Abstract:
A component system of footwear corrective alignment insoles provides adjustment of the alignment of a human foot based upon evaluation and measurement of structural anomalies in the foot. A subtalar joint goniometer measures the angular alignment of the foot with a patient&#39;s leg properly inclined with respect thereto. A database contains data with selected relationships between the degree of a patient&#39;s foot pronation and supination and a variety of corrective pads for use with an insole for correcting pronation and supination. The foot pronation and supination is corrected by first measuring a patient&#39;s foot pronation and supination, comparing the measured pronation or supination with a database that correlates degrees of pronation and supination with a variety of corrective pads for use with a corrective alignment insole, selecting corrective pads from the database that correspond to the measured pronation or supination, and mounting the selected corrective pads to a base insole.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application claims the benefit of U.S. Provisional Application Ser. No. 60/397,446, filed on Jul. 19, 2002. 
    
    
     BACKGROUND OF INVENTION 
     1. Field of the Invention 
     The invention relates to correcting foot alignment. In one aspect, the invention relates to an apparatus for measuring the alignment of the human foot. In another of its aspects, the invention relates to a footwear corrective alignment insole kit for correcting foot alignment during standing, walking, or running. In another aspect, the invention relates to measuring instruments for determining the type and amount of corrective alignment required for a foot. In another aspect, the invention relates to a method for correcting the alignment of the human foot. 
     2. Description of the Related Art 
     No two human feet are the same. Indeed, an individual&#39;s two feet may have vastly different structural characteristics. For example, a person may have low arches, commonly referred to as “flat feet” or “fallen arches.” Or, a person may suffer from pronation, i.e. the tendency of the foot to roll inward during walking or running. An individual with flexible ankles may suffer from painful pressure points that develop during walking or running due to the inability of the foot to maintain proper stability and alignment. 
     Different approaches are taken to correcting problems with foot alignment and structure. Exercises for strengthening the foot and/or ankles can be performed. However, these may be inadequate to correct structural problems such as a low arch. Alternatively, footwear corrective alignment insoles can be used to attempt to compensate for alignment and structural problems, particularly for raising and supporting a fallen arch. Or a corrective alignment insole can be used to stabilize the heel to prevent side-to-side movement of the foot. Frequently, corrective alignment insoles are inadequate to stabilize the foot during the full range of motion experienced during walking or running. Additionally, corrective alignment insoles are generally located underneath the arch and heel portion of the foot, and do not extend beneath the plantar region of the foot and the toes. Consequently, as the foot rolls forward, weight is transferred off the corrective alignment insole which can affect the correction of the foot movement, even exacerbating the problems that the corrective alignment insole is intended to correct. 
     SUMMARY OF INVENTION 
     In a first embodiment of the invention, a method of making a shoe correction for the alignment of a person&#39;s foot, comprises the steps of, while the person is standing on the foot, inclining the person&#39;s lower leg forwardly about the foot a preselected angle from the vertical, and, while maintaining the person&#39;s lower leg in the forward inclined position at the preselected angle, measuring the lateral angular alignment of the foot. The method can further comprise the step of selecting from a database appropriate corrective components for incorporation into a shoe to correct the alignment of the person&#39;s foot, wherein the database has a correlation between a range of lateral angular alignment values and appropriate corrective components. 
     The corrective components can include combinations of corrective alignment insole components, including supination, pronation, and arch control pads. The method can further comprise the step of constructing a corrective alignment insole from a base insole and the selected supination, pronation, and arch control pads. 
     The database can further include a correlation between lateral angular alignment values and an appropriate shoe type, and can further comprise the step of incorporating the corrective alignment insole into the selected shoe type. 
     The measuring step can be carried out with the aid of a subtalar joint goniometer. The measuring step can include the step of inscribing a reference line along the Achilles&#39; tendon portion of the person&#39;s foot, and measuring the lateral angular alignment of the reference line. The method can further comprise the step of constructing a corrective alignment shoe by incorporating into the shoe the selected corrective components. 
     In an alternate embodiment, a method of making a shoe correction for the alignment of a person&#39;s foot can comprise the steps of measuring the lateral angular alignment of the person&#39;s foot with respect to a lower portion of the leg, and selecting from a database appropriate corrective components for incorporation into a shoe to correct the alignment of the person&#39;s foot. 
     In yet another embodiment, a kit for quantifying and making a shoe correction for a misalignment of a person&#39;s foot comprises a dorsiflexion template adapted to position the person&#39;s lower leg at a preselected forward angle with respect to an upper surface of the person&#39;s foot adjacent the ankle when the person is standing on the foot, and a subtalar joint inclinometer to measure the lateral angular alignment of the person&#39;s foot when the person&#39;s lower leg is inclined at the preselected angle. The kit can further comprise at least one corrective alignment insole component comprising a base insole in the general shape of a person&#39;s footprint having a lateral portion, a medial portion, and an arch stability portion, at least one supination control pad for adjusting the supination alignment of the person&#39;s foot, at least one pronation control pad for adjusting the pronation alignment of the person&#39;s foot, and at least one arch control pad for adjusting the support of the person&#39;s arch. 
     The kit can further comprise a database which correlates a range of lateral angular alignment values combinations with at least one of the corrective alignment insole components, wherein the at least one of the corrective alignment insole components can be selected from the database based upon the lateral angular alignment measurement obtained from the subtalar joint inclinometer. 
     The subtalar joint inclinometer can comprise a subtalar joint goniometer comprising a base portion having an indicator arrow extending orthogonally upwardly therefrom and an alignment portion pivotally attached to the base portion having a protractor scale inscribed thereon. The subtalar joint inclinometer can also comprise a calcaneal bisection gauge comprising a pair of arcuate wings pivotably connected by a hinge to locate the mid-line of the person&#39;s heel, and an angle finder to measure the inclination of the mid-line. 
     In another embodiment of the invention, a corrective alignment insole assembly for making a shoe correction for the alignment of a person&#39;s foot comprises a base insole in the general shape of a person&#39;s footprint having a lateral portion, a medial portion, and an arch stability portion, and adapted for correcting both pronation and supination in combination with at least one of at least one supination control pad, at least one pronation control pad, or at least one arch control pad, at least one supination control pad for adjusting the supination alignment of the person&#39;s foot at least one pronation control pad for adjusting the pronation alignment of the person&#39;s foot, and at least one arch control pad for adjusting the support of the person&#39;s arch, wherein the at least one supination control pad, the at least one pronation control pad, and the at least one arch control pad are selected based upon a lateral angular alignment measurement of the person&#39;s foot. 
     The base insole can be divided into an irregularly-shaped supination control portion extending along the lateral portion of the base insole, an irregularly-shaped motion control portion extending along the medial portion of the base insole, and a crescent-shaped arch stability portion extending along the arch portion of the base insole. 
     The at least one supination control pad can comprise an irregularly-shaped member having a variable wedge-shaped cross section corresponding in size and shape to the supination control portion of the base insole, and having an anterior end, a posterior end, a medial edge, and a lateral edge, wherein the thickness of the at least one supination control pad decreases from the lateral edge to the medial edge, and from a portion along the lateral edge to the anterior end and the posterior end. The at least one supination control pad can range in thickness from a maximum of 3/16 inch at the center lateral edge to 1/16 inch at the posterior end, to zero inches at the anterior end and along the medial edge. The at least one supination control pad can further comprise an irregularly-shaped central portion. 
     A supplementary supination control pad can comprise an irregularly-shaped member having a generally wedge-shaped cross section corresponding in size and shape to the supplementary supination control pad portion, attached to the supination control pad at a central portion thereof the supplementary supination control pad portion for increasing the maximum thickness of the supination control pad at its center lateral portion, and having an anterior end, a posterior end, a medial edge, and a lateral edge, wherein the thickness of the supination control pad decreases from the lateral edge to the medial edge, and from a portion along the lateral edge to the anterior end and the posterior end. The supplementary supination control pad can vary in thickness from a maximum of ⅛ inch at the center lateral edge to zero inches at the anterior end, the posterior end, and the medial edge. 
     The at least one motion control pad can comprise an irregularly-shaped elongated member having a variable wedge-shaped cross section corresponding in size and shape to the motion control portion of the base insole, and having an anterior end, a posterior end, a medial edge, and a lateral edge, wherein the thickness of the at least one motion control pad decreases from the medial edge to the lateral edge, and from the portion along the medial edge to the anterior end and the posterior end. The at least one motion control pad can range in thickness from a maximum of 3/16-inch along the anterior portion of the medial edge, to ⅛-inch at the posterior end, to zero inches at the anterior end and along the lateral edge. 
     The at least one motion control pad can comprise an irregularly-shaped supplementary motion control pad portion located at the anterior medial portion of the at least one motion control pad. The supplementary motion control pad can comprise an irregularly-shaped member having a generally wedge-shaped cross-section corresponding in size and shape to the supplementary motion control pad portion, attached to the motion control pad at the supplementary motion control pad portion for increasing the maximum thickness of the motion control pad at its anterior medial portion, and having an anterior end, a posterior end, a medial edge, and a lateral edge, wherein the thickness of the at least one supplementary motion control pad decreases from the center medial edge to the anterior end, the posterior end, and the lateral edge. The supplementary motion control pad can vary in thickness from a maximum of ⅛ inch at the center medial edge to zero inches at the anterior end, the posterior end, and the lateral edge. 
     The at least one arch stability pad can comprise a crescent-shaped member having a generally wedge-shaped cross section corresponding in size and shape to the arch stability portion of the base insole, and having an anterior end, a posterior end, a medial edge, and a lateral edge, wherein the thickness of the at least one arch stability pad decreases from the center medial edge to the lateral edge, the anterior end and the posterior end. The at least one arch stability pad can range in thickness from a maximum of 3/16 inch at the center medial edge to zero inch from the anterior end along the lateral edge to the posterior end. 
     The at least one arch stability pad can comprise a supplementary arch stability pad comprising a crescent-shaped member having a generally wedge-shaped cross-section for attachment to the at least one arch stability pad for increasing the maximum thickness of the at least one arch stability pad at the arch stability portion of the base insole, and having an anterior end, a posterior end, a medial edge, and a lateral edge, wherein the thickness of the supplementary arch stability pad decreases from the center medial edge to the lateral edge, the anterior end, and the posterior end. The supplementary arch stability pad can vary in thickness from a maximum of 3/16 inch at the center medial edge to zero inch from the anterior end along the lateral edge to the posterior end. 
     The base insole can further comprise a resilient heel cushioning zone for cushioning impact to the heel. The resilient heel cushioning zone can comprise a pattern of cutout sections adapted to provide resilient cushioning immediately beneath the person&#39;s heel, or a low density gel pad adapted to provides resilient cushioning immediately beneath the person&#39;s heel. The low density gel pad can comprise a low density gel polymer. 
     In yet another embodiment, a subtalar joint inclinometer for measuring the lateral angular alignment of a person&#39;s foot when the person is in a standing position comprises, a base having a first portion adapted to be positioned beneath the heel of a person in a standing position and a second portion orthogonal with respect to the first portion and adapted to be placed adjacent to the Achilles tendon of the person whose heel is positioned on the base first portion; a heel alignment member adapted to be positioned on the heel of the person whose heel is positioned on the base first portion; and a protractor scale indicia on one of the base second portion and the heel alignment member and a reference line indicia on the other of the base second portion and the heel alignment member, wherein the reference line indicia is aligned with a zero position on the protractor scale indicia when the person&#39;s heel has a zero angular alignment and is adapted to indicate on the protractor scale indicia the degree of angular deviation of the person&#39;s foot from zero angular alignment. In one illustrative embodiment, the heel alignment member is pivotally mounted to the base. In another illustrative embodiment, the heel alignment member has wings which are adapted to cradle the heel of the person whose heel is positioned on the base first portion. In a preferred embodiment, the protractor scale indicia is disposed on the heel alignment member and the reference line indicia is disposed on the base second portion. 
     In a further embodiment of the invention, the subtalar joint inclinometer can also comprise a calcaneal bisection gauge for inscribing a reference line on the heel of the person aligned with the person&#39;s Achilles tendon and a protractor for determining the inclination of the reference line when the person is standing. 
     In yet another embodiment of the invention, a database for selecting at least one corrective alignment insole component for making a shoe correction for a misalignment of a person&#39;s foot based upon a measurement of a lateral angular alignment of the person&#39;s foot comprises a plurality of preselected lateral angular alignment values, and at least one corrective alignment insole component, wherein the preselected lateral angular alignment values are correlated to the at least one corrective alignment insole component so that the at least one corrective alignment insole component can be selected from the database based upon the lateral angular alignment measurement. The database can further include a correlation between the plurality of lateral angular alignment values with a variety of shoe types and wherein the appropriate corrective shoe can be selected for use with the selected at least one corrective alignment insole component. The at least one corrective alignment insole component can include at least one of a base insole, a supination control pad, a supplementary supination control pad, a motion control pad, and a supplementary motion control pad. A lateral angular alignment value of −5° to 3° can correlate to an assembly of corrective alignment insole components comprising a base insole, a supination control pad, and a supplementary supination control pad. 
     A lateral angular alignment value of 3° to 6° can correlate to an assembly of corrective alignment insole components comprising a base insole, and a supination control pad. A lateral angular alignment value of 6° to 9° can correlate to an assembly of corrective alignment insole components comprising a base insole. A lateral angular alignment value of 9° to 12° can correlate to an assembly of corrective alignment insole components comprising a base insole, and a supplementary motion control pad. 
     A lateral angular alignment value of 12° to 15° can correlate to an assembly of corrective alignment insole components comprising a base insole, and a motion control pad. A lateral angular alignment value of greater than 15° can correlate to an assembly of corrective alignment insole components comprising a base insole, a motion control pad, and a supplementary motion control pad. 
    
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
       In the drawings: 
         FIG. 1  is a rear elevational view of a human foot showing misalignment of the leg, ankle, and foot due to a fallen arch. 
         FIG. 2  is a rear elevational view of a human foot showing correction of the misalignment of  FIG. 1  from the utilization of a corrective alignment insole according to the invention. 
         FIG. 3  is a side elevational view of a human foot showing the proper positioning of the leg, ankle, and foot utilizing a dorsiflexion template according to the invention. 
         FIG. 4  is a rear elevational view of the foot of  FIG. 3  showing the angular alignment of the leg, ankle, and foot utilizing a subtalar joint goniometer instrument according to the invention. 
         FIG. 5  is a plan view of the dorsiflexion template of  FIG. 3 . 
         FIG. 6  is a perspective view of the subtalar joint goniometer instrument of  FIG. 4 . 
         FIG. 7  is an exploded plan view of the subtalar joint goniometer instrument of  FIG. 4 . 
         FIG. 8  is a bottom plan view of a base insole comprising a first component of a footwear corrective alignment insole according to the invention and an embodiment of a resilient heel cushioning zone. 
         FIG. 9  is an exploded perspective view from underneath of a motion control pad and a supplementary motion control pad comprising a second component of a footwear corrective alignment insole according to the invention. 
         FIG. 10  is a sectional view of the motion control pad shown in  FIG. 9  taken along line  10 — 10  of  FIG. 9 . 
         FIG. 11  is a sectional view of the motion control pad shown in  FIG. 9  taken along line  11 — 11  of  FIG. 9 . 
         FIG. 12  is an exploded perspective view from underneath of a supination control pad and a supplementary supination control pad comprising a third component of a footwear corrective alignment insole according to the invention. 
         FIG. 13  is a sectional view of the supination control pad shown in  FIG. 12  taken along line  13 — 13  of  FIG. 12 . 
         FIG. 14  is a sectional view of the supination control pad shown in  FIG. 12  taken along line  14 — 14  of  FIG. 12 . 
         FIG. 15  is an exploded perspective view from underneath of an arch stability pad and a supplementary arch stability pad comprising a fourth component of a footwear corrective alignment insole according to the invention. 
         FIG. 16  is a sectional view of the arch stability pad shown in  FIG. 15  taken along line  16 — 16  of  FIG. 15 . 
         FIG. 17  is a sectional view of the arch stability pad shown in  FIG. 15  taken along line  17 — 17  of  FIG. 15 . 
         FIG. 18  a perspective view of a calcaneal bisection gauge according to the invention. 
         FIG. 19  is a perspective view of the use of the calcaneal bisection gauge of  FIG. 18  to draw a calcaneal bisection line on a heel. 
         FIG. 20  is a rear elevational view of a foot showing the calcaneal bisection line drawn on the heel. 
         FIG. 21  is a database chart according to the invention for selecting one or more pads for assembly into a corrective alignment insole to correct a misalignment of a foot. 
         FIG. 22  is a foot/leg symptomatic chart for correlating a corrective alignment insole with reported foot, leg, and hip symptoms according to the invention. 
         FIG. 23  is a perspective view of an evaluation of a subtalar neutral position. 
         FIG. 24  is a perspective view of an evaluation of the angular misalignment of the foot width of the lower leg inclined 25°. 
         FIG. 25  is a perspective view of a non-weight bearing evaluation of the alignment of the foot. 
         FIG. 26  is a view of a foot and a leg of a patient lying in a prone position showing a non-weight bearing evaluation of the alignment of the foot. 
         FIG. 27  is an exploded view showing the assembly of the pads of  FIGS. 9 ,  12 , and  15  onto the base insole of  FIG. 8  to form a corrective alignment insole according to the invention. 
         FIG. 28  is a plan view of the base insole shown in  FIG. 8  comprising an alternate embodiment of a resilient heel cushioning zone comprising a low density gel pad. 
         FIG. 29  is a perspective view of the low density gel pad shown in  FIG. 28 . 
         FIG. 30  is a sectional view of the low density gel pad shown in  FIG. 29  taken along line  30 — 30  of  FIG. 29 . 
     
    
    
     DETAILED DESCRIPTION 
     The foot has three main parts: the forefoot, the midfoot, and the hindfoot. The forefoot comprises the five toes, or phalanges, and their connecting long bones, i.e. the metatarsals. The midfoot comprises five irregularly-shaped tarsal bones, forms the foot&#39;s arch, and serves as a “shock absorber” during walking, running, or jumping. The bones of the midfoot are connected to the forefoot and the hindfoot by muscles and the plantar fascia, or the arch ligament. The hindfoot is composed of three joints and links the midfoot to the ankle, called the talus. The top of the talus is connected to the two long bones comprising the lower leg, i.e. the tibia and the fibula, forming a hinge that allows the foot to move up and down. The heel bone, or calcaneus is the largest bone in the foot. It joins the talus to form the subtalar joint, which enables the foot to rotate at the ankle. 
       FIG. 1  shows a portion of a lower extremity  10  of a human illustrating misalignment of a heel  11 , a leg  15 , and ankle  17 , and a foot  19  due to a structural anomaly. For exemplary purposes, the anomaly is shown as a condition commonly referred to as “fallen arches” or “flat feet.” As a consequence of this condition, the ankle  17  is tilted inwardly, known as “pronation,” and the lower leg  15  is inclined so that the foot  19 , lower leg  15 , knee, upper leg, and hip are vertically misaligned. This can result in an improper walking and running motion, placing the leg joints under stress, and increasing the potential for injury and pain. 
       FIG. 2  shows a foot  19  supported on a corrective alignment insole  12  which corrects the misalignment of the foot due to, for example, “fallen arches” by raising the inner or medial portion of the foot  19  according to the invention. The corrective alignment insole  12  can also raise the outer or lateral portion of the foot  19  as necessary to correct other misalignments of the foot  19  and leg  15 , as hereinafter described. The corrective alignment insole  12  also controls the motion of the foot  19  and the leg  15 , restoring the proper alignment of the foot  19  and leg  15  during walking and running. 
     The corrective alignment insole  12  is a component system comprising a base insole and wedge-shaped pads of progressively increasing thickness for raising and tilting selected portions of the foot  19 . The corrective alignment insole  12  can be readily customized to a precise foot structure and required alignment correction because of the adaptability of the component system. The combination of insole and pads required to correct the misalignment is determined by the use of two instruments comprising the invention and a systematic evaluation of the structure of the foot  19 , the ankle, and the leg  15 . 
       FIGS. 3–7  show measuring instrumentation according to the invention.  FIGS. 3–4  show the instrumentation in use.  FIG. 3  shows the first instrument, referred to herein as a “dorsiflexion template”  13 , positioned against the foot  19  at the ankle  17 . Referring to  FIG. 5 , the dorsiflexion template  13  is a generally diamond-shaped, plate-like member having an ankle vertex  16 , a upper edge  18 , and a lower edge  20 . The vertex  16 , upper edge  18 , and lower edge  20  define an obtuse angle α, preferably about 105°. The angle α represents the angle between the leg  15  and the foot  19  at which the heel  11  just begins to lift from a supporting surface as the leg  15  is inclined forward, typically at an angle of about 25° from the vertical. 
     Referring now to  FIG. 4 , a first embodiment of a subtalar joint inclinometer, referred to herein as a “subtalar joint goniometer”  14 , is shown in position relative to the heel  11  for determining the lateral angular alignment of the foot  19 . Referring also to  FIGS. 6 and 7 , the subtalar joint goniometer  14  is a two-piece, pivotably-interconnected angle measuring device comprising a base portion  22  and an alignment protractor  24 . The base portion  22  is a generally trapezoidal-shaped, plate-like member comprising a heel plate  26 , a pair of spaced apart upwardly-extending side walls  28  hingedly attached thereto, and an upwardly-extending rear wall  30  hingedly attached to the heel plate  26 . The heel plate  26  is a generally trapezoidal-shaped member having a pair of spaced-apart edges  25  inclined toward the rear wall  30 , and a rear edge  23 . Each side wall  28  is attached to the heel plate  26  along the inclined edge  25  through a living hinge  27 . The rear wall  30  is attached to the heel plate  26  along the rear edge  23  through a living hinge  29 . As shown in  FIG. 4 , the heel plate  26 , the side walls  28 , and the rear wall  30  form a cradle-like structure into which the heel  11  is placed for measurement of the foot and leg alignment, as hereinafter described. 
     Extending upwardly from the rear wall  30 , perpendicular to the heel plate  26 , is a triangularly-shaped pointer  32 . Extending through the back wall  30 , in axial alignment with the pointer  32 , is an aperture  34  for pivotably mounting the alignment protractor  24  to the base portion  22 . In the preferred embodiment, the base portion  22  is formed from a sheet of material, such as a rigid plastic, or cardboard, and folded along the living hinges  27 ,  29  to form the cradle-like base portion  22 . 
     The alignment protractor  24  is a generally irregularly-shaped member comprising an Achilles plate  36 , a pair of spaced-apart wings  38  hingedly attached thereto, and an alignment scale  40  affixed to the Achilles plate  36 , such as by printing or embossing. The Achilles plate  36  is an irregularly shaped member comprising a pair of spaced-apart inclined edges  33 . Each wing  38  is a generally trapezoidal-shaped member extending laterally from the Achilles plate  36 . Each wing  38  is attached to the Achilles plate  36  along the edge  33  through a living hinge  35 . The lower portion of the Achilles plate  36  terminates in a downwardly-depending, arcuately-shaped pivot flange  37 . The pivot flange  37  is provided with a generally centrally-positioned pivot aperture  42  adapted to be aligned with the aperture  34 . A pin  44  is received through the pivot aperture  42  and the aperture  34  for pivotable movement of the alignment protractor  24  relative to the base portion  22 . Preferably, the alignment protractor  24  is fabricated of the same material as the base portion  22 . 
     The dorsiflexion template  13  and the subtalar joint goniometer  14  can be made available to the public through an Internet website for downloading to a printer. Printing or transferring the dorsiflexion template  13  and the subtalar joint goniometer  14  onto a stiff material, such as cardboard, will enable a consumer to fabricate the instruments for personal or family use. 
     Referring to  FIGS. 18 ,  19  and  24 , an alternate subtalar joint inclinometer, comprising a calcaneal bisection gauge  110  and an angle finder  122 , is shown. It is anticipated that the calcaneal bisection gauge  110  and the angle finder  122  will be used primarily by foot care professionals such as podiatrists and physicians. The calcaneal bisection gauge  110  is used to locate the mid-line of the heel  11 , and comprises a pair of arcuate wings  112 ,  114  pivotably connected by a hinge  116 . The calcaneal bisection gauge  110  can be fabricated of any suitable material, such as a rigid or semi-rigid plastic, aluminum, or stainless steel. The preferred embodiment comprises a thermoplastic with the hinge  116  integrally formed as a living hinge. The hinge  116  terminates at each end in a pair of generally V-shaped spaced-apart notches  118 ,  120  longitudinally aligned with the hinge  116 . The curvature of the wings  112 ,  114  and the action of the hinge  116  enable the calcaneal bisection gauge  110  to “grip” the heel  11 . As shown in  FIG. 19 , with the calcaneal bisection gauge  110  in position against the heel  11 , a pair of angular marks are made on the heel  11  with a suitable marking instrument, such as a ball-point pen, and with the gauge  110  removed the apexes of the marks are connected to form a calcaneal bisection line  130  corresponding to the mid-line of the heel  11  ( FIG. 20 ). 
     The angle finder  122  comprises a suitable conventional protractor, such as a conventional carpenter&#39;s protractor, as shown in  FIG. 24 , for determining the angle between the calcaneal bisection line  130  made using the calcaneal bisection gauge  110  and the vertical. The angle determined from the angle finder  122  is used to select the appropriate footwear corrective alignment insole pads, as hereinafter described. 
       FIGS. 8–17  show the various components of the corrective alignment insole pads according to the invention. The description which follows relates to corrective alignment insole pads that can be assembled and inserted into a shoe, preferably in place of the insole that is initially supplied with the shoe. However, the corrective alignment insole pads can also be initially incorporated into a shoe during manufacture so that the shoe is supplied to a purchaser with the corrective alignment insole pads already in place. 
     Referring to  FIGS. 8–11 , a base insole  50  comprises a generally plate-like foot-shaped member having a toe end  52  and a heel end  54 . The base insole  50  may be flat, or somewhat curved to correspond to the general profile of the sole of a foot, particularly with a raised arch portion. The base insole  50  has an upper side  51  for contacting the foot  19 , and an underside  53  for contacting the mid-sole of the footwear. In the preferred embodiment, the base insole  50  and hereinafter described pads are provided in a variety of lengths and widths to accommodate a suitable range of foot sizes. 
     The base insole  50  comprises a layered structure comprising a supporting shell, an overlying cellular foam layer, and a breathable polyester fabric cover. The shell is preferably fabricated of a semi-rigid plastic, such as polyurethane. The foam layer can be a closed-cell foam or an open-cell foam depending on the degree of cushioning and support desired. As shown in  FIG. 8 , the heel end  54  is provided with a heel shock absorption grid  62  generally at the center thereof, and comprising a pattern of cutout sections in the cellular foam layer which provides a resilient cushioning zone immediately beneath the heel  11 . The underside  53  of the base insole  50  is provided with a plurality of selectively positioned alignment apertures  64  extending into the base insole  50 . 
     An alternative resilient heel cushioning zone is shown in  FIGS. 28–30 . Instead of the heel shock absorption grid  62 , a low density gel pad  134  is added to the heel end  54 . The low density gel pad  134  is shown in  FIGS. 28 and 29  as a circular-shaped pad comprising a circular center pedestal  136  with an annular perimeter flange  138  extending radially outwardly therefrom. Preferably, the perimeter flange  138  is tapered toward its perimeter. Alternatively, the gel pad  134  can be an oval or other shape suitable for incorporating into the heel end  54 . As shown in  FIGS. 29 and 30 , the gel pad  134  is provided with a plurality of suitably-spaced circular recesses  140  adapted for controlling the cushioning properties of the pad  134 . The size, number, and depth of the recesses  140  can be selected to provide a pre-selected degree of resilience and cushioning to the gel pad  134 . 
     In the embodiment shown in  FIGS. 28–30 , the base insole  50  is provided with a circular recess or cutout adapted to receive the center pedestal  136  so that the perimeter flange  138  lays over the base insole  50 . The insertion of the center pedestal  136  in the recess/cutout prevents the gel pad  134  from shifting during use. Preferably, the gel pad  134  comprises a low density gel polymer, although other materials can be employed based upon the degree of resilience and cushioning desired. 
     The base insole  50  is divided into a supination control portion  56  extending along the lateral portion of the base insole  50  (identified by the dotted line in  FIG. 8 ), a motion control portion  58  extending along the medial portion of the base insole  50  (identified by the combined dashed and dotted line in  FIG. 8 ), and an arch stability portion  60  extending along the arch portion of the base insole  50  (identified by the dotted line in  FIG. 8 ). 
     As shown in  FIG. 9 , a motion control pad  70  is an irregularly-shaped generally elongated member having a variable wedge-shaped cross section corresponding in size and shape to the motion control portion  58  of the base insole  50 , and having an anterior end  71 , a posterior end  73 , a medial edge  75 , a lateral edge  77 , an obverse side  79 , and a reverse side  80 . The motion control pad  70  is preferably fabricated of EVA, with a cross-section as shown in  FIGS. 10 and 11 , and is attached to the underside  53  of the base insole  50  at the motion control portion  58 . The thickness of the motion control pad  70  decreases from the medial edge  75  to the lateral edge  77 , and from the portion along the medial edge  75  to the anterior end  71  and the posterior end  73 . Preferably, the motion control pad  70  ranges in thickness from a maximum of 3/16-inch along the anterior portion of the medial edge 75, to ⅛-inch at the posterior end  73 , to zero inches at the anterior end  71  and along the lateral edge  77 . In  FIG. 9 , the thicknesses of the motion control pad  70  are indicated in parentheses. 
     The motion control pad  70  is provided with an irregularly-shaped supplementary motion control pad portion  69  located at the anterior medial portion of the motion control pad  70  (identified by the dotted outline in  FIG. 9 ). The reverse side  80  of the motion control pad  70  is provided with a plurality of alignment posts  66  for insertion into the mating alignment apertures  64  of the motion control portion  58  of the base insole  50  for attaching the motion control pad  70  to the base insole  50 . The obverse side  79  of the supplementary motion control pad portion  69  is provided with a plurality of selectively positioned alignment apertures  64  extending into the motion control pad  70 . 
     As also shown in  FIG. 9 , a supplementary motion control pad  76  is an irregularly-shaped member, preferably fabricated of EVA, having a generally wedge-shaped cross-section corresponding in size and shape to the supplementary motion control pad portion  69 , and is attached to the motion control pad  70  at the supplementary motion control pad portion  69  for increasing the maximum thickness of the motion control pad  70  at its anterior medial portion. The supplementary motion control pad  76  has an anterior end  100 , a posterior end  102 , a medial edge  104 , a lateral edge  106 , an obverse side  107 , and a reverse side  108 . Preferably, the supplementary motion control pad  76  varies in thickness from a maximum of ⅛ inch at the center medial edge  104  to zero inches at the anterior end  100 , the posterior end  102 , and the lateral edge  106 . 
     The reverse side  108  of the supplementary motion control pad  76  is provided with a plurality of alignment posts  66  for insertion into the mating alignment apertures  64  of the supplementary motion control pad portion  69  for attaching the supplementary motion control pad  76  to the motion control pad  70 . Alternatively, the supplementary motion control pad  76  can be attached directly to the base insole  50 . 
     Referring now to  FIG. 12 , a supination control pad  68  is an irregularly-shaped member having a variable wedge-shaped cross section corresponding in size and shape to the supination control portion  56  of the base insole  50 , and having an anterior end  61 , a posterior end  63 , a medial edge  65 , a lateral edge  67 , an obverse side  81 , and a reverse side  82 . The supination control pad  68  is preferably fabricated of EVA, with a cross section as shown in  FIGS. 13 and 14 , and is attached to the underside  53  of the base insole  50  at the supination control portion  56 . The thickness of the supination control pad  68  decreases from the lateral edge  67  to the medial edge  65 , and from the portion along the lateral edge  67  to the anterior end  61  and the posterior end  63 . Preferably, the supination control pad  68  ranges in thickness from a maximum of 3/16 inch at the center lateral edge to 1/16 inch at the posterior end  63 , to zero inches at the anterior end  61  and along the medial edge  65 . In  FIG. 12 , the thicknesses of the supination control pad  68  are indicated in parentheses. 
     The supination control pad  68  is provided with an irregularly-shaped supplementary supination control pad portion  57  located at the center lateral portion of the supination control pad  68  (identified by the dotted outline in  FIG. 12 ). The reverse side  82  of the supination control pad  68  is provided with a plurality of alignment posts  66  for mating communication with the alignment apertures  64  of the supination control portion  56  of the base insole  50  for attaching the supination control pad  68  to the base insole  50 . The obverse side  81  of the supplementary supination control pad portion  57  is provided with a plurality of selectively positioned alignment apertures  64  extending into the supination control pad  68 . 
     As also shown in  FIG. 12 , a supplementary supination control pad  74  is an irregularly-shaped member, preferably fabricated of EVA, having a generally wedge-shaped cross section corresponding in size and shape to the supplementary supination control pad portion  57 , and is attached to the supination control pad  68  at the supplementary supination control pad portion  57  for increasing the maximum thickness of the supination control pad  68  at its center lateral portion. The supplementary supination control pad  74  has an anterior end  101 , a posterior end  103 , a medial edge  105 , a lateral edge  98 , an obverse side  99 , and a reverse side  109 . Preferably, the supplementary supination control pad  74  varies in thickness from a maximum of ⅛ inch at the center lateral edge  98  to zero inches at the anterior end  101 , the posterior end  103 , and the medial edge  105 . 
     As shown in  FIG. 15 , an arch stability pad  72  is a generally crescent-shaped member having a generally wedge-shaped cross section corresponding in size and shape to the arch stability portion  60  of the base insole  50 , and having an anterior end  83 , a posterior end  84 , a medial edge  85 , a lateral edge  86 , an obverse side  87 , and a reverse side  88 . The arch stability pad  72  is preferably fabricated of EVA, with a cross-section as shown in  FIGS. 16 and 17 , and is attached to the underside  53  of the base insole  50  at the arch stability portion  60 . The thickness of the arch stability pad  72  decreases from the center medial edge  85  to the lateral edge  86 , the anterior end  83  and the posterior end  84 . Preferably, the arch stability pad  72  ranges in thickness from a maximum of 3/16 inch at the center medial edge  85  to zero inch from the anterior end  83  along the lateral edge  86  to the posterior end  84 . In  FIG. 15 , the thicknesses of the arch stability pad  70  are indicated in parentheses. 
     The reverse side  88  of the arch stability pad  72  is provided with a plurality of alignment posts  66  for mating communication with the alignment apertures  64  of the arch stability portion  60  of the base insole  50  for attaching the arch stability pad  72  to the base insole  50 . The obverse side  87  of the arch stability pad  72  is provided with a plurality of selectively positioned alignment apertures  64  extending into the arch stability pad  72  for attachment of a supplemental arch stability pad  78 . 
     As also shown in  FIG. 15 , a supplementary arch stability pad  78  is a generally crescent-shaped member, preferably fabricated of EVA, having a generally wedge-shaped thickness for attachment to the arch stability pad  72  for increasing the maximum thickness of the arch stability pad  72  at the arch stability portion  60  of the base insole  50 . The supplementary arch stability pad  78  has an anterior end  89 , a posterior end  90 , a medial edge  91 , a lateral edge  92 , an obverse side  93 , and a reverse side  94 . Preferably, the supplementary arch stability pad  78  varies in thickness from a maximum of 3/16 inch at the center medial edge  91  to zero inch from the anterior end  89  along the lateral edge  92  to the posterior end  90 . In  FIG. 15 , the thicknesses of the supplemental arch stability pad  78  are indicated in parentheses. 
       FIG. 27  shows the base insole  50  with the proper positioning of the supination control pads  68 ,  74 , the motion control pads  70 ,  76 , and the arch stability pads  72 ,  78  on the underside  53  of the base insole  50  to form the corrective alignment insole  12  as herein described. The insole  50  can be utilized with or without pads as determined by the measurements described herein. The measurements are used to determine specific pads to be attached to the base insole  50  to form a corrective alignment insole  12 , as hereinafter described. The corrective alignment insole  12 , incorporating selected pads, can be utilized as an insole to be placed by the user in a selected shoe after removing the original insole. In such a case, only one pair of corrective alignment insoles  12  is needed. Alternatively, a corrective alignment insole as described herein can be incorporated into a shoe as the original insole, thereby rendering the shoe a complete corrective alignment shoe. A user would then select a style of shoe having the required corrective alignment insole already installed. 
       FIG. 21  shows a database embodied in a chart for determining the particular combination of corrective alignment insole components needed based upon the results from the measurements obtained with the dorsiflexion template  13  and the subtalar joint goniometer  14 , or alternatively the calcaneal bisection gauge  110  and the angle finder  122 .  FIG. 22  shows a foot/leg symptomatic database embodied in a chart for use with the database chart of  FIG. 21  for refining the selection of corrective alignment insole components based upon a patient&#39;s description of various foot and leg symptoms. Alternatively, the databases can be embodied in a suitable alternate form, such as a computer database in digital form, or the like. These databases are used as part of a diagnostic and therapeutic method for systematically evaluating the misalignment of the patient&#39;s foot and leg, and selecting the necessary corrective alignment insole pads to correct the misalignment and reducing the patient&#39;s symptoms. This diagnostic and therapeutic method will now be described. 
     It is anticipated that the dorsiflexion template  13  and the subtalar joint goniometer  14  will be utilized by footwear sales personnel and the consumer, whereas the calcaneal bisection gauge  110  and the angle finder  122  will be used by podiatrists, orthopedic surgeons, and other footcare specialists. However, it will be understood that the use of the instruments is not so limited and that any of the instruments can be successfully utilized by a person having an understanding of their proper use. 
     There are five generally-recognized foot types which are quantified through the use of the method and instruments described herein. These include over-supination, mild supination, neutral, mild pronation, and over-pronation. The unique method described herein further divides over-pronation into two subcategories based upon the degree of angular displacement of the foot. Supination refers to the tendency of the foot to roll outwardly or laterally during walking or running. Pronation refers to the tendency of the foot to roll inwardly or medially during walking or running. The patient&#39;s description of his or her foot and leg symptoms is used with the foot/leg symptomatic chart ( FIG. 22 ) to identify likely corrective alignment insole pads and any medical conditions that may require additional diagnosis and treatment. 
     Shoes are frequently manufactured with selected structural qualities to accommodate the different foot types described herein. Thus, certain shoes will be preferred for a pronating foot, while other shoes will be preferred for a supinating foot. These shoe types and the associated foot types are set out in the foot/leg symptomatic chart of  FIG. 22 . The measurements obtained with the dorsiflexion template  13  and the subtalar joint goniometer  14 , or the calcaneal bisection gauge  110  and the angle finder  122 , are used to place the patient&#39;s foot into one of the above foot types using the measurement chart ( FIG. 21 ), select a recommended shoe type, and select the corrective alignment insole components. 
     For example, having determined the angular alignment of the foot as herein described and obtained a measurement of 10 degrees, the database chart prescribes a shoe providing full stability having a corrective alignment insole to correct mild pronation comprising a neutral base insole  50  with a supplementary motion control pad  76 , identified in the measurement chart  130  as a “D” corrective alignment insole. 
     The dorsiflexion template  13  and the subtalar joint goniometer  14  are utilized as shown in  FIGS. 3 and 4 . The dorsiflexion template  13  is placed at the front apex of the ankle  17  between the leg  15  and the foot  19 , and the leg  15  is inclined forward so that the leg  15  contacts the upside per side  18  of the dorsiflexion template  13  and the foot  19  contacts the lower side  20  of the dorsiflexion template  13 , thus orienting the leg  15  at the proper inclination for use of the subtalar joint goniometer  14 . While the inclination of the leg  15 , as determined with the dorsiflexion template  13 , is maintained, the heel  11  is placed on the heel plate  26  in contact with the alignment protractor  24  so that the heel  11  can be “wrapped” with the wings  38 , as shown in  FIG. 4 . The alignment protractor  24  will thus be placed in proper orientation relative to the heel  11  and the ankle  17 . The angular alignment of the heel  11  and the ankle  17  can then be read from the alignment protractor  24 . The angle thus determined is used with the database chart of  FIG. 21  to select the proper corrective alignment insole  12  and footwear. 
     Alternatively, a footcare professional can use the dorsiflexion template  13  and the subtalar joint goniometer  14 , or the calcaneal bisection gauge  110  and the angle finder  122 , in combination with a medical evaluation, to determine the angle of alignment and the proper corrective alignment insole  12  and footwear from the database chart of  FIG. 21 . The following description assumes that the footcare professional will utilize the calcaneal bisection gauge  110  and the angle finder  122 . 
     Preferably, a sequence of specific steps is taken in utilizing the invention. The method of utilizing the information to select a corrective alignment insole includes a sequence of evaluation steps comprising a standing visual assessment or “weight-bearing” assessment, a non-weight-bearing or prone measurement, and subtalar joint measurements using the subtalar joint goniometer  14 . The standing visual assessment and prone measurement involve observational and diagnostic techniques familiar to a person of ordinary skill in orthopedics, podiatry, and other medical arts related to the feet, although these techniques are utilized in a novel way in conjunction with the unique subtalar joint measurements to identify the proper corrective alignment insole. 
     During the “weight-bearing” assessment, three measurements are taken. The first is an evaluation of the subtalar neutral position. The evaluation is performed with a patient initially in a prone position. With the patient in the prone position, the calcaneal bisection gauge  110  is used to establish the calcaneal bisection line  130  as heretofore described. The patient then stands with his or her knees approximately four inches apart (i.e. a “fist width” apart). The medial and lateral heads of the talus bone are palpated while the patient rotates his or her hips from side to side until both heads of the talus bone can be palpated evenly on both sides ( FIG. 23 ). While the patient holds that position, the subtalar joint goniometer  14  or angle finder  122  are used to determine the heel angle. This angle defines the subtalar neutral position, and is recorded. 
     The next measurement is an evaluation of the “relaxed” position. The patient stands in an upright, relaxed posture with the feet slightly apart in a natural position. A second measurement of the heel angle is taken and recorded. 
     The final measurement defines 25° of standing dorsiflexion. For this measurement, the patient stands with his or her feet spread slightly apart and squats until the Achilles area of the heel  11  is inclined 25° from the vertical. Twenty-five degrees is determined either by a direct angular measurement using the angle finder  122 , as shown in  FIG. 24 , or by using the dorsiflexion template  13 . While the patient holds this position, the heel angle, as defined by the calcaneal line, is determined and recorded. 
     The non-weight-bearing assessment is performed with the patient lying face-down on an evaluation table with both feet extending off the edge of the table. Both heads of the talus bone are palpated while the fifth metatarsal head is grasped so that the ankle  17  can be rotated from side to side ( FIG. 25 ). The ankle  17  is rotated until the talus heads are even on both sides. When the point is reached at which the talus heads are even, gentle pressure is placed on the bottom of the fifth metatarsal head to force the foot into dorsiflexion ( FIG. 26 ). The foot will assume one of three orientations: neutral, i.e. effectively no misalignment, varus, i.e. a supinated alignment, or valgus, i.e. a pronated alignment. These findings are recorded for later reference. 
     The following represents expected normal ranges of measurement:
     Weight-Bearing: 0°–3°   Non-Weight-Bearing: 4°–6°   Standing Dorsiflexion: 7°–9°   

     The difference between the weight-bearing measurement and the standing dorsiflexion measurement represents the total pronation. A value of 6° or less frequently indicates a tendency toward oversupination. A value of 10° or greater frequently indicates a tendency toward over-pronation. If the weight-bearing measurement is different than the non-weight-bearing measurement, the foot is referred to as a “compensated foot.” Conversely, if the weight-bearing measurement is the same as the non-weight-bearing measurement, the foot is referred to as an “uncompensated foot.” 
     The total pronation measurement, i.e. the difference between the weight-bearing measurement and the standing dorsiflexion measurement, is used to determine the correct corrective alignment insole from the database chart ( FIG. 21 ). The database chart is also utilized to identify the shoe type with which the corrective alignment insole should be used. The foot/leg symptomatic chart ( FIG. 22 ) can also be used as an initial diagnostic chart or to further confirm or refine the selection of the corrective alignment insole type from the database chart. The symptomatic chart identifies common symptoms which many patients describe and which can be alleviated by the proper corrective alignment insole. For example, the foot/leg symptomatic chart indicates that lateral shin pain may be alleviated through a type A or B corrective alignment insole. A total pronation measurement of 4°, indicating mild supination and the use of a type B corrective alignment insole, would confirm the selection of a type B corrective alignment insole as indicated by the patient&#39;s complaint of lateral shin pain. 
     As an alternative to the database chart shown in  FIG. 21 , the subtalar joint goniometer measurements can be incorporated into a computerized database and correlated with shoe type information and specific combinations of corrective alignment insole components in a computerized program for quickly selecting proper shoe types and corrective alignment insole components for a range of subtalar joint goniometer measurements. 
     The method of measuring the alignment of a foot and the selection of a shoe type and corrective alignment insole components can be formalized into a sequence of steps, which can be incorporated into a comprehensive computer program. 
     The method can include the following steps:
     While standing, inclining the leg approximately 25° from the vertical utilizing a dorsiflexion template;   While maintaining the leg in the inclined position, taking a measurement of the lateral angular alignment of the foot utilizing a subtalar joint goniometer;   Reading the lateral angular alignment value from the subtalar joint goniometer;   Referring the lateral angular alignment value to a database chart which correlates a range of lateral angular alignment values from a subtalar joint goniometer with shoe types and combinations of corrective alignment insole components;   Selecting a shoe type and a combination of corrective alignment insole components from the database chart corresponding to the lateral angular alignment value obtained from the subtalar joint goniometer measurement;   Constructing a corrective alignment insole from a base insole and one or more supination or pronation control pads and arch control pads identified in the database chart corresponding to the lateral angular alignment value obtained from the subtalar joint goniometer measurement; and   Utilizing the corrective alignment insole to correct the alignment of the foot by incorporating the corrective alignment insole into the shoe type identified in the database chart corresponding to the lateral angular alignment value obtained from the subtalar joint goniometer measurement.   

     Prevention and correction of biomechanical injuries to the lower extremities is possible with the novel corrective system described herein. Utilizing the unique measuring tools as described herein, footcare specialists, shoe stores, and consumers can select appropriate footwear and a customized corrective alignment insole quickly and accurately, thereby enhancing the effectiveness of the foot alignment correction and decreasing costs. Unlike prior art corrective alignment insoles, the novel corrective system described herein focuses corrective action away from the arch alone and onto the entire foot and its biomechanical behavior during walking or running. The corrective alignment insole can be accurately customized by selecting a specific combination of the unique support pads for any of six different foot types and arch heights. Ankle mobility is controlled using support pads specifically configured and combined for motion control, stability, neutral conditions, or supination control. 
     While the invention has been specifically described in connection with certain specific embodiments thereof, it is to be understood that this is by way of illustration and not of limitation, and the scope of the appended claims should be construed as broadly as the prior art will permit.