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EP4213722A1 - Système d'adaptation d'aides à la marche assisté par capteur - Google Patents

Système d'adaptation d'aides à la marche assisté par capteur

Info

Publication number
EP4213722A1
EP4213722A1 EP21787039.3A EP21787039A EP4213722A1 EP 4213722 A1 EP4213722 A1 EP 4213722A1 EP 21787039 A EP21787039 A EP 21787039A EP 4213722 A1 EP4213722 A1 EP 4213722A1
Authority
EP
European Patent Office
Prior art keywords
data
computer
imu
gait
inertial measurement
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP21787039.3A
Other languages
German (de)
English (en)
Inventor
Jan-Hagen SCHRÖDER
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
MOWA Healthcare AG
Original Assignee
MOWA Healthcare AG
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by MOWA Healthcare AG filed Critical MOWA Healthcare AG
Publication of EP4213722A1 publication Critical patent/EP4213722A1/fr
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/103Measuring devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11Measuring movement of the entire body or parts thereof, e.g. head or hand tremor or mobility of a limb
    • A61B5/112Gait analysis
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813Specially adapted to be attached to a specific body part
    • A61B5/6828Leg
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00Measuring for diagnostic purposes; Identification of persons
    • A61B5/68Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813Specially adapted to be attached to a specific body part
    • A61B5/6829Foot or ankle
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/02Details of sensors specially adapted for in-vivo measurements
    • A61B2562/0219Inertial sensors, e.g. accelerometers, gyroscopes, tilt switches
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2562/00Details of sensors; Constructional details of sensor housings or probes; Accessories for sensors
    • A61B2562/04Arrangements of multiple sensors of the same type

Definitions

  • the invention relates to a technical system for analyzing a person's movement data.
  • a first area of application can be the analysis of optimal medical patient care with walking aids, such as orthoses and prostheses, with specific application specifications, which fully consider the patient status, the medical diagnosis and the orthopedic-technical rules.
  • Orthoses are medical aids to support limitations in the functionality of extremities, for example as a result of cerebral palsy, foot drop, strokes, muscular dystrophies or polio myelitis. Orthoses allow the fixation of body parts to stabilize movement and/or protect and support movement of joints. Orthoses are applied externally to the extremity to be treated and worn over long periods of time.
  • Prostheses are medical aids to replace amputated body parts of the upper and lower extremities and are therefore used on the body to compensate for the loss of function.
  • the gait analysis examines, among other things, movement patterns, acting forces as well as temporal and comparative parameters such as step cadence and symmetries [11],
  • VICON's gold standard is an optical tracking system consisting of several cameras that have to be precisely installed and calibrated in the room.
  • the system enables high-precision measurements, but is not suitable for long-term monitoring of everyday activities due to the fixed installation.
  • the system is expensive and takes up a relatively large amount of space.
  • a smaller and cheaper method is gait analysis with walnut-sized inertial measurement units (IMU).
  • IMU inertial measurement units
  • a single IMU can calculate its orientation in space. If one IMU is fixed to the leg for each segment, the segments can be compared with one another. This in turn allows the movement of the legs to be calculated and thus enables a flexible, location-independent gait analysis.
  • EP 2 922 506 B1 describes a system with a very large degree of freedom of use, which could be used for universal supply.
  • the object of the invention is therefore to resolve the desiderata shown in a meaningful way in a closed system, namely the agile, gravity-independent data acquisition of human movement data using simple sensors and easy-to-use data acquisition stations and their comprehensive analysis according to medical and orthopedic-technical assessment parameters for reliable assessment and deficit treatment.
  • the solution to the problem according to the invention essentially consists of providing a walking aid adjustment system with a plurality of IMU sensors (IMU: inertial measurement unit), as explained below.
  • IMU inertial measurement unit
  • the subject matter of the invention is therefore a walking aid adjustment system containing
  • IMU inertial measurement units
  • a measuring station with a first computer with a receiving device for the sensor data, which can simultaneously transmit the measured data to a second computer
  • the invention is based on the use of one or more so-called inertial measuring units (IMU), as they are known from other technical fields, for example from flight navigation.
  • IMUs inertial measuring units
  • Such IMUs have three mutually orthogonal acceleration sensors (accelerometers) for detecting translational movements in the three spatial axes and three mutually orthogonal angular rate sensors (gyroscopes) for detecting rotating movements in the three spatial axes.
  • Micro-electro-mechanical systems which can be built in the form of integrated circuits, can be used for the purpose of the invention.
  • the power consumption should be dimensioned in such a way that several hours of operation are possible with the help of conventional rechargeable batteries, so that long-term studies are possible.
  • the Axiamote XI model from Axiamo is preferably selected for the purpose of the invention.
  • a single IMU sensor enables the complete description of the dynamic and static situation of a joint in relation to the physical parameters of orthopedic technology.
  • the system employs a plurality of IMU sensors, the number of which is determined by the medical diagnosis at hand.
  • the complexity of the human gait is illustrated in Figure 1; Here, particular attention is drawn to the dynamic behavior of the pelvis, which in itself requires a large number of sensors for medical and orthopedic-technical analysis.
  • the special, gravity-independent IMU sensors with their simple applicability are used here.
  • the use of IMU sensors is also much more economical than today's standard sensors.
  • the IMU sensors can be provided with Velcro and/or magnet attachments so that they can be easily fixed to different body regions (FIG. 3).
  • the sensors are fixed to different body parts of a subject.
  • 9 sensors are shown as an example in FIG. For certain simple analyses, a single sensor can be sufficient, in more complex cases more than 9 sensors can be used. Of course, the amount of data increases with the number of sensors, but at the same time the quality of the measurements also increases.
  • the sensors determine the accelerations that occur in the three spatial axes and the rotational movements.
  • suitable analysis software see below, the time course of the joint angles can be determined from the data from two sensors fixed to the same extremity.
  • the angle of the knee joint in the gait cycle can be determined in a time-resolved manner from a sensor on the thigh and a sensor on the lower leg (see FIG. 2, top). Deviations in gait behavior can be identified by comparing the patient with a patient who is not restricted in movement and by comparing the left leg with the right leg. The same applies to the analysis of the ankle angles and the angles in the hip joints. Since the fixing devices are typically tapes with Velcro fasteners, they can be attached to bare skin as well as to items of clothing and/or orthoses in a simple manner. This allows the gait pattern to be compared with and without an orthosis, for example.
  • Each sensor first transmits the respective data to the first computer for further evaluation.
  • the transmission could of course be cable-based.
  • wireless transmission through Near Field Communication (NFC), e.g. Bluetooth®
  • NFC Near Field Communication
  • a standard PC, a tablet PC, a smartphone or similar can be used as the first computer.
  • the actual analysis is preferably carried out in a larger data center, since the data analysis is computationally intensive. For this reason, the second computer is usually spatially separated from the first computer. Analysis and storage of the data can also be implemented virtually using cloud technologies. After the actual analysis has been carried out on the second computer, the determined movement data is sent back to the first computer for display and further use.
  • the representation is usually visual on the display of the first computer, possibly with the help of a connected monitor.
  • This division also allows the second computer to be designed in such a way that a large number of measuring stations are connected. This not only enables better utilization of the second computer, but also the collection of as much data as possible in a database (DB) and the use of AI software, so that a self-learning system is created overall.
  • DB database
  • the measuring station for local data acquisition is the only locally required system hardware, which means a comparatively low initial investment for the local end user.
  • the measuring station is used for data acquisition and calibration before the measurement run ( Figure 3).
  • the measuring station serves as a link between the IMU sensors and the associated analysis software on the second computer.
  • the data is transmitted securely and anonymously (if necessary using local servers) to the data center for data analysis.
  • further physiological data of the subjects can also be acquired (e.g. height, weight, age, gender, body circumferences at various points, etc.), which can flow into further analysis.
  • the software then takes care of the analysis process set out below.
  • the actual movement data (e.g. the progression of the knee angle over time) is calculated from the determined data using appropriate software on the second computer.
  • the following methods are used for this:
  • the program starts calibrating the sensors. Then the continuous loop is started, in which the data is measured, processed and displayed. The individual steps are carried out as follows.
  • the gyroscope and accelerometer in the IMU must be calibrated at launch to provide the most accurate readings possible. This process usually takes a few seconds and can be carried out using proven methods such as the Kalbr Library [1].
  • the raw data of the individual IMUs (without magnetometer) are queried by the controller and must then be synchronized for all IMUs used.
  • the sampling rate should be as high as possible and can be clocked down later. Methods from Axiamo GmbH can be used for synchronization.
  • the synced data can then be sent to a more powerful computer, such as a tablet, for data processing.
  • the raw data of the IMUs are pre-filtered by novel neural networks. This already enables a first reduction in the drift that can be expected from MEMS-based IMUs. Pre-filtering can also be expected to increase the precision of the conventional methods used in the next step.
  • Gyroscopes have already been successfully pre-filtered when used on drones [2] and this method is to be further promoted for use on humans.
  • the pre-filtered data is merged by Sensor Fusion using proven methods.
  • the angular velocities of the gyroscope are transformed with linear accelerations of the accelerometer using methods such as the Kalman filter [3] or complementary filter [4] to orient the IMU sensor.
  • these methods can be used to determine the XY plane correctly.
  • the information required to determine the remaining levels is missing (eg measuring the earth's magnetic field with a magnetometer), which means that the Z-axis of the IMU sensor is subject to a drift.
  • an axis common to all sensors can be determined with decision rules (heuristics).
  • a commonly used heuristic is the zero velocity update [5], which uses the wearer's walking direction as a reference.
  • the gait parameters can then be calculated using the filtered data.
  • the gait parameters are extracted by proven methods [6,7,8]. For this, the standing still of one leg is used as the beginning or end of a step.
  • AI the optional filtering of the accelerometer data by AI, a more precise calculation of the spatial parameters can be achieved, which can be calculated less accurately without filtering due to the noise of the accelerometer.
  • the data can be displayed and interpreted e.g. on an app on a tablet, similar to the Gait Up system [9].
  • the statistics can then be saved and used for other applications.
  • Each measurement can be stored in a database, creating a collection of data over time that can be further analyzed.
  • the doctor is still required today for the actual gait analysis and very special high-speed camera technology including a data center for image analysis.
  • the gait laboratory always has to complete a very complex gait learning phase at the start, during which the local reference gait has to be established on site; the costs are correspondingly high and the use is locally limited.
  • the professional translation of medical classifications and diagnoses into usable algorithms is therefore central to medical usability.
  • this 3D representation enables the differential gait image to be determined as a local reference gait image. Due to the simple structure of the system, the course of therapy can be measured and documented. Furthermore, the course of therapy can be compared with reference data from other subjects with the same symptoms.
  • the aim of the 3D representation is the mathematical determination of the deviations from a reference data set; these deviations must then be compensated for with the right tools, for which reference data from other subjects with the same symptoms are used.
  • the system according to the invention not only leads to a visual representation of the gait pattern on the basis of which aids (such as orthoses) are then tested until a significant improvement in the gait pattern is achieved, as is the case with systems from the prior art is known. Instead, the system according to the invention itself (on the basis of the measurements and the reference data) already proposes the most suitable aid. This eliminates the need for complex Attempts to adapt aids with repeated gait analysis. The system according to the invention therefore avoids the repeated production of aids (e.g.,
  • the system of the present invention therefore further eliminates the need for repeated gait analysis in a gait laboratory and the associated costs, logistics, and patient frustration.
  • the knowledge of the technical possibilities represents the added value of the system according to the invention, since this is the only way that the abstracted knowledge (and possibly worked out in own AI algorithms) can be made accessible to the patient's local care provider.
  • a DB with direct access to the physical parameters of the supply components is not yet available in this form.
  • Another advantage of the system is the significantly simplified and standardized documentation and communication based on the 3D representation.
  • the simulation of the orthopedic-technical deficit compensation with the help of the 3D representation is extremely helpful for improving compliance and acceptance by the patient, since the desired gait pattern is immediately available visually.
  • a property of the system according to the invention is the standardization of the processes, which makes it possible to analyze the control process over long periods of time.
  • the core is the standardized measurement setup for constant data acquisition, which ensures data integrity.
  • the accuracy of the measurements and the documentation options also allow the system to be used outside of the orthosis fitting.
  • the course of neurological, in particular neurodegenerative, diseases can be tracked and documented.
  • the success of a drug therapy can be recorded objectively.
  • systems according to the invention can be used in which only 1 or 2 IMUs (e.g. on the wrist) are used.
  • the measuring station with a first computer with a receiving device for the sensor data from the IMUs can be implemented by a smartphone with an appropriately adapted app, with the smartphone being able to transmit the measured data to a second computer for analysis.
  • AI algorithms that may be used can be described as self-learning, which in the long run will make the system more and more "intelligent”. This also allows for the possibility of transferring the principle to prosthesis fittings, which could be implemented using a separate prosthesis component database.
  • the walking aid adjustment system consists only of the components listed below, a) one or more inertial measurement units (IMU) with the possibility of data transmission to an evaluation computer, b) a number of fastening devices corresponding to the number of IMUs, in order to fix the inertial measurement units (IMU) to different body parts of a patient, c) a measurement station with a first computer with a receiving device for the sensor data of the IMUs, which can transmit the measured data to a second computer, d) a second computer for analyzing the measured data with a database and for optionally comparing the measured data with data from other measurements, e) software for analyzing the movement data, which runs on the second computer, with the analysis result being sent back to the first computer, and f) a display on or connected to the first computer to display the analysis result, without the need for additional sensors and/or tools , Such as scanning devices (sensing calipers), Kraftme Ground reaction force sensing plates, geomagnetic sensors, a sensor array, or a number
  • the IMU sensors can collect additional physiological data, eg measure the subject's vital signs (eg body temperature, pulse rate, blood pressure, oxygen saturation) or determine the exact location (eg via GPS data). This allows, for example, monitoring of the course of therapy, for example by measuring the distances covered.
  • the first computer can be realized, for example, by a smartphone or tablet belonging to the subject, and the data can be forwarded over the Internet in real time. credentials
  • Figure 1 shows the complexity of the human gait pattern with the many degrees of freedom in movement.
  • the first line shows different phases of the movement when walking in side view.
  • the second row shows the weight distribution on the soles of the feet during the movement phases shown in the first row.
  • the third line shows the position of the pelvis during the movement phases shown in the first line (seen from above).
  • the fourth line shows the position of the pelvis during the movement phases shown in the first line (seen from the front).
  • FIG. 2 shows the result of measurements with the system according to the invention:
  • knee angle measurements (right leg). Shown below are the ankle angle measurements.
  • Figure 3 shows the measuring station with the screen of the first computer and various sensors on a stand (shown on the left). The sensors are attached manually to the subject's leg (on the right in FIG. 3).
  • FIG. 4 shows the positioning of sensors on a subject.
  • FIG. 4 shows the positioning of sensors on a subject.
  • FIG. 5 shows measurement results of the gait analysis of a patient with an adapted orthosis, namely a) measurement of the knee angle during the gait cycle (bottom left in FIG. 5 b) measurement of the varus or valgus position of the knee joint during the gait cycle ( "gait cycle"), top left in Figure 5

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  • Health & Medical Sciences (AREA)
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  • Medical Informatics (AREA)
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  • Veterinary Medicine (AREA)
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  • Physiology (AREA)
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  • Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)

Abstract

L'invention concerne un système technique pour l'analyse de données de mouvement d'un être humain sur la base d'une ou de plusieurs unités de mesure inertielles (IMU) avec possibilité de transmission de données à un ordinateur d'évaluation. Un premier domaine d'application peut être l'analyse pour une prise en charge médicale optimale de patients au moyen d'aides à la marche, telles que des orthèses et des prothèses, avec prescriptions d'utilisation spécifiques, prenant en considération de manière globale l'état du patient, le diagnostic médical ainsi que les règles techniques en orthopédie.
EP21787039.3A 2020-09-18 2021-09-20 Système d'adaptation d'aides à la marche assisté par capteur Pending EP4213722A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102020005730.6A DE102020005730A1 (de) 2020-09-18 2020-09-18 Sensorgestütztes Gehhilfen-Anpassungssystem
PCT/IB2021/058547 WO2022058974A1 (fr) 2020-09-18 2021-09-20 Système d'adaptation d'aides à la marche assisté par capteur

Publications (1)

Publication Number Publication Date
EP4213722A1 true EP4213722A1 (fr) 2023-07-26

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ID=78080382

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Application Number Title Priority Date Filing Date
EP21787039.3A Pending EP4213722A1 (fr) 2020-09-18 2021-09-20 Système d'adaptation d'aides à la marche assisté par capteur

Country Status (4)

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US (1) US20240023833A1 (fr)
EP (1) EP4213722A1 (fr)
DE (1) DE102020005730A1 (fr)
WO (1) WO2022058974A1 (fr)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102023000912A1 (de) 2023-03-10 2024-09-12 Mowa Healthcare Ag IMU-Kalibrierungssystem
US12372376B1 (en) * 2025-01-31 2025-07-29 Aim Design, Llc AI assisted calibration of IMUS

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102007052806A1 (de) 2007-11-06 2009-05-14 Zebris Medical Gmbh Messanordnung und Verfahren zur Untersuchung des Ganges
EP2585835A1 (fr) * 2010-06-22 2013-05-01 Stephen J. McGregor Procédé de surveillance de mouvement de corps humain
DE102012023028A1 (de) 2012-11-26 2014-06-12 Orthopunkt Ag Modulares Orthesensystem und Kit zu dessen Anpassung
US11484710B2 (en) * 2019-01-07 2022-11-01 Evolution Devices, Inc. Device and system for real-time gait modulation and methods of operation thereof

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Publication number Publication date
US20240023833A1 (en) 2024-01-25
WO2022058974A1 (fr) 2022-03-24
DE102020005730A1 (de) 2022-03-24

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