LOAD-DETECTING ORTHOSIS

20220000392 · 2022-01-06

    Inventors

    Cpc classification

    International classification

    Abstract

    A loading-detecting orthosis includes a sensor that generates sensor signals and that has sensor elements in pressure areas. The loading-detecting orthosis further includes sensor signal-evaluating electronics that are designed to indicate critical loading. The sensor signal-evaluating electronics are designed to ascertain characteristic values regarding pressure loading events detected at least per pressure area by way of the sensor elements, to form a sum value into which the characteristic values are incorporated by amount in weighted form such that at least three different weights are used, and to generate an alert signal when the sum value exceeds a certain amount.

    Claims

    1-10. (canceled)

    11. A loading-detecting orthosis comprising: a sensor; and sensor signal-evaluating electronics; wherein: the sensor includes sensor elements in a plurality of pressure areas and configured to generate sensor signals; and the sensor signal-evaluating electronics are configured to indicate critical loading by performing the following: ascertaining characteristic values regarding pressure loading events detected, at least per pressure area of the plurality of pressure areas, by way of the sensor elements; weighting the characteristic values using at least three different weights to form weighted characteristic values; forming a sum value based on the weighted characteristic values; and generating an alert signal when the sum value exceeds a stipulated amount.

    12. The loading-detecting orthosis of claim 11, wherein the sensor signal-evaluating electronics are furthermore designed such that characteristic values are classified through comparison with a multiplicity of threshold values, and the weighting is performed based on the classification such that greater weightings are obtained as the characteristic values become larger.

    13. The loading-detecting orthosis of claim 12, wherein the classification is performed to obtain a single classified characteristic value per user step.

    14. The loading-detecting orthosis of claim 13, wherein the sensor signal-evaluating electronics are configured to perform the weighting based on a temporal density of respective ones of the characteristic values that are above one or more predefined threshold values.

    15. The loading-detecting orthosis of claim 12, wherein the sensor signal-evaluating electronics are configured to perform the weighting based on a temporal density of respective ones of the characteristic values that are above one or more predefined threshold values.

    16. The loading-detecting orthosis of claim 15, wherein the weighting based on the temporal density is performed such that contributions from pressure loading events to the sum value are caused to subside over time.

    17. The loading-detecting orthosis of claim 16, wherein the weighting based on the temporal density is performed such that the smaller or shorter the pressure loading event, the faster the contribution by the respective pressure loading event subsides.

    18. The loading-detecting orthosis of claim 12, wherein: the sensor is part of an insole; the plurality of pressure areas include no more than four pressure areas; and the sensor signal-evaluating electronics are configured to perform the weighting based on a temporal density of respective ones of the characteristic values that are above one or more predefined threshold values.

    19. The loading-detecting orthosis of claim 18, wherein: the sensor signal-evaluating electronics include first circuits and second circuits; the second circuits are connected to the sensor elements via a wireless interface; and the first circuits are positioned closer to the sensor elements than the second circuits.

    20. The loading-detecting orthosis of claim 19, wherein the wireless interface is a Bluetooth and/or WiFi interface.

    21. The loading-detecting orthosis of claim 12, wherein the sensor signal-evaluating electronics are configured to combine values weighted by pressure area before the ascertaining of the characteristic values.

    22. The loading-detecting orthosis of claim 11, wherein the sensor is standardized for a particular shoe size or shoe size group.

    23. The loading-detecting orthosis of claim 22, wherein the sensor is part of an insole.

    24. The loading-detecting orthosis of claim 11, wherein the plurality of pressure areas include no more than four pressure areas and no more than four sensor elements per pressure area.

    25. The loading-detecting orthosis of claim 11, wherein the sensor signal-evaluating electronics are configured to obtain the characteristic values through A/D conversion of pressure loading sensor element signals and to weight them at least by pressure area.

    26. An arrangement comprising: an insole having a sensor for detecting a load; and sensor signal-evaluating electronics; wherein: the sensor includes sensor elements in a plurality of pressure areas and configured to generate sensor signals; and the sensor signal-evaluating electronics are configured to indicate critical loading by performing the following: ascertaining characteristic values regarding pressure loading events detected, at least per pressure area of the plurality of pressure areas, by way of the sensor elements; weighting the characteristic values using at least three different weights to form weighted characteristic values; forming a sum value based on the weighted characteristic values; and generating an alert signal when the sum value exceeds a stipulated amount.

    27. The arrangement of claim 26, wherein the insole is adapted to equalize loading and/or damp pressure peaks.

    28. The arrangement of claim 27, wherein: the sensor signal-evaluating electronics include first circuits and second circuits; the second circuits are connected to the sensor elements via a wireless interface; and the first circuits are positioned closer to the sensor elements than the second circuits.

    29. The arrangement of claim 26, wherein the sensor signal-evaluating electronics are configured to perform the weighting based on a temporal density of respective ones of the characteristic values that are above one or more predefined threshold values.

    30. The arrangement of claim 29, wherein: the sensor signal-evaluating electronics include first circuits and second circuits; the second circuits are connected to the sensor elements via a wireless interface; the first circuits are positioned closer to the sensor elements than the second circuits; and the insole is adapted to equalize loading and/or damp pressure peaks.

    31. The arrangement of claim 30, wherein the weighting based on the temporal density is performed such that contributions from pressure loading events to the sum value are caused to subside over time.

    Description

    BRIEF DESCRIPTION OF THE DRAWINGS

    [0041] FIG. 1 shows a loading-detecting orthosis according to an example embodiment of the present invention.

    [0042] FIG. 2 shows a horizontal section through a sensor insole according to an example embodiment of the present invention.

    [0043] FIG. 3 shows evaluation electronics for the sensor of FIG. 2 according to an example embodiment of the present invention.

    [0044] FIG. 4 shows a unit for generating warning signals according to an example embodiment of the present invention.

    [0045] FIGS. 5a-c show an illustration of the calibration of a sole sensor for a loading-detecting orthosis according to FIG. 1, according to an example embodiment of the present invention.

    DETAILED DESCRIPTION

    [0046] According to FIG. 1, a loading-detecting orthosis 1, referenced generally by 1, comprises a sensor 2 that generates sensor signals and that has sensor elements 2a, 2b, 2c (cf. FIG. 2) in pressure areas, indicated by dashed circles I and II, and sensor signal-evaluating electronics 3 therefor that are designed to indicate loading critical to the orthosis user, wherein the sensor signal-evaluating electronics 3a, 3b (cf. FIG. 4) are designed to ascertain characteristic values regarding pressure loading events detected per pressure area by way of the sensor elements 2a, 2b, 2c, to form a sum value into which the characteristic values are incorporated by amount in weighted form such that at least 3 different weightings are used, and to generate an alert signal when the sum value exceeds a certain amount.

    [0047] The loading-detecting orthosis 1 in the illustrated exemplary embodiment is in this case an orthosis able to be used for example following a tibia fracture, in which the bones are held in the correct position in relation to one another following the fracture so that they fuse back together again correctly. During the healing process, it is possible for the user to walk using the orthosis 1, but said user has to take care that he does not overload the healing fracture when walking. He will therefore typically support himself using mobility aids such as crutches or the like in order to keep the loading on the healing leg low. Depending on the progress of the healing, the maximum permissible loading will increase again over time until the user is able to subject his leg to full load again and no longer requires the loading-detecting orthosis. Until this time, on the one hand, regular but low loading in accordance with medical knowledge is expedient for encouraging the healing process; overloading should at the same time be avoided.

    [0048] Such overloading can occur because the user systematically ignores the weakness of the healing point and for instance uses a mobility aid, such as a crutch, only on one side instead of on both sides as recommended by a doctor, because he is carrying heavy items or the like. It can however also be the case that he stumbles for instance during normal cautious walking and has to use the weak leg to regain balance, which can likewise lead to pressure loading that is critical.

    [0049] The sensor 2 is then incorporated, with the sensor elements 2a to 2c arranged in the pressure areas I and II, in an insole for the loading-detecting orthosis. The insole can be a standard insole that is structured with a cushioning foam or polymer material, if necessary has warming layers toward the inside of the foot, and is designed to be breathable in a manner known per se in order to reduce foot perspiration and the like.

    [0050] It is pointed out in particular that the sensor elements 2a to 2c and that part 3a of the evaluating electronics to be provided in the insole and the connecting lines therefor and/or the connections and/or the energy supplies take up only a small amount of space and in particular cover or take up only a small surface area of the insole. It is additionally possible to arrange the individual slightly larger-area components, specifically the sensor elements 2a, 2b, 2c and the part 3a of the evaluating electronics, at a distance from one another and to arrange only very thin and also flexible lines between them. This improves the breathability of a corresponding insole, because the impaired surface unavailable for breathability due to the components remains small. The additional use of flexible films as carriers for integrated circuits provided in the insole is also disclosed as being possible and preferred.

    [0051] It is additionally possible to arrange the sensor elements underneath a covering and damping layer facing the foot, in particular, as shown in FIG. 1, directly facing a harder, that is to say less elastic sole region of the orthosis. This is already advantageous because unpleasant pressure loading for the user caused by the sensor elements, which are slightly harder in comparison with the (sole) surroundings, is avoided. The sensor thus does not lead to impairments with regard to the walking sensation.

    [0052] It is also possible to use a lower sole layer in which the corresponding sensor elements and the corresponding part 3a of the evaluating electronics are provided, and to individually install an insole adapted to a foot above this lower or lowermost insole layer. The fact that, in such a situation, ultimately the sensor elements etc. however do not need to lie directly on the outer surface, but can also be covered from below in order to protect them, is also disclosed as advantageous.

    [0053] Regardless of the possibility of manually creating individually tailored insoles, in particularly advantageous example embodiments, a standardized insole is used, this having to differ only in terms of the left or right foot and a shoe size or shoe size group. In addition, in particular when very large article numbers are produced overall, it is possible to draw distinctions in order to provide more sensitive or less sensitive sensor elements for more lightweight or heavier users having the same or different shoe sizes; it is pointed out that, instead of sensor elements of differing sensitivity, cover layers or underlayers that distribute pressure to differing extents can also be used.

    [0054] The pressure areas I and II are selected such that the loading that occurs when the user is walking and standing on the heel or the ball of the foot is able to be detected in an optimum manner. The sensor 2c can for example be arranged where, in a large number of healthy users, the highest average loading occurs in the heel region when said users are standing or walking. The greatest loading when standing for a large number of users can be ascertained for example using conventional blueprint technology, in which a user stands on a sheet of copier paper the bottom of which is colored blue and underneath which a white sheet of paper is arranged. The greatest loading for typical users can then be evaluated through photogrammetry or the like and averaged. Evaluation using modern means is understandably also possible, if not absolutely necessary.

    [0055] That part 3a of the evaluating electronics that is arranged at or in or on the insole is then designed and active as follows:

    [0056] The signals received from the sensor elements 2a, 2b, 2c via lines 2a1, 2b1, 2c1 are channeled from interfaces 3a1, 3a2, 3a3 to signal conditioning stages 3a4, 3a5, 3a6, currently indicated here in the form of amplifiers, where they are amplified and filtered if necessary, for example in order to reduce noise components caused by high-frequency components, etc. Impedance matching can also be performed, this being advantageous in particular where the sensor elements 2a to 2c are formed as resistive elements whose electrical resistance changes with active pressure. Appropriate sensor elements are known, but it is pointed out that other pressure-sensitive elements can likewise be used, such as for example strain gages etc.

    [0057] The conditioned sensor signals are fed to an ADC 3a7 that selectively has enough inputs on which a conversion from analog to digital can be performed in parallel; there is preferably however cycling or switching between all of the individual inputs. It is pointed out that the conditioned sensor signals do not necessarily have to be fed individually to dedicated inputs of an analog-to-digital converter, but rather that it would also likewise be possible to connect a multiplexer or the like upstream of the ADC 3a7. It is also pointed out that conventional analog-to-digital converters are easily capable of sampling at several 10 kHz even when inexpensive analog-to-digital converters are involved, this generally being more than sufficient when cycling is intended to be performed between different sensors, given the relatively slow movement specifically for physically impaired users. This applies even where brief loading peaks occur, for instance caused by strong sudden stamping or the requirement to regain balance after stumbling. ADC accuracies of 8 bits, preferably 10 or 12 bits, are easily sufficient.

    [0058] The digital signals from the analog-to-digital converter 3a7 are fed to a microcontroller 3a8, whose output is in turn routed to an I/O interface 3a9. The microcontroller 3a8 is assigned a non-volatile read-only memory ROM 3a10 and a random access memory RAM 3a11. The corresponding parts are supplied with power from a power supply 3a12, as indicated by the dashed lines going from the power supply 3a12 to the individual units 3a1 to 3a11.

    [0059] The battery does not need to be directly on a circuit board or a flexible film close to the other components to store energy. Depending on how long the battery is intended to supply power to the circuit, it may be advantageous to arrange a slightly larger energy storage arrangement, for example a button cell, at a slight distance, in particular in an easily exchangeable manner, and/or there can be provision to provide an energy harvesting arrangement that obtains energy from the step movements, specifically in a manner sufficient to supply power to the arrangement.

    [0060] It is pointed out that the microcontroller 3a8 has conventional circuits such as for example a clock for recording a current time, such that pressure event-related data or characteristic values can be stored in a manner provided with timestamps.

    [0061] The ROM 3a10 contains program modules that make it possible, when executed on the microcontroller 3a8, to identify steps in the profiles of the signals obtained from the ADC and to recognize, in steps or per time period, pressure loading events, at least per pressure area, on the sensor elements 2a, 2b for the pressure area I or 2c for the pressure area II. The ROM 3a10 can furthermore contain information in order to prompt the microcontroller 3a8 to examine the digitized characteristic values per step or per time period, in particular when stationary per time period, for peak values and to identify these.

    [0062] The ADC 3a7 needs only for instance a sampling frequency of for example 100 Hz per sensor, which is easily sufficient, especially in the case of physically impaired people, to record 15-30 values per step without any problems. This makes it possible to also possibly consider multiple values in averaged form in the peak value determination, for example around an approximate peak, in order thereby to reduce noise effects, sampling-induced effects etc. 3-6 values can for example be combined, and the respective peak loading can then be detected. The microcontroller 3a8 is also able to be programmed, either before the peak value calculation and/or after the peak value calculation, to determine an average value of the two sensor elements 2a, 2b that belong to the pressure area I. This can be achieved either through joint evaluation of the sensor element signals, that is to say through the joint signal conditioning and signal conversion, unlike what is shown, or else a pressure peak is identified in each case separately for each sensor element 2a, 2b in order then to offset the pressure peaks with one another, for example through averaging. The latter has the advantage that critical or atypical loading is recognized even better. It is also pointed out that, instead of pressure peak averaging, the temporal average values of the pressure loading detected in each sensor element can also be offset, in particular averaged, across the sensor elements of a pressure area.

    [0063] The microcontroller 3a8 can furthermore be designed or programmed to correct the ADC values that are obtained from the analog-to-digital converter as output signals. Specifically, it will be understandable that it is desirable to be able to offer inexpensive sensors; this can however result in the reproducibility of data decreasing. Especially because overloading is intended to be reliably avoided, it is then advantageous to detect actually occurring pressure loading in a more precise manner.

    [0064] Different loading can thus occur on each of the sensor elements 2a, 2b in spite of the same stepping force on the ground, for instance depending on exact foot posture, ball surface area, etc. It is possible to compensate this by loading the loading-detecting orthosis with a defined force following insertion of the insole by the user. Such a force can be estimated well by stepping on a set of weighing scales or the like. It has proven here that, although repeated stepping with the same force leads to reproducibly identical sizes of the pressure loading events for one and the same user, differences are observed from user to user, specifically partially with regard to the overall size of the respective events and partially with regard to the distribution of the pressure loading on the various sensor elements. It is understandable that this is to do inter alia with the standing and walking habits and for example the shape of the foot, for example due to callus-induced hardening in the ball region, etc. It is accordingly sufficient to perform calibration with static forces or loading, even though overloading should be expected when walking due to the dynamic forces occurring in the process.

    [0065] It is thus advantageous to first of all record measured values and to calibrate the pressure event signals from the sensor elements on the basis thereof. This makes it possible to perform more precise weighting of the characteristic values, in particular for particularly lightweight people and/or for people with atypical foot shapes.

    [0066] The arrangement is therefore designed to be put into a calibration mode via an operating device such as a cell phone, see FIG. 4, and the I/O interface 3a9, in which calibration mode the pressure sensor signals are stored, and then to receive an actually achieved associated loading value via the interface 3a9. For this purpose, it is possible to determine individual values for individual pressure loading and to calibrate the overall curve on the basis of these individual values, as indicated in FIG. 5. In this case, FIG. 5a illustrates a standard calibration curve that illustrates the resistance profile as a function of a loading of the sensor; FIG. 5b shows that a measured value for a particular user in the case of a measured loading of 10 kg there exhibits considerably lower resistance values than expected according to the standard curve, and FIG. 5c illustrates a correspondingly corrected calibration curve that was determined from a corresponding calibration table.

    [0067] Such a calibration can be performed as follows: A loading that is uncritical for the user, and with which a healing leg can thus be loaded for as long as desired, is first of all determined. The user, using only the leg on which the orthosis is located, then steps on a sufficiently sensitive weighing scales, said user loading the corresponding leg to an increasingly great extent until the predefined loading is reached. (The loading indicated on the weighing scales will understandably consist firstly of the loading caused by the orthosis and secondly caused by the placing of the leg in the orthosis; a loading on the scales that is higher by the weight of the orthosis can accordingly possibly be selected, or a measurement of the weight of the orthosis is taken beforehand.) As soon as the desired loading is reached on the weighing scales, a calibration can be triggered. This can be performed by the user himself by operating a smartphone or the like having a suitable app, or by an assistant. It is pointed out that a weighing scales could possibly also trigger a corresponding signal.

    [0068] From the calibration at a fixed weight value, a sensor value can then be used to conclude as to the actual loading. A user-specific calibration table (or, as illustrated, calibration curve) can be determined using a known general calibration curve incorporating firstly the actual sensor signal values for a known loading, and at least one user-specific calibration value.

    [0069] It is pointed out that incorporating a single user-specific calibration value is generally sufficient because the loading distribution does not change significantly with increasing loads in the load range critical for healing.

    [0070] The calibration, respectively a calibration table, can be stored in the RAM 3a11.

    [0071] It is thus possible to correlate the electronic measured signals with at most very little outlay with loading actually occurring for a particular user. It is useful here that, even with few sensor elements, the loading pattern determined on the foot for one and the same user generally also remains the same for different loading and scales well with the overall loading.

    [0072] The arrangement is furthermore designed to obtain a maximum value for the loading via the interface 3a9 and to store this in the RAM 3a11. It is pointed out that it is preferred and possible, instead of a temporally fixed value that is defined as an absolute upper limit for loading, to define a temporal upper limit profile that specifies how the maximum permissible loadability should increase over days and/or weeks. It is furthermore pointed out that either the lower threshold values can be derived from the defined upper limit for loading, for instance through a percentage-based reduction by 10%, 20%, 30% or 25% and 50% or by for example ⅕, ¼, ⅓ and ½, or else that suitable additional threshold values can be jointly stored, this having the advantage of allowing better adaptation to particular patients. More precise adaptation of the further threshold values to the maximum loading is thereby in particular made possible depending on the respective intervention, that is to say specific fracture, specific operation etc.

    [0073] The microcontroller 3a8 is furthermore designed firstly to store the detected peak values of the pressure loading in the RAM 3a11, possibly temporally averaged over the pressure peak and spatially averaged over the pressure area, specifically preferably together with time information; individual values, in particular per episode, and particularly large individual peak events are also stored. The events are at the same time already assessed in the sole as to whether, individually or taken together, they indicate critical loading or overloading. This can be performed where a complete evaluation according to the invention is not intended to be performed, for instance in order to keep the computational burden close to the sole lower, for example such that only a conservative estimate is performed, for instance with equal weightings for any loading exceeding one of the thresholds or a sum value formation is performed without taking into account a subsidence behavior.

    [0074] The arrangement is designed to transmit the data to a smartphone, a smartwatch or a similar mobile device via radio, in particular via Bluetooth. Connections are set up, etc., for this purpose, as is conventional. This is performed either upon request from the mobile device or actively by the insole, in particular when the event store there is already largely full or when particularly critical or a large number of almost critical events are observed.

    [0075] It is also pointed out that the mobile device can on the one hand output an alert signal to the patient of the loading-detecting orthosis; it is pointed out that such a signal output does not need to be performed directly by the mobile device. It is thus possible for example for the loading-detecting orthosis itself to communicate not only with the smartphone of the user (wherein, in preferred variants, communication can in particular also be set up with devices that are used by doctors, physiotherapists, orthopedic shoemakers etc. for the initial or repeated setting of limit values and weightings), but that the smartphone itself can in turn be connected to other devices, for example an alert signal transmitter, for instance a smartwatch having a vibrating alarm that gives the user a tactile alert signal on his wrist. As an alternative or in addition, it is also possible for signals to be forwarded from the mobile device, such as the smartphone, to a control center. This does not necessarily have to take place in real time, in particular where only a statistical evaluation is intended to take place, for instance in order to obtain additional findings about general healing processes of patient cohorts or to check, over longer intervals such as daily or weekly, whether a patient is moving enough, has subjected himself to overloading and so on. In this case, a central configuration or reconfiguration can then also be performed remotely, such that the patient himself is relieved from such configuration tasks, but his aid is nevertheless adjusted with regard to a duration that has elapsed since an intervention or accident or observed diagnostic success. The data accrued in the case of large numbers of patients then also help to define loading that is typically still permissible, limit values and so on. Where at present acceptable limit values still have to be estimated by a treating doctor or physiotherapist to a more or less precautionary extent, a value that takes better consideration of experiences with other patients is able to be proposed or specified by using a database, for example a value that was uncritical for patients of a similar age or similar physical constitution and comparable injuries and did not lead to any problems, including not taking into consideration occasionally occurring exceedances of the limit values. It is pointed out that a remote configuration can be performed both by medically trained personnel such as doctors or physiotherapists, but also possibly by machine, as long as there are no approval-based obstacles to this. It will be easily understood that particular circumstances can be taken into consideration in the remote configuration as well, for instance adapting the limit loading in the case of very heavy patients.

    [0076] It is also pointed out that, based on the analysis of the loading data, it is possible not only to generate warning signals, but that there is possibly also the option of recognizing the extent to which a patient requires further training. It is thus possible for instance to easily recognize events in which the patient is going up or down stairs. It is known that problems can occur particularly often when climbing stairs; training for climbing stairs is therefore performed separately in many cases. When it is established that problems occur specifically when using stairs, this being possible using the loading-detecting orthosis, the patient can for instance be requested to take specific training for climbing stairs. This is possible in principle for example by transmitting loading data to a control center and analyzing them there—preferably automatically. The result of an automatic analysis can then be indicated to an experienced professional, for instance a physiotherapist, who then contacts the patient if necessary and schedules (post-)training. This can possibly also be performed fully automatically. One alternative to transmitting data to a control center and analyzing the data in the control center is that of performing analysis locally, for instance on the smartphone of the user, and, if the analysis indicates that particular problem areas are present in a patient, for instance insufficient stair climbing, the patient can then be given the incentive or possibility, if necessary, of contacting a physiotherapist for post-training, of viewing training videos or the like. Such a local evaluation is understandably particularly advantageous where patients are particularly concerned with their data being protected.

    [0077] It is furthermore pointed out that the loading-detecting orthosis according to the present invention has already collected data that indicate that problems were observed even in those patients for which, although loading classified as critical by the doctor had not been exceeded more often than for other patients, very high loading below the maximum permissible loading recommended by the doctor has still occurred on a regular basis. This demonstrates firstly that an orthosis of the present invention that detects frequent, high loading, even if this loading is not critical on its own, can contribute to significantly reducing post-treatments and at the same time be able to better specify limit loading.

    [0078] The evaluation unit in the mobile radio device is then designed, upon receiving data, to form a sum value into which the characteristic values from the unit 3a are incorporated by amount in weighted form such that at least 3 different weightings are used, and to generate a warning signal when the sum value is too large. The evaluating electronics 3b in the mobile radio device (FIG. 4) are designed to compare the obtained characteristic values with threshold values and possibly to classify them. This can in particular be performed step by step.

    [0079] It is possible to trigger transmission of data only whenever a first threshold, as indicated in a (preliminary) evaluation in the component 3a close to the sole, is exceeded and/or a (preliminary) evaluation on the part 3a close to the sole shows overall that critical loading is exceeded repeatedly.

    [0080] An overall evaluation can also be performed close to the sole, and transmission of suitable data to the unit 3b can take place only when a for instance acoustic or vibration signal is intended to be indicated to the user. This often saves overall on energy due to the lower data transmission expenditure. It is however pointed out that the overall electronics can be arranged directly on the orthosis for the sake of simplicity. In such a case, an acoustically, vibrationally and/or optically active alarm can be generated on the orthosis and/or, in the event of an alarm, preferably wireless transmission to an alarm transmitter can be triggered, such as to a smartphone or a smartwatch.

    [0081] By virtue of the invention, it is possible to guarantee a high level of safety with at the same time great comfort for the user in an energy-saving manner and with little effort.

    [0082] What has been described above is thus, inter alia, but not exclusively, a loading-detecting orthosis having a standard sensor that generates sensor signals and that has no more than four pressure areas and no more than four sensor elements per pressure area, sensor signal-evaluating electronics therefor, and individual adaptation to individual patients, wherein the sensor signal-evaluating electronics are designed to indicate loading critical for the individual, wherein the sensor signal-evaluating electronics are designed to sample the pressure loading of the sensor elements at least per pressure area and to weight them, to run through a step identification, to classify load peaks for each step through comparison with a multiplicity of threshold values and to form a sum value into which load peaks are incorporated in weighted form such that higher load peaks receive higher weightings, and to generate an alert or warning signal when the sum value exceeds a particular amount, that is to say becomes too large.