From Design to Clinical Translation: Unraveling Orthotist Perspectives on 3D Printed Accommodative Insoles

Abstract

Background

Custom accommodative insoles have become the gold standard for managing plantar pressures and reducing ulceration risk in persons with diabetes. With advances in 3D printing technologies, methods of fabricating 3D printed accommodative insoles have emerged. Clinician feedback is imperative to developing a 3D printed accommodative insole that meets clinical needs and is more effective than the current standard of care.

Objective

To inform the development of 3D printed accommodative insoles by gaining clinician perspective on insole requirements and application of the digital workflow for seamless translation into the clinical setting.

Study Design

Qualitative study

Methods

Four focus groups with a total of 16 Orthotists were held, prompting discussions on the current standard of care accommodative insole and other 3D printed insoles we have developed. Sessions were recorded, transcribed, and main themes were derived from transcriptions.

Results

Review and analysis of the transcripts resulted in four main themes: 1) Reimbursement, 2) Durability, 3) Effectiveness, and 4) Workflow application in clinic.

Conclusions

The responses showed areas to focus improvements on the 3D printed insole design and ways to ease the transition into a clinical setting. Clinician support is crucial in the adoption of a new device to clinical practice. Their feedback is essential to ensuring the item meets the clinical needs and the workflow is not disruptive to the clinical setting.

Clinical relevance

Understanding clinician perspective on current SoC disadvantages and shortcomings, areas for improvement in the 3D printed insole fabrication, and what is feasible in clinic appointments will help inform insole design and aid in translating new 3D-printing technology to clinical care for improved patient outcomes.

Introduction

Diabetic foot ulceration continues to be a prevalent issue in the United States that can benefit from further investigation into proper management and prevention. In the United States alone, 37.3 million people or about 11.3% of the US population live with diabetes¹. This number is expected to continue to grow reaching 33% by 2050². Complications of diabetes, such as foot wounds and ulcers, are a leading cause of amputation in the United States, with over 100,000 amputations occurring yearly as a result³. In 2018, 154,000 lower extremity amputations were recorded as a direct complication of diabetes. Of these amputations, 84% are said to have begun due to an ulceration⁴. The financial cost associated with treating these ulcers is estimated around $85,000⁵. Proving to be a costly healthcare expense, especially when you consider that recurrence of ulcers is as high as 40% within a year and upwards of 75% within 5 years⁶. To reduce the number of amputations in the diabetic population, proper management of foot health to prevent ulceration is essential.

Custom Standard of Care (SoC) accommodative insoles have become the gold standard, along with therapeutic footwear, commonly prescribed to this population to redistribute plantar pressures and decrease ulceration risk⁷. They are a cost-effective, non-surgical solution that has demonstrated the ability to offload regions of high plantar pressures^7,8. These SoC insoles are traditionally created from an impression of the individual’s feet in a foam crush box to capture shape, then are hand fabricated using open and closed cell foams. There are two major limitations of the current SoC: (1) The fabrication processes commonly require hand modifications which can lead to variability in the final product and the effectiveness of the insoles. (2) Each insole has a lifespan of about four months because the open and closed cell foams used to fabricate them have varying durometers and the softer durometers breakdown quickly. It is then up to the user to switch out the insole for a new one to maintain the offloading properties and prevent ulceration.

Following recent advances in additive manufacturing, 3D-printing technologies, and materials our team has designed accommodative patient-specific insoles (3DP) using 3D-printed metamaterials. The production incorporates a scan of a foam crush box impression to determine insole shape and an in-shoe dynamic pressure assessment to identify regions of high plantar pressure to offload with reliefs. The material used for the 3D insoles was the Carbon ® Elastomeric Polyurethane (EPU) 41^9,10 as its mechanical properties of elasticity and durability were best suited for insole use. Our team used the Carbon® design engine⁹ to develop a lattice structure to emulate a multilayer construction, comparable to the SoC insoles¹¹. This was done by adjusting the parameters of the lattice unit size and thickness. The different lattice structures are also used to provide reliefs in the corresponding high-pressure areas^7,11. The combination of the scan and pressure assessment is used to produce a computerized 3D model which can be modified to the clinician’s desires for a patient’s specific needs. Our work to date has demonstrated the design workflow (Figure 1) and viability of the materials through mechanical testing ^11,12. Additionally, our prior work indicates that our new design may be more effective in offloading specified areas of high pressure in healthy and diabetic individuals compared to the SoC ⁷. However, it is unknown how these potentially effective devices will be received by clinicians and how the proposed production workflow could be incorporated into current clinical procedures.

Figure 1.

Insole Design Workflow

Therefore, the purpose of this study is to further inform the development of 3DP accommodative insoles by gaining clinician perspective on insole requirements and application of the digital workflow for seamless translation into the clinical setting. The three main goals of this work are to: 1) obtain clinician perspectives on current advantages and disadvantages of SoC and 3DP insoles to understand their insole needs, 2) identify and iterate on areas for improvement in the construction and design of 3D printed insoles to better align with stakeholder needs, and 3) determine the feasibility of translating the insoles and fabrication workflow into a clinical setting. Integrating Orthotist feedback will improve future insole iterations and lead to a more effective and durable accommodative insole, requiring minimal adjustment to the evaluation and duration of the current clinic appointment.

Methods

Participants:

Participants were Prosthetist/Orthotist clinicians all located in the Greater Puget Sound area of Washington state. There was a total of sixteen (8 male, 8 female) participants who worked at either the Veteran’s Affairs (VA) prosthetics clinic or a private prosthetics clinic (Table 1). All participants had experience in the care of diabetic feet, with the years of practice amongst the participants ranging from 0.5 to 40 years with an average of 10.4 years. To diversify opinions, we involved clinicians of varying practice backgrounds, years in practice, and age. All participants signed Institutional Review Board (IRB) approved consent and Health Insurance Portability and Accountability Act of 1996 (HIPPA) release forms prior to commencing focus groups.

Table 1.

Standardized Questions for Focus Group Discussions

Standardized Questions

• What are the advantages of the current design for accommodative insoles? • What are the disadvantages of the current design for accommodative insoles? • Are there specific features you dislike? What is the biggest downfall? • Do you have any ideas for ways to improve insoles? • What is the biggest challenge in getting people who need an insole to use an insole? • Which one, if any, of the insoles you saw today did you like the best? Why? • Which one, if any, of the insoles you saw today did you like the least? Why? • What are the essential qualities you seek when prescribing insoles?

Procedures:

Four total focus group sessions were held, with each clinician participating in one session. Groups ranged in size of 2-9 clinicians. The average length of each session was 39 minutes. Each focus group began with a brief description of the study purpose and the goals for the group. During the focus groups, clinicians were shown three orthotics: a SoC insole, a hybrid insole, and a fully 3DP insole (Figure 2)⁷. The fully 3DP insole is fabricated with a custom lattice of varying strut diameters and spacing meant to emulate the mechanical properties of SoC insoles¹². The hybrid insole was similarly designed, but with the top 4 mm consisting of a Poron-Plastazote bilaminate sheet glued to the surface to attain the same overall geometry of the fully-3D printed version with a surface feel of the SoC. The moderator used a semi-structured interview approach to promote discussion¹³. A series of standardized questions (Table 2) was used to ensure discussion touched on potential advantages, disadvantages, and areas for improvement of each insole style. At least three investigators were present for each session.

Figure 2:

Insoles (a) SoC, (b) 3DP with bilaminate top layer, (c) full 3DP. Offloading regions indicated in red.

Table 2.

Focus Group Demographics

	Group 1			Group 2		Group 3		Group 4
Age	32	37	52	31	47	43	29	55	41	33	29	23	29	63	26	33
Gender	F	M	M	F	M	M	F	M	F	F	M	F	F	M	F	M
Years in Practice	3	10	25	8	23	18	5	15	9	3	1	0.5	1	40	3	1.25
Highest Level of Education	MS	MS	BS	MS	BS	BS	MS	BS	MS	MS	BS	BS	MS	BS	MS	MS

Data Analysis:

Focus group sessions were audio-recorded and abridged transcripts were transcribed to capture a condensed version of the focus groups and omit the irrelevant discussions¹⁴. Audio recordings were listened to, and the transcripts were read multiple times to pinpoint statements that aligned with the goals of the study. Significant responses from each session were identified weighing several factors: frequency, specificity, emotion, and extensiveness^14–16. The identified responses were then grouped into themes and analyzed using a constant comparative framework to determine relationships between the ideas¹⁷.

Results

Focus group participants discussed many different topics and concerns regarding key features required of accommodative insoles and their clinical use. Review and analysis of the transcripts resulted in four main themes: 1) Reimbursement, 2) Durability, 3) Effectiveness, and 4) 3DP Workflow application in clinic. Each theme is described and supported with quotes from the focus groups.

Reimbursement

The matter of reimbursement was discussed in all four focus group sessions. Although clinicians within the VA system worry less about reimbursement pricing than those practicing in private practice, they still need items to have an assigned Medicare code. The clinicians’ main concerns were whether the 3DP insoles would get a Medicare HCPC code assigned. They had questions about whether the material used to fabricate the 3DP insoles would qualify or meet the criteria for an accommodative insole.

“Medicare doesn’t recognize fully 3D printed insoles as multidensity because they are just counting the layers.”

“Certain things have to be on here (SoC insole) to qualify for an A5513, like a certain covering. Do these (3DP insole) qualify for that?”

Our belief that the 3DP insoles would have a significantly increased lifespan with no to little deformation up to a year, led to questions about what the exact definition of accommodative insoles relied on.

“I kind of assumed that taking on the shape of the foot is part of the definition of an accommodative FO, so it has to kind of deform over time.”

Many clinicians raised overall frustration and concerns with the reimbursement and Medicare guidelines for accommodative insoles. Keeping the yearly cost of the 3DP insoles low or comparable to SoC insoles is important to clinicians because of the money they are already losing to poor reimbursement.

“I know that they (accommodative insoles) are really effective, I’m just really mad at our reimbursement system.”

“Whether anyone in this room will admit it, foot orthotics are horrid. We are not reimbursed accurately. There have been all kinds of studies done in Europe that have shown and proved that if someone is making foot orthotics and watching the patient’s foot, the amputation level is way down, but Medicare makes it really hard for us to get coverage.”

“When learning about insoles I was told reimbursement is really low, most clinics will lose money. But I thought well what about the prosthetics side, that’s where clinics will make a lot of money. I said isn’t that a conflict of interest? If we succeed, we lose money and if we fail, we make money.”

Durability

The next theme was the topic of Durability of the insole, which could be broken down into two key subcategories: 1) Time to replacement, and 2) Hygiene.

Time to Replacement

Some clinicians believe that a major shortcoming of the SoC insoles is how quickly they pack out and need to be replaced.

“This (SoC insole) could easily not last 3 months, it could last a couple weeks for someone really active.”

“Durability is limited, that’s kind of the nature of a diabetic FO.”

“These (SoC insoles) wear out quickly. Sometimes faster than the yearly allotment.”

Although Medicare guidelines allow for the delivery of 3 accommodative insoles per year, clinicians have concerns about many patients’ abilities to identify when they need replacement and their compliance in swapping them for a new pair.

“At what stage do insoles lose their protective qualities? It is hard to many patients to identify that.”

“Your patient needs to make sure they are trading them out which frequently doesn’t happen, so they come in with the foam completely packed out and not remotely close to offloading anything.”

Discussion of what the ideal lifespan of an accommodative insole should be led to questions of whether the need for frequent insole replacement is beneficial for patient’s foot health.

“And one thing I would say about the longevity is, we do want them to last longer, but we don’t want them to last too long because those often are patients that only come back in because they need new insoles. And that is good because we want to see them and have them assessed by podiatry as well. So, it is finding the good balance where you aren’t sending them out on something that will last too long.”

“From a durability standpoint they are designed to pack out over time. That is their purpose, to in theory alleviate pressure from areas that might be more prone to ulceration.”

“They aren’t designed to last a long time so if you wear them out, we will just order more. It’s better to wear these out than wear your feet out.”

Hygiene

The open structure of the 3DP insoles had most clinicians concerned about the ability of the user to keep them clean and hygienic.

“The open structure is both a good and a bad, a double-edged sword. Many patients complain that the foam makes their feet sweat, the downside is many patients have poor hygiene and I think about all the crud that would get stuck in here and potentially cause wounds.”

“Something that could be really annoying with the holes, is a lot of patients have a lot of pet hair and I could see that getting imbedded in the insole.”

“I’d be concerned about the bodily fluids and bacteria growing in the insoles, or worse getting foreign objects stuck that could poke or rub and eventually cause a wound.”

There was also a concern of how any items getting into the insole could affect the function of the insole itself.

“If you get stuff in your shoe or the insole, does it affect how compliant the material is?”

The porous layup is required in the 3DP insoles for the curing process of fabrication, so many clinicians offered the same suggestions for improvement. The addition of a thin topcover to aid in keeping foreign objects out of the insole. Our current iteration of the 3DP insoles is black in color and one clinician raised the point that most accommodative insoles are lightly colored as a precaution to see any drainage that may be happening.

“With this black color you won’t be able to see any drainage or anything else coming off the patient’s foot, so may just want to consider a lighter color if possible.”

Effectiveness

The third theme that arose from the focus groups was that of Effectiveness, which can be sorted into multiple subcategories: 1) Reduction of Ulcer causing forces, 2) Ease of Use, and 3) Time of Fabrication.

Reduction of Ulcer causing Forces

When considering accommodative insoles, one of the most important features is that they work to reduce and prevent ulceration or further amputations. This is done by reducing high pressure areas, which is usually done with the addition of reliefs in the insole.

“They (SoC insoles) are decent at reducing pressure points when used correctly, but reliefs are not always tapered well and the edge pressure can cause wounds.”

Using a crush box to capture an impression of the foot and an outside vendor to fabricate the insole, many clinicians feel that it can be difficult to convey specific reliefs that are needed. In many cases, this will result in the clinicians choosing to add the reliefs in themselves after they receive the fabricated insoles, which adds more time to their appointment.

“It is hard to offload very specific locations with a crush box capture.”

“It can be really tough to properly convey the modifications that are needed to third party fabricators.”

“Even when you send a crush box it (SoC insole) can even come back looking pretty generic.”

Ulcers are caused by the combination of pressure and shear. While shear is difficult to measure, it is increased by tacky materials with high coefficients of friction. Many clinicians had concerns with the top surface of the 3DP insoles that would be in contact with the patient’s feet.

“It (3DP insole) felt kind of sticky at the top, so I was worried about shear. But it does seem like you get some potential shear translation with the matrix and both pressure and shear are required to create a wound.”

“It is so tacky I would be worried about skin breakdown.”

Clinicians felt that the addition of a very thin top cover could address the shear issue and would also serve to keep materials or fluids out of the lattice to better improve the hygiene concerns.

Ease of Modifications

In current SoC insoles, clinicians can easily make modifications in the clinic after they have been fabricated. They are very comfortable with the materials that are currently used in insoles and the ability to grind away or build up material as needed.

“They (SoC insoles) are very easy to adjust. If they need more arch, we can easily add foam to build it up. If they have an open sore, we can go underneath and relieve that, add more metatarsal arch to offload it. So, these are super easy to adjust and even go beyond what the custom foot orthotic is.”

They raised concerns about the 3DP insole material and whether they would be able to grind on it or modify it at all. They worried that it may not be feasible to have insoles that need to be remade anytime a slight modification is needed.

“We need to be able to adjust it and shape it and we need to be able to glue to it and make changes. That would be part of the standard of care as opposed to remaking it, so that would be a new paradigm for us. Doesn’t mean it doesn’t work, but if you can’t even glue things on it then you’re going to have to have it remade. Which is maybe a better approach, but it just means more visits and more visits cost more money.

Time of Fabrication

In some instances, it is imperative that the fabrication time is quick to ensure existing wounds and ulcers are protected quickly and the patient is not forced to alter his daily living while waiting for the insoles. Many clinicians use outside vendors for insole fabrication, and some feel that they are turned around quickly, while other clinicians believe it is too slow. With the 3DP insoles, the fabrication time should be reduced since it will be made off a scan and the 3D printing process itself is quick. When it comes to replacing or remaking insoles, clinicians were able to identify the benefits or reduced practitioner time.

“That’s why we’ve gone this way (3D printed) because we are trying to figure out how to do this more effectively and once we have somebody fit it’s a matter of hitting print again and the material cost is really low and it is going to save us a lot of practitioner time.”

When it came to the matter of clinician time, they felt that they would adopt the 3DP insoles even if they performed the same as the SoC insoles, if ultimately it saved clinician time.

“If the patient feedback was good and they (3DP insoles) reduced our overall time commitment, both with the patient and modifying multiple pairs of them, I would definitely use them.”

3DP Workflow Application in Clinic

A main purpose of the focus groups was to identify the main barriers to implementing the 3DP insole workflow in the clinical setting and getting feedback on the feasibility of the additions to the clinic appointments. There were three major areas that were addressed regarding translation to the clinic: 1) Addition of pressure readings to appointment, 2) New Technology Adoption, and 3) 3D insole use.

Addition of Pressure Readings to Appointment

The 3DP insoles are fabricated using both a scan of the foam crush box and a pressure-based reading to identify areas of high pressure and necessary relief locations. It is expected that the measurement of pressures would add about 10 minutes to the initial evaluation appointment. Clinicians did not feel that the addition of the pressure readings to the appointment would be a barrier.

“I think it would be pretty easy to incorporate the pressure measurements into an appointment as long as everyone is properly trained on the software and it works.”

The only real concern surrounding the pressure readings was whether each patient would be able to walk the distance required for reliable measurements.

“The amount of steps needed for the pressure measurement could be a barrier as some users cannot take 15 steps”

New Technology Adoption

Adoption of new technologies in a clinical setting can be difficult as it requires time to train and become familiar with the hardware and/or software. This can require time away from patient care or longer appointments while learning to implement the technology. The clinicians had some thoughts about new technology translation that is not specific to our project.

“In most cases the easiest way to implement a digital workflow is to start by teaching it in school. For clinicians who have been practicing for a while, it can be difficult to move away from what they have learned as the gold standard.”

“It is hard to implement any new workflow or technology into a clinic if no one there already knows it. You need someone to take it upon themselves to become the expert and assist the others in understanding.”

3D Insole Use

When it comes to the implementation of the 3DP insoles in the clinic, the buy in of the clinician and the patients will be crucial. Clinicians feel that the patients will be the easier of the two to convert, while the clinicians will need a bit more evidence to move away from the SoC insoles that they are so familiar with.

“I think a lot of people think newer is better. For selling it to the patient standpoint, I think that will be one of your lowest barriers.”

“I will want to see evidence that patients like them and they are working as they are designed to. Then if they also save time and money, that will be an added benefit to win me over.”

As an added method of getting clinicians on board, it was suggested to get orthopedic shoe companies involved and leverage their shoe last shape to be uploaded into the software and ensure that the insoles would fit properly in the shoes.

Discussion

The purpose of this study was to further inform the development of 3DP accommodative insoles by gaining clinician perspective on what is required of the insole and the workflow to seamlessly translate them into the clinical setting. Discussions in the focus groups provided a clear understanding of each of the three main goals of this work.

1). Advantages and Disadvantages of the SoC and 3DP insoles

The matter of reimbursement is a major advantage of the current SoC as there is already an approved billable code. The clinicians agreed that having a reimbursable code is a major barrier to clinical acceptance of new devices. The current code for a custom, accommodative insole is A5513 and specifies the following: For diabetics only, multiple density insert, custom molded from model of patient’s foot, total contact with patient’s foot, including arch, base layer minimum of 3/16 inch material of shore a 35 durometer (or higher), includes arch filler and other shaping material, custom fabricated, each¹⁸. While the 3DP insoles fit much of these criteria, the use of different materials and fabrication techniques may not fulfill the material specifics or the need for multiple layers. Further evidence will be required to provide the Centers for Medicare and Medicaid Services (CMS) to ensure the material properties and layup of 3DP insoles meet the criteria necessary to qualify for the existing accommodative insole code or whether a new code will be assigned to it. Nickerson et al. showed that the lattice structures used in our 3DP insoles align with those of the SoC insoles¹². Future efforts will push to show that multiple density can be achieved in more ways than just multiple clearly defined layers of different materials.

Durability is an area where we expect the 3DP insole performance to surpass the SoC. Although the materials are specified by the code, clinicians feel that the current SoC materials lack durability and pack out much more quickly than the determined 4-month lifespan. Hudak et al. showed that by 100,000 cycles, which is representative of less than 2 months of use, the SoC insoles already deformed to 23.59% of its original thickness, however, the fully 3DP insoles had only deformed to 5.45%. Previous research has shown that the material properties of the 3DP insoles are able to provide improved durability while still being representative of the SoC insoles¹².

Effectiveness of the SoC insoles was an area where clinician opinions were mixed. Some feel that SoC insoles are effective at reducing plantar pressures, while others believed they have mixed evidence. Previous studies⁷ showed the effectiveness of the 3DP insoles at reducing plantar pressure in populations with no deformities or risk factors. Clinicians agree that fabrication from a crush box mold can be difficult to convey necessary modifications such as reliefs, so many times they are left having to do it themselves during the appointment. Because clinicians are familiar with the SoC materials, they can modify the insoles easily in clinic when needed. The 3DP materials are not as easy to grind or glue on, so there is a lot of emphasis on an accurate capture and pressure reading to ensure they are fabricated as close to perfect as possible. With a more accurate insole fabrication process and longer lifespan of the insoles, we hope to make the use of the 3DP insoles more appealing to clinicians by saving them time. Our goal is that even with the addition of the pressure reading to the initial appointment, the overall time saved for clinicians during the fitting and follow-up visits will be greater.

2). 3DP insole stakeholder guided improvements and next steps

The clinician concerns about the hygiene of the 3DP insole’s porous structure has been addressed in our current iteration of the fully 3DP insoles with a thin 3D-printed top cover (Figure 3) that reduces the number of openings in the insole. The porous nature of the 3DP insole’s surface cannot be fully eliminated, as some holes are required for the specific fabrication process of our materials and layup. The existing evidence of the 3DP insole’s ability to reduce plantar pressures in a healthy adult population⁷ and the design incorporating adjustable lattice structures¹¹ which are representative of the SoC properties¹² are important first steps in the case for obtaining a billable code. The reimbursement rate of the 3DP insoles will need to be large enough to make it economical for clinicians to adopt the technology, covering the cost of materials, fabrication, and clinician time. With reduced frequency of insole replacement and clinician time, the 3DP insoles will offer a more cost and time effective solution. However, as clinicians stated, there needs to be further research into the appropriate length of time to keep an individual with diabetes and at-risk feet in the same pair of insoles, as a motivating factor for many insole users to be seen for a foot health assessment is the need for new insoles.

Figure 3.

Updated 3DP insole with thin topcover.

3). Feasibility of translating the insoles and fabrication workflow into a clinical setting

The addition of the new pressure sensing and scanning technologies to the clinical setting will require training and full clinician buy in. The clinicians feel that the addition of approximately 10 minutes to capture plantar pressure and scan the foot would not be a major burden to the appointment, especially if it results in fewer appointments and less clinician time down the road. However, prior to investing the time to train and become familiar with the 3DP insoles and the technologies required to fabricate them, the clinicians want to see the evidence that they improve patient outcomes. Previous studies have shown the ability of the 3DP insoles in reducing areas of high pressure in individuals without ulceration risk, deformity, or neuropathy⁷. Further user testing is underway to prove the efficiency of the insoles in reducing high pressures in users with at-risk feet (VA RR&D Merit Award A3539R). It will be important to gather user feedback on the comfort of the insoles compared to the SoC and collect any other subjective feedback from them to further improve the 3DP insole design.

Limitations

The themes pulled from these focus groups are only representative of the perspectives of the sixteen clinicians who participated. The clinicians all practice within the same geographical location. Discussions with more clinicians in a broader geographical area may elicit new or differing feedback regarding the 3DP insoles. It is acknowledged that participants with strong opinions can heaviliy sway and dominate the discussion in focus group settings¹⁹. The moderators worked to encourage all participants to be involved in the conversation and expand on any gestures of agreement. The groups were kept small to allow for more individual contributions²⁰. It can also be noted that because of the semi-structured interview style and the differing group compositions, the conversation in the focus groups was led in different directions creating limits to the generalizations that can be made¹⁹. The use of a healthcare provider as a moderator can affect group discussions, for this reason only one of the three moderators at each session was a healthcare provider^20,21. The moderators used unbiased prompting in efforts to avoid influencing the discussions and keep the clinicians comfortable enough to share their true thoughts and experiences ²².

Conclusion

Overall, clinicians expressed enthusiasm about the potential for improvements in the accommodative insole market. They were vocal about believing in the direction we are going with the 3D printing technologies. Addressing the concerns and improvements of the identified themes is essential to modify the design of future iterations of the 3DP insoles. Optimizing the 3DP insoles to perform effectively and meet clinician needs will continue to improve clinical care and patient outcomes for individuals using accommodative insoles.