Even patients who obediently wear their O&P devices can pose a clinical challenge if they wear their devices past the point of breakdown. Experts offer suggestions for dealing with patients who are hard on devices—including those who are very large, very active, or very frugal.
By Shalmali Pal
Managing adult patients who are noncompliant with their O&P devices is a persistent problem for lower extremity practitioners. But what about a patient who willingly complies with her prescribed device—and then uses it to the point that could verge on device abuse?
For instance, there is the patient with a custom foot orthosis who will wear the insert until a hole appears in the bottom—and then duct tape the hole up and continue using the device. Then there is the patient who reports no “unusual” changes to his daily activities with the device on, only to eventually inform the practitioner that its harvest time in his agricultural community, so he’s been wearing the device for 12-hour days. Or the patient in his early 20s with an ankle foot orthosis (AFO) who spends his weekends at clubs slam dancing (in which people deliberately collide with each other), device and all. Finally, there is the patient with diabetic neuropathy who doesn’t feel the discomfort caused by a damaged brace, and continues to wear the device in its distressed state.
No one could accuse these patients—all real people encountered by the experts LER spoke with for this article—of being noncompliant. They happily wear their devices, and go about living their real lives. But a prescribed device, whether an AFO, knee brace, or foot orthosis, can only take so much “reality” before it begins to break down, potentially putting the user at some health risk. A device works best when it is worn, but also when it is worn properly and cared for. All of this means practitioners need to fit a device in more ways than one.
“It is crucial that practitioners understand as much about a patient’s past, current, and expected levels of function as possible before formulating a treatment plan,” said John T. Brinkmann, CPO/L, an assistant professor with the Northwestern University Prosthetics-Orthotics Center in Chicago. “Revisiting this issue is important during subsequent appointments, since use patterns change signifi- cantly and patients may not think to include relevant information when asked about their function. This requires good interviewing skills, which includes listening closely for clues about what to ask more about.”
Why the wear and tear?
There are a variety of reasons that a patient may put a device under excessive duress. Patient size—which can be related to obesity or excess weight, muscularity, or an otherwise large body habitus—and abnormal biomechanics (eg, spasticity, contracture, malalignment) are the perhaps the easiest for practitioners to oversee.
Practitioners will need to make accommodations for these issues before prescribing and fitting a device, and adjust the type of material used in the device to handle any excess loading, whether that’s from weight or abnormal biomechanics, said Linda Laakso MSc, CO(c), a staff orthotist at Custom Orthotic Design Group in Mississauga, Canada.
“The design of a brace will affect how it wears, and by using certain design characteristics, a brace can be stronger, lighter, more streamlined—all criteria that are identified during an assessment and incorporated into the brace,” Laakso said. “An example would be to increase the amount of plastic that covers the uprights and joints to make them stronger versus cutting the plastic back to make the brace lighter.”
Brinkmann agreed that a full discussion with the patient on how the extra weight will impact the device needs to take place. For instance, devices can be modified to withstand greater maximal loads or made more durable.
“However, those strategies come with a cost—the device is usually more heavy and bulky, or may require the use of more expensive components,” he explained. “Part of the clinical decision- making process is to balance these patient needs that are often competing. Making sure that the patient understands the potential consequences of any design decision, and has a say in the process, is an important part of effective clinical decision-making.”
Rob Conenello, DPM, a podiatrist with Orangetown Podiatry in New York, and a past president of the American Academy of Podiatric Sports Medicine, said he will emphasize that the device is an important aspect of any healthy lifestyle plan.
“We are giving them a device that helps them be active in a better way, so that they can reach the goal of being fit,” Conenello said. “However, I also explain that when there is a greater demand on the device, the likelihood that the device will break down is greater.”
Another reason a patient may put a device through the ringer is because they are frugal or simply don’t make caring for the device a priority. These patients can be a little tougher to manage, but there are ways to get the message across that no device will last forever.
“After we do an initial assessment, we would describe our recommendations, the design of the brace, and what to expect,” Laakso said. “Part of that discussion is how long it takes to get used to the brace, how long it may take to notice a change, and how long the brace usually lasts.”
For instance, most long leg braces or KAFOs last three to five years, as long as there hasn’t been a change in medical condition, a change in a person’s size or shape, or trauma to the brace, she said. But Laakso will also emphasize that a device’s lifetime may vary, based on usage and care.
Laasko authored a page on the Custom Design website that details the appropriate use and care of orthotic devices, such as “Do not exercise with FOs [foot orthoses] within the 2 week break-in period” and “DO NOT dry the orthosis with a hair dryer. Wipe it dry with a towel,” in reference to AFOs or knee braces.1
She emphasized patients still need to be briefed individually on how to care for the devices, even if they’ve had plenty of prior experience with them.
“We also look at the cognitive abilities of the person with respect to being able to follow instructions—very detailed but simple written instructions are given to some people, while a seasoned brace wearer would have a review of the process [or a teach-back method],” she said. “We also would book more frequent follow-ups for people that we are concerned about. The teaching sessions will occur either in full or as a reminder at each visit, as well.”
In the teach-back method (also known as the “show-me” method), the patient is asked to repeat what the practitioner has just demonstrated or explained, to show he or she has understood instructions.
Clinicians should help patients on a tight budget understand that caring for a device increases the chance that it will last for its expected lifetime, the experts stressed.
“I always stress, ‘This is a very important piece of medical equipment that is going to help you. If you treat it well, it will treat you well. Clean it fairly regularly to get rid of dirt and sweat. Take it out of the shoes on a daily basis and let it air dry. If there’s a Velcro closure, try to keep it relatively free of pet hair or lint.’ But I also explain that the device is not going to last forever,” said Conenello, who is a global clinical adviser to Special Olympics International.
David Armstrong, DPM, MD, PhD, a professor of surgery at the University of Arizona College of Medicine, and director of the Southern Arizona Limb Salvage Alliance (SALSA) in Tucson, AZ, pointed out that patients may avoid getting a new device because of financial hardship.
“Devices can be costly, and we are still seeing poor [insurance] reimbursement for the device makers,” he said. “That’s just one of many problems with our current healthcare system, but we have to do something to help these patients. What it really mandates is that the clinician and the entire care team, including those who help with coverage, work together to figure out how to help these people live their ‘normal’ lives.”
There will always be people who wear a device long past its “use by” date, and practitioners may have to accept that their control of the situation will have limits.
“When we see obvious defects, we try to fix them, and if we cannot, we advise the patient to not wear the brace due to the risk of injury,” Laakso said. “I take time to explain potential consequences and suggest a new brace. Since I am not there to watch over people, I suspect that some people do not listen to my recommendations and wear the brace anyway.”
On the go
Very active patients generally fall into two categories—those whose professions are physically demanding and those whose extracurricular activities involve a lot of physical movement, whether related to sports, fitness, the outdoors, or travel.
Many of Conenello’s patients are high-intensity athletes, so their devices wear out sooner rather than later.
“I work with some ultramarathoners, cross-county runners. It’s a given that their devices will get beat up quicker,” he said. “I explain that they are really going to have to spend the time to keep the devices clean and dry. Sometimes we’ll incorporate moisture-wicking products into the devices to help with that.” (See “Materials science targets foot odors and microbes,” LER Foot Health, June 2016, page 21).
Other “obvious” candidates for being tough on devices are patients whose jobs involve manual labor, or require that they spend long periods on their feet. Experts agreed practitioners must get data on a patient’s normal activity levels before the device is even fit.
“It is very important to know the activities that the person will be performing before the brace is made so that materials and design factors can be considered when planning the brace,” Laakso advised. “For example, the brace that I make for a twenty-two-year-old who goes to school every day…would be different from the brace that I would make for a sixty-five-year-old who…only goes out for groceries once a week, even if the weight and size of the two people are the same.”
And bear in mind that a practitioner and a patient may have different definitions of what constitutes normal use or unusual activity.
“I’ve been in encounters where patients said they had not changed their wear pattern, only to find out several questions later that they began walking on a treadmill for exercise earlier that week, or doubled their daily wear time because it was harvest season,” Brinkmann noted. “The patients in each of these situations considered their activity ‘normal’ and not worth mentioning when asked, ‘Have you been doing anything unusual in the past week?’”
So, how can practitioners ensure that they get as much valid information as possible? By asking questions about normal or unusual activity at the first fitting, and then continuing to ask at every follow-up appointment.
Brinkmann suggested rephrasing a question if the initial answer seems too vague.
“In both of these cases, if I’d given up after asking only once about any change in their activity level, I wouldn’t have gotten that necessary information. It really takes some creative questions and actively listening to get an accurate picture of their activities,” he said.
Laakso said she will start with some general questions about expected levels of activity, which can serve as a springboard for more information, as she develops a rapport with the patient. If she runs into a patient who is not readily sharing information, she’ll take a different tack.
“If they are not at all forthcoming, I explain that I can only provide treatment if I have a good idea of what they need with respect to their medical requirements in addition to their lifestyle requirements,” she said. “Once I come up with a potential treatment plan, I will describe it to the person and explain why. This often results in more of a discussion where the person provides a lot more information.”
At SALSA, Armstrong and colleagues have been testing out wearable tracking devices for nearly two decades to quantify patient activity. Products like phone-based activity apps can be useful to clinicians who are trying to get a handle on patient activity levels.
“We look at it as ‘dosing activity,’ the way we would dose a drug,” Armstrong explained. “With drugs, you have a peak and a trough—if a dose is too high, there can be adverse effects, but if it’s too low, the drug may not be effective. We’re always looking for that ‘sweet spot.’ So, if we can quantify activity through these wearables, then we can coax people into finding that same ‘sweet spot’ in terms of the right amount of activity [with the device].”
Having these data from wearables can also help patients identify what Armstrong called unrecognized “pockets of activity.
“The data looks a bit like an ECG [electrocardiogram] graph. We’ll go over the wearable readings with the patient, and point out a change in activity level, based on the device’s readout. That’s when the patient will say, ‘Oh, that’s right, my grandchildren were visiting and we spent the day at the park. I forgot about that.’”
Laakso noted that a patient’s usual activity also may include other people, and that can have an impact on a device. She shared the example of a nonambulatory, wheelchair-bound patient with bilateral AFOs (he needed them just to transfer in and out of the chair). He required a catheter that had to be changed several times a day. Unfortunately, the home healthcare workers were careless and allowed urine to drip onto the patient’s braces and shoes.
“This didn’t just happen once; it was over a long period of time,” she said. “His braces broke down sooner because of the urine exposure. I wrote a scathing letter to the home health company. That’s an example of a ‘daily activity’ that a patient may not think to mention.”
Give and take
Adapting devices to accommodate a patient’s stated (or suspected) activity level requires practitioners to think outside the box, Brinkmann noted.
“It is important for practitioners to understand optimal material selection, design features, and fabrication techniques when initially recommending a specific design, and to recognize signs of material failure and poor fit and function,” he stressed. “One reason continuing education for practitioners is important is that it challenges ‘the way we’ve always done it,’ and helps us provide solutions to problems that we may have considered ‘normal’ in the past.”
He pointed out that some of the problems with fit and component failure could be resolved with different designs and/or materials. For example, switching to prepreg carbon fiber from thermoplastics for a lower limb orthosis can render the device stronger and offers multiple benefits in terms of gait (See “Strengthening the case for carbon fiber AFOs,” October 2010, page 23).
But a more advanced component, such as a carbon fiber AFO, may require some adaptation in terms of biomechanics, and patients must be educated on their proper wear and use, as the material’s springy surface will push back (rather than compress) and potentially reduce the need for flexion in the hips, knees, and ankles. Patients will need to be briefed on those differences.2-4
“For example, improper ascent and descent of stairs can cause breakage,” Brinkmann said. “But in general, as technology, our assessment, and the fitting process all improve, we may be able to prevent fatigue or breakage that we’ve come to accept as normal.” (See “AFO stiffness can help optimize patient function,” November 2016, page 29.)
Conenello gave the example of a very active patient with a relatively rigid foot, who would not benefit from a rigid, thermoplastic device.
“So I’ll utilize a more forgiving material, like an EVA or a leather laminate—something that is more accommodating,” he said. “The caveat there is that this material will not last as long, so I explain that there will come a time when we’ll have to refurbish it or change the device, and that may be sooner rather than later.”
Is there a way for practitioners to predict breakdown? Yes, to some extent.
Laakso suggested focusing on preventing “early breakdown,” versus any breakdown.
“A brace made to the individual characteristics of the patient is the most important factor in making sure the brace does not break down prematurely,” she said. “Regular check-ups and maintenance will help prolong the life of a brace. The check-ups are important to ensure that joints are properly lubricated and aligned and that there are no nicks or cracks in the plastic.”
Armstrong said the day of embedded sensors in devices that can predict some degree of device failure is not far away.5 These sensors can predict strain on a device or Young’s elastic modulus (the measure of a stiffness of solid materials) and communicate that information to the practitioner before it’s too late, he said.
“The advantages of the wearables plus the embedded sensor technology is that we will be able to identify failure before we even see them in the clinic. It’s like On-Star for the body,” he explained, referring to the remote-link communications systems in vehicles.
- Laakso L. “Instructions for use and care of orthotic devices.” Custom Orthotic Design website. http://www.customorthotic.ca/use-and-care-of-your-orthosisdevice. Accessed February 6, 2017.
- Wolf SI, Alimusaj M, Rettig O, et al. Dynamic assist by carbon fiber spring AFOs for patients with myelomeningocele. Gait Posture 2008;28(1):175-177.
- Rao N, Wening J, Hasso, D, et al. The effects of two different ankle-foot orthoses on gait of patients with acute hemiparetic cerebrovascular accident. Rehabil Res Pract 2014;2014:301469.
- Ingraham P. A consumer’s guide to the science and controversies of orthotics, special shoes, and other (allegedly) corrective foot devices 2014. https://www.painscience.com/articles/orthotics.php. Updated December 22, 2014. Accessed February 6, 2017.
- Pal S. Telemedicine: Going virtual improves communication and outcomes. LER Tech Check blog. http://lermagazine.com/home-feature/telemedicine-going-virtual-improves-communication-and-outcomes. Published December 2015. Accessed February 6, 2017.