William W. DeToro, CO
Very little objective data have been published regarding the
control offered by specific ankle-foot orthoses designs, despite their
widespread clinical application. In addition, the proliferation of custom
designs and prefabricated variants in recent years has made it increasingly
difficult to judge the effectiveness of a particular ankle-foot orthoses before
completion of the fitting.
A review of the literature showed that no definitive method for
measuring load deflection characteristics of orthoses has been established to
date. For this pilot study, we investigated the use of a simple digital
tensiometer to objectively quantify the plantarflexion resistance supplied at
the forefoot for a variety of common orthoses.
In the study, the tested orthoses fell into three distinctive
groupings based on the average static resistance to plantarflexion. These data
suggest that nonambulatory orthoses can be readily identified by the minimal
plantarflexion resistance offered, whereas ambulatory devices can be classified
as those offering moderate plantarflexion resistance versus those that function
as a plantarflexion stop.This grouping according to biomechanical performance
in the sagittal plane may have clinical significance and therefore may be
useful in determining what specific ankle-foot orthoses should be prescribed.
(J Prosthet Orthot. 2001;13:39-44.)
Key words: Plantarflexion, resistance, ankle-foot orthoses,
biomechanical control
Ankle-Foot-Orthoses [AFOs] are one of the most commonly
prescribed lower limb orthoses, largely because of
their versatility in providing selected biomechanical controls to augment
impaired functions. They are also generally well tolerated by those who wear
them and are therefore are often
associated with a positive clinical outcome.
Despite their widespread clinical application, only a limited amount of objective data have been published regarding the control offered by specific AFO designs. This study was conducted to objectively document, in a simple manner, the resistance to plantarflexion of a variety of commonly prescribed AFOs. These data may prove useful in verifying the effectiveness of such orthoses when they are used to facilitate ambulation for individuals with neuromuscular impairments and in developing prescription criteria for their clinical application.
Previous authors have shown that
the sagittal plane stiffness of the tested AFOs varies widely1,2 and that the resistance provided
significantly affects pathologic gait.3
It has also been shown that, for a given individual with a gait disorder, the
range of acceptable resistances is fairly narrow.4
These recent objective data support the concept of providing functional
orthoses based on the patient's biomechanical deficits, or "biomechanical
matching," as originally termed by Sarno and Lehneis.5
No definitive method for
measuring load deflection characteristics of orthoses has been established,4 although there is general consensus in
the literature that sagittal plane stiffness is of particular clinical
importance. The proliferation of custom designs and prefabricated variants in
recent years has made it increasingly difficult to judge the effectiveness of a
particular AFO before completion of the fitting. For this reason, we
investigated the use of a simple digital tensiometer to objectively quantify
the plantarflexion resistance supplied st the forefoot for a variety of common
orthoses, as suggested by Rubin and Dixon6
in 1973.
To ensure that the orthoses tested were representative of actual devices that might be provided in a clinical setting, a healthy 59-year-old 6 feet 3 inches tall and weighing 245 pounds, was recruited as a volunteer subject. A negative impression was taken of his right lower leg in the conventional manner, using fiberglass casting tape wrapped over a single layer of cotton stockinet. His foot was placed in a neutral position on a casting plate to simulate the footbed of a conventional shoe with a 12 mm (half inch) heel rise. Routine circumferential and linear measurements of the casted limb were also recorded.
The negative impression was filled with plaster to create a positive model that was then rectified in accordance with standard industry practice. All casting artifacts and stockinet marks were removed, and the malleolar regions were built up with plaster patches to create slight relief areas over these bony prominences.
The final model, which may be considered representative of
a typical large adult male lower leg, was then duplicated in rigid polyurethane
foam over a plywood core and reinforced externally with a polyester resin
vacuum-bag lamination over a single layer of nylon stockinet. The laminated
model was then used to create the test apparatus, which was similar to that described by Golay et al.2
Tested orthoses
The original plaster positive model was then used to fabricate eight different custom-made AFOs of varying biomechanical designs, as described in Table 1. Three of the custom orthoses were the minimal-contact sidebar and band type, and five were total-contact thermoplastic orthoses. All were constructed in accordance with industry-standard fabrication methods using readily available components and materials that are routinely incorporated in typically prescribed orthoses.
Ten prefabricated AFOs were also fitted to the positive model. The prefabricated orthoses selected represent a range of commonly prescribed devices. The tested orthoses are listed in Table 1.
TABLE ONE: Characteristics of the tested
orthoses
|
Sample Number |
Manufacturer |
Material Used |
Ankle Control |
Source for Joints |
|
1 |
Custom made |
Aluminum & leather |
Klenzak joint, spring loaded |
USMC[a] #21140802 |
|
2 |
Custom made |
Aluminum & leather |
Klenzak joint, with solid rod |
USMC #2140802 |
|
3 |
Custom made |
Aluminum & leather |
Thrust bearing Phelps joint, 90 degree stop |
USMC #19017 |
|
4 |
Custom made |
4 mm thermoplastic polypropylene-polyethylene copolymer |
Solid ankle trimline |
Not applicable |
|
5 |
Custom made |
4 mm thermoplastic polypropylene-polyethylene copolymer |
Posterior leaf spring trimline |
Not applicable |
|
6 |
Custom made |
4 mm thermoplastic polypropylene-polyethylene copolymer |
Tamarack #742-L-85 ankle joints [dorsiflexion assist] |
Becker[b] |
|
7 |
Custom made |
4 mm thermoplastic polypropylene-polyethylene copolymer |
Becker 760-L Oklahoma Ankle Joints; Precision O&P PSA-100-A adjustable dorsiflexion spring assist |
Becker Precision O&P[c] |
|
8 |
Custom made |
4 mm thermoplastic polypropylene-polyethylene copolymer |
Becker 760-L Oklahoma Ankle Joints; Precision O&P Elite Line PAS-100-A adjustable plantar flexion stop |
Becker Precision O&P |
|
9 |
Orthomerica[d] OA-3547-01 |
3 mm polypropylene homopolymer plastic |
Trimline at ankle midline [limited motion] |
Not applicable |
|
10 |
Select Medical Products[e] #001203 |
Low temperature Kydex thermoplastic |
Not adjustable |
Not applicable |
|
11 |
Flexboot-01FB2 Flexboot Ortho[f] |
Low temperature Kydex thermoplastic |
Not adjustable |
Not applicable |
|
12 |
New Age Oscar Orthosis Corrective Systems[g] |
Low temperature Kydex thermoplastic |
Not adjustable |
Not applicable |
|
13 |
Multi-Podus-10MP Restorative Care of America[h] |
Low temperature Kydex thermoplastic |
Not adjustable |
Not applicable |
|
14 |
EZ-Boot #10-320 Orthotic Rehab[i] |
Unspecified plastic |
Not adjustable |
Not applicable |
|
15 |
PRAFO-650 Anatomical Concepts, Inc.[j] |
Injection-molded Polypropylene, 1/8” anodized aluminum upright |
Standard aluminum posterior bar |
Not applicable |
|
16 |
PRAFO-650HD Anatomical Concepts, Inc. |
Injection-molded polypropylene, 3/16” anodized aluminum upright |
Heavy duty aluminum posterior bar |
Not applicable |
|
17 |
PRAFO-650APU Anatomical Concepts, Inc. |
Injection-molded polypropylene, 1/8” extruded aluminum upright |
Adjustable aluminum posterior bar |
Not applicable |
|
18 |
PRAFO-650SS Anatomical Concepts, Inc. |
Injection-molded polypropylene, 1/8” spring steel upright |
Spring steel posterior bar |
v |
All orthoses were fitted and adjusted to the test model by an experienced orthotist who is certified by the American Board for Certification in Prosthetics and Orthotics. The prefabricated devices were adjusted in accordance with the manufacturer’s written instructions and guidelines.
Test Apparatus
The test apparatus was constructed by placing a single axis hinge in the transmalleolar region of the wood-reinforced foam model of the subject’s lower leg. Sufficient material was removed so that the model could bend freely from 20 degrees of dorsiflexion to 20 degrees of plantarflexion to stimulate normal sagittal plane ankle motion in this range.
The shank of the articulated leg model was mounted rigidly to the back of the test stand so that the foot segment could move freely, as shown in Figure 1. The various orthoses provided the resistance to plantarflexion motion. Plantarflexion motion was measured by placing a stainless steel band across the dorsum of the model in the region corresponding to the metatarsal heads, located 25.4 cm (10 inches) anterior to the ankle joint for this individual.
A MARK-10 digital force gauge with certified calibration (MARK-10 Corporation, Hicksville, NY) was connected from the steel band to a screw drive, which was used to apply a distraction force that would cause the model to plantarflex. A liquid-filled angle measurement device was attached solidly to the plantar surface of the foot segment so that it read “0.0” degrees when the midline of the foot segment was at a right angle to the midline of the shank segment. As the foot segment was plantarflexed, the measured angle increased up to 20 degrees, which was the maximum movement allowed by the test apparatus.
Testing
To eliminate any measurement artifacts due to compression of soft interfaces, all materials lining the orthoses were removed and the calf section was rigidly bolted to the shank portion of the model. The screw jack was then used to deflect the foot portion of the model in 1 degree increments, from 0 to 10 degrees of plantarflexion, similar to the method of Sumiya et al.4 The resistance supplied by each orthosis was recorded for a total of ten trials. Figure 2 illustrates the average resistance provided by each orthosis at 10 degrees of plantarflexion.
A second set of measurements was performed on all
orthoses that could be altered from a neutral position to one that held the
foot segment in 10 degrees of dorsiflexion. This change
in position was accomplished by adjusting the stops, bending the
uprights, or thermal remolding of the orthosis. Figure 3 shows the average resistance generated at 10 degrees
of plantarflexion for those othoses that could be tested in this manner.
As might be expected, the resistance provided by the
orthoses increased as the foot segment was pulled in the direction of
plantarflexion, whether the starting point was from 10 degrees of dorsiflexion
or from the neutral [zero degree] position. Furthermore, those orthoses that
could be adjusted to a more acute dorsiflexion angle all demonstrated greater
resistance to plantarflexion motion than they did
when adjusted to a neutral position.
Although the range of resistances measured was
large, the orthoses could be classified into three relatively distinct groups
based on this parameter. Since the magnitude of the resistance to
plantarflexion will directly affect the amount of toe clearance in midswing for
individuals with pretibial muscle group deficiencies, this grouping may have
clinical significance.
This study found that commonly prescribed
contemporary AFO designs can be grouped
according to the maximum static resistance provided when the AFO is deflected up
to 10 degrees of plantarflexion. The designs that stopped
plantarflexion movement all provided the greatest magnitude of measured resistance
and were predominantly custom-made devices.
The devices that provided intermediate levels
of resistance but also allowed a significant range of ankle motion included
custom-made devices and all except the
heavy-duty PRAFO designs. The group that provided only minimal resistance were
all non-adjustable, prefabricated splints best
suited for non-ambulatory applications.
Prescribing physicians, orthotic clinicians, and
reimbursement authorities may be able to use such objective data to help
distinguish among orthoses that are
superficially similar in appearance but offer distinctly different
biomechanical advantages. In principle, it may be possible in the future to use the results from instrumented
analysis of an individual's pathologic gait patterns to specify the desired
amount of plantarflexion resistance for the orthosis
so that it is no longer necessary to determine
this by subjective means during iterative clinical walking trials. That is, if the missing ankle moments can be specified,
then it should be possible to design an orthotsis that offers an equivalent
corrective force. Measurement and
publication of a much broader array of data about the resistances and motion
provided by lower-limb orthoses in all planes may be helpful in increasing objectivity
in the prescription and design of such devices.
The
author gratefully acknowledges the assistance of John W. Michael, CPO,
FAAOP of CPO Services, Inc. in the preparation of this manuscript.
Tables, Figures, and Legends
Figure 1:
The model, with a single axis hinge at malleolar level, permits free movement from 20 degrees of plantarflexion to 20 degrees of dorsiflexion and is anchored rigidly to a vertical stand. Test orthoses were attached rigidly to the calf segment; static dorsiflexion resistance was measured at the metatarsal heads, to simulate the clinical effect of walking with an AFO intended to compensate for dorsiflexion weakness. A digital goniometer measured the deflection angle, and a digital tensiometer recorded the static force applied at the metatarsal head region.

Figure 2:
Average
static resistance measured at 10 degrees of plantarflexion for orthoses that
were initially set in neutral plantarflexion-dorsiflexion.

Figure 3:
Average static resistance measured at 10 degrees of plantarflexion for orthoses that were initially set in 10 degrees of dorsiflexion.




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