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The mammoth American healthcare system rarely appears to be too interested in the world of O&P. On those rare occasions when our profession does garner some attention, the last voice the Centers for Medicare & Medicaid Services (CMS) seems to consider is that of the O&P providers themselves. Fortunately, there are smaller ships elsewhere in the world where informed O&P practitioners are closer to the rudder. Scotland represents one such practice environment. In 2009, Scotland’s National Health Service (NHS) engaged orthotists and other interested medical professionals to develop a Best Practice Statement to guide the use of AFOs following stroke. The purpose of this article is to review some of the concepts contained within this foundational document that might serve as a model for future practice statements.

Limited Role of Prefabricated Devices

Early in the document, the role of prefabricated AFOs in post-cerebral vascular accident (CVA) care is defined by a series of key points. Within this context, the following characteristics and conditions for prescription are defined for prefabricated AFOs:

• Should be prescribed based on biomechanical deficit and clearly identified functional objectives rather than convenience.
• Are primarily of benefit in improving swing phase.
• Are of limited value in the presence of complex gait abnormalities or deformities.
• May be utilized as temporary or assessment devices, but should be used with caution.
• Take no account of gastrocnemius shortening, which can develop quickly after a stroke.

Few experienced O&P practitioners would disagree with these statements, but most could also cite individual cases in which legacy stroke patients were referred to them after the sound principles contained in one or more of these statements were circumvented or ignored. This carefully thought-out position on prefabricated AFOs stands in rather stark contrast to the treatment approaches that are commonly observed in the United States as a result of current CMS policy. Given that Medicare will only pay for AFOs for those patients who are discharging from inpatient stay into their homes and the community, the reality is that among Medicare beneficiaries, more expensive custom AFOs are more likely to be received by these less impaired individuals. In contrast, Medicare will not cover the cost of AFOs for more impaired individuals with longer inpatient stays followed by discharge to a skilled nursing facility (SNF). Because the cost of these devices are typically borne by either the hospital or, more frequently, the SNF, those CVA patients with the greatest level of disability, prone to “complex gait abnormalities” are more likely to receive low-cost, prefabricated AFOs.

To be fair, this is not stated policy. The official position of CMS with regard to custom devices is consistent with the sentiments of the Scottish Best Practice Statement, text that would be appropriate in many letters of medical necessity for this population:

“[F]ollowing a stroke, many patients develop complex triplanar deformities in the subtalar and midtarsal joints of the foot. To control these deformities, it is important that the AFO fits intimately and crucially that it applies corrective forces to the appropriate areas of the lower part of the leg and foot comfortably. As no prefabricated AFO can achieve this, a custom-made AFO is indicated in these cases.”

However, the CMS policy precluding payment for these devices while patients are in the hospital or in an SNF often effectively precludes the provision of custom AFOs to the individuals who might stand to benefit the most from them. The provision of cheaper, less effective prefabricated AFOs to this population is one area where U.S. practice patterns differ from that of the Scottish Best Practice Statement.

Timing and Training

The following related series of statements from the Scottish document addresses the important issues of the timing and training that should accompany the provision of an AFO:

• AFOs may help avoid the development of abnormal patterns, or prevent such patterns becoming established, and should therefore be considered for early intervention
• rather than as last resort.
• Additional therapeutic, pharmaceutical, or surgical interventions may be required to optimize AFO function.
• AFOs should be regarded as an adjunct to therapy, not a replacement.

Again, the combined message of these statements would seem obvious. In the presence of severe weakness, when the risks of acquired compensations and deformities are at their highest, the provision of an AFO should occur earlier rather than later. Further, its use should be coupled with adequate physical therapy to derive maximum benefit.

However, once more, current CMS policy often prevents this logical approach. Because of the well-known “two-day rule,” detailing that an AFO can only be billed to CMS if it is provided within 48 hours of discharge from inpatient care, Medicare beneficiaries can’t receive training with the device that they will often use for years after their discharge. Instead, inpatient therapists improvise with whatever donated or prefabricated resources they have in their gyms throughout the inpatient stays, and patients are provided a very different device on their way out of the hospital. Training with this new device occurs either in a less-rigorous outpatient setting or not at all. This stands as another example of a healthcare policy that seems to undermine sound practice guidelines.

The Orthotist’s Role

It would seem intuitive that the professionals with the most first-hand experience in the provision of AFOs should have appreciable input on design details of the device. While this is often the case, it doesn’t always occur, with some physicians largely prescribing AFO type by diagnosis. By comparison, consider the positions of the Scottish best practice document:

• When considering orthotic intervention poststroke, referral by other professionals should take the form of a request for combined assessment, rather than a prescription.
• Assessment for an AFO should be undertaken jointly by a specialist orthotist and specialist physiotherapist.
• AFO design specification should be the responsibility of an orthotist, and must be based on sound biomechanical principles and a clear statement of desired functional outcomes.
• Referrals should be made using a nationally agreed orthotic referral form.

In regard to this last statement, the standardized Orthotic Referral Form requires the referral source to identify the relevant history and diagnosis, presenting problems and treatment objectives. However, it does not ask the referrer to recommend a specific device. That decision is made by the orthotist based on the other information provided by the referral source.

This common-sense approach of allowing the expert to be the expert is juxtaposed by the CMS position of mandating that physicians, who are less experienced in orthotics, sign off on orthotists’ individual L-Code recommendations and in some cases, defend them in their physician’s chart note.

Angle Alignment: The Scottish Approach to “Tuning”

The concept of “tuning” the alignment of an AFO has been well disseminated for some time. At its core are several fundamental concepts.

• Custom-made AFOs should be designed to take account of gastrocnemius shortening (i.e., made in a plantarflexed alignment if necessary). This is because if the AFO holds the foot in a more dorsiflexed position than that which can be achieved with the knee extended, the orthosis will actually limit knee extension, thereby negatively impacting hip and knee control.
• AFOs that permit ankle dorsiflexion (either due to the presence of mechanical ankle joints or the flexibility of the design) are inappropriate in the presence of gastrocnemius shortening as dorsiflexion occurs at the expense of knee extension.
• Solid AFOs, when combined with footwear, should not position the tibia at 90 degrees to the ground. The tibia should incline forward approximately 10 degrees to optimize kinetics and kinematics at the knee and hip.
• Solid AFOs should be tuned by the addition or removal of small heel wedges in order to adjust the inclination of the tibia to optimize gait for each individual patient. For some patients this is a highly sensitive process.

For those who are unfamiliar with the intricacies of AFO tuning, the Best Practice Statement contains an explanatory note within its appendix, detailing the rationale and mechanism of tuning the shank angle of an AFO/shoe combination to maximize standing and walking alignment. These detailed considerations of joint angles and material stiffness stand out in stark contrast compared to competing healthcare systems in which the basic differences between off-the-shelf and custom AFOs are poorly recognized.

AFOs and Quality of Life

There is an inescapable inconvenience that comes with the use of an AFO. The devices are inherently restrictive, can be hot, and will often limit a patient’s choice of shoes. Given these realities, it can be easy to view AFOs as an unfortunate negative element in the lives of end users. However, surveys undertaken as part of the development of the Scottish Best Practice Statement seem to suggest the opposite, as revealed in the following data points:

• 85 percent of respondents managed better on their own with the AFO.
• 69 percent of respondents felt that the AFO helped them get out and meet people.
• 84 percent of respondents reported better confidence levels.
• 96 percent of respondents felt walking was easier using an AFO.
• 58 percent of respondents reported that the AFO takes away their distress.
• 68 percent of respondents reported that the AFO takes away fear of falling.
• 64 percent of respondents reported that the AFO made them feel better about themselves.

While the document provides limited details on the demographics of those surveys, it is clear that the majority of those surveyed found tremendous value in using AFOs with respect to physical function and psychological well-being. The survey results serve as a good reminder that, properly designed and fabricated, and their associated inconveniences notwithstanding, AFOs can ultimately improve end users’ well-being and quality of life.

AFO Screening Tool

While the functional benefits associated with an AFO following stroke are readily evident to established users and experienced providers, there are many stroke survivors with residual gait deficits who have not been evaluated by knowledgeable clinicians and, as a result, contend unnecessarily with gait deficits that might be reasonably addressed through an AFO. While the best practice guidelines include the utopian statement that “all patients with mobility problems following a stroke should have timely and equitable access to specialist orthotic services,” it also seeks to better ensure this access through the creation of a standardized screening tool that would help other allied healthcare providers identify those individuals for whom an AFO might be beneficial.

The one-page questionnaire invites a quick examination of the individual’s ability to transfer, stand, walk, and perform activities of daily living. With respect to the observed walking pattern, the screening tool requests an examination of such elements as swing phase clearance, the quality of the individual’s initial contact, stability during midstance, and alignment during late stance. If the screening tool identifies deficiencies or concerns, then a referral to a joint assessment clinic is encouraged.

Conclusion

Clinicians have spent years refining their expertise in the provision of care. Each has developed his or her own guidelines for providing optimal care. As such, the creation of a canonized “Best Practice Guideline” may at first seem redundant or unnecessary. However, the Scottish document helps demonstrate the value of such efforts. The reality is that healthcare systems require regulatory policy, and when these policies are made without the participation of the providers within the profession, they can create compromised treatment practices similar to those observed in the United States under current CMS guidelines. The Scottish Best Practice Statement is unique both in that it is the first of its kind and in the obvious influence of clinical orthotists in its creation. As such, it stands as a good example of how treatment guidelines can guide logical care decisions that protect the best interests of the patients being treated.

Phil Stevens, MEd, CPO, FAAOP, is in clinical practice with Hanger Clinic, Salt Lake City, Utah. He can be reached at

Resources

Author’s note: The Best Practice Statement can be accessed at www.oandp.com/link/270. Within the appendices are guidelines on tuning AFOs (Appendix 7), The Ankle-Foot Orthosis Screening Tool (Appendix 9), and the Orthotic Referral Form (Appendix 10) referred to in this article.