WO2023067135A1 - Method and system for validating an orthopaedic correction for an individual - Google Patents

Abstract

The invention relates to a system and a method for validating an orthopaedic correction for an individual. The method comprises in particular: - a step (140) of acquiring movement data which are generated during a displacement of the individual in the presence of the orthopaedic correction that is to be validated; - a step (150) of calculating, on the basis of the generated movement data, a value of at least one foot angle for several instants of the displacement; and - a step (160) of comparing the calculated values of at least one foot angle and predetermined foot angle values, so as to validate or not validate the orthopaedic correction (40).

Description

METHOD AND SYSTEM FOR VALIDATING AN ORTHOPEDIC CORRECTION FOR AN INDIVIDUAL

The invention relates to the field of podometry. In particular, it relates to a method for validating an orthopedic correction for an individual.

The invention further relates to a device or system for validating an orthopedic correction of an individual.

Below we describe the known prior art from which the invention has been developed.

The foot, comprising 26 bones, 107 ligaments and nearly 19 muscles, is a particularly complex part of the human body. It also plays an important role since it is the keystone allowing a human being to move. The slightest degradation of the latter can quickly be disabling. Although this is particularly true in the context of the practice of a sport involving contact of the foot with the ground, poor gait during daily activities can have a significant impact on health. The study of the forces applied to the foot during walking is therefore constantly evolving and new systems or new indicators making it possible to facilitate these studies are regularly emerging.

Thus, it has already been proposed to follow the gait of an individual through pressure sensors or inertial units located in particular at the level of the foot. Recent publications show in particular the interest of using inertial units positioned at the level of the foot to access gait data in real time (WO2019077266) or data on gait disorders (WO2019193301) or advanced gait parameters (WO2020217037).

Nevertheless, such solutions do not make it possible to determine whether an orthopedic correction is suitable for an individual.

Plantar orthoses (also called orthopedic corrections) are generally devices inserted into shoes to provide support to the foot by redistributing the reaction forces of the ground acting on the joints of the foot while standing, walking or running. These orthopedic corrections can be either pre-molded (also called pre-made) or custom made from a cast or impression of the foot. They are used by everyone from athletes to the elderly to accommodate biomechanical deformities and various soft tissue conditions. These orthopedic corrections are most often used for people with foot problems. However, these orthopedic corrections can have an effect on knee, hip and spine deformities. Moreover, they have even been shown to be effective in solving back problems (Cambron et al., 2017; “Shoe Orthotics for the Treatment of Chronic Low BackPain: A Randomized Controlled Trial”; Archives of Physical Medicine and Rehabilitation 2017;98: 1752-62).

Current innovations in orthopedic corrections are mainly based on the methods of manufacturing personalized orthopedic insoles and in particular on the combination of materials used and the machining processes employed (Anggoro et al., 2021; “Advanced design and manufacturing of custom orthotics insoles based on hybrid Taguchi-response surface method”; Heliyon, Volume 7, ISSUE 3, e06481, March 01, 2021). In addition, it has been proposed for some years to replace the traditional manufacturing approach, characterized by waste of material, time and labor, with additive manufacturing technologies (Wang et al., 2020; “ A Review of the Application of Additive Manufacturing in Prosthetic and Orthotic Clinics from a Biomechanical Perspective”; Engineering 6 (2020) 1258-1266).

The design phase requires the expert eye of the practitioner and can be assisted by the implementation of video capture. Indeed, it has recently been shown that the kinetic contributions of the foot change throughout a walk and more particularly a run (Honert, et al., 2021; “Changes in ankle work, foot work, and tibialis anterior activation throughout a long run”; Journal of Sport and Health Science, https://doi.org/10.1016/j.jshs.2021.02.003). Thus, this reinforces the need for methods for validating orthopedic corrections capable of carrying out measurements during a movement of the foot, whether during a walk or a run. Indeed, the correction must be effective during a dynamic step and not when the foot is static.

Video analyzes require the installation of very expensive installations in which the majority of practitioners cannot invest. To provide an affordable solution, the substitution of two-dimensional or three-dimensional video analysis by inertial sensors has been studied in certain fields (Hughes et al, 2019; “Are tibial angles measured with inertial sensors useful surrogates for frontal plane projection angles measured using 2-dimensional video analysis during single leg squat tasks? A reliability and agreement study in elite football (soccer) players”; Journal of Electromyography and Kinesiology Volume 44, February 2019, Pages 21-30). However, these methods were not able to show a possible substitution of video analyzes by analyzes via inertial units. Indeed, within the framework of the study of the projection angle of the frontal plane, it has been shown that inertial units do not make it possible to provide measurements of the absolute tibial angle and of the relative tibial angle consistent with two-dimensional video data.

Methods have also been proposed, based on force sensors, making it possible to determine the characteristics of an individual's gait and detect foot anomalies such as flat feet or hollow feet (Mei et al, 2020; “ Foot type classification using sensor-enabled footwear and 1D-CNN”; Measurement 165 (2020),108184). However, such methods do not make it possible to assess the level of validity of an orthopedic correction.

Finally, a semi-rigid plantar orthosis has been proposed (WO17192409) comprising 3-axis accelerometers, gyroscopes, magnetometers and strain gauges integrated in one or more flexible regions with a microprocessor and a wireless transmitter. It has been proposed that the data generated by these sensors can be used to track the gait cycle. Data on the flexion, or rotation of parts of the orthosis are processed and compared to the ideal or to data from other tests to assess the effectiveness of the orthosis. However, this method requires equipping each orthopedic correction manufactured with motion sensors and sophisticated communication systems. This increases the cost of the solution and reduces its democratization.

Thus, the existing solutions are not optimal. They require the deployment of expensive equipment or take the form of a system integrating numerous devices whose implementation must be carried out under specific conditions in order to obtain relevant measurements. Under these conditions, they do not allow an orthopedic correction to be easily and accurately validated.

There is therefore a need for a new solution allowing a dynamic analysis of the orthopedic correction of an individual so as to allow its validation or not, preferably in the context of a movement of the individual.

The object of the invention is to remedy the drawbacks of the prior art. In particular, the aim of the invention is to propose a method making it possible to quickly validate, and preferably in real time, an orthopedic correction for an individual and this without the need to use expensive or fragile equipment. The invention also aims to propose a device and a system allowing the validation of an orthopedic correction for an individual.

The invention relates in particular to a method for validating an orthopedic correction for an individual, said method comprising:
- a step for acquiring movement data which has been generated, by at least one inertial unit positioned at the level of one foot of the individual, during a movement of the individual in the presence of the orthopedic correction to be validated ;
- a calculation step, by one or more processors, from the movement data acquired, of a value of at least one foot angle for several instants of the movement of the individual; And
a step of comparison, by the processor or processors, of the values of at least one calculated foot angle and of predetermined foot angle values, so as to validate or not the orthopedic correction.

The applicant has developed a solution for validating an orthopedic correction capable of determining whether or not an orthopedic correction is suitable for an individual, based on movement data generated by at least one inertial unit. By taking into consideration a value of at least one foot angle for several instants of movement and by comparing these values with predetermined expected values, the present invention makes it possible to determine whether an orthopedic correction meets the needs of the individual.

Such a technical solution makes it possible to dispense with expensive image capture devices or to base validation solely on subjective criteria. Thus, this solution, which can be implemented in real time, makes it possible to quickly validate an orthopedic correction for an individual and this without the need to use expensive or fragile equipment. In addition, the use of a measuring device makes it possible to quantify the correction, in a real situation on the one hand and to objectify the validation on the other hand.

According to other optional characteristics of the method, the latter may optionally include one or more of the following characteristics, alone or in combination:
- During the acquisition step, the at least one inertial unit is positioned against the foot of the individual. As will be illustrated later, this can allow an improvement in accuracy and precision.
- It includes a step for calculating an effective correction, preferably expressed in degrees. This allows the practitioner to quantify the correction in degrees relative to a movement of the individual without orthopedic correction.
- It further comprises a step for acquiring movement data which have been generated, by at least one inertial unit positioned at the level of one foot of the individual, during a movement of the individual in the absence of orthopedic correction to be validated. This movement data generated in the absence of a correction can be used to calculate the predetermined foot angle values used during the comparison step. Alternatively, when the orthopedic correction can be attached to the foot, footwear becomes unnecessary and the correction can be placed against the foot of the individual just like the inertial unit.
- It further comprises a step of calculating a corridor of normality, said method then comprising the following steps executed by one or more processors: a step of acquiring movement data which have been generated, by at least one inertial unit positioned at the level of one foot of the individual, when the individual moves in the absence of orthopedic correction to be validated; and a step of calculating a normality corridor, from the acquired movement data. This corridor of normality can be used as predetermined foot angle values during the comparison step. Advantageously, when a normality corridor is calculated, it replaces the predetermined expected foot angle values and makes it possible to improve the accuracy of the validation of the orthopedic correction.
the predetermined foot angle values are expected foot angle values which have been predetermined from data relating to the morphology of the individual and/or from characteristics of the article of footwear. Alternatively, the expected foot angle values may correspond to standard values for any individual without taking into account the morphological characteristics of the individual. However, preferably, the predetermined foot angle values are predetermined at least in part from the foot angle values observed in the absence of correction, possibly modified.
- the movement data acquisition step comprises the acquisition of movement data generated by two inertial units each positioned respectively at the level of a foot of the individual. Advantageously, the inertial unit is able to acquire acceleration and angular velocity data each on three axes. This makes it possible to simultaneously assess the orthopedic correction of each of the individual's two feet.
- It comprises a step of positioning at least one inertial unit at the foot of the individual. In particular, it comprises a step of positioning at least one inertial unit at the level of the foot of the individual to whom the orthopedic correction is applied. This positioning at the level of the foot can for example include the fixing, for example via an adhesive substance, of the inertial unit on the foot. The positioning can also be carried out on the article of footwear or in a sole of the article of footwear.
- It comprises a step of generating movement data during which the at least one inertial unit is positioned against the foot of the individual, on the article of footwear or in a sole of the article of footwear. Thus, the process can be carried out directly at the practitioner's premises with initially the positioning of the inertial unit(s), the generation of data during a movement (eg walking or running) then in a shorter time interval at 10 minutes, the validation or not of the orthopedic correction. Furthermore, such a solution does not require a standardized laboratory environment, but only a flat surface allowing the individual to move or a treadmill.
- the comparison step comprises a calculation of a value of deviation of the foot angle values calculated with respect to the predetermined foot angle values. When the predetermined foot angle values correspond to expected foot angle values, the generation of a deviation value makes it possible to quantify to what extent the orthopedic correction does not conform to the needs of the individual. Alternatively, when the predetermined foot angle values correspond to foot angle values without correction, the generation of a deviation value makes it possible to quantify to what extent the orthopedic correction has caused a sufficient modification of the gait of the patient. 'individual.
- the motion data includes acceleration and angular velocity values along three axes. These data make it possible to improve the precision of the validation of the orthopedic correction. These data may also include the derivatives and integrals of these physical quantities.
- the values of at least one foot angle calculated and compared comprise angle values selected from: an angle of the antero-posterior axis of the foot with respect to its line of progression, an angle of the antero-posterior axis posterior of the foot with respect to a plane formed by the ground, an angle of the transverse axis of the foot with respect to its line of progression or an angle of the transverse axis of the foot with respect to a plane formed by the ground. The use of these particular angles makes it possible to improve the accuracy of the validation of the orthopedic correction.
the foot angle values of at least three instants of movement, preferably of at least five instants of movement, are calculated and then compared during the comparison step. The use of foot angle values over several instants of the displacement makes it possible to improve the accuracy of the validation of the orthopedic correction.
- the displacement comprises at least one oscillation phase and the values of at least one foot angle calculated and compared comprise at least one foot angle value obtained from movement data generated during the oscillation phase. This makes it possible to improve the accuracy of orthopedic correction validation and to use data that is inaccessible with technologies based on force sensors. Indeed, the modifications made by the orthopedic correction on a foot at the time of the stance phase can influence the oscillating phase of this same foot or the oscillating phase of the other foot.
- the foot angle values are calculated for at least twenty walking cycles, preferably at least thirty and even more preferably at least fifty; and the values of at least one calculated foot angle, used during the comparison step, correspond to values obtained from at least twenty walking cycles, preferably at least thirty and even more preferably at least minus fifty. Thus, this advantageously makes it possible not to base a validation on one or a few measurements, but on a plurality of operating cycles making it possible to increase the robustness of the validation method according to the invention. In particular, the values used for the comparison step correspond to an average or a median of the values obtained for the various walking cycles considered.
- the foot angle values are calculated for a plurality of gait cycles which have been previously selected on the basis of one or more calculated characteristics of the gait cycle; the said calculated characteristic(s) of the gait cycle comprising: a maximum acceleration value, a maximum propulsion speed value, a stride frequency, a stride length, a gait speed, a duration of the stance phase, and/or a duration of the oscillating phase.

According to a second object, the invention relates to a system for validating an orthopedic correction for an individual, said system comprising:
- at least one inertial unit, said inertial unit being arranged to be positioned at the level of a foot of the individual and being configured to generate movement data;
- one or more processors configured for:
- Acquiring movement data generated by the at least one inertial unit positioned at the foot of the individual, during a movement of the individual in the presence of the orthopedic correction to be validated;
- Calculate from the movement data acquired, a value of at least one foot angle for several instants of movement; And
- Compare values of at least one calculated foot angle and predetermined foot angle values, so as to validate or not the orthopedic correction.
In particular, the system for validating an orthopedic correction according to the invention may comprise two electronic boxes each comprising at least one of the inertial units and a computer device comprising the one or more processors, said electronic boxes comprising means of communication configured to transmitting, preferably in real time, the movement data to the computing device.

Other characteristics and advantages of the invention will be better understood on reading the description which follows and with reference to the appended drawings, given by way of illustration and in no way limiting.
There shows a diagram of a method according to one embodiment of the invention. Optional steps are outlined in dotted lines.
There illustrates different positions of the inertial unit coupled to an article of footwear or to a foot fitted with an orthopedic correction.
There represents the illustration of two corridors of normality calculated by a method according to the invention and of two lines of plantar pressure.
There represents a diagram of an embodiment of the invention which may include a step for calculating a corridor of normality. The dotted steps are optional within the scope of carrying out this embodiment.
There depicts an illustration of four steps of an individual, highlighting foot angles that may be considered within the scope of the present invention.
There represents a system for validating an orthopedic correction according to the present invention.

The figures do not necessarily respect the scales, in particular in thickness, and this for purposes of illustration.

Aspects of the present invention are described with reference to flow charts and/or block diagrams of methods, apparatus (systems), and computer program products according to embodiments of the invention.

In the figures, flowcharts and block diagrams illustrate the architecture, functionality, and operation of possible implementations of systems, methods, and computer program products according to various embodiments of the present invention. In this regard, each block in the flowcharts or block diagrams may represent a system, device, module, or code, which includes one or more executable instructions to implement the specified logical function(s). In some implementations, the functions associated with the blocks may appear in a different order than that shown in the figures. For example, two blocks shown in succession may, in fact, be executed substantially simultaneously, or the blocks may sometimes be executed in reverse order, depending on the functionality involved. Each block in the block diagrams and/or flowchart, and combinations of blocks in the block diagrams and/or flowchart, may be implemented by special hardware systems that perform the specified functions or acts or perform combinations of special equipment and computer instructions.

Below, we describe a summary of the invention and the associated vocabulary, before presenting in more detail how the invention overcomes the drawbacks of the prior art.

In the rest of the description, the expression "motion data" can correspond within the meaning of the invention to data comprising values of acceleration, angular velocity, magnetic fields or even fusion data obtained from one or more of these values. The movement data can be raw data or preprocessed data. Preferably, the movement data includes acceleration and angular velocity values, preprocessed or not.

The expression "orthopedic correction" corresponds, for example, in the meaning of the invention to an orthosis. Such an orthosis is preferably capable of correcting the behavior of a lower limb. In particular, an orthopedic correction may correspond to any device, whether articulated or not, intended: to correct defects in the kinetics of the lower limbs; to correct deformities of the lower limbs; and/or possibly allowing the rehabilitation of the lower limbs. In particular, an orthopedic correction can be intended to correct a defective static foot or an anomaly of the plantar relief, to compensate for the anomalies of the foot, to correct a static and dynamic imbalance of the individual or to prevent complications in the event of diabetes . An orthopedic correction is particularly suitable for an individual suffering from flat foot, pes cavus, disabling rheumatoid and neurotrophic condition of the foot, metatarsalgia, or even diabetes.

The expression " validation of an orthopedic correction " can correspond in the sense of the invention to an evaluation of the adequacy between an orthopedic correction and the needs of an individual. The validation may in particular correspond to a binary or non-binary, numeric, alphanumeric or alphabetic value indicating whether an orthopedic correction is suitable for the individual. In particular, the validation can correspond to a non-binary numerical value indicating to what extent the orthopedic correction is adapted to the individual. Thus, a practitioner can, with regard to the validation value, decide whether the orthopedic correction is appropriate or not. This validation can in particular be based on predetermined rules.

The expression " physical characteristics of an orthopedic correction " may correspond in the sense of the invention to the shape or construction of the orthosis acting as an orthopedic correction.

The expression " positioned at the level of a foot " may correspond in the sense of the invention to the positioning of an inertial unit on the foot, in an item of footwear or on an item of footwear. This can also be interpreted as a coupling of the inertial unit with the foot since the movements of the inertial unit will then be a direct function of the movements of the foot of the individual.

The expression "walking cycle" within the meaning of the invention corresponds to the time interval between two presses of the heel of the same leg on the ground, or more generally two identical repeated events.

The expression "stance phase" within the meaning of the invention may correspond, in the context of an analysis of the walking or running cycle, to the moment when the foot is at least partly in contact with the ground. It can include the attack of the step, the anterior step, the posterior step, and the propulsion which ends with the detachment of the foot.

The expression "instant of the stance phase" within the meaning of the invention corresponds to a time interval occurring during the pose of the foot, also called the stance phase of the foot.

The expression "foot angle values" within the meaning of the invention may correspond to angle values making it possible to represent the position of an individual's foot in its environment, that is to say by example with respect to a predetermined benchmark. This position may relate to the limbs of the individual with, for example, the angle formed by the axis of the tibia and the anteroposterior axis of the foot. This position can also be related to elements external to the individual with for example the angle formed by the anteroposterior axis of the foot and the ground. Finally, this position can also be relative to an angle formed by the anteroposterior axis of the foot and a calculated line of tread or a calculated trajectory of the foot. The angle values of the foot can also be used in the context of the invention in the form of a variable calculated from the angle values of the foot, such as a line of plantar pressure.

The expression "predetermined reference" within the meaning of the invention may correspond to an inertial reference such as a terrestrial reference or a non-inertial reference such as one or more limbs of the individual or even a reference generated from movement data of the individual.

In the rest of the description, the expression "line of plantar pressure" within the meaning of the invention corresponds to the evolution of the position of the center of plantar pressures (e.g. barycentre) during the movement of an individual (e.g. . a walk or a run), preferably from the pose of the heel until the takeoff of the toes.

By "sole" is meant an object that separates the individual's foot from the ground. A shoe can comprise an upper sole layer in direct contact with the foot of the individual and a lower sole layer in direct contact with the ground or more generally the external environment. A shoe may also include a removable insole.

By "removable" is meant the ability to be easily detached, removed or disassembled without having to destroy the fastening means either because there are no fastening means or because the fastening means are easily and quickly removable (e.g. notch, screw, tab, lug, clips). For example, by removable, it should be understood that the object is not fixed by welding or by any other means not intended to allow the object to be detached.

The term "process", "calculate", "determine", "display", "transform", "extract", "compare" or more broadly "executable operation", within the meaning of the invention, an action performed by a device or processor unless the context indicates otherwise. In this respect, operations refer to actions and/or processes of a data processing system, for example a computer system or an electronic computing device, which manipulate and transform data represented as physical (electronic ) in computer system memories or other information storage, transmission or display devices. These operations can be based on applications or software.

The terms or expressions "application", "software", "program code", and "executable code" mean any expression, code or notation, of a set of instructions intended to cause data processing to perform a particular function directly or indirectly (e.g. after a conversion operation to another code). Sample program code may include, but is not limited to, a subroutine, function, executable application, source code, object code, library, and/or any other sequence of instructions designed for the running on a computer system.

By "processor" is meant, within the meaning of the invention, at least one hardware circuit configured to execute operations according to instructions contained in a code. The hardware circuit may be an integrated circuit. Examples of a processor include, but are not limited to, central processing unit, graphics processor, application-specific integrated circuit (ASIC), and programmable logic circuit.

"Computer device" means any device comprising a processing unit or a processor, for example in the form of a microcontroller cooperating with a data memory, possibly a program memory, said memories being able to be dissociated. The processing unit cooperates with said memories by means of an internal communication bus.

By "coupled", in the sense of the invention, we mean connected, directly or indirectly with one or more intermediate elements. Two elements can be coupled mechanically, electrically or linked by a communication channel.

The study of the gait of individuals is expanding rapidly and monitoring and characterization processes are multiplying. Nevertheless, certain practices used for decades such as the design and validation of orthopedic corrections are carried out without objective digital support or require fragile and expensive equipment, limiting the democratization of the validation of these corrections on the basis of objective measurements. . In addition, no solution has ever been proposed that makes it possible, without a controlled environment and/or a cumbersome or expensive device, to evaluate and validate an orthopedic correction prepared for a given individual.

While the analysis by two-dimensional or three-dimensional camera has recently been proposed for fine studies in the study of the gait and without proposing a solution for the validation of an orthopedic correction, the applicant has developed a solution making it possible to validate an orthopedic correction at from movement data coming from a simple inertial unit.

Thus, according to a first aspect, the invention relates to a method 100 for validating an orthopedic correction 40 for an individual.

The validation of an orthopedic correction makes it possible to confirm that the orthopedic correction indeed leads to a modification of the kinetics of the feet of the individual during the movements of the individual and that this will be able to correct the various affections of the individual caused by kinetics abnormal foot displacement.

In particular, an orthopedic correction validation method according to the invention will comprise the following steps: a step of acquisition 140 of movement data which was generated during a movement of the individual in the presence of the orthopedic correction to be validated; a calculation step 150 of a value of at least one foot angle for several instants of the movement; and a step 160 of comparing the values of at least one calculated foot angle and predetermined foot angle values, so as to validate or not the orthopedic correction 40.

As shown in , a method according to the invention may also comprise the following steps: positioning 110 of at least one inertial unit at the foot of the individual; calculation of a value of at least one foot angle without correction for several instants of the movement, which may correspond to an initialization of the measurement 120; a step 130 of applying the orthopedic correction 40 to be validated to at least one foot of the individual; footwear 130a of the feet of the individual in at least one article of footwear 30 comprising the orthopedic correction 40 to be validated; calculation of an effective correction 170 in degrees.

The method 100 for validating an orthopedic correction 40 for an individual according to the invention is preferably implemented by one or more processors 12,22. As will be detailed below, the method is implemented from data comprising movement data, or calculated from movement data, generated by at least one inertial unit 11 coupled to the foot of said individual (eg . positioned at the level of the individual's foot).

The processor(s) 12,22 implementing the method according to the invention may be integrated into an electronic box 10 also incorporating the inertial unit(s) or else be integrated into a computing device 20, such as a computer or a computer server. , configured to receive data generated by the inertial unit(s) 11. A system 1 for validating an orthopedic correction according to the invention will be detailed further in the remainder of this description.

As shown in , a method according to the invention may comprise a step 110 of positioning at least one inertial unit at the level of one foot of the individual. The inertial unit 11 could for example be a six-axis or nine-axis inertial unit. As will be detailed later, the at least one inertial unit can be integrated into an electronic box 10.

The present invention will be detailed in the context of the use of an inertial unit positioned at the level of an individual's foot, but preferably, the present invention will be implemented with at least one inertial unit positioned at the level of each of an individual's feet so as to study both of the individual's feet.

The positioning 110 of at least one inertial unit at the foot of the individual can be considered as a coupling of at least one inertial unit 11 to one foot of the individual. In this sense, the positioning 110 of at least one inertial unit at the level of the foot may be a direct coupling or an indirect coupling. In general, the at least one inertial unit 11 can be positioned against the foot of the individual, on the item of footwear or in a sole of the item of footwear.

Thus, as illustrated in , the at least one inertial unit 11b can be integrated into a sole of an article of footwear. Nevertheless, the at least one inertial unit 11a, 11c can also be configured so as to be able to be fixed on an article of footwear. The positioning of the inertial unit on an article of footwear may depend on the arrangement of the inertial unit. It could for example be configured so as to be fixable on the back of an item of footwear or on the instep. For example, the illustrates an individual's foot coupled to inertial units positioned at three different locations: at the level of the buttress (inertial unit 11a); in the sole (inertial unit 11b) exterior or interior; or even on the front of the foot (inertial unit 11c), for example at the level of the laces or the tongue. These different embodiments could be considered as indirect couplings because the at least one inertial unit is not in contact with the foot of the individual, but in contact with an article of footwear itself in contact with the foot of the 'individual.

The at least one inertial unit can also be integrated directly into the orthopedic correction. This may be the case for example when the inertial unit 11b is integrated into a removable insole, the sole forming the orthopedic correction. In the case where the method includes an initialization step, the at least one inertial unit could be positioned in a reference sole used to study the gait of the individual before the implementation of the orthopedic correction then in a second time, the at least one inertial unit would be positioned directly in the orthopedic correction, for example in a removable manner.

The positioning 110 of at least one inertial unit 11 at the level of a foot of the individual or the coupling between the at least one inertial unit and the foot of the individual can be such that the use of an article footwear is not necessary. To illustrate this, the also shows that the invention can be implemented from an inertial unit 11d directly coupled to the foot of the individual. This coupling can use an adhesive material making it possible to bond the inertial unit temporarily to the foot or else thanks to an accessory capable of holding the inertial unit against the foot of the individual. Advantageously, this positioning can be maintained by means of adhesive materials, elastic bands or by any other means making it possible to fix the inertial unit on the individual's foot in a punctual manner. The accessory could for example be elastic and take the form of an ankle brace or a strap.

This embodiment can be particularly advantageous when the orthopedic correction 40 to be validated is not integrated into an article of footwear, but can be fixed at the level of the individual's foot. This is the case, for example, when the orthopedic correction 40 corresponds to an orthosis of the metatarsal pad type, toe correctors or foot splints. The positioning and maintenance of the orthopedic correction is generally ensured using adhesive materials, elastic bands or by any other means 41 making it possible to maintain the orthopedic correction against the foot of the individual.

However, this positioning in direct contact with the individual's foot is also advantageous when it is necessary to put on an article of footwear. Indeed, while it could have been considered that the presence of an inertial unit against the foot of the individual wearing a shoe could represent discomfort leading to biased results, the data presented in table 1 illustrate that better results are obtained with this configuration when the individual wears an article of footwear.

Thus, preferably, the positioning step 110 may include the positioning of at least one inertial unit 11 on the foot of the individual for whom the orthopedic correction 40 must be validated. In particular, the at least one inertial unit 11 can be positioned on the individual's foot before the orthopedic correction 40 is applied. This can for example make it possible to determine foot angle values in the absence of orthopedic correction.

The applicant has also determined that certain embodiments relating to the positioning of the inertial unit could make it possible to significantly increase the performance of its validation method based on movement data generated by an inertial unit. Table 1 below illustrates the advantage of certain positions and in particular of the presence of a positioning step 110 of the inertial unit 11 against the foot of the individual compared to other positions of the inertial unit 11 .

[Table 1]
Positioning of the inertial unit Sensitivity Specificity Against the foot of the individual 0.95 0.91 On the tongue of the shoe 0.88 0.78 In the sole 0.92 0.89 In orthopedic correction 0.89 0.90
Table 1 illustrates the sensitivity and specificity of a validation method according to the invention as a function of the positioning of the inertial unit. Sensitivity and specificity data can be obtained by comparison with validation data obtained by conventional means of the state of the art (i.e. validation opinion from a practitioner).

Alternatively, the positioning step 110 may include the positioning of at least one inertial unit on an article of footwear of the individual for which the orthopedic correction 40 must be validated. In particular, the at least one inertial unit 11 can be positioned on the article of footwear 30 before the orthopedic correction 40 is applied. This can for example make it possible to determine foot angle values in the absence of correction orthopedic.

The applicant has developed a method based on motion data generated by one or more inertial units. Thus, a method according to the invention will be able to use movement data coming from several inertial units 11 positioned at the level of the feet of the individual. For example, the method according to the invention could be based on movement data coming from two inertial units 11 each positioned respectively at the level of one of the feet of the individual (preferably against the foot of the individual). In particular, the method according to the invention may comprise a step of generating movement data by at least one inertial unit 11, the inertial unit 11 being able to be positioned in an electronic box 10 fixed to an article of footwear 30 worn by the individual whose orthopedic correction must be validated.

The data generated by the inertial unit 11 can preferably be generated during a walk of the individual, a run or any other exercise likely to generate data that can be used in the context of an analysis of foot displacement kinetics in the foot. 'space. This data is called motion data. The inertial unit 11 is preferably coupled to an article of footwear, but more generally it is coupled to the foot of an individual (ie. positioned at the level of the foot of the individual). The coupling can therefore be direct or via an article of footwear.

In the context of the method according to the invention, the motion data preferably includes acceleration values and angular velocity values as a function of time. In addition, they may include values of magnetic fields as a function of time.

As mentioned, motion data can include time series. Thus, in the context of the method according to the invention, the movement data are preferably generated for a plurality of instants of the foot pose.

In particular, during a step of generation of movement data by the inertial unit or units, the movement data are generated for at least ten instants of the pose of the foot, preferably at least twenty and more preferably at least fifty.

Preferably, the movement data will comprise movement data generated from the moment of placing the heel to the moment of placing the toes (limits included). The motion data may also include motion data generated from the time the heel takes off to the time the toes take off (limits included). Indeed, the applicant has determined that these data were of particular importance for improving the performance of the method according to the invention.

In addition, the method 100 for validating an orthopedic correction according to the invention may include a step of preprocessing the movement data generated by the inertial unit(s) 11.

In particular, this motion data preprocessing step may correspond to the preprocessing of acceleration, angular velocity, and/or magnetic field values. For example, it may include in particular at least one processing selected from: frequency filtering, gravity suppression on the acceleration values, gravity suppression, noise suppression on the acceleration values and suppression drift on the measured angular velocity values.

Thus, the movement data can correspond to data generated by an inertial unit 11 which have been normalized, filtered, supplemented or else to data which have been merged for example by Kalman filtering. Preferably, the motion data includes variable values in the form of time series. These variable values may preferably correspond to acceleration and angular velocity values. They may possibly comprise magnetic field data or a fusion of these data.

As shown in , a method according to the invention may include a step 120 of calculating a value of at least one foot angle for several instants of movement without correction. This step can be considered as a measurement initialization step.

This calculation step 120 of a value of at least one foot angle for several instants of movement without correction makes it possible, during a method for validating an orthopedic correction, to establish an initialization or a tare specific to the individual concerned. Thus, the following steps of the method could be based in part on these foot angle values obtained for several instants of the movement without correction. They could in particular be used during the validation step in comparison with these foot angle values obtained for several instants of displacement with correction.

These foot angle values obtained for several instants of movement without correction can be used directly or modified according to data from the literature such as reference values or even according to data relating to the morphology of the individual.

In addition, a method according to the invention may include a step of calculating a corridor 123 of normality.

Each individual has a different gait influenced by their morphology and their history (eg injury, illness, etc.). Thus, when a practitioner must determine the form that an orthopedic correction should take, he takes into account the specific parameters of the individual to make a tailor-made orthopedic correction or to combine the appropriate inserts to provide a suitable correction.

In the context of the present invention, the applicant has developed a solution capable of taking into account in an automated manner at least part of the morphology and the history of the individual. The corridor of normality of an individual may correspond to a set of angle values that the foot of an individual may present, in a plurality of instants, during a gait cycle without his gait being considered. as abnormal. Such a corridor of normality 65a, 65b is illustrated in the . In particular, the illustrates for each of the feet 31a, 32b of an individual, a left 65a and right 65b normality corridor as well as left 60a and right 60b plantar pressure lines obtained without orthopedic correction for each of the individual's feet. In connection with the , the individual may have different lines of plantar pressure 60a, 60b for each of these feet and different corridors of normality 65a, 65b for each of these feet.

For a plurality of instants of a stance phase, the normality corridor may comprise a range of values (eg min max) for several angles of the foot (or feet) of the individual. As presented on the , the root angle values used in the method can be substituted by values calculated from these root angle values. This is for example the case of a plantar pressure line calculated from the foot angle values.

Preferably, the calculation of the corridor of normality will be based on the foot angle values calculated for several instants of the movement without correction. In particular, from the foot angle values obtained from movement data generated during a movement without correction, the method according to the invention will be able to calculate a corridor of normality by applying one or more mathematical transformations. For example, the calculation of the normality corridor may comprise the establishment of a range of foot angle values for a plurality of instants making it possible to bring the foot angle values of the individual closer to the angle values feet considered normal. On the , line 61a represents a line of plantar pressure considered normal. The normality corridor 65a was calculated from the foot angle values obtained from movement data generated during movement without correction, but also from movement data (here a line of plantar pressure) considered to reflect a normality.

As shown in , the calculation 120 of a value of at least one foot angle without correction for several instants of movement may include an optional step 121 of fitting the individual's feet in an article of footwear not including the orthopedic correction to be validated. Alternatively, the calculation of a value of at least one foot angle without correction for several instants of the displacement could be carried out when the individual is not wearing an article of footwear.

For example, after positioning 110 of at least one inertial unit at the level of the individual's foot, the calculation 120 of a value of at least one foot angle without correction includes a step 122 of acquisition of movement data generated when the individual moves in the absence of orthopedic correction to be validated. This acquisition is for example carried out by one or more processors 12,22.

These movement data are preferences generated by at least one inertial unit coupled to a foot of the individual. Alternatively, this movement data could be generated by force sensors or by a system comprising video capture. Nevertheless, advantageously the step of calculating a normality corridor uses the at least one inertial unit 11 coupled to a foot of the individual used for the rest of the method according to the invention. The acquisition may comprise a transmission of the movement data generated (for example by the at least one inertial unit) to a processor or to a memory coupled to a processor.

The method according to the invention may include a step 123 of calculating a normality corridor. This corridor of normality may be similar for all individuals and be based on bibliographic data relating to individuals' gait and what could be considered normal gait. Alternatively, the corridor of normality can be a function of the individual concerned, taking into account, for example, his morphology.

In an even more personalized way and as has been discussed, the corridor of normality can in particular depend on the approach of the individual in the absence of correction. Thus, the normality corridor can be based at least in part on foot angle values calculated from motion data generated in the absence of correction. The calculation is for example carried out by one or more processors 12,22. As will be detailed later, these processors 12,22 can be integrated into an electronic box 10 or a computer device 20.

The normality corridor can in particular be calculated from a comparison between the movement data generated and reference data. Preferably, the step will include the calculation of a minimum value and a maximum value of a foot angle, this for several instants of a gait cycle and in particular of a stance phase.

As illustrated by , according to a preferred embodiment, a method according to the invention may comprise:
- a step 110 of positioning an inertial unit at the level of a foot of the individual, preferably against the foot of the individual, more preferably at the level of the metatarsals;
- a step 122 of acquisition of movement data generated, by at least one inertial unit 11 positioned at the level of a foot of the individual, during a movement of the individual in the absence of the orthopedic correction to be validated;
- a step 130a of fitting the feet of the individual in at least one item of footwear 30 comprising the orthopedic correction 40 to be validated or positioning the orthopedic correction 40 on at least one foot of the individual;
- a step 140 of acquisition of movement data which have been generated, by at least one inertial unit 11 positioned at the level of a foot of the individual, during a movement of the individual in the presence of the orthopedic correction to validate ;
- a calculation step 150, by one or more processors 22, from the movement data acquired, of a value of at least one foot angle for several instants of the movement of the individual; And
- a comparison step 160, by one or more processors 22, of the values of at least one calculated foot angle and of predetermined foot angle values, so as to validate or not the orthopedic correction 40.

In this case, the predetermined foot angle values may have been calculated from the movement data generated during the movement of the individual in the absence of the orthopedic correction to be validated.

As shown in , a method according to the invention may comprise a step 130 of applying the orthopedic correction to be validated to at least one foot of the individual. This can in particular involve a step 130a of putting on the individual's feet in at least one article of footwear 30 comprising the orthopedic correction to be validated or positioning the orthopedic correction 40 on at least one foot of the individual.

Generally, orthopedic correction takes the form of a corrective insole, one or more inserts, or a heel pad. The validation process will include an application of the orthopedic correction, for example via the insertion of the orthopedic correction in an article of footwear to be worn by the individual or via a positioning directly on a foot of the individual of the orthopedic correction.

For the design of an orthopedic correction, most of the studies, analyzes and calculations are carried out upstream of the preparation of the orthopedic correction. Thus, the practitioner generally bases himself on the feeling of the individual using the orthopedic correction and on a visual inspection to determine if the correction is effective. Alternatively, some practitioners are able to deploy digital analysis means such as two- or three-dimensional cameras to verify a correction. However, such analyzes are not within everyone's reach.

In addition, as mentioned, the validation is based on movement data generated by one or more inertial units positioned at the level of the individual's foot. Thus, the method may include before or after the fitting or the application of the orthopedic correction the positioning 110 of at least one inertial unit at the level of the foot of the individual.

In the context of the invention, the validation method then comprises a step 140 of acquiring movement data generated during a movement of the individual in the presence of the orthopedic correction 40 to be validated. The acquisition may comprise a transmission of the movement data generated (for example by the at least one inertial unit) to a processor or to a memory coupled to a processor. The processor or processors 12,22 can for example be integrated into an electronic box 10 comprising at least one inertial unit or into a computing device 20 configured to receive movement data.

Preferably, the acquisition step 140 of movement data comprises the acquisition of movement data generated by at least two inertial units each positioned respectively at the level of a foot of the individual (or even each coupled respectively to one foot of the individual).

In the context of the invention, the validation method comprises a step 150 of calculating a value of at least one foot angle for several instants of the movement of the individual in the presence of the orthopedic correction to be validated. This calculation step 150 is preferably carried out from the movement data generated by the at least one inertial unit 11. This calculation step is preferably carried out by one or more processors 12,22 which can for example be integrated into a box electronic 10 comprising at least one inertial unit or to a computer device 20 configured to receive the movement data. In particular, the calculation 150 of a value of at least one foot angle is made with respect to a predetermined reference.

The step 150 of calculating a value of at least one foot angle preferably corresponds to a step of calculating angle values for the two feet of the individual.

As has been shown, walking or running can influence the absorption achieved by the soft tissues of the foot. Indeed, muscle fatigue and in particular anterior tibial fatigue can influence the amount of work absorbed by the soft tissues of the foot or the padding of the shoe. Thus, the kinetic behavior of the feet changes throughout a movement such as a long run.

Thus, the calculation step 150 is advantageously carried out using movement data generated by the at least one inertial unit 11 during a walk or a run. In particular, the movement data acquired includes several instants corresponding to a walking cycle. For example, the acquired movement data includes several instants corresponding to the attack of the step, the anterior step, the posterior step, and/or the propulsion.

In addition, preferably, the foot angle values are calculated over at least two instants of the pose of the individual's foot, or stance phase. Preferably, the step 150 of calculating a value of at least one foot angle includes the calculation of angle values for at least two instants of the pose of the foot, preferably at least five and more favorite at least ten.

There are many methods for calculating foot angle values according to the reference frames used. Indeed, the foot angle values generally correspond to the angle values of a foot with respect to its environment. Examples of foot angle values that can be calculated are shown in Figures 2 and 5.

To the , the values of angles 52.54 could for example be calculated as a function of the walking line 50 of the individual. They may also be calculated relative to the ground or even relative to the anteroposterior axis 51,53 of the individual's foot. The walking line 50 can itself be calculated conventionally by the methods known to those skilled in the art and then used as a reference for calculating the angle values of the foot within the scope of the present invention.

Preferably, the calculated foot angle values comprise angle values selected from: an angle of the antero-posterior axis of the foot with respect to its line of progression, an angle of the antero-posterior axis of the foot with respect to a plane formed by the ground, an angle of the transverse axis of the foot with respect to its line of progression or an angle of the transverse axis of the foot with respect to a plane formed by the ground.

In addition to the fact of using values of the angle of the foot calculated at several instants of the pose of the foot, the present invention derives a particular advantage from the use of values of several angles of the foot. Thus, preferably, the step 150 of calculating a value of at least one foot angle comprises the calculation of values of at least two foot angles, preferably of at least three foot angles and of more preferably at least four angles of the foot.

Among the angles that can be used in the context of the invention, we can for example cite the strike angle corresponding to a measurement of the angle between the base of the foot and the ground at initial contact. This angle can continue to be measured during the attack phase of the step until the forward step phase. As shown in , the angle 46 between the base of the foot 45 and the ground can also be measured during the propulsion phase.

In addition, the movement data generated during a movement of the individual in the absence of orthopedic correction to be validated or in the presence of orthopedic correction to be validated can be used to calculate descriptors of a gait such as speed, acceleration, spatial displacement, or even angular and linear speed.

The values of these descriptors of a gait may be used in particular within the framework of a gait cycle selection to be used for a validation phase or directly during the validation stage of the orthopedic correction.

In the context of the invention, the validation method includes a step 160 of comparing the values of at least one calculated foot angle and predetermined foot angle values. This calculation step is preferably carried out by one or more processors 12,22 which can for example be integrated into the electronic box 10 or into the computer device 20. In particular, this comparison 160 makes it possible to validate or not the orthopedic correction 40.

In general, as has been discussed, the predetermined foot angle values can for example be selected from:
- reference foot angle values, for example from the literature;
- foot angle values calculated during movement of the individual without correction;
- foot angle values calculated during movement of the individual without correction, but corrected for example by values related to the morphology of the individual.

The predetermined foot angle values can be recorded in an electronic box 10 comprising at least one inertial unit or a computer device 20 configured to receive movement data from an inertial unit. These values can represent predetermined expected values of at least one foot angle over one or more instants of the pose of the foot. Thus, these values could, for example, take the form of numerical charts making it possible, from values of at least one calculated foot angle, to determine whether the orthopedic correction is effective and therefore whether it can be validated. These values can alternatively represent the predetermined values of at least one foot angle over one or more instants of the pose of the foot during a movement without correction of the individual. Thus, these values will be reference values making it possible to determine whether the orthopedic correction is significantly effective compared to a displacement without correction and therefore whether it can be validated.

These predetermined foot angle values may for example be a function of physiological characteristics of the individual. In particular, the predetermined foot angle values have been predetermined from data relating to the morphology of the individual and/or characteristics of the article of footwear. Preferably, these predetermined foot angle values may be taken from the normality corridor 65a, 65b calculated according to an embodiment of the present invention. Indeed, they are then perfectly adapted to the individual and allow a better validation of the orthopedic correction.

As mentioned, the dynamics of foot movement are important when evaluating an orthopedic correction. Thus, the comparison 160 is preferably made from the angle values calculated over the at least two times when the individual's foot is posed. In particular, the comparison 160 can be made from the angle values calculated on the at least two instants of the pose of the foot of the individual selected among: the instant of pose of the heel, the instant of pose of the toes , the heel lift-off time and the toe lift-off time.

Preferably, the comparison step 160 comprises the use of angle values calculated for at least two instants of the pose of the foot, preferably at least five and more preferably at least ten. Indeed, it is important that the orthopedic correction is able to correct the roll of the foot in a movement and not only the distribution of pressure forces during a stationary phase of the foot.

Advantageously, the calculated angle values used during the comparison 160 comprise a majority of angle values calculated from movement data generated from the moment of placing the heel to the moment of placing the toes (limits included) and from the instant of heel lift-off to the instant of toe lift-off (limits included).

Preferably, the calculated angle values used during the comparison 160 comprise at least 60% of angle values calculated from movement data generated from the instant of heel strike until the instant of pose of the toes (limits included) and from the instant of heel lift-off until the instant of take-off of the toes (limits included).

More preferably, the calculated angle values used during the comparison 160 comprise at least 70% of angle values calculated from motion data generated from the moment of heeling down to the moment of poses of the toes (limits included) and from the moment of takeoff of the heel until the moment of takeoff of the toes.

Even more preferably, the calculated angle values used during the comparison 160 comprise at least 80% of angle values calculated from movement data generated from the instant of heel strike until the instant from the toe landing (limits included) and from the moment of heel lift-off until the moment of toe lift-off (limits included).

This comparison step 160 is preferably performed from values of several angles. Preferably, the comparison step 160 is performed from the values of at least two angles of the foot, preferably of at least three angles of the foot and more preferably at least four angles of the foot.

In the context of the invention, the comparison step 160 can be repeated so as to establish a confirmed validation from several walking or running cycles, in particular several support phases. This increases the reliability of the validation. Indeed, unlike techniques based on observation or motion capture, the present method can exploit a very large number of walking cycles without it becoming tedious for an observer or extremely consuming in computing power during using video capture.

Thus, the foot angle values used during the comparison step 160 are preferably calculated from a plurality of gait cycles (eg median, average, etc.). In particular, the foot angle values used during the comparison step 160 have been calculated from at least twenty walking cycles, preferably at least thirty and even more preferably at least fifty. This makes it possible to create consolidated data across several cycles and therefore to precisely measure the impact of the correction by differentiating it from intra-individual variations. A consolidated displacement line (eg, plantar pressure line) can then be generated and compared against reference data or a reference consolidated displacement line (eg, plantar pressure line) generated under the same conditions, but in the absence of correction.

Preferably, the foot angle values used during the comparison step 160 have been calculated for a plurality of gait cycles which have been previously selected on the basis of one or more calculated characteristics of the gait cycle. market. Indeed, the acquisition of a hundred gait cycles is quite fast and the precision and accuracy of the method according to the invention can be improved by a prior selection of the gait cycles used to calculate the values of foot angles. which will be used during the comparison step 160.

The selection of gait cycles can for example take into account calculated characteristics such as: a maximum acceleration value, a maximum propulsive force value, a step frequency, a step length, a walking speed, a duration of the support phase, and/or a duration of the oscillating phase. If the value of one or more characteristics of the walking cycle exceeds a predetermined threshold then the walking cycle can be discarded and not considered for the remainder of the process.

Moreover, in addition to taking into account the values of foot angles, the present invention has the advantage of being able to base the validation of the correction on biomechanical parameters. Indeed, during the comparison step 160, the method according to the present invention may include taking into account values of biomechanical parameters of the individual.

These values of biomechanical parameters will for example have been calculated from the movement data generated by the inertial units.

In addition, the taking into account of these values of biomechanical parameters of the individual may comprise a comparison between values of biomechanical parameters of the individual calculated from movement data generated during movement with correction and values of biomechanical parameters of the individual calculated from movement data generated during movement without correction.

The biomechanical parameters of the individual can for example be selected from: the force of propulsion, the length of a step, a maximum acceleration value, an acceleration value at a given instant of the gait cycle, a value maximum propulsion force, a propulsion speed value at a given instant of the gait cycle, a step frequency, a step length, a gait speed, a duration of the stance phase, or even a duration of the oscillating phase.

As has been discussed, one of the advantages of the present invention is to be able to objectively validate an orthopedic correction without having to use a pressure sensor or analysis by two or three-dimensional camera whereas this constituted before the present invention a passage obligated to podometry for an objective validation of an orthopedic correction. Thus, advantageously, the method according to the invention does not take into account data coming from a pressure sensor coupled to an article of footwear of the individual.

As mentioned, the feet of an individual do not behave in the same way when stationary, walking or running. Thus, preferably, the comparison step 160 could be carried out from values of at least one foot angle calculated from movement data generated during a walk of the individual and/or from data of movement generated during a race of the individual.

Preferably, the calculated and compared foot angle values comprise angle values selected from: an angle of the antero-posterior axis of the foot with respect to its line of progression, an angle of the antero-posterior axis posterior of the foot with respect to a plane formed by the ground, an angle of the transverse axis of the foot with respect to its line of progression or an angle of the transverse axis of the foot with respect to a plane formed by the ground.

Preferably, the movement includes at least one stance phase, and the values of at least one foot angle calculated and compared include at least one foot angle value obtained during at least one stance phase.

Advantageously, the movement includes at least one oscillation phase and the calculated and compared foot angle values include at least one foot angle value obtained from movement data generated during an oscillation phase. On-board pressure sensors or mats equipped with pressure sensors cannot access the position of the foot during the swing phase. However, this position has an impact on the general gait of an individual and can be influenced by orthopedic corrections. The present invention advantageously makes it possible to take into consideration the oscillating phase so as to validate an orthopedic correction both on the basis of a behavior of the foot during the stance phase and during the oscillating phase.

Further, the comparison step 160 may include a calculation of one or more deviation values of the calculated foot angle values from the predetermined foot angle values. Thus, a validation can be issued if the calculated deviation value is less than a reference deviation value. For example, there may be a comparison of the calculated toe angle values to the toe angle values associated with the normality corridor. Thus, there will be calculation of a deviation value over one or more instants of the pose of the foot allowing, in comparison with one or more deviation values, to determine whether or not the orthopedic correction can be validated.

In the context of the present invention, it is possible that the method results in the orthopedic correction not being validated. It can then be considered that the shape and/or the constitution of the orthopedic correction are not adapted to the individual.

In addition, the present invention comprises a step of calculating an effective correction 170. This step of calculating is preferably carried out by one or more processors 12,22 which can for example be integrated into an electronic box 10 further comprising at least one inertial unit or to a computer device 20 configured to receive movement data generated by at least one inertial unit.

The foot and the articles of footwear contain soft tissues which, depending on the type of movement (e.g. walking/running) or the orthopedic inserts used, will deform, thus influencing the orthopedic correction. In particular, the orthopedic correction comprising soft or elastic zones, there is a modification of the angle of correction according to the interaction between the foot of the individual and the orthopedic correction.

In this context, the present invention can advantageously include a step of calculating an effective correction 180 making it possible to quantify the correction obtained by the orthopedic correction.

For this, the step of calculating an orthopedic correction may be based on a comparison of values of foot angles calculated in the absence of orthopedic correction and values of foot angles calculated in the presence of orthopedic correction.

Advantageously, the validation of the orthopedic correction is carried out in real time, that is to say less than 1 hour after the generation of the data by one or more of the inertial units, preferably less than 10 minutes, in a more preferably less than one minute, even more preferably less than 10 seconds.

Preferably, the method can also include a data storage step. This storage is preferably done continuously. In particular, this may correspond to the storage of all the data generated and/or calculated within the framework of a method according to the invention. The stored data can for example be raw data as generated by the motion sensors, pre-processed data, transformed data or orthopedic correction validation data.

Finally, a method in accordance with the invention may comprise a step of transmitting data to a remote computing device.

According to another aspect, the invention relates to a system 1 for validating an orthopedic correction for an individual.

As shown in , a system 1 for validating an orthopedic correction according to the invention will comprise at least one inertial unit 11 and one or more processors 12, 22.

In addition, a system 1 for validating an orthopedic correction according to the invention may include a data memory 13.23 and a means of communication 14.24.

The validation system 1 according to the invention can be arranged in the form of an electronic box 10 comprising at least one inertial unit 11 and one or more processors 12 configured to validate an orthopedic correction, for example by implementing a method according to the invention. However, preferably, the validation system 1 according to the invention is arranged in the form of an electronic box 10 comprising the at least one inertial unit 11 and a computer device 20 comprising a means of communication 24 configured to receive the movement data generated by the at least one inertial unit and one or more processors 22 configured to validate an orthopedic correction, for example by implementing a method of the invention.

Thus, a validation system 1 according to the invention comprises at least one inertial unit 11.

This at least one inertial unit 11 is configured to generate movement data during movement of the individual in the presence or not of an orthopedic correction to be validated. In addition, it is preferably arranged to be coupled to a foot of the individual, that is to say arranged to be positioned at the level of a foot of the individual.

The inertial unit 11 is for example made up of at least one accelerometer and a gyroscope. Preferably, it comprises several accelerometers and gyroscopes. More preferably, the inertial unit 11 comprises at least one accelerometer and at least one gyroscope.

The inertial unit 11 is able to acquire movement data representative of a movement (acceleration and/or speed, for example angular speed) of the foot along the axes X, Y, Z during the movement of the individual. The electronic box 10 can also comprise one or more magnetometers so as to acquire three additional raw signals corresponding to the values of magnetic fields in three dimensions.

In particular, the validation system 1 according to the invention may comprise one or more electronic boxes 10 comprising at least one inertial unit 11, said electronic box being arranged to be positioned at the level of a foot of the individual.

The electronic box(es) may be arranged so as to be positioned against a foot of the individual or on an item of footwear worn by the individual. Alternatively, the electronic box 10 could be integrated into a sole. The soles that can be used in the context of the validation system 1 according to the invention can, for example, correspond to outer soles or to inner soles of shoes. These soles can be removable or be permanently integrated into the sole of the shoes.

An electronic box 10 advantageously weighs only a few grams (eg less than 10 grams) and has a small size suitable for positioning on a foot or a shoe of the individual (eg volume less than or equal to 10 cm3, preferably less than or equal to 8 cm3). This low volume limits the impact on user comfort.

Each electronic box 10 can also include other sensors, in particular an inclinometer, a barometer, a temperature sensor, a humidity sensor and an altimeter to benefit from increased precision.

A validation system 1 according to the invention also comprises one or more processors 12,22.

This or these processors are advantageously configured to execute instructions making it possible to implement all or part of the embodiments of the validation method according to the invention.

In particular, this or these processors 12.22 are configured for:
- Acquire movement data generated by the at least one inertial unit 11 positioned at the level of a foot of the individual;
- Calculate from the movement data acquired, a value of at least one foot angle for several instants of movement; And
- Compare values of at least one calculated foot angle and predetermined foot angle values, so as to validate or not the orthopedic correction.

The one or more processors 12 can be positioned at the level of the electronic box 10. However, the validation system 1 according to the invention can comprise a computer device 20 comprising one or more processors 22 configured to process the movement data coming from the electronic boxes 10.

Preferably, the validation system 1 according to the invention comprises a computer device 20 comprising one or more processors 22 configured to implement one or more embodiments, whether or not they are preferred of the method according to the invention.

Advantageously, a dedicated application is installed on this computer device 20 in order to process the information transmitted by the electronic device(s) 10 and allow the user to interact with the invention.

The computing device 20 is generally a tablet, a mobile telephone ("smartphone" in English terminology), a computer or a server.

In addition, the electronic box 10 and / or the computer device 20 may include a data memory 13.23 configured to store at least part of the data generated by the inertial unit 11 and / or the processor 12.22.

Finally, the electronic box 10 and/or the computer device 20 may comprise a means of communication 14,24 configured to transmit movement data and/or data relating to the validation of the orthopedic correction. The means of communication are capable of receiving and transmitting the data on at least one communication network R1, for example intended for a server 70. Preferably the communication is carried out via a wireless protocol such as wifi , 3G, 4G, and/or Bluetooth.

The invention may be the subject of numerous variants and applications other than those described above. In particular, unless otherwise indicated, the various structural and functional characteristics of each of the implementations described above should not be considered as combined and/or closely and/or inextricably linked to each other, but on the contrary as simple juxtapositions. Furthermore, the structural and/or functional characteristics of the various embodiments described above may be the subject, in whole or in part, of any different juxtaposition or any different combination.

Claims (13)

Method (100) for validating a desired correction to be provided by an orthopedic correction (40) for an individual presenting at least one condition caused by abnormal foot displacement kinetics, said validation being intended to confirm that said orthopedic correction causes the desired correction of the kinetics of the feet of said individual when moving said individual, said method comprising:
- a first step of acquisition (122) of foot movement data in space, which have been generated for a plurality of instants of the pose of the foot, by at least one inertial unit (11) positioned at the level of at least one foot of the individual, in the context of a movement of the individual in the absence of the orthopedic correction (40) to be validated, referred to as initialization movement data, the foot movement data being generated from the moment the heel is posed until the moment the toes are posed and/or from the moment the heel takes off until the moment the toes take off,
- a first calculation step (120), by one or more processors (22), of at least one predetermined foot angle value for several instants of the movement of the individual without orthopedic correction (40) to be validated, from the initialization movement data,
- a second acquisition step (140) of foot movement data in space, which have been generated for a plurality of instants of the pose of the foot, by at least said inertial unit (11) positioned at the level of said foot of the individual, in the context of a movement of the individual in the presence of the orthopedic correction (40) to be validated, said acquired data;
- a second calculation step (150), by one or more processors (22), of at least one calculated foot angle value for several instants of the movement of the individual in the presence of the orthopedic correction (40) at validating, based on the acquired foot movement data; And,
- a step for validating the desired correction provided by the orthopedic correction (40), the validation step comprising a step for comparing (160), by the processor(s) (22), at least one calculated value of root angle and at least one predetermined root angle value. Method (100) for validating an orthopedic correction (40) according to claim 1, characterized in that, during the second acquisition step (140) of foot movement data in space, which have been generated during a movement of the individual in the presence of the orthopedic correction to be validated, the at least one inertial unit (11) is positioned against the foot of the individual. Method (100) for validating an orthopedic correction (40) according to one of Claims 1 or 2, characterized in that the first calculation step (120) further comprises a step of calculating a normality corridor of plantar pressure line, from initialization movement data, said plantar pressure line normality corridor being obtained from a set of angle values that the foot of said individual presents, in a plurality of instants displacement without correction, during a gait cycle without its gait being considered abnormal, said plantar pressure line normality corridor being used as values of predetermined foot angles. Method (100) for validating an orthopedic correction according to any one of Claims 1 to 3, characterized in that the predetermined foot angle values are expected foot angle values which have been predetermined from data relating to the morphology of the individual. Method (100) for validating an orthopedic correction according to any one of Claims 1 to 4, characterized in that the predetermined foot angle values are expected foot angle values which have been predetermined from characteristics of the footwear. Method (100) for validating an orthopedic correction according to any one of Claims 1 to 5, characterized in that in the first acquisition step (122) and the second acquisition step (140) of movement data foot in space, the foot movement data is generated by two inertial units (11), each being positioned respectively at the level of a foot of the individual. Method (100) for validating an orthopedic correction (40) according to any one of Claims 1 to 6, characterized in that the comparison step (160) comprises a calculation of a value of deviation of the values of foot angle calculated with respect to the predetermined foot angle values. Method (100) for validating an orthopedic correction (40) according to any one of Claims 1 to 7, characterized in that the foot angle values of at least three instants of the displacement, preferably of at least five instants of the displacement, are calculated and then compared during the comparison step (160). Method (100) for validating an orthopedic correction (40) according to any one of Claims 1 to 8, characterized in that the displacement comprises at least one phase of oscillation and in that the values of at least one foot angles calculated and compared comprise at least one foot angle value obtained during the oscillation phase. Method (100) for validating an orthopedic correction (40) according to any one of Claims 1 to 9, characterized in that the foot angle values are calculated for at least twenty walking cycles; and the values of at least one calculated foot angle, used during the step of comparing (160), correspond to values obtained from at least twenty gait cycles. Method (100) for validating an orthopedic correction (40) according to any one of Claims 1 to 10, characterized in that the foot angle values are calculated for a plurality of gait cycles which have been previously selected on the basis of one or more calculated characteristics of the walk cycle; said calculated characteristic(s) of the gait cycle comprising: a maximum acceleration value, a maximum propulsion speed value, a step frequency, a step length, a gait speed, a stance phase duration, and/or a duration of the oscillating phase. System (1) for validating a desired correction to be provided by an orthopedic correction (40) for an individual presenting at least one condition caused by abnormal foot displacement kinetics, said validation being intended to confirm that said orthopedic correction causes the desired correction of the kinetics of the feet of said individual during the movement of said individual, said system comprising:
- at least one inertial unit (11), said inertial unit being arranged to be positioned at the level of a foot of the individual and being configured to generate foot movement data in space, for a plurality of instants of the placing of the foot, in the context of a movement of the individual in the absence of the orthopedic correction (40) to be validated, referred to as initialization movement data, the foot movement data being generated from the moment of laying of the heel until the moment of laying of the toes and/or from the moment of taking off of the heel until the moment of taking off of the toes;
- one or more processors (12,22) configured for:
- acquiring foot movement data in space, which are generated by the at least one inertial unit positioned at the level of the foot of the individual, during a movement of the individual in the absence of the correction orthopedic (40) to be validated,
- calculating at least one predetermined foot angle value for several instants of movement without correction, from the initialization movement data;
- acquiring foot movement data in space, which are generated by the at least one inertial unit positioned at the level of the foot of the individual, during a movement of the individual in the presence of the orthopedic correction at to validate ;
- calculating a value of at least one foot angle for several instants of the movement, from the acquired foot movement data; And
- validating the desired correction provided by the orthopedic correction (40) by comparing values of at least one calculated foot angle and predetermined foot angle values. System (1) for validating an orthopedic correction (40) according to claim 12, characterized in that it comprises two electronic boxes (10) each comprising at least one of the inertial units (11) and a computer device (20) comprising the one or more processors (22), said electronic boxes (10) comprising communication means configured to transmit, preferably in real time, the foot movement data to the computer device (20).

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