Abstract:
A semi-rigid foot orthotic can have 3-axis accelerometers, gyroscopes, magnetometers, and strain gauges embedded in one or more flexible regions along with a microprocessor and wireless transmitter. Data from the sensors can be used to track the gait cycle. Data on the flexing, bending, or rotating of portions of the orthotic are processed and compared to ideal or data from other runs to rate the effectiveness of the orthotic. The orthotic and the sole of the shoe have relative freedom of motion between them. By doing a 3D comparing of the location, motion and orientation of the shoe from the same information for at least one orthotic region; determining shoe-to-orthotic relative motion. Modifications or adjustments can be made to improve the user-experience. The computation can involve either or both of a cloud based server and an external hand-held device in wireless communication with the orthotic.

Description:
RELATED APPLICATIONS 
       [0001]    This application hereby claims the benefit of, and incorporates in its entirety U.S. provisional application 62/331,915, filed May 4, 2016, by reference herein. The present application is a continuation of application PCT/US17/30303 filed Apr. 29, 2017; that also claims the benefit of U.S. provisional application 62/331,915. 
     
    
     FIELD 
       [0002]    This disclosure is related to a device and method for data collection and analysis of dynamic orthotic performance. 
       BACKGROUND 
       [0003]    Optimum fitting of foot orthotics to a particular user can be thought of as much an art as a science. It is said that some people are helped enormously even by a rolled up piece of newspaper put in their shoe, while others require multiple visits to a podiatrist for fine-tuning, usually accomplished by adding or removing material from an orthotic. For many years the prevailing thought that “supporting the arch” was the best way to control gait but newer thinking has focused on designing orthotics to restrict and influence motion as well as improve dynamic alignment of the joints in the lower extremity. 
         [0004]    This improved alignment reduces the rotational and vertical joint forces resulting from ground reaction forces being transmitted up the kinetic chain of the lower extremity. To restrict and influence motion, newer orthotics are constructed from semi-rigid materials that flex, bend, or rotate under load. During the stance phase of the gait cycle (from heel strike, through mid-stance, to propulsion) weight is placed on the orthotic causing a complex flexing, bending, or rotating in three planes—the sagittal, frontal, and transverse, at multiple regions on the orthotic. All of that movement occurs in the shoe, under the foot and thus is not information directly available to a clinician evaluating the effectiveness of the orthotic. Although a clinician can carefully watch a person walking back and forth while wearing a trial orthotic, the users&#39; reported subjective experience provides the primary clues to the clinician. That often is not any more helpful than “it doesn&#39;t feel right”. 
         [0005]    It is desirable to make fitting an orthotic to an individual more science and less art. It is also desirable to reduce the need for a clinician in many cases and to lower the overall cost of getting effective orthotics on users&#39; feet. 
       SUMMARY 
       [0006]    The problem is solved by an instrumented, semi-rigid orthotic. One or more flexible portions of the orthotic can have embedded or secured sensors to detect and measure flexing, bending, or rotating in three planes. The sensors can include accelerometers, gyroscopes, magnetometers, strain gauges, and force transducers at one or more locations on the orthotic. Data can be read from those sensors by a microprocessor that also can be embedded in or secured to the orthotic. Preprocessing of the data can be performed by the microprocessor and further processing can be optionally performed on an external computing device like a smart phone or tablet computer or cloud-based server. The external device can be in wired or wireless communication with the microprocessor. Results can be displayed on the portable device. 
         [0007]    Preprocessing of the raw data can include determining the direction, magnitude and timing of flexing, bending, or rotating of the orthotic leading to data about the motions of the subtalar and midtarsal joints. Preprocessing can also extract the duration, position, velocity and acceleration of any flexing, bending, or rotating at multiple locations on the orthotic. The timing can be meaningfully expressed in terms of the point in the stance phase of a gait cycle that an event occurs. This allows measurement and recording of the bending and the motion at the same time. Comparison to data previously taken from that subject or other subjects with the same or other orthotics can be made to determine the effectiveness of the orthotic. Orthotic effectiveness is more than the user&#39;s subjective experience; it can also include achieving an optimal clinical alignment of the entire lower extremity. Further, recommendations for altering the geometry or rigidity of the orthotic can be a component of the results produced by the analysis. If the orthotic was one with variable tilt settings, the recommendation to alter the geometry could be recommending a new setting. Measuring how the foot and also the thigh move can help create an algorithm to use orthotic flexing, bending, or rotating to evaluate issues with foot, knee and ankle motion. 
         [0008]    Each movement pattern the sensors pick up during walking, swinging a golf club, a cycling stroke, or during any other movement tasks represent distinct patterns that can be grouped into categories, studied, and used in a model. With adjustable orthotics, gait patterns can be modified. Some applications will combine data from an instrumented orthotic with more traditional measurements of ground reaction forces or motion capture. 
         [0009]    This is important because the ground reaction forces are transmitted up the entire lower extremity, often resulting in excessive loads and strains on the bones and joints of the lower extremity. These excessive loads on mal-alignment of the joints of the lower extremity can lead to injuries and poor performance in sports and other functional tasks. 
         [0010]    The use of the data analytics can create a database used to structurally classify and develop motion metrics for different structural variations of the lower extremity. 
     
    
     
       BRIEF DESCRIPTION OF THE FIGURES 
         [0011]      FIG. 1  shows a schematic representation of a system for capturing orthotic performance in use; 
           [0012]      FIG. 2  shows, in schematic form, an instrumented orthotic plate with embedded sensors and computing components in dashed lines; 
           [0013]      FIG. 3  Illustrates points in the stance phase of a gait cycle; 
           [0014]      FIG. 4  shows the underside of the device of  FIG. 2  in a schematic representation of the locations of sensors, CPU and electronic interconnect between the electronic components; 
           [0015]      FIGS. 5 a -5 d    show exaggerated states of flexing, bending, or rotating of a flexible forefoot region of the device of  FIG. 2 ; 
           [0016]      FIG. 6  is a simplified cut-away view of a foot in a shoe with an instrumented orthotic; 
           [0017]      FIG. 7  shows a simplified block diagram of the electronics in the system of  FIG. 4  including the portion embedded in the orthotic plate and a portion in an external computing device; 
           [0018]      FIG. 8  is a flowchart of the major steps in the operation of an example instrumented orthotic; 
           [0019]      FIGS. 9 a -9 e    show a variable orthotic from U.S. Pat. No. 8,490,301 viewed from multiple positions as an example of a variable foot orthotic. 
       
    
    
     DETAILED DESCRIPTION 
     System 
       [0020]    In  FIG. 1  a user is shown examining, on her smart phone  105 , the rating produced by the instrumented orthotic system  200  she is wearing. 
         [0021]      FIG. 2  shows the positions of sensors and computing and communicating devices in an example embodiment of an instrumented orthotic. There are position, movement, and orientation sensors in a flexible forefoot area  101  and near the arch  106 . In addition, this embodiment includes a pressure or force sensor  103  at the heel. These devices are electrically connected to a computing unit or microprocessor  104 . The sensors and CPU are thin enough to be embedded in the orthotic and not interfere with its function. 
         [0022]      FIG. 3  illustrates points of the gait cycle during the stance phase. The stance phase is from heel strike to toe propulsion. This is the phase in which the most useful data is obtained by the system since the orthotic is under load. 
         [0023]      FIG. 4  shows a schematic representation of the instrumented orthotic of  FIG. 1 . The electrical interconnection  110  is depicted in this figure. 
         [0024]    In a much exaggerated way,  FIGS. 5 a -5 d    show possible flexing, bending, or rotating of the forefoot region. In attempting to control for over-pronation or over-supination, the forefoot orthotic will flex, bend, or rotate during points in the gait cycle when weight is put on the forefoot. This flexing, bending, or rotating will typically be a complex motion in three dimensions. If known, the direction and degree of flexing, bending, or rotating can inform a clinician who is trying to achieve an optimal clinical alignment of the lower extremity. 
         [0025]      FIG. 6  shows a cut-away schematic view of an instrumented orthotic  200  of these teachings. It is shown being worn within a shoe  400  and supporting a foot  202 . While the portions of the orthotic under the toes and heel rest directly on the sole of the shoe when weight is fully applied, the orthotic can also move in relation to the sole of the shoe at various points in the gait cycle. Regions  300  and  301  have three-dimensional freedom of movement with respect to the sole  201  of the shoe, and ultimately to the ground. These motions can be sensed by the two sets of sensors  101 ,  106  in this embodiment. Some alternative embodiments have a wireless sensor  110  in the shoe. 
         [0026]      FIG. 7  shows a block diagram of the electronics sub-system. The sensors are connected to an integrated circuit that has a processor, memory, and communication abilities. In this example, an integrated digital signal processor (DSP) is included in the example CPU. 
         [0027]    An electronic system, according to this block diagram, includes a microprocessor  104 , a forefoot 3-axis accelerometer/3-axis gyroscope  101 , an arch region 3-axis accelerometer/3-axis gyroscope  106 , and a wireless transmitter  111 . The components are embedded in the orthotic. Suitable components can include the Intel® Quark™ SE microcontroller, said to be the heart of the Intel Curie. The Quark™ SE CPU would be connected to a 3-axis accelerometer, and 3-axis gyroscope, and 3-axis magnetometer IC, also embedded in the orthotic. The STMicroelectronics LSM9DS0 9DOF IMU IC would be a suitable component for this purpose. Strain gauges in two dimensions can also measure the flexing, or bending of the orthotic. The electronic system, overall, will measure and record raw sensor data, pre-process it for external analysis and analyze the data. The sensors can also be used to measure gross foot/shoe movement to follow the gait cycle. Those skilled in the art will know how to determine the point in a gait cycle a person is in from the data provided by the sensors. 
       Operation 
       [0028]      FIG. 8  shows a high level flow chart of the steps in an example operation of the described system embodiment. After starting S 99 , steps S 100  and S 101  implement a loop continuously reading data from the sensors to track the gait phase. When a heel strike is detected S 101 , the data is read and is recorded S 102 . A rapid spike in deceleration around the heel strike indicates the start of the stance phase. This occurs until toe-off is detected in step S 104 , ending the stance phase. After several steps, preprocessing is done that can organize and compress the data. 
         [0029]    With the complete data for a stance phase, and optionally data from the swing phase, recorded, the operation extracts salient features of the data including flex, bend, or rotate direction, magnitude, timing, duration and the acceleration of flexing, bending, or rotating S 105 . The preprocessing and analysis in this embodiment includes taking the combination of raw data from the various sensors to create a normalized, coherent record of the motions and forces for each gait cycle. 
         [0030]    In step S 105 . 5  the relative timing point in the stance phase is aligned and associated with the movement data. The relative orthotic movement data can be aligned on a timeline with the stance phase of the gait cycle for analysis. A person may vary their speed even on a step-by-step basis; therefore the wall-clock time when a relevant data point is captured can be difficult to match for multiple steps from multiple persons. The more useful timing is the point in the gait cycle that a particular event occurs. Establishing a time normalized gait cycle permits comparison of multiple trials to each other. 
         [0031]    In step S 106  the salient data is compared to data from many trials with many users and many orthotic geometries to produce a rating of effectiveness S 107 . Data from trials with individuals with known foot problems and known optimum orthotics, including trials with alternant, non-optimum orthotics, are used for comparison. Comparisons to data previously taken from other subjects or the current subject with the same or other orthotics can be made to determine the effectiveness of the orthotic. Furthermore this data can be compared to data taken on bone and joint motion in a human performance lab. That data can be analyzed with neural nets or by classification and clustering techniques as taught in Seiner U.S. Pat. No. 8,139,822, Designation of a Characteristic of a Physical Capability by Motion Analysis Systems and Methods, to produce a rating of the effectiveness of an orthotic for a wearer. It can also be used to construct a predictive model for improved treatment. 
         [0032]    The operation can optionally include step S 108  and generate a recommendation for an improved orthotic for the tested user. By further analysis and comparison, S 108  produces a recommendation to alter the geometry of the orthotic in an attempt to provide a better fit to a user and achieve an improved alignment. This improved alignment would help the user in achieving optimal clinical alignment of the lower extremity (reducing the rotational and vertical forces being transmitted up the kinetic chain of the lower extremity as a result of ground reaction forces). Recommendations to modify the geometry of the orthotic can include: suggesting a completely new orthotic or adding to or removing material on the present orthotic as traditionally done by podiatrists or orthotists. It could also include a setting change for a variable orthotic, or it could provide information to make a 3D printing of an optimized orthotic. If the user is still walking and still in the trial, the process repeats, starting back at S 100 . 
         [0033]    The orthotic and the sole of the shoe have relative freedom of motion between them. As part of the analysis, the location of the ground can be determined by assuming it is a plane generally tangent to the earth and knowing the location of the shoe at a heel strike. To calculate realtive motion between the floor and the orthotic by effectively doing a 3D comparing of the location, motion and orientation of the shoe from the same information for one or more regions of the orthotic, shoe-orthotic relative motion can be determined. 
       Location of Computation Steps 
       [0034]    Some of the steps of  FIG. 8  are carried out by an instrumented orthotic, particularly by firmware and software executing on the embedded microprocessor  104 . However, to keep the cost, size, and power dissipation low, many subsequent steps may be carried out by an application executing on a smart phone, tablet computer or other external computing device including a remote server  150 . In that case, raw, preprocessed or partially analyzed data may be transmitted from the orthotic to a nearby computing and display device. In some embodiments data may be sent from the phone to a server and database via the cloud and the information returned from the server may supply the final information to have the phone display to a user. 
         [0035]    The embodiment shown has a wireless transceiver for communicating with an external computing device such as a smart phone  105  or tablet computer or cloud-based server. After preliminary preprocessing under the control of software executing on the embedded microprocessor, the data is wirelessly sent to the external device for further processing and analysis. Steps S 99  through S 102  or alternatively S 99  through S 104  might be performed on the orthotics&#39; electronics with the other steps performed on an external device or remote server and database. As mentioned, in some embodiments, the microprocessor may have sufficient computing power to perform more of, or all of, the steps of the analysis. If some data or all data is sent to a remote server with a database, the server may analyze the current data in light of other data from the same subject or in light of an aggregation of data including data from other subjects. 
       Variable Orthotics 
       [0036]    The recommendation for an improved orthotic can include directing setting changes on a variable or adjustable orthotic. Teachings for adjustable orthotics include U.S. Pat. No. 8,749,115 Pas, et al.; U.S. Pat. No. 5,345,701 Smith; U.S. Pat. No. 8,490,301 Seiner; and U7707751 Avent, et al.  FIGS. 9 a -9 e    show views of an example variable orthotic from Seiner U.S. Pat. No. 8,490,301B2, Adjustable Forefoot Posting for Orthotic. Tilt settings on this device are changed by turning a selector wheel  401 . 
         [0037]    If an adjustable orthotic can have its setting changed electrically, the recommended change could be directly transmitted back to the orthotic to directly institute a geometry change. This might be practical if done when there is no weight on the post position. 
         [0038]    With enough computing power embedded in an orthotic that can dynamically alter its geometry, the external electronic computing device may become optional. In some embodiments the external portable electronic device such as a smart cellphone, tablet, or special purpose unit can be used primarily to display results. 
       Variations 
       [0039]    Variations can include versions that are connected by wires to a worn external computing device. The number of locations instrumented for measurement can vary. Sensors can include strain gauges and flex sensors, resistive, piezoelectric, and others. Another variation is a flexible printed circuit board with the electronic computers soldered onto it. The flexible circuit board could be permanently or temporarily adhered to any orthotic to transform it into an instrumented orthotic. 
       Alternate Embodiments 
       [0040]    In some cases the relative position and movement between the sole of the shoe and the orthotic may be deemed to be a useful measurement, a wireless sensor could be imbedded into a shoe or temporary secured to either the inside or outside of the sole as depicted in  FIGS. 1 and 6  as element  110 . The sensors and computing within the orthotic could be used to instrument the shoe, or a much simpler, less power consuming electronics might be used. 
         [0041]    Data could be transmitted directly to the external computing device or, saving power, may be sent to the orthotic directly above it. There are many suitable wireless technologies that can be used to achieve this including near field transmission. 
         [0042]    These teachings can also be applied to other orthotic devices where there is independence of movement between the body and the orthotic. For example “An adjustable orthotic brace”—WO2003088865 Scorvo, describes a dynamically changing leg brace. 
         [0043]    Previous work, including Aminian WO 2012/007855, provide enabling information including the use of inertial sensors attached to a shoe to measure foot position and orientation in 3D. 
         [0044]    In some embodiments there may not be a local device doing significant computing but being used primarily as an output display device. In other embodiments there may not be a local computing device communicating with the instrumented orthotic. The instrumented orthotic may be transmitting to the Internet or other destination via cellular communications. WIFI or other technology. In other embodiments there may be no server connection necessary. 
       Other Uses for the System 
       [0045]    The system can be used in research to collect data otherwise unavailable. Data collected by the dynamic orthotic can be compared to measurements taken in a human performance lab as a tool contributing to research in a predictive model that can help the clinician or consumer with a specific problem. This data could be used in an algorithm for the predictive model to assist clinicians and end users to better treat abnormalities, prevent injuries, as well as improve athletic performance. Algorithms can be constructed to more precisely identify individuals with correctable mechanically induced problems.