SYSTEM FOR DETECTING A GAIT DISORDER IN A USER AND ASSOCIATED METHODS.

Abstract

The invention relates to a system 1 for quantifying a user's gait to obtain a value representative of the evolution of said user's gait, comprising a pair 10 of insoles, the insoles 11, 12, components of said pair 10 of insoles, each comprising an electronic unit 100, 101, 102, each electronic unit 100, 101, 102 comprising: - an inertial platform 110, 111, 112 configured to generate a set of data on the gait of a user of the pair 10 of insoles, a data processing module 120, 121, 122 configured to transform the generated data set into at least one biomechanical parameter, - a data storage module 130, 131, 132 configured to store at least one biomechanical parameter, - a data comparison module 140, 141,142 configured to compare at least one biomechanical parameter to reference biomechanical parameters and calculate a representative value of the evolution of the user's gait, - a first means of communication 150, 151, 152 configured so that the electronic unit 101 of at least one of the insoles is capable of transmitting at least one biomechanical parameter and / or the representative value of the evolution of the user's gait to the external terminal 20, and a power source 160, 161, 162.,

Description

transformed data, or values ​​of biomechanical parameters, representative of pathologies, for example obtained from individuals suffering from at least one pathology which can affect gait, and predetermined threshold values ​​characteristic of certain pathological conditions. Previous transformed data obtained from the individual using the system according to the invention:

[0094] Here the objective is to detect a continuous evolution in a person.

[0095] The data comparison module 140 is in particular capable of monitoring over time, preferably continuously, the evolution of the calculated biomechanical parameters of a user. The module can further be configured to make a comparison at a daily, weekly or monthly frequency.

[0096] Advantageously, the data comparison module 140 is capable of comparing the calculated biomechanical parameter data with the user profile.

[0097] Thus, the system according to the invention will for example be able to identify or detect a decrease in the length of a user's stride over time. Such a decrease is generally not normal and must alert the user who must then be able to take preventive or corrective measures. Transformed data obtained from individuals with at least one pathology that may affect gait

[0098] Here the objective is to verify whether the biomechanical parameters calculated for an individual using the system are not similar to biomechanical parameters associated with walks or gaits considered pathological or pre-pathological or at risk of developing a pathology.

[0099] Thus, the data comparison module 140 according to the invention is configured to compare the transformed data with reference data (e.g. reference biomechanical parameter) comprising biomechanical parameters representative of pathologies or risks of developing pathologies.

[00100] For example, the transformed data can be compared to biomechanical parameters indicative of risks or presence of neurological pathologies such as Parkinson's disease, Huntington's disease, Charcot's disease, neuromuscular pathologies including Duchenne de Boulogne muscular dystrophy, pathologies muscular disorders such as tears or muscular dystrophies, joint pathologies such as sprains, traumatic injuries of the menisci or arthritis or even podiatric pathologies such as tendinopathies, scoliosis or bowed legs.

[00101] More specifically, the values ​​of reference biomechanical parameters can be associated with recognized pathologies, the gaits then being selected from: Parkinsonian steps, Huntington's chorea, normal pressure hydrocephalus, lameness, saluting gait, intermittent radicular claudication, waddling gait, mowing gait, stopping gait, gait with retropulsion, heeling gait, vestibular gait, spastic gait, drunken gait, gait ataxia, hesitant gait, painful gait, "small steps" gait, or trembling gait.

[00102] The system according to the invention does not allow a diagnosis. It nevertheless allows the generation of an alert aimed at warning a user of a problem in his gait which it might be necessary to study further, for example by consulting a doctor.

[00103] For example, in the context of Parkinson's disease, it is now established that certain biomechanical parameters of walking are associated with this disease. A person with Parkinson's disease is observed to have a stooped gait with small steps, or even a lack of initiation, the phenomenon of festination, and postural instability.

[00104] The system, through the various sensors of the inertial platform, is able to detect small steps and calculate the flight time, the contact time as well as the length of the step. If the contact time is greater than the flight time in this case, the small steps are characterized. Postural instability will be detected by several parameters such as those related to walking with retropulsion. In this case, a measurement of the step sequence is carried out to determine the value of the peaks, i.e. the heel position and the toe position, and thus establish thresholds. If the threshold is reached, postural instability can be characterized.

[00105] Furthermore, in the context of Duchenne muscular dystrophy, a neuromuscular disease resulting in degeneration of muscle tissue and presenting in particular as symptoms an awkward gait and frequent falls, the system 1 according to the invention may be configured to measure and record the falls and risks of falling to which the user has been exposed.

[00106] In particular, the data comparison module can be configured to generate data selected from: an index of effectiveness of a treatment protocol: corresponds for example to a value which can help a hospital practitioner to identify a progression in a patient's approach which he can then use within the framework of his own methods in order to evaluate the effectiveness of a treatment; data on the nature of the support: corresponds for example to the way in which the foot is presented on the ground: by the heel, the arch of the foot or the toes; step profile data: corresponds for example to the impact force, the time of impact on the ground, the cadence or even a lameness problem, that is to say an imbalance between the right foot and the left foot; walking technique data: corresponds to the sequence of the step (support phase and swing phase), which is broken down into heel strike, braking phase, valgus push and propulsion phase; a support zone data: corresponds for example to pronation or supination; - corrective solution data: corresponds for example to a corrective solution of the corrective inserts type or a recommended exercises type solution.

[00107] Furthermore, the electronic box according to the invention comprises a first communication means 150, 151, 152 configured so that the electronic box 100 of at least one of the soles is capable of transmitting at least part of the transformed data to an external terminal 20. This data can be transmitted in real time or delayed to an external terminal 20. The external terminal 20 can for example be a remote system such as a tablet, a mobile telephone (“smartphone” in English terminology), a computer or a server.

[00108] Advantageously, each electronic box further comprises a second means of communication configured so that the electronic box 101 of a first sole is able to communicate with the electronic box 102 of a second sole, and in that at least one data processing module 121, 122 is configured to calculate, preferably jointly, sets of data generated from the two soles 11, 12, and more particularly from the inertial platform, making up the pair 10 of soles. Indeed, the calculation of certain biomechanical parameters of interest requires data coming from the two soles.

[00109] The first and second communication means are capable of receiving and transmitting the data over at least one communication network. Preferably, the communication is carried out via a wireless protocol such as WiFi, 3G, 4G, and / or Bluetooth.

[00110] Furthermore, the electronic box according to the invention comprises an energy source 160, 161, 162. The energy source is preferably of the battery type, rechargeable or not. Preferably the energy source is a rechargeable battery. Furthermore, it can be associated with a system for recharging by movement or by external energy. The system for recharging by external energy can in particular be a system for recharging by wired connection or an induction system.

[00111] Furthermore, the electronic box according to the invention may comprise a wired connection means 180, preferably protected by a removable tab. This wired connection means may be, for example, a USB or firewire port. This wired connection means may be used as mentioned above to recharge the battery but also to exchange data and, for example, to update the firmware of the electronic card carrying the various components of the electronic box.

[00112] Indeed, the different components of the electronic box are preferably arranged on an electronic card 170 (or printed circuit). Furthermore, the different means and modules of the electronic box 100 are shown separately in Figures 1 and 2, but the invention can provide various types of arrangement, such as, for example, a single module combining all of the functions described here. Similarly, these means can be divided into several electronic cards or else gathered on a single electronic card. Furthermore, when an action is assigned to a device, a means or a module, this is in fact carried out by a microprocessor of the device or module controlled by instruction codes recorded in a memory. Similarly, if an action is assigned to an application, this is in fact carried out by a microprocessor of the device in a memory in which the instruction codes corresponding to the application are recorded.When a device or module sends or receives a message, that message is sent or received through a communication interface.

[00113] Furthermore, the system 1 comprises an external terminal 20 capable of receiving data such as at least one biomechanical parameter and / or the value representative of the evolution of the user's gait.

[00114] Thus, the user can access data related to his daily physical activities and relating to several biomechanical parameters, such as posture, pronation / supination, impact force, step length, contact time, lameness, balance and several other parameters relating to the user and describing his movements, his gait, his postures and his movements and thus follow their evolution.

[00115] But above all, it can access comparison data, or values ​​representative of the evolution of the gait, which can be related on the one hand, to a comparison over time of the values ​​of biomechanical parameters to follow their evolution and detect anomalies which can be linked to the birth of a pathology or a malformation and, on the other hand, to compare these data with other parameters recognized as being associated with pathologies and to alert the user in the event of a notable similarity revealing a pathology or a malformation and, finally, to allow a health professional to detect a malformation and / or to monitor the effects of a medical treatment prescribed to a patient.

[00116] The external terminal 20 is generally a tablet, a mobile phone (“smartphone” in English terminology), a computer or a server. It may be able to transfer this data to a remote server 30. It is then, for example, possible to access this remote server via a web interface. All communications with the remote server may be secured, for example, by HTTPS protocols and AES 512 encryption. Thus, this may allow, via a client, access to the data by medical personnel responsible for monitoring the user.

[00117] Furthermore, in particular in the context of calculating a value representative of the evolution of the gait, the data comparison module 140 and / or the external terminal 20 may for example be capable of implementing algorithms based on supervised or unsupervised learning methods. Thus, advantageously, the system 1 is configured to implement the values ​​of biomechanical parameters in one or more algorithms, preferably previously calibrated. These algorithms may have been constructed from different learning models, in particular partitioning models, supervised or unsupervised. An unsupervised learning algorithm may for example be selected from an unsupervised Gaussian mixture model, hierarchical clustering (Agglomerative Hierarchical Clustering in Anglo-Saxon terminology), or hierarchical clustering (Divisive Hierarchical Clustering in Anglo-Saxon terminology). Alternatively, the algorithm is based on a supervised statistical learning model configured to minimize a risk of the ordering rule and thus to obtain more efficient prediction rules. In this case, the determination and estimation calculation steps can be based on a model, trained on a dataset and configured to predict a label (e.g. gait similar or not to the recorded gait). For example, for the purposes of calibration, it is possible to use a dataset representative of a situation whose label is known, for example biomechanical parameters characteristic of Parkinson's disease.The dataset can also include multiple labels. The algorithm can be derived from the use of a supervised statistical learning model selected for example from kernel methods (e.g. Wide Margin Separators - Support Vector Machines SVM, Kernel Ridge Regression), ensemble methods (e.g. decision trees) hierarchical partitioning, k-means partitioning, decision trees, logical regression or neural networks.

[00118] The comparison module 140 and / or the external terminal 20 may also be capable of comparing, preferably in real time, the biomechanical parameter data with predetermined critical thresholds of biomechanical parameters or the value representative of the evolution of the gait and of generating an alert according to the result of the comparison. This allows the system to identify potential risks and for example gaits deviating from normality.

[00119] Thus, the system 1 according to the invention will be able to analyze the generated values ​​and refine the analysis so as to interpret the evolution of the values ​​of the parameters over time to detect or not an anomaly in the gait possibly revealing a risk or a pathology or a potential malformation. As soon as the system 1 notes a similarity between the user's data and monitoring parameters characteristic of one or more identified pathologies, it will be able to alert said user by a message on the remote terminal and invite him to contact a health professional to carry out more in-depth examinations.

[00120] Furthermore, the system 1 according to the invention can be used in the context of a prognostic method so as, for example, to monitor the effectiveness of treatments or care protocols prescribed to patients in the context of specific pathologies.

[00121] For example, currently, when a health professional prescribes a treatment to his patient, he is obliged to wait for the next two or three appointments with this patient to be able to evaluate the effectiveness of the prescribed treatment based on biological tests and / or on the sensations reported by the said patient. This method of evaluation, related to certain neurological pathologies, can prove to be random.

[00122] Multiple sclerosis is a disease resulting in repeated, regressive neurological accidents (at least at the beginning of the disease), affecting variable functions (vision, motor skills, sensitivity, etc.), the attacks of which are disseminated in time and space. Since this disease is currently incurable, the prescribed treatments aim to improve functions after an attack or to postpone new attacks. In this case, the health professional is relatively helpless to obtain follow-up of his patient. He also has no means of ensuring that the treatment he has prescribed has a beneficial effect on this patient. The invention makes it possible to overcome this difficulty.

[00123] In another example, associated with a myopathy, in the event that a health professional proposes a particular treatment to his patient suffering from this pathology, he will be able, thanks to the system 1 according to the invention, to take note of the evolution of the gait of his patient and evaluate the effectiveness of the prescribed treatment. If a reduction in collisions and falls is observed in this patient, the professional will be able to conclude that there has been an improvement in the condition of his patient following the effectiveness of the treatment. Otherwise, if the frequency of collisions and falls remains the same or increases, the professional will be able to note the deterioration of the condition of the patient and conclude that the treatment is ineffective.

[00124] In addition, the external terminal 20 or the remote server 30 may comprise: A calculation module capable of studying biomechanical data collected daily and analyzing the evolution of this data over time. The calculation module can, for example, for example, monitoring the evolution of this data over time, which will be linked to the age of this user and their daily physical activities, an alert module capable of alerting the user, and possibly medical personnel, of an abnormal development of one or more biomechanical parameters which may correspond to the appearance or an increased risk of appearance of one or more pathologies, a communication module capable of directly contacting and informing a healthcare professional or any other person chosen and previously indicated by the user in the application and / or capable of regularly providing the user with information related to their daily activity and the evolution of biomechanical parameters over time, - a corrective module capable of proposing, for example via the external terminal, solutions to correct or prevent the malformation by proposing physical exercises or corrective inserts to be integrated under the foot, a prognostic module capable of measuring the effect, and possibly the effectiveness, of a neurological, medical or other treatment protocol by monitoring the evolution of all or part of the gait parameters via, for example, the value representative of the evolution of the user's gait and capable of communicating to the user or directly to his doctor or any other predetermined person all or part of the observed evolutions of the data collected from the gait of said user.

[00125] According to another aspect, the invention relates to a method 200 for quantifying the gait of a user implementing a quantification system comprising a pair 10 of soles and an external terminal 20, the soles 11, 12, composing said pair 10 of soles, each comprising an electronic box 100, 101, 102, each electronic box 100, 101, 102 comprising an inertial platform 110, 111, 112, a data processing module 120, 121, 122, a data storage module 130, 131, 132, a data comparison module 140, 141, 142, a first communication means 150, 151, 152, and an energy source 160, 161, 162. Preferably, the quantification method is implemented from a quantification system according to the invention.

[00126] The quantification method according to the invention comprises the following steps: Generation 210, by the inertial platform 110,111,112, of a set of data on the gait of a user of the pair 10 of insoles, - Transformation 220, by the data processing module 120,121,122, of the generated data set into at least one biomechanical parameter, Storage 230, by the data storage module 130,131,132, of at least one biomechanical parameter, Comparison 240, by the data comparison module 140,141,142, of the at least one biomechanical parameter with reference biomechanical parameters, Calculation 250, by the data comparison module 140,141,142, of a value representative of the evolution of the user's approach, - Transmission 260, by a first means of communication 150,151,152 of at least one of the soles, of at least one biomechanical parameter and / or of the value representative of the evolution of the individual's gait to the external terminal 20.

[00127] Furthermore, the method according to the invention may include a step of identifying the support zones and the progress of the step during the movement of a user (walking or running). Such a step may make it possible to quantify the level of stress on each of the user's feet and possibly prevent deterioration of his gait.

[00128] The method according to the invention may also include a step of determining the sequence of steps taken during the movement of a user. More particularly, it may include a step of defining the user's step profile.

[00129] In particular in this context, the invention can make it possible to propose solutions for correcting the user's gait so as to prevent the appearance of malformations. Thus, the method according to the invention can include a selection of exercises capable of improving said gait and possibly reducing physical fatigue or the risk of injury for the user, a selection of inserts to be put in place, or a selection of other more suitable footwear products.

[00130] Furthermore, the method according to the invention may also include a step of evaluating the development of a disease. Thus, a practitioner will be able to validate and / or adapt a treatment.

[00131] An advantage of the present invention is to specifically allow podiatrists to characterize the gait or walk of a patient, in order to produce suitable insoles for their benefit.

[00132] In this context, according to another aspect, the invention relates to a method of designing orthopedic insoles comprising the following steps: a step of implementing a method of quantifying the approach according to the invention, and - a stage of defining the structure of orthopedic soles based on the monitoring data obtained during the implementation stage.

[00133] In this context, according to another aspect, the invention relates to a method of manufacturing orthopedic insoles comprising the following steps: a step of implementing a method of quantifying the approach according to the invention, - a step of defining the structure of orthopedic soles based on the monitoring data obtained during the implementation step, and a manufacturing stage of the orthopedic insoles defined in the previous stage.

[00134] In the context of the methods for designing and manufacturing orthopedic insoles, the step of defining the structure of orthopedic insoles may comprise the execution of a three-dimensional modeling program of the shape of the insole on the basis of the tracking data obtained during the quantification method. In addition, this step may comprise, in addition to the definition of the shape of the insole and / or the density of different zones of the insole so as to take into account data generated by the system according to the invention, such as, for example, previously generated support zone data. This three-dimensional modeling may also be manually corrected using manual measurements so as to obtain a model that is most suited to the gait of the future user.This 3D model is defined by data (spatial coordinates) which can be used, for example, by a machine tool, for example a digital cutting machine, configured to manufacture at least part of the sole (e.g., flap, tongue, quarters). These cut pieces can then be assembled to form an orthopedic sole or possibly a shoe comprising said orthopedic sole.

[00135] As detailed above, the present invention makes it possible to monitor the evolution of the biomechanical data over time in order to be able to detect any abnormal evolution by comparison with the values ​​of this data collected during the first use and during subsequent uses. In addition, the present The invention allows biomechanical data to be analyzed and compared to specific monitoring parameters, in order to detect a risk of the user developing a pathology or malformation (particularly in children). It can also measure the user's fatigue and risk of joint or muscle injuries: if they run by forcing on their tiptoes, there is a high risk of muscle injuries; conversely, if they run by pressing hard on their heels, the injuries incurred will be joint injuries.

[00136] Advantageously, the invention acts here as an upstream detection system, capable of detecting the slightest anomaly in the user's gait or posture, and revealing the appearance of a specific disorder. Thus, without being a method for making a diagnosis, the present invention can allow a health professional, in the context of specific pathologies (neurological diseases, in particular), to detect an increased risk of developing the pathology, to monitor the effectiveness of a care protocol or treatment prescribed to a patient and also to follow the rehabilitation of a patient (e.g.: football player). The health professional will then have a set of biomechanical information concerning the patient, the analysis and interpretation of which will lead him to a more relevant understanding of the disorders from which the patient suffers.The professional will be able to refine his diagnosis and adapt the treatment protocol based on the information transmitted to him from the patient's biomechanical data.

[00137] Due to all the advantages of the present invention, it is also possible to carry out real-time monitoring of the evolution of the user's gait in order to prevent any deterioration in their state of health as quickly as possible. This is notably possible via a less complex, more robust and more autonomous system compared to those used until now.

[00138] All these advantages therefore contribute to improving functioning and reducing pathological risks.

Claims

Claims 1. System (1) for quantifying the gait of a user to obtain a value representative of the evolution of the gait of said user, comprising a pair (10) of soles, the soles (11, 12), components of said pair (10) of soles, each comprising an electronic box (100, 101, 102), each electronic box (100, 101, 102) comprising: - an inertial platform (110,111,112) configured to generate a set of data on the gait of a user of the pair (10) of soles, - a data processing module (120,121,122) configured to transform the generated data set into at least one biomechanical parameter, - a data storage module (130,131,132) configured to store the at least one biomechanical parameter, - a data comparison module (140,141,142) configured to compare the at least one biomechanical parameter with reference biomechanical parameters and calculate a value representative of the evolution of the user's gait, - a first means of communication (150, 151, 152) configured so that the electronic box (101) of at least one of the soles is capable of transmitting the at least one biomechanical parameter and / or the value representative of the evolution of the user's gait to the external terminal (20), and - a source of energy (160,161,162).

2. System according to claim 1, characterized in that each electronic box further comprises a second communication means configured so that the electronic box (101) of a first sole is able to communicate with the electronic box (102) of a second sole, and in that at least one of the data processing modules (131, 132) is configured to transform data sets generated from the two soles (11, 12) making up the pair (10) of soles into at least one biomechanical parameter.

3. System according to any one of claims 1 to 2, characterized in that each electronic box further comprises other sensors, in particular a magnetometer, a barometer or an altimeter.

4. System according to any one of claims 1 to 3, characterized in that the transformation by the data processing module (120,121,122) comprises the segmentation of the data into a plurality of step phases.

5. System according to any one of claims 1 to 4, characterized in that the data processing module (120,121,122) comprises means capable of calculating an asymmetry between the biomechanical parameters of a right leg compared to the biomechanical parameters of a left leg.

6. System according to any one of claims 1 to 5, characterized in that the data processing module (120,121,122) comprises means capable of calculating the variability of the biomechanical parameters associated with one leg or both legs.

7. System according to any one of claims 1 to 6, characterized in that the data processing module (120, 121, 122) comprises means capable of establishing a profile of biomechanical parameters of the user comprising at least one of the following parameters: stride length, stride angle, impact force, cadence and flight time.

8. System according to any one of claims 1 to 7, characterized in that the data comparison module comprises means capable of generating data selected from: an index of effectiveness of a treatment protocol, data on the nature of the support, data on the step profile, data on walking technique, data on the support zone, and data on a corrective solution.

9. Method for quantifying (200) the gait of a user implementing a quantification system comprising a pair (10) of soles and an external terminal (20), the soles (11, 12), components of said pair (10) of soles, each comprising an electronic box (100, 101, 102), each electronic box (100, 101, 102) comprising an inertial platform (110, 111, 112), a data processing module (120, 121, 122), a data storage module (130, 131, 132), a data comparison module (140, 141, 142), a first communication means (150, 151, 152), and an energy source (160, 161, 162), said method comprising the following steps: - Generation (210), by the inertial platform (110,111,112), of a set of data on the gait of a user of the pair (10) of soles, - Transformation (220), by the data processing module (120,121,122), of the generated data set into at least one biomechanical parameter, - Storage (230), by the data storage module (130,131,132), of at least one biomechanical parameter, - Comparison (240), by the data comparison module (140,141,142), of the at least one biomechanical parameter with reference biomechanical parameters, - Calculation (250), by the data comparison module (140,141,142), of a value representative of the evolution of the user's approach, - Transmission (260), by a first communication means (150,151,152) of at least one of the soles, of at least one biomechanical parameter and / or of the value representative of the evolution of the individual's gait to the external terminal (20).

10. Method for designing orthopedic insoles comprising the following steps: - a step of implementing a method of quantifying the approach according to claim 9, and - a stage of defining the shape and ergonomics of orthopedic insoles based on the monitoring data obtained during the implementation stage.

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