DE102018100201A1 - Shoe sole for a biofeedback system for influencing and / or practicing a standing and / or gait, biofeedback system and method for calibrating a biofeedback system - Google Patents

Abstract

The invention relates to a shoe sole for a biofeedback system for influencing and / or practicing a standing and / or gait of a patient, wherein the shoe sole a sole surface and at least one pressure sensor for measuring a pressure of the foot on the sole of the foot and / or on a Substrate has, and the shoe sole is associated with a background sensor for determining a property of a substrate or the shoe sole has the background sensor, so that an individual pressure threshold depending on the characteristics of the substrate can be determined and the stance and / or gait is adaptable to the ground. Furthermore, the invention relates to a biofeedback system and a method for calibrating a biofeedback system.

Description

The invention relates to a shoe sole for a biofeedback system for influencing and / or practicing a standing and / or gait of a patient, wherein the shoe sole a sole surface and at least one pressure sensor for measuring a pressure of the foot on the shoe sole and / or on a Substrate has. Furthermore, the invention relates to a biofeedback system and to a method for calibrating a biofeedback system.

In patients with diabetes severe and long-term complications occur in the Neven and blood vessels in the legs and feet, which have the result that emotional disorders (neuropathy) and circulatory disorders in the feet as diabetic foot syndrome (so-called diabetic foot) occur.

Patients with diabetic foot syndrome may not be adequately aware of foot overload due to mechanical stimuli, such as pressure or cut injuries, and temperature stimuli due to altered and / or decreased pain perception. In particular, the sole of the foot and the lateral areas of the foot are endangered. Due to the altered and delayed perception often smallest injuries lead to very difficult healing wounds and mechanical stimuli to deep ulcers and inflammation. Inflammation that is not recognized and treated in time can lead to an amputation of parts or of the entire foot and thus to a severe impairment of the quality of life of those affected.

It is important for patients to be able to walk both in the case of emotional disorders and in the case of (partial) amputation. For this purpose, the patient must learn to walk "new" and perform safely even in different soil conditions. It is especially important to avoid further injury to the foot or pressure.

To ensure that the mobility of a patient is not restricted and that complete mobility of the legs and feet is ensured, it is necessary for the patient to be able to adapt his stance and / or gait to the different requirements and to cope with them safely.

From the WO 2011/094464 A1 For example, a system for electrical stimulation by means of a cathode and an anode is known, which receive their voltage supply from piezoelectric cells due to a pressure exerted when walking on the shoe sole, wherein the piezoelectric cells are arranged under the shoe sole and the anode and cathode on the shoe sole. The disadvantage here is that only limited foot area and not the legs are stimulated and the arrangement of the anode and cathode can lead to a pressure load on a diabetic foot.

In the US 2007/0173903 A1 discloses a system for sensory supplementation and stimulation wherein a gait is determined by means of acceleration sensors in a cuff or shoe sole in order to trigger a corresponding stimulation.

In the WO 2016/112229 A1 describes a shoe sole with a self-recognizing polymeric foam which generates voltage signals which are converted into background reaction force data depending on the deformation of the foam.

In the DE 20 2014 105 408 U1 There is described a device for detecting circulatory disorders and malignant inflammations in diabetic foot, in which the sole has known pressure, temperature and motion sensors.

The object of the invention is to improve the state of the art.

The object is achieved by a shoe sole for a biofeedback system for influencing and / or practicing a standing and / or gait of a patient, wherein the shoe sole a sole surface and at least one pressure sensor for measuring a pressure of the foot on the shoe sole and / or has on a substrate, and the shoe sole is assigned a background sensor for determining a property of a substrate or the shoe sole has the background sensor, so that an individual pressure threshold depending on the characteristic of the pressure determinable and the stability and / or gait is adaptable to the ground.

Thus, by means of the shoe sole according to the invention the standing and / or gait of a human, especially a patient with diabetic foot syndrome, adaptable to the properties of the ground and / or the terrain. In particular, the adaptation is individually adjustable both taking into account the external conditions, such as the background, as well as due to the capabilities of the patient. Consequently, for example, the step length, the height of lifting a foot and / or the rolling of a foot individually customizable.

It is particularly advantageous that by means of the shoe sole with a background sensor a patient can practice walking and standing and / or deficits in standing and / or gait are specifically influenced.

An essential idea of the invention is based on the fact that both a pressure sensor is integrated in a shoe sole and an underbody sensor is assigned to the shoe sole or the shoe sole has this background sensor, so that an individual, background-dependent pressure threshold can be determined by interaction and thereby a standing and / or gait optimally adaptable to the ground.

The following concept is explained:

A "shoe sole" is in particular a part of the shoe bottom and thus the part of the shoe which is located below a foot. A shoe sole may in particular represent a layer or layer of the shoe bottom. A shoe sole is in particular an insole, midsole or outsole (outsole). A shoe sole is also a cover insole or a partial cover insole, which is glued and / or arranged on the insole. A shoe sole has in particular a layer or layer or several layers or layers. The "insole" is in particular the sole of the shoe which lies inside the shoe and comes into direct contact with the sole of the foot. The "outsole" or "outsole" is in particular the outer part of the shoe bottom, which is in contact with the ground. A shoe sole is in particular also an "insole", which is loosely inserted as an additional insole in the shoe. An insole may also be an "insole" (footbed or orthopedic insole).

The shoe sole has, in particular, a foot sole surface and at least one pressure sensor, wherein the shoe sole is either associated with a background sensor, which is located, for example, on the outside of the shoe or on the patient, or the shoe sole itself has the background sensor. A shoe sole can furthermore in particular comprise a material or various materials, such as cardboard, plastic, synthetic fabric, leather, rubber, rubber, a mixture of synthetic rubber with natural rubber, wood, cork and / or similar materials.

A "biofeedback system" is, in particular, a system which detects and / or controls changes in state variables of a biological process, which is not accessible to the immediate sensory perception of a person, with technical and / or electronic aids. The biofeedback system serves, in particular, to regulate and / or specifically influence a body function. In particular, the state and / or gait of a person is influenced by means of the biofeedback system. In particular, with the biofeedback system on a suitable body surface, in particular a body surface, which is not on the foot, with actuators (body stimulation) set a stimulus or various types of stimuli that allow biofeedback training an intuitively perceptible stimulus substitution. A biofeedback system can only work as an actuator without stimulation substitution.

"Standard" is understood in particular as the way a human being stays on his feet without changing his location.

By "gait" is meant in particular the type of locomotion of a person with one or two legs. In particular, walking and running fall under gait. The gait includes in particular a movement during a walking movement and / or running movement.

The "sole of the foot" is, in particular, the contact surface of the shoe sole which comes into contact or stands in contact with the sole of the foot. Thus, the sole of the foot is in particular in direct contact with the sole of the foot and / or the underside of a sock surrounding the foot.

A "pressure sensor" is in particular a pressure measuring device which detects the physical variable pressure and / or forms it into an electrical output variable as a measure of the pressure. A pressure sensor may in particular be a piezoresistive, piezoelectric, frequency-analog, capacitive, inductive and / or another pressure sensor. In particular, the pressure sensor converts a local pressure of the foot into a sensor size.

In particular, a "pressure threshold" is a value of the pressure which is used as the limit value for the processing of the pressure signal. In particular, falls below the pressure threshold value of the input value to an output value zero and when exceeding a constant output value. For example, when a pressure threshold value is exceeded, the pressure signal is forwarded to a biofeedback system, an indicator and / or actuator.

"Underground" is understood to mean, in particular, the ground on which a person walks or stands. The underground is in particular the uppermost layer of the earth. A substrate may in particular be even, uneven, firm, soft, unsafe, sandy, loamy and / or bumpy. A subsoil can be, for example, turf, concrete blocks or a bumpy dirt road. A subfloor may also be carpet, slippery tiles, parquet and similar flooring such as those used in buildings.

A "background sensor" is in particular a sensor which detects one or more properties of a subsoil. A subsurface sensor is in particular a technical component which detects certain physical and / or chemical properties and / or a material quality of a substrate qualitatively or quantitatively as a measured variable.

A pressure sensor may in particular be a mechanical, thermoelectric, resistive, piezoelectric, capacitive, inductive, optical and / or magnetic sensor. An underbody sensor is, for example, an impact device, which is arranged on the underside of the shoe sole and directly measures the strength (hardness) of the ground. A background sensor can also be, for example, a sound transducer or ultrasonic transducer. In particular, a background sensor has a voltage supply and / or is supplied with voltage from the outside. The background sensor is arranged in particular on the underside of the shoe sole and / or outsole or on the outside of the shoe and / or on the person wearing the shoe sole and / or the shoe in such a way that the background sensor can measure the ground. In order to exert no pressure stimulus, the background sensor can be arranged for example in the metatarsal region.

In a further embodiment of the invention, the background sensor comprises an optical sensor and / or a sound transmitter and / or receiver.

Thus, the property of the substrate with a simple measurement principle by means of the background sensor can be detected.

An "optical sensor" may be, for example, a CCD sensor or a photocell. A "sound transmitter" is in particular a device which emits an acoustic signal as a sound wave and / or sound waves continuously or discontinuously to the environment. A sound transmitter is, for example, a sound transducer which converts a given electrical signal into an acoustic signal as sound pressure and transmits it. A sound transmitter can also be an active sound transducer, which can both emit and receive an acoustic signal. In this case, an active sound transducer registers in particular a change between the emitted and the again received signal through a background.

A "sound receiver" is in particular a device which converts received sound pressure changes as an acoustic signal into an electrical signal. For example, a sound receiver may be a microphone. In this case, the sound receiver, for example, the running noise of the shoe sole on the ground and determined - for example by means of pattern recognition - from a property of the ground.

In order to measure at several points of the shoe sole and to detect a pressure distribution, the shoe sole has a plurality of pressure sensors distributed over the plantar surface.

Thus, the shoe sole can have a plurality of integrated pressure sensors which are distributed over the entire surface of the shoe sole, wherein these can be defined depending on the medical indication and placed on variable places of the shoe sole surface and thus the sole of the foot.

The "multiple pressure sensors" correspond in their construction and their function to the above-defined pressure sensor.

In a further embodiment, the shoe sole is or are associated with an indicator and / or an actuator, so that a background-dependent signal can be forwarded to the indicator and / or actuator from the shoe sole.

Thus, a patient by means of the indicator and / or actuator can be made directly to a non-optimal state and / or gait, for example, by the indicator indicates an optical or audible signal or the actuator, for example, a pulse.

Biofeedback signals such as tones (volume, pitch, and / or timbre) or visualization (pointers) provide direct feedback to improve regulation through operant control, allowing the patient to independently improve his / her stance and / or gait without stimulation ,

Consequently, the patient himself can try to regulate his or her movement and / or posture in order to improve standing and / or gait. Thus, the patient in particular by repeated attempts and feedback via the indicator and / or actuator itself to improve his stance and / or gait without stimulus substitution.

An "indicator" is in particular a display device without a quantitative statement. An indicator may be, for example, a sounder, an indicator and / or a light indicator. For example, an indicator is a small LED, which, for example, lights up red when an individual background-dependent pressure threshold is exceeded and lights up green when this pressure threshold is undershot.

An "actuator" (also called "actuator") is in particular a drive element which converts an electrical signal into a mechanical movement or into another physical variable, for example into a pressure or a temperature. For example, when an individual, background-dependent pressure threshold value is exceeded, an actuator can give a short pressure pulse to the skin surface of a patient. An actuator may, for example, be an electromechanical actuator or a piezoactuator. An actuator, for example, also represents an actuator assembly of a biofeedback system.

The indicator and / or the actuator may or may be connected, for example, by means of an electrical line to the pressure sensor, the pressure sensors and / or the background sensor and / or a data acquisition and processing unit.

In order to give the patient feedback only during his movement and to minimize the energy requirement of the shoe sole, the shoe sole has an acceleration sensor which activates the indicator and / or actuator.

An "acceleration sensor" is in particular a sensor which measures its acceleration. An acceleration sensor determines in particular an inertial force acting on its test mass and thus an increase or decrease in speed. An acceleration sensor may, for example, be a piezoelectric acceleration sensor, a microsystem and / or another acceleration sensor based on, for example, magnetic induction.

In a further aspect of the invention, the object is achieved by a biofeedback system for influencing and / or practicing a standing and / or gait of a patient, wherein the biofeedback system has an actuator assembly and a previously described shoe sole and the actuator assembly comprises body stimulation sensors which can each be arranged at suitable parts of the body, wherein the biofeedback system has an electronic circuit and is set up such that a pressure determined by the pressure sensor or the pressure sensors and the electronic circuit or a determined pressure distribution and a property of a background determined by the background sensor leads to a body stimulus pattern which can be impressed on the body sites by means of the electronic circuit and the body stimulation sensors.

Thus, a biofeedback system is provided, which in a patient with diabetic foot syndrome and corresponding sensory disorders or lack of the stimuli to perform a certain stance and / or gait replaced (stimulus substitution). Above all, the biofeedback system allows the patient to intuitively absorb stimuli during biofeedback training. Thus, conditions can be created, which allow the patient to obtain a largely safe Gait and feeling while minimizing the risk of falling.

In this case, the electronic circuit is capable of processing the sensor signals and transmitting them wirelessly to an actuator assembly after weighting in the form of a defined data protocol. It is particularly advantageous that the biofeedback system can be adapted both to different findings of the nature of the feet of patients (for example, after partial amputations) and to the conditions of the substrate. Via different positions of the pressure sensors and / or the background sensor, the different capabilities of the patients to intuitively detect and allocate a certain number of stimulus substitutions can also be taken into account in the (sensor) -arctor biofeedback system.

An "electronic circuit" is in particular a combination of electrical and / or electronic components to a functional arrangement.

In particular, a "body stimulus pattern" is a pattern of stimuli imparted to the body surface due to the placement and stimulus signals of the body stimulation sensors.

An "actuator assembly" is a closed unit comprising a plurality of individual parts, which in particular has one or more actuators or physical stimuli sensors. An "actuator" may, for example, be a tactile actuator of the eccentric rotating motor type (ERM, also known as a vibration motor) or linear resonant actuators (LRA vibration actuators). In this case, electrical actuators with respect to signal amplitude, pulse duration and pulse frequency can be parameterized. The tactile actuators (ERM and LRA) are in terms of duty cycle, signal duration, turn-off time and signal amplitude adjustable. The signal amplitude in EMRs also affects the rotation frequency and thus the frequency of the vibration signals.

Tactile and electrical actuators are primarily used for the stimulation substitution, so that tactile signals of the sensor soles are converted into either tactile or electrical stimuli.

A "body stimulation sensor" is, in particular, a sensor which imparts a stimulus to a specific body location. In particular, a stimulus can be an impulse having a specific physical property, such as a temperature, a pressure and / or a voltage.

In order to take into account the property of a subsurface in standing and / or gait or adjust the gait to a changing ground when walking, the biofeedback system is set up so that by means of the background sensor, a background-dependent pressure threshold is determined, which by means of the electronic circuit and the body stimulus sensor is used in imparting the body stimulus pattern.

In a further embodiment of the biofeedback system, the body stimulation sensors have tactile sensors and / or electrical sensors which impress different stimuli, in particular temperature, electronic fields, electrical voltage impulses, local pressure and / or vibrations, on the respective body sites.

Thus, the impressed body stimuli can be adapted to the individual perception options as well as the emotional disorders. It is particularly advantageous that, depending on the location of the impact of the stimulus on the body surface, the stimulus has a different quality and / or quantity. If, for example, the body stimulation sensors are arranged on the thigh in order to stimulate as far as possible the entire leg by means of impressed stimuli to move, it is more advantageous to use electrical voltage impulses, which are transmitted over the entire length of the leg to the foot. In contrast, a temperature stimulus has only a limited range.

For this purpose, the Aktorbaugruppe is particularly modular and allows by the exchange of modules, the adaptation of the module to the use of different actuators and / or body stimulation sensors. Varying the parameters of the tactile actuators and / or body stimulation sensors allows the patient to convey different haptic impressions.

In the case of the use of tactile actuators, haptic impressions of different types (for example, walking over soft or hard ground) are already created in a non-volatile memory in the actuator assembly, so that they can be requested and used purposefully if required. For the use of these resources, a sound transducer is integrated at least in a sensor sole, whose signals are evaluated and assigned to a comparable, haptic impression. In this way, it is possible to set a haptic parameter in the data log that can be identified by the actuator assembly and used for specific actuator controls.

Thus, advantageously, the detection of pressure entries and running noise in an insole pair and its interaction with an actuator assembly for the realization of a sensor substitution to overcome gait and stand weaknesses and reduce the risk of falling in patients with diabetic foot syndrome can be used.

In order to adapt the stimulus to be impressed to the perception of the patient and / or the respective location of the body, the body stimulation sensors have a different shape, in particular a circle, ellipse, triangle, rectangle, square or polygon, and / or different sizes.

In a further embodiment, the biofeedback system is assigned a mobile computing unit so that data and / or signals can be transmitted from the mobile computing unit to the biofeedback system and / or from the biofeedback system to the mobile computing unit.

A "mobile computing unit" is in particular a mobile telephone, a tablet and / or another type of portable computer.

• - Aufnehmen von individuellen Daten eines Patienten mittels des Drucksensors oder der Drucksensoren und/oder des Untergrundsensors der Schuhsohle,
• - Verwenden der individuellen Daten als Kalibrierdaten,
• - Bestimmen einer Druck-Trigger-Schwelle des Drucksensors oder Druck-Trigger-Schwellen der Drucksensoren aus den Kalibrierdaten,

um die Druck-Trigger-Schwelle des Drucksensors oder die Druck-Trigger-Schwellen der Drucksensoren zum Aufprägen des Körperreizmusters mittels der elektronischen Schaltung und der Körperreizsensoren zu verwenden.In an additional aspect of the invention, the object is achieved by a method for calibrating a biofeedback system, wherein the biofeedback system is a biofeedback system described above, with the following steps:

• Taking individual data of a patient by means of the pressure sensor or the pressure sensors and / or the underbody sensor of the shoe sole,
• - using the individual data as calibration data,
• Determining a pressure trigger threshold of the pressure sensor or pressure trigger thresholds of the pressure sensors from the calibration data,

to use the pressure trigger threshold of the pressure sensor or the pressure trigger thresholds of the pressure sensors for impressing the body stimulus pattern by means of the electronic circuit and the body stimulation sensors.

Thus, the biofeedback system can be individually calibrated to the individual patient. In particular, before and / or during the first use of the biofeedback system, the characteristics of the patient, in particular his weight and / or a different standing pressure between his right and his left leg, can be taken into account in a calibration. Consequently, the biofeedback system is optimally adapted to the patient and can be used by the patient to achieve improved stance and / or gait.

In particular, a "pressure trigger threshold" is a pressure value which, when exceeded, generates a pulse (trigger pulse) or a switching process (switching edge) and thus causes a stimulus via the electronic circuit by means of the body stimulation sensors.

A "calibration" is in particular a measuring process for reliable reproducible detection and documentation of a deviation of a measuring device and / or sensor. Calibration also includes adjustment.

Thus, a calibration procedure for the respective patient can be correlated with specific trigger thresholds and a data protocol generated, which in particular can be transmitted wirelessly to the actuator assembly, which is evaluated in particular by the actuator assembly and used to communicate with another, suitable body surface of the patient Actors (physical stimuli) of various kinds stimuli to set, which allow biofeedback training an intuitively perceptible stimulus substitution. Thus, conditions can be created, which allow the patient to obtain a largely safer gait and feeling while minimizing the risk of falling.

To support the sensor-actuator biofeedback system, the soles, which are equipped with pressure sensors and in particular with an electronic module, are inserted into the patient's shoes. The electronic module is capable of processing the sensor signals and transmitting them wirelessly to an actuator assembly after weighting in the form of a defined data protocol.

The weighting requires calibration of the sensor sole for the patient in question. The calibration defines trigger thresholds adapted to the weight of the patient. The calibration can be carried out by means of separate measurement technology and subsequent transmission (for example by means of a smartphone) and storage of the trigger thresholds in a nonvolatile memory as well as in the autocalibration method in which the actuator assembly interacts with the sensor base.

The autocalibration method can be triggered by switching operations on the actuator assembly or by means of a software application (app) from a mobile data terminal (for example a smartphone). If the autocalibration has been triggered, the person to be measured should position himself upright, remain in this state for a few moments, and conclude the calibration procedure by renewed switching action on the actuator device or triggering of an event on the mobile data terminal. In the sensor soles, the pressure input measured in the upright position of the person to be measured forms the basis for the calculation of the trigger thresholds, which are stored in a non-volatile memory after the calculation.

Depending on the measured pressure entry, a value for the respective actuator signal is set in the data log for the respective pressure sensor positions. If the print entry is below the trigger threshold defined for the sensor position, a value equal to 'Ø (zero) is set at the corresponding position in the data log. If the print entry exceeds the trigger threshold defined for the sensor position, a value other than, Ø '(zero) is set at the corresponding position in the data log (for example,' 1 'or a number>, Ø', which expresses the amount of print entry).

Depending on the findings of the patient, sensor positions can also be bundled and represented in the data log with only one common piece of information or even eliminated. In this way, the (sensor-actuator) biofeedback system can, on the one hand, intuitively detect and assign to different abilities of the patients, a certain number of stimulus substitutions and, on the other hand, can be adapted to different findings of the nature of the feet (for example after partial amputations).

The number of effective sensor positions in the data log determines the number of actuators used for stimulus substitution. The actuators are controlled in particular by the actuator assembly. In particular, the data protocol received by the actuator assembly is decisive for the type of activation.

An 'Ø' (zero) contained in the data log excludes the activation of the actuator assigned to this position in the data log. A value deviating from 'Ø' (zero) triggers the assignable actuator, causing it to exert an appeal. Of the The value other than 'Ø' (zero) may contain information on the amplitude, duration, frequency, turn-on and turn-off time, and the nature of the haptic of the stimulus in coded form. In the simplest case, the data in the data log assumes the values 'Ø' or '1'. This is equivalent to a control signal to be switched off or turned on for the respective actuator. The duration of the control signal is determined in this particular case by the duration of the value availability in the data log.

In the case of the use of tactile actuators, haptic impressions of different types (for example walking over soft or hard ground) are already applied in a non-volatile memory in the actuator assembly so that they can be requested and used in a targeted manner when determining the corresponding background by means of the background sensor. For the use of these resources, a sound transducer is integrated at least in one of the sensor soles, the signals of which are evaluated and assigned to a comparable haptic impression. In this way, it is possible to set a haptic parameter in the data log that can be identified by the actuator assembly and used for specific actuator controls.

The arrangement consisting of a combination of sole pair and actuator assembly can have soles with incorporated pressure sensors, wherein the respective right and left soles can be used individually or combined to a right and left sole composite and the pressure sensors in each sole with a data acquisition and processing unit The data collection and processing unit of the soles can exchange the data with an actuator assembly as well as with each other.

The sensor and actuator assemblies can communicate with signal systems visible to patients and / or therapists and / or telemetric recording devices (mobile or stationary data terminals). The actuator assembly comprises, in particular, a data acquisition and processing unit with driver module and power amplifier or generator unit contained therein. The latter unit can be used to control actuators that compensate for the lack of sensory perception under the feet of patients with diabetic foot syndrome through a substituted electrical or tactile imaging at another body site of the patient.

A data acquisition and processing unit integrated in the region of the arch of the foot, in particular consisting of a processor unit, a measuring circuit for detecting pressure inputs and signals from the background sensor, a non-volatile ferrite memory (FRAM), an acceleration sensor, an accumulator, a charging coil can also be realized ,

A non-volatile ferrite memory (FRAM) may include parameters for calibrating the trigger thresholds as well as control parameters and prefabricated haptic patterns for driving actuators of various types.

An acceleration sensor can put the sole-located in the initial state in the power-down state data acquisition and processing unit upon detection of a caused by movement of the sole carrier (patient) acceleration in any direction in the normal operating condition.

An accumulator in turn can provide the required energy for the operation of the data acquisition and processing unit of the sensor soles and be recharged when falling below a defined voltage and inductive coupling with an AC transceiver.

The data acquisition and processing units of the sensor soles can establish and maintain wireless communication with each other, with the actuator assembly and with signal systems visible to patients and / or therapists and / or telemetric markers (mobile and stationary data terminals).

The actuator assembly can realize a data exchange from and to the wirelessly coupled sensor soles and / or with signal systems visible to patients and / or therapists and / or telemetric markers (mobile and stationary data terminals) and use the data contents of transmissions for the specific control of connected actuators.

The data acquisition and processing unit of the actuator assembly can couple via a defined interface various driver modules (Driver) and power amplifier and / or generator units (Amplifier / Generator Unit) as required for the connection of specific actuators (preferably electrical and tactile actuators).

The actuator assembly may be placed in various modes of operation by mechanical switches, capacitive or resistive controls (eg, resistive and capacitive touch screens, capacitive sensor pads), or by controls of coupled signal systems visible to patients and / or therapists and / or telemetry markers (mobile and stationary data terminals) (eg activation, execution and completion of an auto-calibration procedure, regular actuator operation, switching off all channels of the actuator device, parameterization of the actuators).

If required, the actuator assembly can also implement the connection of a display via a predefined interface for displaying states, supporting operation and parameterization.

An accumulator can supply the energy required for the operation of the data acquisition and processing unit of the actuator assembly and can be recharged if it falls below a defined voltage and inductive coupling with an AC transceiver, not shown.

• 1 eine stark schematische Darstellung eines Biofeedback-Systems mit einer Schuhsohle und einer Aktorbaugruppe.

Furthermore, the invention will be explained in more detail with reference to an embodiment. It shows

• 1 a highly schematic representation of a biofeedback system with a shoe sole and an actuator assembly.

A biofeedback system 101 has a shoe sole 103 and an actuator assembly 121 on.

The shoe sole 103 has a plantar surface 104 which in use is in contact with a foot sole of a foot of a diabetic foot syndrome patient. In the shoe sole 103 are pressure sensors 105 arranged distributed. These pressure sensors 105 are designed as capacitive pressure sensors and convert local pressure of the foot into a sensor size.

Furthermore, the shoe sole 103 a sound pickup 107 on, which in this case is arranged on the arch of the foot. Both the pressure sensors 105 as well as the sound pickup 107 are by means of a bus system 111 with a calculator 109 , which is also in the shoe sole 103 is integrated (for illustrative reasons shown outside) connected. About the bus system 111 Both the individual sensors 105 and the sound pickup 107 is supplied with a necessary electrical energy as well as respective measurement data to the computer 109 transmitted. For communication with the actuator assembly 121 is the calculator 109 a transmitting / receiving unit 113 the shoe sole 103 assigned.

The actuator assembly 121 has both vibration sensors 123 and voltage pulse sensors 125 on. The vibration sensors 123 and voltage pulse sensors 125 are with a computing unit 127 energy-supplying and signal-exchanging connected. In addition, the computing unit 127 has a transmitting / receiving unit 129 the actuator assembly 121 on. The transmitting and receiving unit 129 the actuator assembly 121 communicates via Bluetooth with the transmitting and receiving unit 113 the shoe sole 103 , Thus, in particular determined pressure data and sound signals to the arithmetic unit 127 the actuator assembly 121 be transmitted.

Present case should be given: The patient with the diabetic foot syndrome, in which a front foot is amputated, receives a shoe in which the shoe sole 103 with the computer 109 is introduced. The foot slips into the shoe (not shown). In addition, in the hip region of the patient, the actuator assembly 121 with the arithmetic unit 127 arranged. In different places of the thigh are the vibration sensors 123 and the voltage pulse sensors 125 applied directly to the leg by gluing.

By an acceleration sensor (not shown), the biofeedback system 101 activated during movements of the patient's foot.

Then draw the pressure sensors 105 with appropriate running behavior, the respective pressure distribution on the shoe sole 103 on. When used for the first time, this is used to calibrate the system. In addition, determines the Schallaufnehmer 107 due to a running noise a flat asphalt.

A calibration file is determined, with corresponding threshold values for the individual pressure sensors 105 being determined on the basis of the specific background, which is communicated via the communication with the actuator assembly 121 to corresponding signals of the vibration sensors 123 and the voltage pulse sensors 125 leads.

Subsequently, the further walking tests are carried out in different soil conditions. So a running after the asphalt on grass, sand and gravel is carried out as a test and practiced. By means of the sound pickup 107, the respective background is recognized by means of a pattern recognition implemented in the computer 109 and the respectively applicable pressure threshold values in the computer 109 certainly.

If unfavorable walking occurs, the patient receives via the vibration sensors 123 and the voltage pulse sensors 125 in each case a message as to which of the pressure sensors determines a pressure which is above the threshold value. So the new walking can be learned.

LIST OF REFERENCE NUMBERS

101

Biofeedback System

103

sole

104

plantar surface

105

pressure sensor

107

Sound sensor

109

computer

111

bus system

113

Transceiver unit of the shoe sole

121

actuator assembly

123

vibration sensor

125

Voltage pulse sensors

127

computer unit

129

Transmitter / receiver unit of the actuator assembly

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• WO 2011/094464 A1 [0006]
• US 2007/0173903 A1 [0007]
• WO 2016/112229 A1 [0008]
• DE 202014105408 U1 [0009]

Claims (11)

Shoe sole (103) for a biofeedback system (101) for influencing and / or practicing a standing and / or gait of a patient, the shoe sole having a sole surface (104) and at least one pressure sensor (105) for measuring a pressure of the foot on the sole of the shoe and / or on a substrate, characterized in that the shoe sole is associated with a background sensor (107) for determining a property of a substrate or the shoe sole has the background sensor, so that an individual pressure threshold can be determined depending on the property of the substrate and the Stand and / or gait is adaptable to the ground. Shoe sole after Claim 1 , characterized in that the background sensor comprises an optical sensor and / or a sound transmitter and / or receiver (107). Shoe sole according to one of the preceding claims, characterized in that the shoe sole has a plurality of pressure sensors (105) distributed over the sole of the foot. Shoe sole according to one of the preceding claims, characterized in that the shoe sole is or are associated with an indicator and / or an actuator, so that from the shoe sole a background-dependent signal to the indicator and / or actuator can be forwarded. Shoe sole after Claim 4 , characterized in that the shoe sole has an acceleration sensor which activates the indicator and / or the actuator. Biofeedback system (101) for influencing and / or practicing a standing and / or gait of a patient, wherein the biofeedback system, an actuator assembly (121) and a shoe sole (103) according to one of Claims 1 to 5 The actuator assembly has body stimulation sensors (123, 125) which can each be arranged at suitable body locations, wherein the biofeedback system has an electronic circuit (109, 127) and is set up such that one can be detected by means of the pressure sensor or the pressure sensors and the electronic sensor Circuit determined pressure or a determined pressure distribution and determined by means of the background sensor property of a substrate leads to a body stimulus pattern which is imprinted by means of the electronic circuit and the body stimulation of the body sites. Biofeedback system after Claim 6 , characterized in that the biofeedback system is arranged such that by means of the background sensor, a background-dependent pressure threshold value is determined, which is used by means of the electronic circuit and the body stimulation sensors in impressing the body stimulus pattern. Biofeedback system according to one of the preceding claims, characterized in that the body stimulation sensors have tactile sensors and / or electrical sensors which impress different stimuli, in particular temperature, electronic fields, electrical voltage pulses, local pressure and / or vibrations, the respective body sites. Biofeedback system according to one of the preceding claims, characterized in that the body stimulation sensors have a different shape, in particular circle, ellipse, triangle, rectangle, square and / or polygon, and / or different sizes. Biofeedback system according to one of the preceding claims, characterized in that the biofeedback system is associated with a mobile computing unit, so that data and / or signals from the mobile computing unit to the biofeedback system and / or from the biofeedback system to the mobile computing unit are transferable. A method of calibrating a biofeedback system, wherein the biofeedback system is a biofeedback system according to any one of Claims 6 to 10 comprising the following steps: - taking individual data of a patient by means of the pressure sensor or the pressure sensors and / or the bottom sensor of the shoe sole, - using the individual data as calibration data, - determining a pressure trigger threshold of the pressure sensor or pressure trigger Threshing the pressure sensors from the calibration data to use the pressure trigger threshold of the pressure sensor or the pressure trigger thresholds of the pressure sensors for impressing the body stimulus pattern by means of the electronic circuit and the body stimulation sensors.

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