0565 ankle orthoses, ankle-foot orthoses (afos), …...see cpb 0009 - orthopedic casts, braces, and...

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Ankle Orthoses, Ankle-Foot Orthoses (AFOs), and Knee-Ankle-Foot Orthoses (KAFOs) ... of 40

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Ankle Orthoses, Ankle-Foot Orthoses (AFOs), and Knee-Ankle-Foot Orthoses (KAFOs)

Policy History

Last

Review

08/16/2018

Effective: 09/28/2001

Next

Review: 06/13/2019

Review

History

Definitions

Additional

Information

Number: 0565

Policy

*Please see amendment forPennsylvaniaMedicaid

at theend of this CPB.

Aetna considers ankle orthoses, ankle-foot orthoses (AFOs), and knee-ankle-foot

orthoses (KAFOs) medically necessary durable medical equipment (DME) according

to the criteria set forth below. (See background section of this clinical policy bulletin

(CPB) for descriptions of the orthotics discussed in this policy).

I. Ankle Orthotics

Aetna considers ankle orthoses medically necessary DME for members who

meet the criteria set forth below. (See background section of CPB for

descriptions of each of these orthotics).

▪ Ankle air-stirrups : Ankle air-stirrups (e.g., Air Cast) are considered medically

necessary DME when used after an ankle injury (fractures or sprains). Air-

stirrups are considered experimental and investigational for chronically

unstable ankles or to prevent ankle re-injury because of a lack of adequate

evidence of the effectiveness of ankle air-stirrups for these indications.

See CPB 0009 - Orthopedic Casts, Braces, and Splints (../1_99/0009.html).

08/28/2018

http://www.aetna.com/cpb/medical/data/500_599/0565.html

https://www.aetna.com/

http://qawww.aetna.com/cpb/medical/data/500_599/0565_draft.html 08/28/2018


Clinical

Policy

Bulletin

Notes

▪ Elastic ankle sleeves : Aetna considers reusable elastic ankle sleeves

medically necessary DME for use to treat an ankle injury (acute and

rehabilitative stages). Use of elastic ankle sleeves in a chronically unstable

ankle or to prevent ankle re-injury is considered experimental and

investigational because of a lack of adequate evidence of the effectiveness of

elastic ankle sleeves for these indications.

▪ Lace-up ankle braces : Lace-up ankle braces are considered medically

necessary DME when used in members with ankle injuries, when used in

members with chronically unstable ankles, or when used to prevent ankle re-

injury.

▪ Orthopedic ankle cast-braces : Orthopedic ankle cast-braces are considered

medically necessary DME when used after an ankle injury (fractures or

sprains).


▪ Orthoplast ankle stirrups : Orthoplast ankle stirrups are considered

medically necessary DME for use after an acute injury. Use of orthoplast

ankle stirrups in chronically unstable ankles or to prevent ankle re-injury is

considered experimental and investigational because of a lack of adequate

evidence of the effectiveness of orthoplast ankle stirrups for these

indications.

▪ Post-operative rehabilitative ankle braces : Aetna considers post-operative

rehabilitation ankle braces medically necessary when applied within 6 weeks

of surgery. Such post-operative rehabilitative braces are considered an

integral part of surgery. See

also CPB 0009 - Orthopedic Casts, Braces, and Splints (../1_99/0009.html).

▪ Rigid ankle casts : Rigid ankle casts are considered medically necessary

DME when used to treat ankle fractures. Rigid ankle casts are considered

experimental and investigational when used after ankle sprains, for

chronically unstable ankles, or when used to prevent re-injury because of a

lack of adequate evidence of the effectiveness of rigid ankle casts for these

indications.

▪ Semi-rigid ankle casts : Semi-rigid ankle casts are considered medically

necessary DME when used to treat ankle sprains. Semi-rigid ankle casts are

considered experimental and investigational when used after ankle fractures,

for use in chronically unstable ankles, or when used to prevent re-injury

because of a lack of adequate evidence of effectiveness of semi-rigid ankle

cases for these indications.




▪ Stabilizing shoes : Stabilizing shoes for ankle injuries (acute or chronic) are

considered experimental and investigational. Note: In addition, most plans

contractually exclude foot orthotics. Please check benefit plan descriptions.

See CPB 0451 - Foot Orthotics (../400_499/0451.html).

▪ Unna boots : Unna boots are considered medically necessary DME when

used after ankle sprains and other soft tissue injuries. Unna boots are

considered experimental and investigational when used after ankle fractures,

or when used in chronically unstable ankles or to prevent re-injury because of

a lack of adequate evidence of the effectiveness of Unna boots for these

indications.


II. Ankle Foot Orthoses (AFOs) and Knee Ankle Foot Orthoses (KAFOs)

A. AFOs and K AFOs used in minimally ambulatory or non-ambulatory

persons : Static or dynamic positioning ankle foot orthoses (ankle

contracture splints) and foot drop splints

1. Static or dynamic positioning ankle foot orthoses : Aetna considers

static or dynamic positioning ankle-foot orthoses medically necessary

DME if all of the following criteria are met:

a. The static or dynamic positioning ankle-foot orthoses is used as a

component of a therapy program that includes active stretching of the

involved muscles and/or tendons, and

b. The contracture is interfering or expected to interfere significantly with

the member's functional abilities, and

c. There is a reasonable expectation of the ability to correct the

contracture, and

d. The member has a plantar flexion contracture of the ankle with

dorsiflexion on passive range of motion testing of at least 10

degrees (i.e., a non-fixed contracture).

If a static or dynamic positioning ankle-foot orthosis is used for the

treatment of a plantar flexion contracture, the pre-treatment passive

range of motion must be measured with a goniometer and

documented in the medical record. There must be documentation of

an appropriate stretching program carried out by professional staff (in

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a nursing facility) or caregiver (at home).

A static or dynamic positioning ankle-foot orthosis is considered

medically necessary for plantar fasciitis.

If a static or dynamic positioning ankle-foot orthosis is considered

medically necessary, a replacement interface is also considered

medically necessary DME as long as the member continues to meet

medical necessity criteria for the splint. Up to 1 replacement interface

per 6 months is considered medically necessary.

A static or dynamic positioning ankle-foot orthosis and replacement

interface is not considered medically necessary for the following

indications:

▪ Fixed contractures;

▪ Members with foot drop but without an ankle flexion contracture.

Note: In addition, under HMO plans, a static or dynamic positioning

ankle-foot orthosis and replacement interface is not considered

medically necessary when it is used solely for the prevention or

treatment of a heel pressure ulcer because Medicare does not

consider it medically necessary for these indications.

A component of a static or dynamic positioning ankle-foot orthosis

that is used to address positioning of the knee or hip is considered

experimental and investigational because the effectiveness of this

type of component is not established.

2. Foot drop splint/recumbent positioning device : Aetna's HMO plans do

not consider a foot drop splint/recumbent positioning device or

replacement interface medically necessary. A foot drop

splint/recumbent positioning device and replacement interface is not

considered medically necessary under HMO plans when it is used

solely for the prevention or treatment of a heel pressure ulcer because

Medicare does not consider it medically necessary for these

indications. A foot drop splint/recumbent positioning device and

replacement interface is not considered medically necessary for




08/28/2018

members with foot drop who are non-ambulatory because there are

other more appropriate treatment modalities.

3. Additions to AFOs and KAFOs : Additions to AFOs or KAFOs are not

considered medically necessary if either the base orthosis is not

medically necessary or the specific addition is not medically necessary.

B. AFOs and KAFOs used in ambulatory persons

1. AFOs in ambulatory members : Ankle-foot orthoses (AFO) are

considered medically necessary DME for ambulatory members with

weakness or deformity of the foot and ankle, which require

stabilization for medical reasons, and have the potential to benefit

functionally. Members prescribed custom-made “molded-to-patient-

model” AFOs must also meet the criteria set forth in section II.B.3,

below. AFOs are n ot considered m edically necessary for ambulatory

members who do not meet these medical necessity criteria.

Aetna's HMO plans do not consider AFOs and an y related addition

medically necessary when used solely for the treatment of edema

and/or for the prevention or treatment of a heel pressure ulcer in

ambulatory patients, as Medicare d oes not consider AFO's medically

necessary for these indications.

Additions to AFOs or KAFOs are n ot considered medically necessary if

either the base orthosis is not medically necessary or the specific

addition is not medically necessary. (Note: Customized Noodle TA

AFO and the PHAT dynamic carbon fiber AFO are considered non-

covered d eluxe items).

2. KAFOs in ambulatory members : Knee-ankle-foot orthoses (KAFO) are

considered medically necessary DME for ambulatory members for

whom an ankle-foot orthosis is considered medically necessary and

for whom additional knee stability is required. Members prescribed

custom-made “molded-to-patient model” KAFOs must also meet the

criteria set forth in section II.B.3, below. KAFOs are not medically

necessary and are not covered for ambulatory members who do not

meet these coverage criteria.




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Aetna's HMO plans do not consider KAFOs and any related addition

medically necessary when used solely for the treatment of edema

and/or for the prevention or treatment of a heel pressure ulcer in

ambulatory members, as Medicare does not consider KAFO's

medically necessary for these indications.

3. Molded-to-patient model AFO's and KAFO's in ambulatory members :

Custom-made AFOs and K AFOs that are “molded-to-patient-model”

are c onsidered m edically necessary DME for ambulatory members

when the basic medical necessity criteria listed in sections II.B.1 and

II.B.2 above are met and one of the following criteria is met:

a. The condition necessitating the orthosis is expected to be permanent

or of longstanding duration (more than 6 months); or

b. There is a need to control the knee, ankle or foot in more than 1 plane;

or

c. The member could not be fitted with a pre-fabricated (off-the-shelf)

AFO; or

d. The member has a documented neurological, circulatory, or

orthopedic status that requires custom fabricating over a model to

prevent tissue injury; or

e. The member has a healing fracture that lacks normal anatomical

integrity or anthropometric proportions.

4. Additions to AFOs and KAFOs : Additions to AFOs and KAFOs are not

considered medically necessary if either the base orthosis is not

medically necessary and/or the specific addition is not medically

necessary.

5. Concentric adjustable torsion-style mechanisms :

Concentric adjustable torsion style mechanisms used to assist knee

joint extension are considered medically necessary for members who

require knee extension assist in the absence of any co-existing joint

contracture.




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Concentric adjustable torsion style mechanisms used to assist ankle

joint plantarflexion or dorsiflexion are considered medically necessary

for members who require ankle plantar or dorsiflexion assist in the

absence of any co-existing joint contracture.

A dynamic adjustable ankle extension/flexion device is considered

medically necessary for treatment of contractures.

6. Microprocessor-controlled KAFOs : Electronic KAFOs (e.g., the Sensor

Walk Electronic KAFO, C-Brace Orthotronic Mobility System) are

considered experimental and investigational because of insufficient

evidence that they improve ambulation compared to standard KAFOs.

III. General Notes:

▪ Prophylactic orthotics : Aetna does not consider ankle orthotics, AFOs,

and KAFOs medically necessary treatment of disease when used to

prevent injury in a previously uninjured ankle or knee. Such use is solely

preventive, and therefore is considered not considered medically

necessary treatment of disease or injury. In addition, many Aetna plans

exclude coverage of safety items.

See CPB 0623 - Safety Items (../600_699/0623.html).

▪ Repairs and replacements : Repairs to a medically necessary ankle

orthosis, AFO, or KAFO due to wear and tear are considered medically

necessary DME when they are needed to make the orthosis functional.

Replacement of a complete ankle orthosis, AFO, or KAFO or component

of these orthoses due to a significant change in the member's condition or

irreparable wear is considered medically necessary DME if the device is

still medically necessary.

▪ Shoes : Please see CPB 0451 - Foot Orthotics (../400_499/0451.html) for

medical necessity criteria for shoes and related items that are an integral

part of a leg brace.

▪ Socks : Socks used in conjunction with ankle orthoses, AFOs, or KAFOs are

not covered because socks do not meet the contractual definition of

durability for covered DME.

▪ Spare orthotics : Identical spare orthotics purchased for the member's

convenience is not considered medically necessary. More than 1 set of

different orthotics, however, may be medically necessary.




▪ Sports orthotics : Aetna does not consider ankle orthotics, AFOs, and

KAFOs medically necessary if they are to be used only during

participation in sports. Such use is considered not medically necessary,

as participation in sports is considered an elective activity.

See also CPB 0696 - Suit Therapy (../600_699/0696.html).

Background

An orthosis (brace) is a rigid or semi-rigid device that is used for the purpose of

supporting a weak or deformed body member or restricting or eliminating motion in a

diseased or injured part of the body. An orthosis can be either pre-fabricated or

custom-fabricated.

Custom-Made versus Pre-Fabricated (Off-the-Shelf) Orthoses:

A pre-fabricated (off-the-shelf) orthosis is one that is manufactured in quantity

without a specific patient in mind. A pre-fabricated orthosis may be trimmed, bent,

molded (with or without heat), or otherwise modified for use by a specific patient

(i.e., custom-fitted). An orthosis that is assembled from pre-fabricated components

is considered pre-fabricated. Any orthosis that does not meet the definition of a

custom-fabricated (custom-made) orthosis is considered pre-fabricated.

A custom-fabricated (custom-made) orthosis is one that is individually made for a

specific patient starting with basic materials including, but not limited to, plastic,

metal, leather, or cloth in the form of sheets, bars, etc. It involves substantial work

such as cutting, bending, molding, sewing, etc. It may involve the incorporation of

some pre-fabricated components. It involves more than trimming, bending, or

making other modifications to a substantially pre-fabricated item. A molded-to-

patient-model orthosis is a particular type of custom-fabricated orthosis in which an

impression of the specific body part is made (by means of a plaster cast, CAD-CAM

technology, etc.) and this impression is then used to make a positive model (of

plaster or other material) of the body part. The orthosis is then molded on this

positive model.

Ankle Orthotics:

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Ankle orthotics may potentially be useful after an acute ankle injury (acute ankle

sprain (ligament injury) or fracture), for rehabilitation, to prevent ankle re-injury, and

for chronically unstable ankles. Whether a specific ankle orthotic is effective

depends on the particular indication for its use.

There are 4 potential uses for ankle supports: (i) Prophylaxis (used primarily in

patients with a history of ankle injury); (ii) Rehabilitation (for the first few weeks

following injury until full function is obtained); (iii) Treatment of acute injury (i.e.,

beginning within 3 days following injury); and (iv) Treatment of chronic

instability. The length of time that ankle supports need to be used following injury

varies depending largely on the type and severity of the injury

Treatment after acute injury: The ankle begins to swell after injury, and swelling

continues to increase for about 3 days following injury. Significant swelling persists

for about 2 weeks following injury.

Rehabilitation: Ankle supports have been used for the first few weeks following injury

to prevent re-injury during early return to activity. After the pain has subsided and

the patient can walk without a limp, use of the ankle support is only appropriate

during high-risk activities (i.e., especially racquetball, football, and basketball).

Leaving the ankle support on all the time only serves to restrict functional range of

motion and encourage psychological dependence.

Prophylaxis: Ankle supports have been used to prevent injury in uninjured

individuals and persons with a history of ankle sprain. There is generally no reason

for prophylactic bracing in low-risk activities, such as standing, walking, or climbing

stairs. And it is not clear that prophylactic bracing should be advocated for use

during high-risk sports as well, because of prophylactic bracing's cost,

inconvenience, and possible detraction from athletic performance.

Chronic instability: Ankle supports are used to stabilize the ankle in patients with

chronic instability. In most instances, they are to be used only during high-risk

sports and activities. It is unusual for ankle supports to be prescribed for use during

normal daily activities.

Many types of ankle supports exist as an alternative to ankle taping. In addition,

shoes for some sports (particularly basketball) are available with high tops and built

in straps for additional ankle protection.

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Ankle Orthoses, Ankle-Foot Orthoses (AFOs), and Knee-Ankle-Foot Orthoses (KAFO... of 40

Recent studies have shown that use of ankle supports during early rehabilitation of

acute grade I or grade II ankle sprains (partial ligament rupture) produced results as

good as cast immobilization, with more rapid return to activity.

The following is a description of various types of ankle supports, and a summary of

the evidence of their effectiveness. Numerous difficulties arise in interpreting the

studies of the various treatments for ankle sprains. First, most ankle sprains heal

well regardless of the form of treatment; thus, almost all treatments produce good

results. It is difficult to measure marginal differences among them.

Second, difficulties arise in comparing different treatment protocols and brands of

products. Research is needed to standardize forms of treatment and to compare the

many products on the market.

Third, research has focused on which provide the best mechanical support of the

ankle in laboratory stress testing, but it has not been demonstrated that this is the

most important factor in predicting clinical outcomes. It may be that the quality of

the proprioceptive (position-sense) feedback from the device is the most important

predictor of clinical outcomes.

Taping:

A number of studies have supported the use of tape in helping stabilize the ankle

and reducing sprains in persons with previous sprains.

The goal of taping is to prevent the ankle ligaments from being stressed to the point

of injury. Taping should limit ankle inversion and eversion but allow functional

dorsiflexion and plantarflexion. There is evidence that ankle taping also helps

prevent injury by stimulating proprioceptive (position-sense) nerve fibers, causing

the peroneus brevis muscle to be activated just before heel strike.

For treatment of acute injury (beginning within about 3 days following injury), taping

may be used to provide support and to help reduce edema (swelling). Felt or foam

pads may be applied under the tape to help reduce edema.

Taping may be used for rehabilitation (i.e., to prevent re-injury during early return to

activity). About 3 days after the injury, swelling subsides, and tape is re-applied to

decrease the risk of re-injury. Using tape to prevent injury, however, is a time-

08/28/2018




consuming procedure, so it is recommended for early stages of rehabilitation only.

Tape may be applied for the first few weeks after return to activity for rehabilitation of

ankle injuries.

Taping may be used prophylactically in persons with or without a prior ankle sprain,

although it is not recommended for routine use for this indication. Although taping

probably reduces the rate of ankle injuries, it loses support rapidly with movement

and sweating. This is not as much as a factor in acute sprains, because in which

tape is not stressed so much. For use prophylactically, however, it is not a time- and

cost-effective option compared to the alternatives described below.

Taping has also been recommended as a possible treatment for chronic instability,

although it is not recommended for routine use in this situation. With movement and

sweating, tape rapidly loses support. Also, if used permanently, tape becomes

expensive. This approach is probably not as cost- and time-effective as other

options described below.

One-inch wide standard tape is used for the foot, and 1½-inch tape for the ankle.

Areas sensitive to blistering must be protected with lubricated gauze sponges.

Special adherent spray may be applied under the tape. If tape is to be re-applied

often, an underwrap is used to prevent chronic skin irritation.

Tape should only be wrapped by a person well-trained in its application, such as a

trainer, physician, nurse, or physician assistant. Improperly applied tape may cause

further injury.

Elastic tape has also been studied, and although it provides more compression than

non-elastic tape, it loses its restriction of range of motion even more than standard

tape.

Tape and wrapping does not meet the durability requirement for covered durable

medical equipment, in that it is not reusable and is not “made to withstand prolonged

use.” Although Aetna will cover taping or wrapping provided by a healthcare

provider in their office, take-home tape and wrapping are not covered.

Elastic Wrapping and Sleeves:

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Wrapping with elastic bandages is useful in the early stages (about the first 3 days)

of ankle sprain to provide compression that reduces swelling. It is used as an

adjunct to ice and elevation. It needs to be changed often to monitor the skin.

Wrapping has not been proven to be useful for other indications: prevention of re-

injury, prophylactic use, and use for chronic ankle instability. This is because

wrapping provides little or no support during activity.

Elastic ankle sleeves that are pulled over the foot like open-ended socks offer no

value as supports. They may, however, enhance proprioception. They may also

provide even compression to reduce ankle edema. Thus, they have been shown to

be useful only in treating an acute ankle sprain (i.e., within about 3 days after injury).

Like elastic wrapping, elastic ankle sleeves have not been proven to be useful for

rehabilitation, prophylaxis, or use in chronically unstable ankles.

Certain manufacturers, e.g., Stromgen, combine the comfort of even compression

by using Spandex, elastic, and Velcro strap combinations to restrict eversion, and

inversion. They have been used primarily for prophylaxis.

Bracing:

Like taping, bracing can be used in an acute injury, during rehabilitation to prevent

re-injury, prophylactically, and in chronically unstable ankles. Braces come in 3

main types: casts, lace-up wraps, and plastic orthoses. Casts can be either semi-

rigid or rigid; lace-up braces and plastic orthoses are considered semi-rigid.

Braces have been shown to have several advantages over taping. They can be

used by persons who do not have access to a person skilled in taping techniques.

In some cases, they can be more cost-effective than taping. But some braces may

migrate during vigorous movement because of the lack of adhesion to skin. This

movement may cause the brace to fail to provide support. But tape adhesion or

straps to reduce migration may help. During wear-and-tear, Velcro fasteners tend to

fail and release, straps or buckles break, and elastic stretches out. Off-the-shelf

braces may not fit persons who are too tall, are obese, or deformed. Custom-made

braces are available, but are generally more expensive.

Rigid Plaster Casts:

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Rigid plaster casting, once a common treatment for acute ankle sprains, has now

been generally abandoned for this use. Plaster casting continues to be used in foot

and ankle fractures.

Compared with taping, rigid plaster casting has been shown to increase the time to

return to activity and has not been shown to produce a better outcome, even in

patients with grade III ankle sprains (complete rupture of a ligament).

Still, rigid casting is an option to consider for the early post-operative phase or in

cases of gross ankle instability. When acute swelling subsides, the cast should be

replaced with a better fitting one. It should be replaced with semi-rigid bracing as

soon as possible, usually within 1 to 2 weeks.

Rigid casting is not used to prevent re-injury during rehabilitation, for prophylaxis, or

for chronic instability.

Soft (Semi-Rigid) Casts:

Semi-rigid casting is done with a wrap that hardens somewhat after application but

does not become completely rigid. The Una (Unna's) boot (Graham Field, Inc.,

Hauppage, NY) is a semi-rigid cast that consists of a gauze bandage that contains

glycerin and gelatin and is applied over a felt bone around the anklebone (the medial

malleolus). In an acute sprain, it provides some support and compression. Ice is

commonly applied around the boot, but no studies have demonstrated adequate

tissue cooling with this technique. In the treatment of acute ankle injuries, semi-rigid

casts have not been shown to be more effective than tape. Semi-rigid casting does

not offer enough support to be used to prevent injury during rehabilitation, for

prophylaxis, or for chronic instability.

Lace-Up Braces:

Lace-up braces have been proven to be as effective as tape at restricting ankle

range of motion, and unlike tape, lace-ups do not tend to lose their supportive ability

during activity. Lace-up braces are a cost-effective alternative to taping. They are

safe, easy to apply, and reusable. They are not of much value in the acute stage of

injury because they do not provide good uniform compression. They are probably of

some value in preventing re-injury during rehabilitation, for prophylactic use, and for

use in patients with chronic ankle instability.

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There are a number of brands of lace-ups available; no controlled comparisons have

been performed to determine if one brand offers advantages over others. Examples

of variants of standard lace-ups include: (i) Braces that use Velcro closures in place

of laces; (ii) The Cramer brace (Cramer Products, Gardner, KS), which

incorporates a lace-up design with outside straps to provide a heel lock; (iii) The

McDavid ankle lace-up brace (McDavid Knee Guard, Chicago, IL) and the

Swede-O ankle lace-up brace (Swede-O Universal, North Branch, MN), which can

accommodate steel or plastic stays for extra support.

Air-Stirrups:

The air-stirrup is a pre-fabricated semi-rigid orthosis. The largest-selling brand is the

Aircast air-stirrup ankle brace (Aircast, Summit, NJ), which is composed of a rigid

outer plastic shell that fits up both sides of the leg and is connected under the heel. It

is lined with inner air bags and is attached to the leg with Velcro. As with lace-up

ankle supports, some clinicians combine use of the air-stirrup with taping. The air-

stirrup is an off-the-shelf device that does not require custom fitting. It can be worn

under regular shoes.

The air-stirrup decreases inversion and eversion, and protects the already injured

ligament and soft tissues from re-injury, thereby decreasing rehabilitation time. The

pressure in the air-stirrup increases when weight-bearing, which is thought to

provide intermittent compression during walking that aids in the milking out of

edematous fluid. The air-stirrup can also be readjusted to allow total contact fitting

while swelling is fluctuating.

The air-stirrup can be used after acute ankle sprains and in the early stages of

rehabilitation to prevent recurrent sprain. It can also be used after rigid casting and

for treatment of some fractures. There is currently insufficient evidence for their use

for prophylaxis or in chronic instability, although some newer variations of the splint

have been designed for this purpose.

Other Semi-Rigid Orthoses:

Other semi-rigid orthoses have not been studied adequately to make accurate

comparisons with taping or with air-stirrups. These include the following:

08/28/2018




▪ DonJoy Ankle Ligament Protector (DonJoy, Carlsbad, CA) is a plastic brace that

seems to restrict range of motion as well as the air-stirrup and possibly better

than tape, although no head-to-head comparisons have been published.

▪ The Active Ankle (Active Ankle Systems, Louisville, KY) has a stirrup and air cell

liner with a hinged ankle may also be useful.

▪ The Malleoloc (Bauerfiend USA, Kennesaw, GA) is a stabilizing ankle orthosis

that uses a wrap-around ankle brace in conjunction with Velcro strapping.

Although it shows promise, definitive proof if its effectiveness is not yet available.

Other Ankle-Stabilizing Orthoses:

▪ Non-Elastic Cloth Wrapping: Non-elastic cloth wrap (also known as the Louisiana

heel lock) has been applied over socks to prevent ankle injury. The advantage of

this system is that the wrap can be washed or reused, thus reducing cost.

Cloth wrapping may improve position-sense, but it appears to offer less benefit

than taping. Its use in ankle injuries has not been adequately studied.

▪ Nylon and Nylon/Elastic Wrapping: Nylon or Nylon/Elastic heel wraps to be

placed over socks may also improve position sense, but like non-elastic cloth

wrapping, their use in ankle injuries has not been adequately studied.

▪ Orthoplast Stirrup: The orthoplast stirrup is a strip of thermoplastic material

custom-fitted to run under the heel and up both sides of the leg. The ankle

bones (malleoli) and other bony prominences are covered with foam padding,

and the stirrup is fitted with an elastic bandage.

Orthoplast is a low-temperature thermoplastic that becomes pliable when

submerged in hot water. It is applied directly to the patient and molded evenly

around the ankle. The fabrication is simple enough to be carried out in the office or

clinic.

The orthoplast stirrup has been successfully used to treat ankle sprains, but

because it is relatively hard, it does not adapt to reduction in swelling. It has not

been shown to decrease inversion range of motion more than tape, and is most

commonly used in the acute or early rehabilitative stages. Orthoplast deteriorates

with long-term use, limiting its usefulness in prophylaxis and for chronic ankle

sprains.

Stabilizing Shoes:

Several shoe designs have been used for prevention and treatment of ankle sprains.

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▪ Acute injury, rehabilitation, and chronic instability: The use of ankle-stabilizing

shoes, such as the Kunzli line of shoes (Swiss Balance, Santa Monica, CA), to

treat ankle sprain and to prevent re-injury have not been studied adequately to

date.

▪ Prophylaxis: High-topped shoes have been shown to increase ankle stiffness in

sports. However, the advantage of high-topped shoes over low-topped shoes in

prophylaxis has been shown to be relatively small. The prophylactic benefits of

various shoe types in sports have not been adequately investigated.

Cast-Braces:

A number of hinged polypropylene cast braces have been used in the treatment of

ankle sprains. These involve have a foot section with heel stabilizer, a lateral ankle

extension, and an articulating ankle joint joining the two. An example is the

Sarmiento cast brace, which is removable and fits in the patient's shoe. They were

designed primarily for long-term use in athletes who suffer from recurrent ankle

sprains (i.e., prophylaxis and chronic instability).

Cast-braces require custom fitting by an orthotist for proper impression, fabrication,

and fitting. Fitting of a fresh ankle sprain with a cast-brace is usually not

recommended because changes in swelling of the ankle during the initial recovery

phase will compromise the cast-brace's fit.

Although these cast-braces have reportedly given good results in the treatment of

ankle sprains, they are cumbersome, expensive, and have not been shown to offer

any benefits over other forms of treatment.

The Boston Ankle System:

The Boston Ankle System (Physical Support Systems, Boston, MA) is a custom-

fitted ankle stabilizer. The Boston Ankle System is made of polypropylene and

requires an exact impression. The services of an orthotist are often required for fine

adjustment and accurate fitting.

Ice Pack with Air-Stirrup:

The Cryo/Strap (Aircast, Summit, NJ) ice pack with air-stirrup uses a U-pad for

compression of the soft tissue around the ankle. The pad contains a liquid that can

be frozen and is held in place by an elastic strap. A modified air-stirrup is worn over

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this device. This system has been shown to provide uniform compression and to

decrease skin temperature for up to 90 mins. It has not been shown, however, to

improve long-term outcomes.

Ankle-Foot Orthoses (AFOs) and Knee-Ankle-Foot Orthoses (KAFOs):

Ankle-foot orthoses (AFOs) extend well above the ankle (usually to near the top of

the calf) and are fastened around the lower leg above the ankle. These features

distinguish them from foot orthotics, which are shoe inserts that do not extend above

the ankle.

Below the knee, the components of a KAFO are the same as those of an AFO.

However, the KAFO extends to the knee joint and thigh.

A non-ambulatory ankle-foot orthosis may be either an ankle contracture splint or a

foot drop splint.

Figueiredo et al (2008) performed a literature review evaluating the quality of current

research on the influence of AFO on gait in children with cerebral palsy (CP). Two

between-group and 18 within-group studies met the inclusion criteria indicating a low

level of evidence. Between-group studies each scored "4" on the PEDro Scale, and

17 within-group studies scored "3" and 1 scored "2", indicating low-quality. Standard

terminology for AFO was not used and only 6 studies described functional status

using appropriate instruments. The authors concluded that studies using high-

quality methods are still needed to support evidence-based decisions regarding the

use of AFO for this population.

In a pilot study, Sheffler et al (2008) examined if an AFO would improve gait velocity

and tasks of functional ambulation in patients with multiple sclerosis (MS). This

cross-sectional study enrolled 15 participants with diagnosis of MS, dorsiflexion and

eversion weakness, and more than 3 months of using a physician-prescribed AFO.

Subjects' ambulation was evaluated (i) without an AFO and (ii) with an AFO.

Outcome measures were the Timed 25-Foot (T25-FW) walk portion of the Multiple

Sclerosis Functional Composite and the 5 trials (Floor, Carpet, Up and Go,

Obstacles, Stairs) of the Modified Emory Functional Ambulation Profile (mEFAP).

The mean timed differences on the T25-FW and the 5 components of the mEFAP

between the AFO versus no device trials were not statistically significant. The

authors concluded that in MS subjects with dorsiflexion and eversion weakness, no

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statistically significant improvement was found performing timed tasks of functional

ambulation with an AFO.

The Intrepid Dynamic Exoskeleton Orthosis (IDEO) is a custom molded energy-

storing AFO that was reportedly developed for individuals who have suffered

massive tissue, nerve and bone damage to supposedly return capabilities to the

injured ankle. Purportedly, the individual can return to a high level of activity, such as

running. The IDEO device is molded out of lightweight black carbon that includes a

foot plate and a strut that runs up the back of the calf to a cuff that is situated just

below the knee. Reportedly, when force is applied to the foot plate, the strut bends.

As the individual steps down, it bends the foot plate, transferring energy forward.

Bedigrew et al (2014) noted that patients with severe lower extremity trauma have

significant disability 2 years after injury that worsens by 7 years. Up to 15 % seek

late amputation. Recently, an energy-storing orthosis demonstrated improved

function compared with standard orthoses; however, the effect when integrated with

rehabilitation over time is unknown. These researchers questioned (i) Does an

8-week integrated orthotic and rehabilitation initiative improve physical

performance, pain, and outcomes in patients with lower extremity functional

deficits or pain? (ii) Is the magnitude of recovery different if enrolled more than

2 years after their injury versus earlier? (iii) Does participation decrease the

number considering late amputation? These investigators prospectively

evaluated 84 service members (53 less than and 31 greater than 2 years after

injury) who enrolled in the initiative. A total of 58 sustained fractures, 53 sustained

nerve injuries with weakness, and 6 had arthritis (there was some overlap in the

patients with fractures and nerve injuries, which resulted in a total of greater than

84). They completed 4 weeks of physical therapy without the orthosis followed by 4

weeks with it. Testing was conducted at weeks 0, 4, and 8. Validated physical

performance tests and patient-reported outcome surveys were used as well as

questions pertaining to whether patients were considering an amputation. By 8

weeks, patients improved in all physical performance measures and all relevant

patient-reported outcomes. Patients less than and greater than 2 years after injury

improved similarly; 41 of 50 patients initially considering amputation favored limb

salvage at the end of 8 weeks. The authors found that this integrated orthotic and

rehabilitation initiative improved physical performance, pain, and patient-reported

outcomes in patients with severe, traumatic lower extremity deficits and that these

improvements were sustained for more than 2 years after injury. They stated that

efforts are underway to examine if the “Return to Run” clinical pathway with the




IDEO can be successfully implemented at additional military centers in patients

greater than 2 years from injury while sustaining similar improvements in patient

outcomes. The authors noted that the ability to translate this integrated orthotic and

rehabilitation program into the civilian setting is unknown and warrants further

investigation.

Microprocessor-Controlled KAFOs:

Microprocessor activated mobility devices combine electronic components with

specialized orthotic braces to reportedly provide assistance in walking to individuals

with back injuries or leg muscle weakness. Examples of microprocessor activated

devices include, but may not be limited to, the C-Brace Orthotronic Mobility System

or the Sensor Walk Stance Control knee brace.

The Sensor Walk is a microprocessor-controlled KAFO designed to assist wearers

achieve a safer, more physiologically correct gait. It does this by unlocking the knee

joint when the wearer is ready for swing phase and locking it again for stability during

stance phase. The Sensor Walk system includes an onboard microprocessor,

a clutch spring knee joint, foot pressure sensors, a knee angle sensor,

a battery, and a battery charger. When the sound limb has been loaded during

walking and the affected side is about to enter swing phase (with the toe still on the

ground) the microprocessor reads signal information from the foot and knee sensors

and allows the knee to go into flexion. When the orthosis begins to extend agai

n, the knee will enter a stable phase, preventing any flexion while allowing full

extension for stance phase. The Sensor Walk will support the wearer if they load it

at any point while it is extending, offering them exceptional stability. Wearers can

dis-engage the knee joint, such as for sitting, simply by pressing the manual release

switch. The Sensor Walk offers 12 hours of continuous use before it needs to be re-

charged, and contains an audible warning to alert the use if the battery is running

low. When the Sensor Walk is turned off, it offers the stability of a traditional locked

KAFO throughout the gait cycle. The Sensor Walk has Manual Release Function. A

control collar at the knee joint can be manually pushed back to temporarily over-ride

the locking mechanism and put the joint into free-swing mode. As soon as the collar

is released, the joint will be able to lock. To over-ride the Sensor Walk’s locking

mechanism for a longer period, a Manual Release Rocker Switch can be pressed to

lock the control collar in the free-swing mode. When the Manual Release Rocker

Switch is pressed and the joint is in free-swing mode, the switch will show an amber

dot to indicate that caution should be used. In normal operating mode, the switch will

show a green dot indicating that the locking feature will function normally. The




Sensor WaIk is comprised of the following parts: (i) a traditional, double-upright

KAFO with a free-articulating medial knee joint, (ii) a lateral mechanical clutch,

(iii) 6-spring knee joint, (iv) microprocessor-controlled electronics, (v) foot

sensors, (vi) a battery, and (vii) a battery charger. The foot sensor plate includes 4

sensors arranged in a straight line on the bottom of the foot plate. They are

numbered from 1 to 4, beginning with the most posterior. The sensors overlap by

3/8 inch (10 mm), and are wired to a sensor selection switch located in the

electronics of the Sensor Walk. The Sensor Walk comes delivered with sensors 1

and 2 activated, but, if necessary, other sensors can be selected to optimize patient

fitting.

Irby et al (2005) noted that individuals with weak or absent quadriceps who wish to

walk independently were prescribed KAFOs. New stance control orthosis (SCO)

designs automatically release the knee to allow swing phase flexion and extension

while still locking the joint during stance. A total of 21 subjects were fitted

unilaterally with the Dynamic Knee Brace System (DKBS), a non-commercial SCO --

13 were experienced KAFO users (average of 28 +/- 18 years of experience) while 8

were novice users. Novice users demonstrated increased velocity (55 versus 71

cm/sec, p = 0.048) and cadence (77 versus 85 steps/min, p < 0.05) when using the

DKBS over the traditional locked KAFO. Experienced KAFO users tended to have

reduced velocity and cadence measures when using the SCO (p < 0.10). Knee

range of motion was significantly greater for the novice group than for the

experienced group (55.2 +/- 4.8 versus 42.6 +/- 3.8 degrees, p = 0.05). Peak knee

extension moments tended to be greater for the experienced group (0.29 +/- 0.21

versus 0.087 +/- 0.047 Nm/kg, p = 0.09). This report described gait changes during

the introductory phase of DKBS adoption. Experienced KAFO users undoubtedly

had ingrained gait patterns designed to compensate for walking with a standard

locked KAFO. These patterns may have limited the ability of those users from

taking full and immediate advantage of the SCO capabilities. Also, alternate SCO

systems may engender different results. The authors concluded that comparison

studies and longer term field studies are needed to clarify benefits of the various

bracing options.

Zissimopoulos et al (2007) noted that users of traditional KAFOs walk with either

locked or unlocked knee joints depending on the level of stability required. Some

users may benefit from new stance-control KAFOs that prevent stance-phase knee

flexion but allow swing-phase flexion. These researchrs collected data from 9 non-

disabled adults who walked with KAFOs that incorporated the Horton Stance-Control




Orthotic Knee Joint (SCOKJ) in the locked, unlocked, and auto (which provides knee

stability during stance phase and knee flexion during swing phase) modes to

investigate the biomechanical and energetic effects of stance-control orthoses.

Studying non-disabled subjects allowed these researchers to analyze the effects of

stance-control orthoses in a homogenous population. In general, gait kinematics for

the auto and unlocked modes were more similar than for the auto and locked

modes. Despite the elimination of hip hiking in the auto mode, oxygen cost was not

different between the auto and locked modes (p > 0.99). The SCOKJ allowed non-

disabled subjects to walk with a more normal gait pattern; however, future research

should explore the effect of stance-control orthoses on persons with gait pathology.

Davis et al (2010) stated that Stance Control knee-ankle foot orthoses (SCO) differ

from their traditional locked knee counterparts by allowing free knee flexion during

swing while providing stability during stance. It is widely accepted that free knee

flexion during swing normalizes gait and therefore improves walking speed and

reduces the energy requirements of walking. Limited research has been carried out

to evaluate the benefits of SCOs when compared to locked KAFOs. The purpose of

this study was to evaluate the effectiveness of SCOs used for patients with lower

limb pathology. Energy expenditure and walking velocity were measured in 10

subjects using an orthosis incorporating a SCOKJ. A GAITRite walkway was used to

measure temporo-spatial gait characteristics. A Cosmed K4b2 portable metabolic

system was used to measure energy expenditure and heart rate during walking.

Two conditions were tested: (i) walking with stance control active (stance control)

and (ii) walking with the knee joint locked. Ten subjects completed the GAITRite

testing; 9 subjects completed the Cosmed testing. Walking velocity was significantly

increased in the stance control condition (p < 0.001). There was no difference in the

energy cost of walking (p = 0.515) or physiological cost index (p = 0.093) between

conditions. The authors concluded that these findings supported previous evidence

that stance control knee-ankle foot orthoses increase walking velocity compared to

locked knee devices. However, the stance control condition did not decrease energy

expenditure during walking.

Ankle Contraction Splints / Static Dynamic AFOs:

According to Medicare Durable Medical Equipment Carrier Guidelines, a static-

dynamic AFO is a pre-fabricated AFO that has all of the following characteristics:

1. Applies a dorsiflexion force to the ankle , and

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2. Designed to accommodate either plantar fasciitis or an ankle with a plantar

flexion contracture up to 45° , and

3. Has a soft interface, and

4. Used by a patient who is minimally ambulatory or non-ambulatory.

Ankle flexion contracture is a condition in which there is shortening of the muscles

and/or tendons that plantarflex the ankle with the resulting inability to bring the ankle

to 0 degrees by passive range of motion. (0 degrees ankle position is when the foot

is perpendicular to the lower leg.)

Foot Drop Splint:

A foot drop splint/recumbent positioning device is a pre-fabricated AFO, which has

all of the following characteristics:

1. Designed to maintain the foot at a fixed position of 0° (i.e., perpendicular to the

lower leg), and

2. Has a soft interface, and

3. Not designed to accommodate an ankle with a plantar flexion contracture, and

4. Used by a patient who is non-ambulatory.

Foot drop is a condition in which there is weakness and/or lack of use of the

muscles that dorsiflex the ankle but there is the ability to bring the ankle to 0

degrees by passive range of motion.

Foot and Ankle Orthoses for Rheumatoid Arthritis:

Hennessy and colleagues (2012) evaluated the evidence for the effectiveness of

custom orthoses for the foot and ankle in rheumatoid arthritis. Studies were

identified in appropriate electronic databases (from 1950 to March 2011). The

search term "rheumatoid arthritis" with "foot" and "ankle" and related terms were

used in conjunction with "orthoses" and synonyms. Included studies were

quantitative longitudinal studies and included randomized controlled trials (RCTs),

case-control trials, cohort studies, and case series studies. All outcome measures

were investigated. Quality assessment was conducted using the Cochrane

Collaboration criteria with additional criteria for sample population

representativeness, quality of statistical analysis, and compliant intervention use and

presence of cointerventions. Meta-analyses were conducted for outcome domains

with multiple RCTs. Qualitative data synthesis was conducted for the remaining

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outcome domains. Levels of evidence were then assigned to each outcome

measure. The inclusion criteria were met by 17 studies -- 2 studies had high-quality

for internal validity and 3 studies had high-quality for external validity. No study had

high-quality for both internal and external validity. Six outcome domains were

identified. There was weak evidence for custom orthoses reducing pain and forefoot

plantar pressures. Evidence was inconclusive for foot function, walking speed, gait

parameters, and reducing hallux abductovalgus angle progression. The authors

concluded that custom orthoses may be beneficial in reducing pain and elevated

forefoot plantar pressures in the rheumatoid foot and ankle. However, they stated

that more definitive research is needed in this area.

AFOs and KAFOs for Knee Instability Related to Neuromuscularand Central Nervous System Disorders:

In a pilot study, Arazpour and co-workers (2016) determined the effect of a powered

KAFO on the physiological cost index, walking speed and the distance walked in

people with poliomyelitis compared to when walking with a KAFO with drop lock

knee joints. A total of 7 subjects with poliomyelitis volunteered for the study and

undertook gait analysis with both types of KAFOs. Walking with the powered KAFO

significantly reduced walking speed (p = 0.015) and the distance walked (p = 0.004),

and also, it did not improve physiological cost index values (p = 0.009) compared to

walking with the locked KAFO. The authors concluded that using a powered KAFO

did not significantly improve any of the primary outcome measures during walking

for poliomyelitis subjects. They stated that this powered KAFO design did not

improve the physiological cost index of walking for people with poliomyelitis when

compared to walking with a KAFO with drop lock knee joints. This may have been

due to the short training period used or the bulky design and additional weight of the

powered orthosis; further research is therefore warranted.

In a Health Technology Assessment on “Orthotic management of instability of the

knee related to neuromuscular and central nervous system disorders: systematic

review, qualitative study, survey and costing analysis”, O’Connor and associates

(2016) concluded that various types of orthoses (KAFOs [mainly carbon fiber],

stance control KAFO and hip KAFOs) were used in the United Kingdom Nation

Health Service to manage patients with neuromuscular disorder (NMD)/central

nervous system (CNS) conditions (e.g., inclusion body myositis, post-polio

syndrome, post-stroke, and spinal cord injury [SCI]) and knee instability, both

custom-made and pre-fabricated, of variable cost. They stated that evidence on the




effectiveness of the orthoses was limited, especially in relation to the outcomes that

were important to orthoses users.

Kobayashi and colleagues (2016) noted that genu recurvatum (knee

hyperextension) is a common issue for individuals post-stroke; AFOs are used to

improve genu recurvatum, but evidence is limited concerning their effectiveness.

These researchers examined the effect of changing the plantarflexion resistance of

an articulated AFO on genu recurvatum in patients post-stroke. Gait analysis was

performed on 6 individuals post-stroke with genu recurvatum using an articulated

AFO whose plantarflexion resistance was adjustable at 4 levels. Gait data were

collected using a Bertec split-belt instrumented treadmill in a 3D motion analysis

laboratory. Gait parameters were extracted and plotted for each subject under the 4

plantarflexion resistance conditions of the AFO. Gait parameters included peak

ankle plantarflexion angle, peak ankle dorsiflexion moment, peak knee extension

angle and peak knee flexion moment. A non-parametric Friedman test was

performed followed by a post-hoc Wilcoxon Signed-Rank test for statistical

analyses. All the gait parameters demonstrated statistically significant differences

among the 4 resistance conditions of the AFO. Increasing the amount of

plantarflexion resistance of the AFO generally reduced genu recurvatum in all

subjects. However, individual analyses showed that the responses to the changes

in the plantarflexion resistance of the AFO were not necessarily linear, and

appeared unique to each subject. The authors concluded that plantarflexion

resistance of an articulated AFO should be adjusted to improve genu recurvatum in

patients post-stroke; and future studies should examine what clinical factors would

influence the individual differences.

In a pilot study, Kobayashi and associates (2016) studied the mechanical properties

of a novel articulated AFO with adjustable plantarflexion resistance, dorsiflexion

resistance and alignment, and its effect on ankle and knee joint kinematics and

kinetics in an individual post-stroke during gait. The mechanical properties of the

AFO were quantified. Gait analysis was performed using a 3D motion capture

system with a split-belt instrumented treadmill under 12 different settings of the

mechanical properties of the AFO [i.e., 4 plantarflexion resistances (P1<P4), 4

dorsiflexion resistances (D1<D4), 4 initial alignments (A1<A4)]. The AFO

demonstrated systematic changes in moment-angle relationship in response to

changes in AFO joint settings. The gait analysis demonstrated that the ankle and

knee angle and moment were responsive to changes in the AFO joint settings.

Mean ankle angle at initial contact changed from -0.86° (P1) to 0.91° (P4) and from




-1.48° (A1) to 4.45° (A4), while mean peak dorsiflexion angle changed from 12.01°

(D1) to 6.40° (D4) at mid-stance. The authors concluded that the novel articulated

AFO appeared effective in influencing lower-limb joint kinematics and kinetics of gait

in the individual post-stroke. The findings of this pilot study need to be further

investigated.

In a RCT, Nikamp and co-workers (2017) examined the 6-month clinical e ffects of

providing AFOs at different moments (early or delayed) in (sub)acute stroke; this

was a follow-up to a published trial. Participants were unilateral hemiparetic stroke

subjects maximal 6 weeks post-stroke with indication for AFO use. Subjects were

randomly assigned to early (at inclusion; week 1) or delayed provision (8 weeks

later; week 9). Functional tests assessing balance and mobility were performed bi-

weekly for 17 weeks and at week 26. A total of 33 subjects were randomized. No

differences at week 26 were found between both groups for any of the outcome

measures. However, results suggested that early provision led to better outcomes

in the first 11 to 13 weeks. Berg Balance Scale (p = 0.006), Functional Ambulation

Categories (p = 0.033) and 6-minute walk test (6MWT; p < 0.001) showed

significantly different patterns over time. Clinically relevant but statistically non-

significant differences of 4 to 10 weeks in reaching independent walking with higher

balance levels were found, favoring early provision. The authors concluded that no

6-month differences in functional outcomes of providing AFOs at different moments

in the early rehabilitation after stroke were found. Moreover, they stated that these

findings suggested that there was a period of 11 to 13 weeks in which early

provision may be beneficial, possibly resulting in early independent and safe

walking. However, they noted that this study was under-powered; further

investigation including larger numbers of subjects is needed.

In a systematic review, McDaid and colleagues (2017) evaluated the effectiveness

of orthotic devices for the management of instability of the knee in adults with a

NMD or CNS disorder. Interventions employed were orthoses (e.g., AFOs, KAFOs,

and knee orthoses or mixed design with no restrictions in design or material) with

the clinical aim of controlling knee instability. Outcomes included condition-specific

or generic patient-reported measures assessing function, disability, independence,

activities of daily living (ADLs), quality of life (QOL) or psychosocial outcomes; pain;

walking ability; functional assessments; biomechanical analysis; adverse effects;

usage; patient satisfaction and the acceptability of a device; as well as resource

utilization data. A total of 21 studies including 478 patients were included. Orthotic

devices were evaluated in patients with inclusion body myositis, post-polio




syndrome, post-stroke syndrome, and SCI). The review included 2 RCTs, 3 non-

RCTs and 16 case series. Most were small, single-center studies with only 6 of 21

following patients for 1 year or longer. They met between 1 and 5 of 9 quality criteria

and reported methods and results poorly. They mainly assessed outcomes related

to gait analysis and energy consumption with limited use of standardized, validated,

patient-reported outcome measures. There was an absence of evidence on

outcomes of direct importance to patients such as reduction in pain and falls. The

authors concluded that there is a need for high-quality research, especially RCTs,

on the effectiveness of AFOs, KAFOs and other orthotic devices for managing knee

instability related to NMD and CNS conditions. They stated that this research

should address outcomes that are important to patients; and there may also be

value in developing a national registry.

In a systematic review, Daryabor and associates (2018) evaluated the efficacy of

different designs of AFOs and comparison between them on the gait parameters of

individuals with hemiplegic stroke. The search strategy was based on the

population intervention comparison outcome (PICO) method. A search was

performed in PubMed, ISI Web of Knowledge, Scopus, Science Direct, and Google

Scholar databases. A total of 27 articles were found for the final evaluation. All

types of AFOs had positive effects on ankle kinematic in the first rocker and swing

phases, but not on knee kinematics in the swing phase, hip kinematics or the third

rocker function. All trials, except 2, assessed immediate or short-term effects only.

The articulated passive AFO compared with the non-articulated passive AFO had

better effects on some aspects of the gait of patients with hemiplegia following

stroke, more investigations are needed in this regard though. The authors

concluded that an AFO can immediately improve the dropped foot in the stance and

swing phases. Moreover, they stated that the effects of long-term usage and

comparison among the different types of AFOs need to be evaluated.

CPT Codes / HCPCS Codes / ICD-10 Codes

Information in the [brackets] below has been added for clarification

purposes. Codes requiring a 7th character are represented by "+":

Code Code Description

CPT codes covered if selection criteria are met:

29405 - 29425 Application of short leg cast (below knee to toes) [rigid for ankle fractures

only] [semi-rigid for ankle sprains only]




29515 Application of short leg splint (calf to foot) [for plantar flexion

contractures, without foot drop, with reasonable expectation of correction,

that interfere with functional abilities, and are a component of a therapy

program]

29580 Strapping: Unna boot [ for ankle sprains and soft tissue injuries-not ankle

fractures, chronically unstable ankles, or to prevent re-injury]

HCPCS codes covered if selection criteria are met:

E1815 Dynamic adjustable ankle extension/flexion device, includes soft interface

material

L1900 Ankle-foot orthosis (AFO), spring wire, dorsiflexion assist calf band,

custom fabricated

L1902 Ankle orthosis, ankle gauntlet or similar, with or without joints,

prefabricated, off-the-shelf

L1904 Ankle orthosis, ankle gauntlet or similar, with or without joints, custom

fabricated

L1906 Ankle foot orthosis, multiligamentus ankle support, prefabricated, off-the-

shelf

L1907 Ankle orthosis, supramalleolar with straps, with or without interface/pads,

custom fabricated

L1910 AFO, posterior, single bar, clasp attachment to shoe counter,

prefabricated, includes fitting and adjustment

L1920 AFO, single upright with static or adjustable stop (Phelps or Perlstein

type), custom fabricated

L1930 AFO, plastic or other material, prefabricated, includes fitting and

adjustment

L1932 AFO, rigid anterior tibial section, total carbon fiber or equal material,

prefabricated, includes fitting and adjustment [not covered for Noodle TA

AFO]

L1940 AFO, plastic or other material, custom-fabricated

L1945 AFO, molded to patient model, plastic, rigid anterior tibial section (floor

reaction), custom-fabricated

L1950 Ankle foot orthosis, spiral, (Institute of Rehabilitative Medicine type),

plastic, custom-fabricated





L1951 Ankle foot orthosis, spiral (Institute of Rehabilitative Medicine type),

plastic or other material, prefabricated, includes fitting and adjustment

L1960 AFO, posterior solid ankle, plastic, custom-fabricated

L1970 AFO, plastic, with ankle joint, custom-fabricated

L1971 Ankle foot orthosis, plastic or other material with ankle joint,


L1980 AFO, single upright free plantar dorsiflexion, solid stirrup, calf band/cuff

(single bar "BK" orthosis), custom-fabricated

L1990 AFO, double upright free plantar dorsiflexion, solid stirrup, calf band/cuff

(double bar "BK" orthosis), custom-fabricated

L2000 Knee-ankle-foot orthosis (KAFO), single upright, free knee, free ankle,

solid stirrup, thigh and calf bands/cuffs (single bar "AK" orthosis), custom-

fabricated

L2005 Knee-ankle-foot orthosis, any material, single or double upright, stance

control, automatic lock and swing phase release, any type activation,

includes ankle joint, any type, custom fabricated

L2010 KAFO, single upright, free ankle, solid stirrup, thigh and calf bands/cuffs

(single bar "AK" orthosis), without knee joint, custom-fabricated

L2020 KAFO, double upright, free knee, free ankle, solid stirrup, thigh and calf

bands/cuffs (double bar "AK" orthosis), custom-fabricated

L2030 KAFO, double upright, free ankle, solid stirrup, thigh and calf bands/cuffs,

(double bar "AK" orthosis), without knee joint, custom-fabricated

L2034 Knee-ankle-foot orthosis, full plastic, single upright, with or without free

motion knee, medial lateral rotation control, with or without free motion

ankle, custom-fabricated

L2035 KAFO, full plastic, static, (pediatric size), without free motion ankle,


L2036 Knee-ankle-foot orthosis, full plastic, double upright, with or without free

motion knee, with or without free motion ankle, custom-fabricated

L2037 Knee-ankle-foot orthosis, full plastic, single upright, with or without free

motion knee, with or without free motion ankle, custom-fabricated

L2038 Knee-ankle-foot orthosis, full plastic, with or without free motion knee,

multi-axis ankle, custom-fabricated





L2106 AFO, fracture orthosis, tibial fracture cast orthosis, thermoplastic type

casting material, custom-fabricated

L2108 AFO, fracture orthosis, tibial fracture cast orthosis, custom-fabricated

L2112 AFO, fracture orthosis, tibial fracture orthosis, soft, prefabricated,

includes fitting and adjustment

L2114 AFO, fracture orthosis, tibial fracture orthosis, semi-rigid, prefabricated,

includes fitting and adjustment [for ankle sprains only]

L2116 AFO, fracture orthosis, tibial fracture orthosis, rigid, prefabricated,

includes fitting and adjustment [for ankle fractures only]

L2126 KAFO, fracture orthosis, femoral fracture cast orthosis, thermoplastic

type casting material, custom-fabricated

L2128 KAFO, fracture orthosis, femoral fracture cast orthosis, custom-fabricated

L2132 KAFO, fracture orthosis, femoral fracture cast orthosis, soft,


L2134 KAFO, fracture orthosis, femoral fracture cast orthosis, semi-rigid,

prefabricated, includes fitting and adjustment [for ankle sprains only]

L2136 KAFO, fracture orthosis, femoral fracture cast orthosis, rigid,

prefabricated, includes fitting and adjustment [for ankle fractures only]

L2180 Addition to lower extremity fracture orthosis, plastic shoe insert with ankle

joints

L2182 Addition to lower extremity fracture orthosis, drop lock knee joint

L2184 Addition to lower extremity fracture orthosis, limited motion knee joint

L2186 Addition to lower extremity fracture orthosis, adjustable motion knee joint,

Lerman type

L2188 Addition to lower extremity fracture orthosis, quadrilateral brim

L2190 Addition to lower extremity fracture orthosis, waist belt

L2192 Addition to lower extremity fracture orthosis, hip joint, pelvic band, thigh

flange, and pelvic belt

L2200 Addition to lower extremity, limited ankle motion, each joint

L2210 Addition to lower extremity, dorsiflexion assist (plantar flexion resist),

each joint





L2220 Addition to lower extremity, dorsiflexion and plantar flexion assist/resist,

each joint

L2230 Addition to lower extremity, split flat caliper stirrups and plate attachment

L2232 Addition to lower extremity orthosis, rocker bottom for total contact ankle

foot orthosis, for custom fabricated orthosis only

L2240 Addition to lower extremity, round caliper and plate attachment

L2250 Addition to lower extremity, foot plate, molded to patient model, stirrup

attachment

L2260 Addition to lower extremity, reinforced solid stirrup (Scott-Craig type)

L2265 Addition to lower extremity, long tongue stirrup

L2270 Addition to lower extremity, varus/valgus correction ("T") strap,

padded/lined or malleolus pad

L2275 Addition to lower extremity, varus/valgus correction, plastic modification,

padded/lined

L2280 Addition to lower extremity, molded inner boot

L2300 Addition to lower extremity, abduction bar (bilateral hip involvement),

jointed, adjustable

L2310 Addition to lower extremity, abduction bar, straight

L2320 Addition to lower extremity, non-molded lacer, for custom fabrictaed

orthosis only [lace-up ankle brace]

L2330 Addition to lower extremity, lacer molded to patient model, for custom

fabricated orthosis only [lace-up ankle brace]

L2335 Addition to lower extremity, anterior swing band

L2340 Addition to lower extremity, pre-tibial shell, molded to patient model

L2350 Addition to lower extremity, prosthetic type, (BK) socket, molded to

patient model, (used for "PTB", "AFO" orthoses)

L2360 Addition to lower extremity, extended steel shank

L2370 Addition to lower extremity, Patten bottom

L2375 Addition to lower extremity, torsion control, ankle joint and half solid

stirrup

L2380 Addition to lower extremity, torsion control, straight knee joint, each joint





L2385 Addition to lower extremity, straight knee joint, heavy duty, each joint

L2387 Addition to lower extremity, polycentric knee joint, for custom fabricated

knee ankle foot orthosis, each joint

L2390 Addition to lower extremity, offset knee joint, each joint

L2395 Addition to lower extremity, offset knee joint, heavy duty, each joint

L2397 Addition to lower extremity, orthosis, suspension sleeve

L2405 Addition to knee joint, drop lock, each

L2415 Addition to knee lock with integrated release mechanism (ball, cable, or

equal), any material, each joint

L2425 Addition to knee joint, disc or dial lock for adjustable knee flexion, each

joint

L2430 Addition to knee joint, ratchet lock for active and progressive knee

extension, each joint

L2492 Addition to knee joint, lift loop for drop lock ring

L2750 Addition to lower extremity orthosis, plating chrome or nickel, per bar

L2755 Addition to lower extremity orthosis, high strength, lightweight material, all

hybrid lamination/prepreg composite, per segment, for custom fabricated

orthosis only

L2760 Addition to lower extremity orthosis, extension, per extension, per bar (for

lineal adjustment for growth)

L2768 Orthotic side bar disconnect device, per bar

L2780 Addition to lower extremity orthosis, non-corrosive finish, per bar

L2785 Addition to lower extremity orthosis, drop lock retainer, each

L2795 Addition to lower extremity orthosis, knee control, full kneecap

L2800 Addition to lower extremity orthosis, knee control, kneecap, medial or

lateral pull, for use with custom fabricated orthosis only

L2810 Addition to lower extremity orthosis, knee control, condylar pad

L2820 Addition to lower extremity orthosis, soft interface for molded plastic,

below knee section

L2830 Addition to lower extremity orthosis, soft interface for molded plastic,

above knee section





L2840 Addition to lower extremity orthosis, tibial length sock, fracture or equal,

each

L2850 Addition to lower extremity orthosis, femoral length sock, fracture or

equal, each

L2861 Addition to lower extremity joint, knee or ankle, concentric adjustable

torsion style mechanism for custom fabricated orthotics only, each [for

members who require ankle plantar or dorsiflexion assist in the absence

of any co-existing joint contracture]

L2999 Lower extremity orthosis, not otherwise specified [not covered for

C-Brace Orthotonic Mobility System]

L3208 Surgical boot, each, infant

L3209 Surgical boot, each, child

L3211 Surgical boot, each, junior

L3212 Benesch boot, pair, infant

L3213 Benesch boot, pair, child

L3214 Benesch boot, pair, junior

L3260 Surgical boot/shoe, each

L3500 - L3595 Miscellaneous shoe additions [covered only if base orthosis is covered]

L3620 Transfer of an orthosis from one shoe to another, solid stirrup, existing

L3630 Transfer of an orthosis from one shoe to another, solid stirrup, new

L4002 Replacement strap, any orthosis, includes all components, any length,

any type

L4010 Replace trilateral socket brim

L4020 Replace quadrilateral socket brim, molded to patient model

L4030 Replace quadrilateral socket brim, custom fitted

L4040 Replace molded thigh lacer, for custom fabricated orthosis only

L4045 Replace non-molded thigh lacer, for custom fabricated orthosis only

L4050 Replace molded calf lacer, for custom fabricated orthosis only

L4055 Replace non-molded calf lacer, for custom fabricated orthosis only

L4060 Replace high roll cuff

L4070 Replace proximal and distal upright for KAFO





L4080 Replace metal bands KAFO, proximal thigh

L4090 Replace metal bands KAFO-AFO, calf or distal thigh

L4100 Replace leather cuff KAFO, proximal thigh

L4110 Replace leather cuff KAFO-AFO, calf or distal thigh

L4130 Replace pretibial shell

L4205 Repair of orthotic device, labor component, per 15 minutes

L4210 Repair of orthotic device, repair or replace minor parts

L4350 Ankle control orthosis, stirrup style, rigid, includes any type interface

(e.g., pneumatic, gel), prefabricated, off-the-shelf

L4360 Walking boot, pneumatic and/or vacuum, with or without joints, with or

without interface material, prefabricated item that has been trimmed,

bent, molded, assembled, or otherwise customized to fit a specific patient

by an individual with expertise

L4386 Walking boot, non-pneumatic, with or without joints, with or without

interface material, prefabricated item that has been trimmed, bent,

molded, assembled, or otherwise customized to fit a specific patient by

an individual with expertise

L4387 Walking boot, non-pneumatic, with or without joints, with or without

interface material, prefabricated, off-the-shelf

L4392 Replacement soft interface material, static AFO [covered only if orthosis

is covered]

L4394 Replace soft interface material, foot drop splint [covered only if foot drop

splint is covered]

L4396 Static or dynamic ankle foot orthosis, including soft interface material,

adjustable for fit, for positioning, may be used for minimal ambulation,

prefabricated item that has been trimmed, bent, molded, assembled, or

otherwise customized to fit a specific patient by an individual with

expertise

L4397 Static or dynamic ankle foot orthosis, including soft interface material,

adjustable for fit, for positioning, may be used for minimal ambulation,

prefabricated, off-the-shelf

L4398 Foot drop splint, recumbent positioning device, prefabricated, off-the-

shelf





Q4037 - Q4040 Cast supplies, short leg cast [rigid for ankle fractures only] [semi-rigid for

ankle sprains only]

Q4045 - Q4048 Cast supplies, short leg splint [for plantar flexion non-fixed contractures

without foot drop, with reasonable expectation of correction, that interfere

with functional abilities, and are a component of a therapy program]

S8451 Splint, prefabricated, wrist or ankle [for plantar flexion non-fixed

contractures without foot drop, with reasonable expectation of correction,

that interfere with functional abilities, and are a component of a therapy

program]

ICD-10 codes covered if selection criteria are met (not all-inclusive):

M24.571 -

M24.576

Contracture, ankle and foot

M24.871 -

M24.876

M25.271 -

M25.279

M25.371 -

M25.376

Other joint derangement, not elsewhere classified, ankle and foot

M62.471 -

M62.479

M67.00 -

M67.02

Contracture of muscle, ankle and foot

M72.2 Plantar fascial fibromatosis

M84.461+ -

M84.473+

Pathological fracture, tibia and fibula, ankle, foot





S82.301+ -

S82.309+

S82.391+ -

S82.399+

S82.51x+ -

S82.66x+

S82.841+ -

S82.856+

S82.871+ -

S82.899+

S89.101+ -

S89.199+

S89.301+ -

S89.399+

Fracture of ankle

S86.011+ -

S86.019+

S93.401+ -

S93.499+

S96.011+ -

S96.019+

S96.111+ -

S96.119+

S96.211+ -

S96.219+

S96.811+ -

S96.819+

S96.911+ -

S96.919+

Sprains and strains of ankle

S91.001+ -

S91.009+

S93.01x+ -

S93.06x+

Subluxation and dislocation of ankle joint

Numerous

options

Injury, other and unspecified, knee, leg, ankle, and foot




The above policy is based on the following references:


1. National Heritage Insurance Company (NHIC). Ankle-Foot/Knee-Ankle-Foot

Orthosis. Local Coverage Determination No. L11527. Durable Medical

Equipment Medicare Administrative Carrier Jurisdiction A. Chico, CA: NHIC;

revised March 1, 2008.

2. Buschbacher RM. Ankle sprain evaluation and bracing. In Physical

Rehabilitation of the Injured Athlete. JR Andrews, GL Harrelson, eds.

Philadelphia, PA: WB Saunders Co.; 1991:221-239.

3. Barringer WJ. Principles of orthotic management of athletic injury. In Clinical

Sports Medicine. WA Grana, A Kalenak, eds. Philadelphia, PA: WB Saunders

Co.; 1991:315-331.

4. Reider B, Belniak R, Miller DW. Football. In Sports Medicine: The School-Age

Athlete. 2nd ed. B Reider, ed. Philadelphia, PA: WB Saunders Co.; 1996:613-

645.

5. American Academy of Orthopedic Surgeons. Athletic Training and Sports

Medicine. 2nd ed. Rosemont, IL: American Academy of Orthopedic Surgeons;

1991:705-715.

6. Hald RD, Fandel DM. Taping and bracing. In Sports Medicine and

Rehabilitation: A Sports-Specific Approach. RM Buschbacher, RL Braddom,

eds. Philadelphia, PA: Hanley & Belfus, Inc; 1994:337-354.

7. Handoll HH, Rowe BH, Quinn KM, et al. Interventions for preventing ankle

ligament injuries. Cochrane Database Syst Rev. 2001;(3):CD000018.

8. Bono CM, Berberian WS. Orthotic devices. Degenerative disorders of the foot

and ankle. Foot Ankle Clin. 2001;6(2):329-340.

9. Buonomo LJ, Klein JS, Keiper TL. Orthotic devices. Custom-made,

prefabricated, and material selection. Foot Ankle Clin. 2001;6(2):249-252.

10. Grissom SP, Blanton S. Treatment of upper motoneuron plantarflexion

contractures by using an adjustable ankle-foot orthosis. Arch Phys Med

Rehabil. 2001;82(2):270-273.

11. Mauritz KH. Gait training in hemiplegia. Eur J Neurol. 2002;9 Suppl 1:23-29;

discussion 53-61.

12. Gok H, Kucukdeveci A, Altinkaynak H, et al. Effects of ankle-foot orthoses on

hemiparetic gait. Clin Rehabil. 2003;17(2):137-139.

13. Kerkhoffs GMMJ, Struijs PAA, Marti RK, et al. Different functional treatment

strategies for acute lateral ankle ligament injuries in adults. Cochrane Database

Syst Rev. 2002;(3):CD002938.




14. Sackley C, Disler PB, Turner-Stokes L, Wade DT. Rehabilitation interventions

for foot drop in neuromuscular disease. Cochrane Database Syst Rev. 2007;

(2):CD003908.

15. Rome K, Brown CL. Randomized clinical trial into the impact of rigid foot

orthoses on balance parameters in excessively pronated feet. Clin Rehabil.

2004;18(6):624-630.

16. Pinzur MS, Slovenkai MP, Trepman E, et al. Guidelines for diabetic foot care:

Recommendations endorsed by the Diabetes Committee of the American

Orthopaedic Foot and Ankle Society. Foot Ankle Int. 2005;26(1):113-119.

17. Struijs P, Kerkhoffs G. Ankle sprain. In: BMJ Clinical Evidence. London, UK:

BMJ Publication Group; March 2007.

18. De Pisi F. Aids and orthoses in patients with stroke consequences. Clin Exp

Hypertens. 2006;28(3-4):383-385.

19. Hijmans JM, Geertzen JH, Dijkstra PU, Postema K. A systematic review of the

effects of shoes and other ankle or foot appliances on balance in older people

and people with peripheral nervous system disorders. Gait Posture. 2007;25

(2):316-323.

20. Richie DH Jr. Effects of foot orthoses on patients with chronic ankle instability.

J Am Podiatr Med Assoc. 2007;97(1):19-30.

21. Lin CWC, Moseley AM, Refshauge KM. Rehabilitation for ankle fractures in

adults. Cochrane Database Syst Rev. 2008;(3):CD005595.

22. Figueiredo EM, Ferreira GB, Maia Moreira RC, et al. Efficacy of ankle-foot

orthoses on gait of children with cerebral palsy: Systematic review of literature.

Pediatr Phys Ther. 2008;20(3):207-223.

23. Sheffler LR, Hennessey MT, Knutson JS, et al. Functional effect of an ankle

foot orthosis on gait in multiple sclerosis: A pilot study. Am J Phys Med

Rehabil. 2008;87(1):26-32.

24. Cooke MW, Marsh JL, Clark M, et al. Treatment of severe ankle sprain: A

pragmatic randomised controlled trial comparing the clinical effecitveness and

cost-effectiveness of three types of mechanical ankle support with tubular

bandage. The CAST trial. Health Technol Assess. 2009;13(13):1-144.

25. Irby SE, Bernhardt KA, Kaufman KR. Gait of stance control orthosis users: The

dynamic knee brace system. Prosthet Orthot Int. 2005;29(3):269-282.

26. Zissimopoulos A, Fatone S, Gard SA. Biomechanical and energetic effects of a

stance-control orthotic knee joint. J Rehabil Res Dev. 2007;44(4):503-513.

27. Davis PC, Bach TM, Pereira DM. The effect of stance control orthoses on gait

characteristics and energy expenditure in knee-ankle-foot orthosis users.

Prosthet Orthot Int. 2010;34(2):206-215.




28. Maas JC, Dallmeijer AJ, Huijing PA, et al. Splint: The efficacy of orthotic

management in rest to prevent equinus in children with cerebral palsy, a

randomised controlled trial. BMC Pediatr. 2012;12:38.

29. Hennessy K, Woodburn J, Steultjens MP. Custom foot orthoses for

rheumatoid arthritis: A systematic review. Arthritis Care Res (Hoboken).

2012;64(3):311-320.

30. U.S, Food and Drug Administration (FDA). 510(k) summary: Sensor Walk.

Silver Spring, MD: FDA; May 3, 2006.

31. Arazpour M, Ahmadi Bani M, Hutchins SW, et al. Influence of orthotic gait

training with powered hip orthosis on walking in paraplegic patients.

Disabil Rehabil Assist Technol. 2014;9(3):226-230.

32. Arazpour M, Hutchins SW, Ahmadi Bani M. The efficacy of powered

orthoses on walking in persons with paraplegia. Prosthet Orthot Int.

2015;39(2):90-99.

33. Ahmadi Bani M, Arazpour M, Farahmand F, et al. The efficiency of

mechanical orthoses in affecting parameters associated with daily living in

spinal cord injury patients: A literature review. Disabil Rehabil Assist

Technol. 2015;10(3):183-190.

34. Noridian Medicare.Local coverage determination (LCD): Ankle-foot/knee-

ankle-foot orthosis (L33686). Fargo, ND: Noridian; 2017.

35. Arazpour M, Ahmadi Bani M, Samadian M, et al. The physiological cost

index of walking with a powered knee-ankle-foot orthosis in subjects with

poliomyelitis: A pilot study. Prosthet Orthot Int. 2016;40(4):454-459.

36. O'Connor J, McCaughan D, McDaid C, et al. Orthotic management of

instability of the knee related to neuromuscular and central nervous

system disorders: systematic review, qualitative study, survey and costing

analysis. Health Technol Assess. 2016;20(55):1-262.

37. Kobayashi T, Orendurff MS, Singer ML, et al. Reduction of genu recurvatum

through adjustment of plantarflexion resistance of an articulated ankle-

foot orthosis in individuals post-stroke. Clin Biomech (Bristol, Avon).

2016;35:81-85.

38. Kobayashi T, Orendurff MS, Hunt G, et al. An articulated ankle-foot orthosis

with adjustable plantarflexion resistance, dorsiflexion resistance and

alignment: A pilot study on mechanical properties and effects on stroke

hemiparetic gait. Med Eng Phys. 2017;44:94-101.

39. Aboutorabi A, Arazpour M, Ahmadi Bani M, et al. Efficacy of ankle foot

orthoses types on walking in children with cerebral palsy: A systematic

review. Ann Phys Rehabil Med. 2017;60(6):393-402.




40. Nikamp CD, Buurke JH, van der Palen J, et al. Six-month effects of early or

delayed provision of an ankle-foot orthosis in patients with (sub)acute

stroke: A randomized controlled trial. Clin Rehabil. 2017;31(12):1616-1624.

41. McDaid C, Fayter D, Booth A, et al. Systematic review of the evidence on

orthotic devices for the management of knee instability related to

neuromuscular and central nervous system disorders. BMJ Open. 2017;7

(9):e015927.

42. Daryabor A, Arazpour M, Aminian G. Effect of different designs of ankle-

foot orthoses on gait in patients with stroke: A systematic review. Gait

Posture. 2018;62:268-279.

43. Prenton S, Hollands KL, Kenney LPJ, Onmanee P. Functional electrical

stimulation and ankle foot orthoses provide equivalent therapeutic effects

on foot drop: A meta-analysis providing direction for future research. J

Rehabil Med. 2018;50(2):129-139.



Copyright Aetna Inc. All rights reserved. Clinical Policy Bulletins are developed by Aetna to assist in administering plan

benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial,

general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care

services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in

private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible

for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to

change.

Copyright © 2001-2018 Aetna Inc.



AETNA BETTER HEALTH® OF PENNSYLVANIA

Amendment to Aetna Clinical Policy Bulletin Number: 0565 Ankle Orthoses, Ankle-

Foot Orthoses (AFOs), and Knee-Ankle-Foot Orthoses (KAFOs)

For the Pennsylvania Medical Assistance plan: The pre-fabricated “Noodle T!!FO” and the “PHAT dynamic carbon fiber AFO”, which is made by Bio- Mechanical Composites Inc. will be considered for coverage on a case by case basis if deemed to be medically necessary. Prior authorization would be required.

www.aetnabetterhealth.com/pennsylvania revised 08/16/2018

http://www.aetnabetterhealth.com/pennsylvania

0565 ankle orthoses, ankle-foot orthoses (afos), …...see cpb 0009 - orthopedic casts, braces, and...

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