric gait by creating something that guides the motion rather than restricts it. We are able to instantly create lower-limb orthoses with varying degrees of stiffness and support to address the needs of the patient. It’s no longer a process of trial and error. We can make better estimates of movement and custom design an orthosis for the patient that can reinforce the critical areas, allow flexibility, while minimizing the coverage of the patient found with thermoplastic. We can compensate for sizing changes due to growth more quickly, and there is more time spent learning from each patient.” Friedmann agrees that this customization opens a new class of orthotic treatments. “Having that artistic [option] in our designs allows us the opportunity to create flex zones like honeycomb shapes to create lighter varying stiffnesses. We can then add areas for a more rigid medial wall with a thin, lightweight lateral wall to control a valgus presentation.” He cautions, however, that the increased flexibility requires additional research to understand the implications of those modifications. Custom Control Configurations Researchers such as Géza Kogler, PhD, CO, director of the O&P master’s program at Kennesaw State University, developed an instrumented AFO and diagnostic tool to quantify the consequences a specific stiffness has on joint kinematics during walking. “We can take in-clinic measures of ankle joint motion, pressure, and torque to determine a user-specific stiffness for optimal walking performance. To me it’s a total game changer for practitioners because we have historically relied on experiential estimates for ideal stiffness, and now we have a promising opportunity to base our prescription formulation on clinically relevant data. “My vision is to develop a marketable version of the diagnostic AFO, coupled with an industry change toward embedded sensors included with all AFOs. I think what we will find is that the realm of orthoses we currently provide may need to be totally redesigned and reimagined beyond simple deformable struts and ankle joints with only nominal motion control parameters. These concepts are only achievable if the ideas can be applied in the clinic and beyond the research laboratory. My previous students at Georgia Tech and now at Kennesaw State are already being exposed to the importance of diagnostic measures and their clinical value in treatment and prognosis.” 3D Visualization and the Metaverse Brian Emling, MSPO, CPO/L, who is part of the limb deficiency team at Children’s Healthcare in Atlanta, used 3D printing to aid in visualization rather than for direct functionality. This is similar to visualization used at Walter Reed National Military Medical Center to understand heterotopic ossification from soldiers’ explosion injuries. Emling describes a patient who has Gorham-Stout disease, also known as vanishing bone disease, who was referred to the limb deficiency team because he was struggling with activities of daily living as the disease largely affected his hand and distal forearm. “We really had no way of knowing how the child’s limb difference secondary to the pathological process impacted wrist and digit function,” he says. “The soft tissue movement and displacement of the digits during wrist activation raised questions on where articulations were actually taking place. I was able to get a CT scan of the arm, then segment the soft tissue and bone to generate a 3D visualization where I could see that the metacarpal bones did not have an articulation with the proximal carpal attachments. I also better understood how finger flexor activation caused distraction of the digits into the palm. With longitudinal distraction of the digits the phalangeal fragments would compress into the distal ulna and radius then begin to flex into the palm.” Mark Holowka, CPO/L, MSPO, FAAOP, senior prosthetist-orthotist at Children’s Healthcare of Atlanta, indicates that visualization can also be used for spinal orthoses. “Unfortunately, we had to trade off the design and artistic control when we created a TLSO for scoliosis by using rote modification standards. Now we can use metaverse imagery developed for lidar systems, cell phones, and driverless cars to directly see in 3D what the shape is doing to the anatomy with small finite corrections over time. We can see more dynamically what can be happening and create a modality of treatment more like a therapeutic device or modality. We can directly see the effect of the orthosis.” Describing a recent case, Holowka says, “We were able to use augmented reality (AR) to directly see and visualize the spine orientation and protruding ribs into the lungs and estimate what a device might look like, what its effect would be. Also, we can use biofeedback so patients can experience a prosthesis or orthosis before it is even made.” Innovation Requires Responsibility Brian Giavedoni, MBA, CP, FAAOP, prosthetic supervisor at Children’s Healthcare of Atlanta, offers some cautions, however. “I think the most important thing to remember with any technology is that just because it’s new does not necessarily mean it’s better or that it applies to everybody. I think in our profession we have come to understand that there is always going to be that percentage of the population that simply does not adapt well to the new technology, or [that] the new technology doesn’t really accomplish what it is supposed to do.” He adds that pediatric patients are different. “What may be the perfect system for a geriatric patient or for an adult amputee high-activity patient may be very different than what would be suitable for the pediatric patient. Something even as simple as scanning that has been pretty well integrated into most practices around the country can still be a challenge with a very young child that refuses to sit still while the scanning takes place.” “I remember a patient wearing a suspension liner constantly fighting fungal issues,” he says. “While many of the kids we treat are fitted with liners, there is a subgroup where this was a major issue. The simple solution was to move them to wicking socks and a small, ¼-inch airhole at the distal aspect of the socket. An outer suspension sleeve was used, and the fungal issues resolved within a week. “In this case, liner technology advances are wonderful when applied to the correct patient under the correct conditions. The key takeaway is that children are physiologically undergoing changes daily and any changes in technology need to be assessed taking that into account,” Giavedoni says. Gerald Stark, PhD, MSEM, CPO/L, FAAOP(D), is a senior clinical specialist at Ottobock Healthcare, Austin, Texas. Top photograph: pololia/stock.adobe.com

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