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)
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).
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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).
See CPB 0009 - Orthopedic Casts, Braces, and Splints (../1_99/0009.html).
▪ 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.
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▪ 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.
See CPB 0009 - Orthopedic Casts, Braces, and Splints (../1_99/0009.html).
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
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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.
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▪ 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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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-
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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:
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▪ 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
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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
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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
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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
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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
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-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
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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]
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Code Code Description
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
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Code Code Description
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,
prefabricated, includes fitting and adjustment
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,
prefabricated, includes fitting and adjustment
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
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Code Code Description
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,
prefabricated, includes fitting and adjustment
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
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Code Code Description
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
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Code Code Description
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
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Code Code Description
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
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Code Code Description
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
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Code Code Description
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
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Code Code Description
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
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The above policy is based on the following references:
Ankle Orthoses, Ankle-Foot Orthoses (AFOs), and Knee-Ankle-Foot Orthoses (KAFO... Page 36 of 40
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.
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Ankle Orthoses, Ankle-Foot Orthoses (AFOs), and Knee-Ankle-Foot Orthoses (KAFO... Page 37 of 40
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.
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Ankle Orthoses, Ankle-Foot Orthoses (AFOs), and Knee-Ankle-Foot Orthoses (KAFO... Page 38 of 40
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.
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Ankle Orthoses, Ankle-Foot Orthoses (AFOs), and Knee-Ankle-Foot Orthoses (KAFO... Page 39 of 40
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.
Ankle Orthoses, Ankle-Foot Orthoses (AFOs), and Knee-Ankle-Foot Orthoses (KAFO... Page 40 of 40
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.
http://qawww.aetna.com/cpb/medical/data/500_599/0565_draft.html 08/28/2018
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