Prosthetic device for a lower extremity, adjustment device for a prosthetic device and method for manual adjustment

Description

[0001] The invention relates to a prosthetic device for a lower extremity comprising a prosthetic foot and a lower leg section attached to the prosthetic foot, as well as a device for manually adjusting the orientation of the lower leg section relative to the prosthetic foot. The invention also relates to an adjustment device for manually adjusting the orientation of a lower leg section relative to a prosthetic foot, a prosthetic device, or a lower extremity, and a method for manually adjusting the orientation of a lower leg section, a prosthetic device, or a lower extremity relative to a prosthetic foot attached to the lower leg section, wherein an adjustment device with an inertial angle sensor is arranged on the prosthetic device, which detects the orientation of the lower leg section in space and is coupled to an output device.

[0002] Prostheses replace missing or no longer present limbs, with the general aim that the prosthesis should replace not only the form but also at least part of the function of the limb. Lower extremity prostheses have a foot component, the prosthetic foot, which is fixed to the patient. If the lower leg or part of the lower leg is still present, the prosthetic foot can be fixed to the respective stump using a lower leg socket. The lower leg socket can be fixed to the stump in various ways, for example, with a prosthetic liner and suction socket technology. If the natural knee joint is no longer present, the prosthesis is usually fixed to a thigh stump using a thigh socket.A prosthetic knee joint is attached to the femoral shaft, which includes a lower leg tube or lower leg section to connect the prosthetic foot to the prosthetic knee joint. Damping devices, adjustment mechanisms, sensors, and control devices, for example, for controlling the damping mechanism to influence the prosthetic knee joint, can be arranged on or in the lower leg section.

[0003] The prosthetic foot can be mounted on the lower leg section with joints and a motor to assist the patient in the intended movement. Coordinating movements in the knee and ankle joints is very complex with this design; furthermore, the drive mechanism requires considerable space and is comparatively heavy. In the simplest embodiment of a prosthetic foot, it is designed as a jointless prosthetic foot and, once aligned, is permanently fixed to the lower leg section. Adjusting the alignment of the prosthetic foot to different heel heights when the patient changes shoes is difficult in this case. Prosthetic feet that are pivotable around an ankle joint and incorporate a passive damping device to influence dorsiflexion or plantarflexion are also known.Furthermore, prosthetic feet exist with a foot section and a proximal connecting element that is pivotably connected to the ball. The foot section can be adjusted relative to the connecting element via an adjustment mechanism. The adjustment mechanism can be associated with at least one position sensor, which is coupled to a signal generation element that outputs a signal indicating when the foot section has reached its target position, depending on the signal from the position sensor. The position sensor determines the relative position of the foot section to the connecting element or the lower leg section attached to it. Alternatively, the position sensor determines the spatial orientation of the foot section during an adjustment process. Such a prosthetic foot is known from DE 10 2014 010 938 A1. This makes it possible to recall heel height settings.

[0004] WO 2018 / 085014 A1 concerns a method and a control system for prosthetic feet in which multiple accelerometers are used to acquire sensor data. This sensor data is filtered and evaluated to generate a reference signal for controlling non-gait-related movements of a prosthesis. Such movements include, for example, sliding the foot across the ground, crossing the legs while sitting, standing, or shifting weight while standing.

[0005] WO 2015 / 024612 A1 concerns a method for controlling an artificial knee joint in which a lower leg component is attached and to which a resistance device is assigned, by which the flexion resistance is changed depending on sensor data. A linear acceleration of the lower leg component is determined and compared with at least one threshold value. When a threshold value for the linear acceleration of the lower leg component is reached, the flexion resistance is changed. An inertial angle sensor can be attached to the lower leg component to measure an absolute angle of the lower leg component.

[0006] A disadvantage of the device proposed in the prior art is that the correct position must be set individually for each shoe, as only the relative angle between the prosthetic foot and lower leg is determined. Therefore, for a new heel height, the correct setting must first be determined and saved as a reference. Furthermore, the user must identify the signal corresponding to the respective heel height from a multitude of reference signals, which can lead to incorrect settings.

[0007] The object of the present invention is therefore to provide a prosthetic device, an adjustment device and a method for adjusting the orientation of a lower leg part of a prosthetic device, which is easy to use and gives the user reliable feedback on the correct prosthetic setup.

[0008] According to the invention, this problem is solved by a prosthetic device with the features of the main claim and an adjustment device, as well as a method with the features of the dependent claims. Advantageous embodiments and further developments of the invention are disclosed in the dependent claims, the description, and the figures.

[0009] The prosthetic device for a lower extremity, comprising a prosthetic foot and a lower leg section attached to the prosthetic foot, as well as a device for manually adjusting the orientation of the lower leg section relative to the prosthetic foot, includes an inertial angle sensor that detects the orientation of the lower leg section in space and is coupled to an output device that communicates the orientation of the lower leg section in space, or the achievement of a predefined orientation, to the user via an output signal. The output device preferably communicates the predefined orientation of the lower leg section in space to the user in a way that is recognizable to the user, for example, visually, audibly, or tactilely, thus providing feedback on the orientation of the lower leg section in space.The output can be qualitative and / or quantitative, or it can indicate via a signal that a previously stored orientation of the lower leg component in space has been achieved. Instead of measuring the orientation of the prosthetic foot in space and comparing it to the desired orientation, the spatial position of the lower leg component is detected, not its relative position to the prosthetic foot. With such a prosthetic device, after mounting an adjustable prosthetic foot to the lower leg component, an orthotist can optimally adjust the prosthetic device, thus ensuring an optimal prosthetic setup. The prosthetic setup refers to the positioning and orientation of the individual prosthetic components relative to each other.The prosthetic assembly is individually adjusted for each patient and significantly contributes to the functionality and acceptance of the prosthesis by the patient. Once the prosthetic assembly is correctly adjusted, the patient can easily find the optimal prosthetic assembly again using the prosthetic device according to the invention, even when using a different shoe model with a different heel height and sole stiffness. By adjusting the prosthetic foot relative to the lower part until the stored standard angle or reference angle of the lower part in space is reached, the optimal position set by the prosthetist is easily found. The prosthetic foot can then be fixed to the lower leg part in this position after a shoe change or similar event.The combination of determining the lower leg angle using an inertial sensor or sensors and an output device allows the heel height to be adjusted for any prosthetic foot equipped with a mechanism for manually adjusting the orientation of the lower leg section. Adjusting the orientation of the lower leg section is a completely manual process, from unlocking the joint and adjusting the angle to locking it again. Therefore, no complex mechatronic ankle joint is required. Instead, the patient is offered a simple and reliable way to find the correct setting for different heel heights for any adjustable ankle joint. The orientation in space refers specifically to the orientation of the lower leg section relative to the direction of gravity.If the lower leg is located within the sagittal plane, for example, the orientation of the lower leg component is defined by its forward or backward tilt in the opposite direction to the plumb line. When the user of the prosthetic device unlocks the prosthetic foot, particularly manually, the prosthetic foot can be moved relative to the lower leg component. This advantageously occurs when the prosthetic foot is in place and the lower leg component is pivoted within the sagittal plane, for example, around a pivot axis in the region of the ankle joint. A signal perceptible to the user is emitted when the lower leg component reaches the correct position.

[0010] A further development of the invention provides that the inertial angle sensor and the output device are integrated as a single module within the prosthetic device or detachably attached to it. This makes it possible to retrofit the adjustment device to a prosthetic device or to equip prosthetic devices not originally designed for it with the module. In principle, the inertial angle sensor is intended to be located at any point on the lower leg component, for example, far distally, in order to detect the spatial orientation as accurately as possible. Preferably, the inertial sensor is located proximal to the prosthetic foot and proximal to the ankle joint, thus saving valuable installation space within the prosthetic foot.The output device can be located in an easily accessible or readily perceptible location, for example, on a lower leg socket, a thigh socket, or at a separate location independent of the prosthetic device. If designed as a separate element, the output device can be a pendant on a keyring, carried in a pocket, worn as a wristband, or implemented as an app on a mobile phone, allowing the user to receive feedback as conveniently as possible. In this configuration, the inertial angle sensor is preferably connected to the output device wirelessly, via radio, or a similar data transmission method. If designed as a module, particularly a retrofittable module, the inertial angle sensor and the output device are permanently connected, especially by cable. With a separate arrangement, the output device can be connected to the inertial angle sensor only when needed.The inertial angle sensor is coupled to a transmitter, which can also be part of a control unit for the rest of the prosthetic device. This transmitter provides the output unit with the corresponding signal regarding the position of the lower leg component in space. Both the inertial angle sensor and the output unit are preferably coupled to a control unit in which the sensor data is evaluated. The control unit includes, for example, a computer and a storage device for evaluating the sensor data, comparing it to a reference angle in space, and outputting a signal.

[0011] The inertial angle sensor can preferably be arranged on the lower leg component. Alternatively, the inertial angle sensor can be attached to a proximal element of the prosthetic device, for example, to the upper part of a prosthetic knee joint or to a femoral stem. The spatial position of the lower leg component can be calculated from the information about the spatial orientation of the proximal element in conjunction with an angle sensor that measures the position of the lower leg component relative to the femoral stem. Alternatively or additionally, the lower leg angle can be determined at a predefined relative angle between the femur and lower leg, thus eliminating the need for an angle sensor. For this purpose, it could be stipulated that the user always performs, or is required to perform, the adjustment with the knee fully extended.

[0012] A further development of the invention provides that a load sensor is arranged on the prosthetic device and coupled to the output device in such a way that the output signal is sent when a load is detected. The orientation of the lower leg component can change under different loads, particularly under different axial loads. When changing shoes, different lower leg orientations and thus different prosthetic configurations can occur due to varying sole stiffness and geometry. The load sensor ensures that the adjustment is always made under the same load, e.g., axial load, thereby guaranteeing a consistent prosthetic configuration.The load sensor can be designed as an axial force sensor, pressure sensor or torque sensor and can be located, for example, in the lower leg part, in a connecting device from the prosthetic foot to the lower leg part, at a joint or on the prosthetic foot.

[0013] The output device is preferably designed to output a visual, acoustic, and / or tactile signal and can indicate either the current spatial position of the lower leg component, particularly in the sagittal plane, the deviation in a specific direction from the entered and stored orientation, and / or the achievement of the predefined orientation. The output device can also be connected to or integrated with the device for manually adjusting the orientation of the lower leg component. In this case, the user unlocks the adjustment mechanism and manually moves the prosthetic foot until the reference position is reached. Upon reaching the reference position, a signal is emitted, providing the user with feedback that the correct setting has been found.

[0014] Preferably, the prosthetic foot is mounted in a way that allows it to pivot in the sagittal plane to compensate for changes in heel height. If the position in the frontal plane is also monitored, a warning signal can be issued, for example, if the deviation from a preset value is too great.

[0015] A further development of the invention provides that a shutdown device switches off the inertial angle sensor and / or the output unit, or the connection between the inertial angle sensor and the output unit, after the predefined orientation has been reached, thus saving energy. The output unit preferably operates only when adjustment and adaptation to a new shoe is required. For this purpose, the prosthetic device can be put into an adjustment mode, for example, via an input field in the output unit or via another switch or command. Once the adjustment and adaptation are complete, this can be detected automatically or confirmed manually. The adjustment mode then ends, and the output unit is switched off.The inertial angle sensor can be used for other purposes, such as providing sensor data to a control unit of another prosthetic component, for example, to control a prosthetic knee joint. Preferably, the inertial angle sensor is designed as part of a control unit of the prosthetic device, so that the spatial orientation data of the inertial angle sensor can be used not only to detect and adjust changes in heel height or shoe fit, but also during walking as a basis for, for example, changing the damping resistance in the ankle joint and / or the knee joint.

[0016] The adjustment device for manually adjusting the orientation of a lower leg component relative to a prosthetic foot, prosthetic device, or lower extremity comprises an inertial angle sensor that detects the orientation of the lower leg component in space and is coupled to an output device that indicates the orientation of the lower leg component in space, or the achievement of a predefined orientation, to the user via an output signal. In particular, the output is provided as an optical, acoustic, and / or tactile signal. In one embodiment of the invention, the output device is combined with the inertial angle sensor and a computing unit for evaluating the inertial angle sensor data and transmitting it to the output device into a single module.

[0017] The adjustment device may be equipped with a fastening device for securing it to a prosthetic component. For example, positive locking elements such as clips, hook-and-loop fasteners, screws, snap elements and / or hooks, or frictional locking elements such as magnets, may be arranged or formed on the respective component to ensure a permanent or releasable and replaceable attachment. Preferably, the attachment to the lower leg component or another prosthetic component is in a defined orientation, for example, along a contact edge or other guide, such as a rail or in a groove.

[0018] The method for manually adjusting the orientation of a lower leg component of a prosthetic device on a lower extremity relative to a prosthetic foot attached to the lower leg component, wherein an adjustment device with an inertial angle sensor is arranged on the prosthetic device. This sensor detects the orientation of the lower leg component in space and is coupled to an output device. The method provides that a reference orientation of the lower leg component in space is set for a user, and that the achievement of the preset reference orientation is indicated to the user by an output signal. The reference orientation of the lower leg component is preferably performed by an orthotist or another expert trained for this purpose.The input for the reference orientation is preferably performed with the prosthesis in place, using a reference setup for the prosthesis under typical load. Typical load includes, for example, standing with even weight distribution on the prosthetic and non-prosthetic sides. With this method, the orientation of the lower leg component in space can be used as the relevant parameter, eliminating the need to store different reference positions for each prosthetic foot. The user receives only a single signal when the reference orientation is reached, possibly with instructions indicating the required adjustment in which direction to achieve it. The adjustment is performed manually, specifically by pivoting the prosthesis around an ankle joint axis perpendicular to the longitudinal extension of the lower leg component in the frontal plane.This ensures that the lower leg section is only pivoted in the sagittal plane. Alternatively, pivoting can occur at the attachment point of the foot section to the lower leg section, for example at the so-called pyramid adapter, where pivoting in the frontal plane is also generally possible.

[0019] The orientation of the lower leg section is preferably adjusted with the prosthesis device in place, especially when weight is applied, in order to ensure a consistent prosthesis setup for the user even with different shoes.

[0020] The adjustment can be initiated and executed automatically with each prosthetic foot change, each change in heel height, or upon a separate activation signal. For example, if a spatial orientation deviating from the reference orientation is detected after the prosthetic device has been fitted, a notification can be issued to the user to reorient or check the prosthesis, and an adjustment or check mode can be activated. After the adjustment has been completed, the adjustment device preferably switches off automatically; in particular, the output device is switched off to minimize energy consumption. For example, if a shoe is changed, the output device provides an output signal or feedback indicating that the current lower leg orientation deviates from the reference orientation.The relative angle between the lower leg and the prosthetic foot is then manually adjusted until the output device provides a signal or feedback indicating that the lower leg orientation matches or closely approximates the reference orientation. Once the correct position is reached, the prosthetic foot is fixed in this position, typically manually, so that the proximal connection element of the prosthetic foot, such as a pyramid adapter, no longer moves relative to the lower leg component. The prosthetic foot itself may have a joint or be able to move within certain areas relative to the lower leg component. The end of the adjustment process can be indicated or output via the output device, for example, after automatic detection of the correct setting or upon receipt of a corresponding confirmation signal.

[0021] Exemplary embodiments of the invention are explained in more detail below with reference to the accompanying figures. These show: Figure 1 – a schematic representation of an adjustment process; Figure 2 – a prosthetic device with different shoes; Figure 3 – a schematic representation of a prosthetic device with a lower leg socket; Figure 4 – a variant of the Figure 3 with prosthetic knee joint and femoral shaft; Figure 5 - a schematic representation with a separate dispensing device; and Figure 6 - a variant with an integrated dispensing device.

[0022] The Figure 1Figure 1 shows three positions or states in which a prosthetic device can be during use. The left-hand illustration of Figure 1 shows the prosthetic device with a prosthetic foot 10 and a lower leg section 20. A prosthetic knee joint is arranged at the proximal end of the lower leg section 20 and is connected to a femoral socket (not shown). The prosthetic device is secured to a residual femur via the femoral socket. In the illustrated embodiment, an inertial angle sensor 30, also referred to as an inertial measurement unit or IMU, is arranged on the lower leg section 20. This sensor can be configured as an assembly consisting of one or more gyroscopes, optionally supplemented with accelerometers. The left-hand illustration of the Figure 1The displayed orientation is stored as a reference orientation, with the respective longitudinal extensions of the prosthetic foot 10 and the lower leg section 20 serving as reference points. The stored reference orientation is the so-called reference setup of the prosthetic device, which is set, saved, and documented by an orthotist. Storage can occur in a memory device, which may be part of a control unit for controlling a damping device in the prosthetic knee joint. The inertial angle sensor 30 can also be part of the control unit for the prosthetic knee joint. The prosthetic setup is the spatial arrangement of the individual prosthetic components relative to one another. In the reference setting, the aim is to ensure that all prosthetic components are optimally aligned so that the prosthesis user can derive the greatest possible benefit from the prosthetic device.Since the prosthetic device is usually worn with a shoe 11, it is necessary to adjust the prosthetic assembly with a shoe 11 in place. The shoe 11 is generally a model that the user usually wears. If the shoe model is changed and the shoe 11 has a different heel height, as shown in the middle illustration... Figure 1 As shown, the prosthesis structure changes, and in particular the orientation of the lower leg part 20. In the middle illustration of the Figure 1It can be seen that the longitudinal extension of the lower leg section 20 is tilted forward due to the different heel height; the inclination of the prosthetic foot 10 is also altered. The inertial angle sensor 30 or the IMU 30 detects the inclination and orientation of the lower leg section 30 in space, either after activation of a verification mode by the user or automatically. Since the orientation of the lower leg section 30 no longer corresponds to the reference orientation, a signal indicating that the alignment and prosthetic assembly are no longer correct is output via an output device (not shown). Subsequently, for example, a lock on a pivot axis around which the prosthetic foot 10 can be pivoted relative to the lower leg section 20 is unlocked or released, and the lower leg section 20 is pivoted until the reference orientation is restored.Once this occurs, the output device sends a corresponding signal to the user, who can then reactivate the locking device and lock the pivot axis. The correct spatial orientation is detected via the IMU or the inertial angle sensor 30 and indicated by an optical, acoustic, and / or tactile signal. Alternatively, the output device can display the current spatial orientation angle or the distance to the reference angle or reference orientation. In the right-hand illustration, the lower leg section 20 has returned to its original reference orientation, as indicated by the dashed line.

[0023] In the Figure 2The relevant components of the prosthetic device are shown in detail. The left illustration shows a prosthetic foot 10 in a shoe 11 with a heel 12. The prosthetic foot 10 has a pivoting mechanism 15 around which the lower leg section 20, in the form of a lower leg tube, can be pivoted about a pivot axis. An inertial angle sensor 30 is attached to the lower leg section 20. The second illustration from the left shows an alternative shoe 11 with a higher heel 12. In the third illustration from the left, the prosthetic foot 10 is inserted into the alternative shoe 11. Due to the different heel-to-toe drop between the two shoe models, it is necessary to pivot the lower leg section 20 in the opposite direction, i.e., backwards. For this purpose, the lower leg section 20 is pivoted backwards in the direction of the arrow, and the pivoting process is then...The spatial orientation of the lower leg section 20 is checked via the inertial angle sensor 30. As soon as the correct orientation of the lower leg section 20 in space is achieved, particularly when the patient is bearing weight evenly on both the prosthetic and non-prosthetic sides, an optical, acoustic, and / or tactile signal is output via an output device 40, indicating that the correct orientation has been reached. The user then locks the pivoting device 15 to prevent unintentional displacement of the prosthetic foot 10 relative to the lower leg section 30. The power supply to the output device 40 can then be interrupted to conserve energy. The inertial angle sensor 30 can continue to be used to provide sensor data.

[0024] In the Figure 3A schematic representation shows the prosthetic device with the prosthetic base 10, the lower leg section 20, and the attached inertial angle sensor 30. The prosthetic base 10 is pivotably mounted on the lower leg section 20 about an axis via the pivoting device 15. The lower leg section 20 has a lower leg shaft and a lower leg tube to which the inertial angle sensor 30 is attached, either permanently or detachably. A mounting device 70 is also provided on the lower leg shaft, to which the output device 40 (not shown) or a module consisting of the inertial angle sensor 30 and the output device 40 can be attached. The module, the output device 40, and / or the inertial angle sensor 30 are preferably designed to be detachably and non-destructively attached to the mounting device 70.The inertial angle sensor 30 or the IMU can be fixed in place using positive locking elements such as screws, bolts, hooks, or clips, or by frictional locking using magnets, or with a combination of positive and frictional locking elements. The sensor 30 can be integrated into or detachably attached to a part of the ankle joint that is rigidly connected to the lower leg section 20. Alternatively, the sensor 30 can be mounted on a structural part of the lower leg section 20, such as the lower leg tube or the lower leg shaft.

[0025] In the Figure 4A prosthetic device is schematically depicted in which a proximal prosthetic component 50 is arranged on the lower leg part 20. The proximal prosthetic component 50 is, for example, a femoral stem with a connecting tube to a prosthetic knee joint 25. In the illustrated embodiment, the inertial angle sensor 30 is again arranged on the lower leg part 20; alternatively, the inertial angle sensor 30 and, if applicable, also the output device 40 can be integrated or detachably attached to the knee joint 25, the femoral stem, or a connecting part between the femoral stem and the prosthetic knee joint. The inertial angle sensor 30 can also be arranged on the upper part of a prosthetic knee joint.In conjunction with an angle sensor that detects the angle between the lower leg part 20 and the proximal component 50, the spatial orientation of the lower leg part 20 can be detected from the spatial orientation of the proximal component 50. In the exemplary embodiment of the . Figure 4 Furthermore, load sensors 60 are provided, which are arranged on the prosthetic base 10 and the pivoting device 15. The load sensors 60 can be, for example, axial force sensors, pressure sensors, and / or torque sensors to detect the respective load on the prosthetic device. The load sensors 60 or the load sensor 60 are coupled to a control unit, which is also coupled to the inertial angle sensor 30. This allows, for example, the detection of whether or not an adjustment of the prosthetic assembly is taking place when the prosthetic device is under load. The output device 40 is shown in the exemplary embodiment according to Figure 4combined with the inertial angle sensor 30 to form a module and fixed to the lower leg part 20.

[0026] In the Figure 5 The output device 40 is separate from the inertial angle sensor 30 and spatially isolated, for example in the form of a mobile phone, to which corresponding data from the inertial angle sensor 30 is wirelessly transmitted, optionally via a separate transmitter. Data transmission from the sensor to the output device 40 can occur via radio, WLAN, Bluetooth, NFC, or other transmission methods. In addition to a visual display, the output device can provide acoustic feedback or a vibration signal to inform the user about the correct setting after a change in elevation.

[0027] In the Figure 6A further variant of the invention is shown, in which the output device 40 is arranged on the prosthetic socket 50 as a proximal component. The output device 40 is integrated into the prosthetic socket 50. The inertial angle sensor 30 or the IMU is arranged on the lower leg section 20. The transmission from the inertial angle sensor 30 to the output device 40 is wireless. After manually unlocking the prosthetic foot 10 relative to the lower leg section 20, the prosthetic foot 10 is placed on the floor, for example, with a shoe, in particular a shoe with a heel height that differs from a previously fitted shoe. The contact of the prosthetic foot 10 with the floor is detected via the force sensor 60. The lower leg section 20 is pivoted about the ankle joint 15 until the previously set reference orientation of the lower leg section 20 in space is reached.For example, the lower leg section 20 may be positioned within the sagittal plane or within a defined angular range medial and lateral to the sagittal plane. Upon reaching the reference orientation of the lower leg section 20, the output device 40 emits an optical, acoustic, or tactile signal indicating that the desired position has been achieved.

Claims

1. A prosthetic device for a lower extremity, comprising a prosthetic foot (10) and a lower-leg part (20) fastened to the prosthetic foot (10), and a device for manually adjusting an orientation of the lower-leg part (20) relative to the prosthetic foot (10), characterized in that an inertial angle sensor (30) is arranged on the prosthetic device, serves to detect the orientation of the lower-leg part (20) in space and is coupled to an output device (40) which outputs, in a manner identifiable by a user by way of an output signal, the orientation of the lower-leg part (20) in space or the attainment of an orientation defined in advance.

2. The prosthetic device as claimed in claim 1, characterized in that the inertial angle sensor (30) and the output device (40) are combined as a module and integrated in the prosthetic device or detachably fastened thereto.

3. The prosthetic device as claimed in claim 1 or 2, characterized in that the inertial angle sensor (30) is arranged on the lower-leg part (20) or the prosthetic device has a prosthesis component (50) arranged proximal to the lower-leg part (20), the inertial angle sensor (30) being arranged on said prosthesis component (50).

4. The prosthetic device as claimed in any one of the preceding claims, characterized in that a load sensor (60) is arranged on the prosthetic device and is coupled to the output device (40) in such a way that the output signal is output if a load is detected.

5. The prosthetic device as claimed in claim 4, characterized in that the load sensor (60) is designed as an axial force sensor, pressure sensor or torque sensor.

6. The prosthetic device as claimed in any one of the preceding claims, characterized in that the output device (40) is designed to output an optical, acoustic and / or tactile output signal.

7. The prosthetic device as claimed in any one of the preceding claims, characterized in that the prosthetic foot (10) is mounted so as to be pivotable in the sagittal plane.

8. The prosthetic device as claimed in any one of the preceding claims, characterized by a deactivation device, which deactivates the inertial angle sensor (30) and / or the output device (40) or the connection between the inertial angle sensor (30) and the output device (40) after the orientation defined in advance has been attained.

9. An adjustment device for manually adjusting an orientation of a lower-leg part (20) relative to a prosthetic foot (10) of a prosthetic device of a lower extremity, characterized in that the adjustment device comprises an inertial angle sensor (30) which detects the orientation of the lower-leg part (20) in space and which is coupled to an output device (40) which outputs, in a manner identifiable by a user by way of an output signal, the orientation of the lower-leg part (20) in space or the attainment of an orientation defined in advance.

10. The adjustment device as claimed in claim 9, characterized in that the output device (40) is designed to output an optical, acoustic and / or tactile output signal.

11. The adjustment device as claimed in claim 9 or 10, characterized in that a fastening device (70) for securing to a prosthetic device is arranged or formed on the adjustment device.

12. A method for manually adjusting an orientation of a lower-leg part (20) of a prosthetic device of a lower extremity relative to a prosthetic foot (10) fastened to the lower-leg part (20), wherein an adjustment device with an inertial angle sensor (30) is arranged on the prosthetic device, the inertial angle sensor detecting the orientation of the lower-leg part (20) in space and being coupled to an output device (40), characterized in that a reference orientation of the lower-leg part (20) in space is set for a user and the attainment of the reference orientation set in advance is output in a manner identifiable by a user by way of an output signal.

13. The method as claimed in claim 12, characterized in that the adjustment is performed in the case of an applied, more particularly loaded prosthetic device.

14. The method as claimed in claim 12 or 13, characterized in that the adjustment is carried out automatically for each change in prosthetic foot, for each change in heel height or following an activation signal.