Improvements in or relating to a sole

Abstract

A sole comprising a foot support element 201 and a wedge member 202 actuatable to push against the foot support to lift it. The wedge may be arranged underneath the foot support and may engage a slope on the foot support. There may be multiple slopes and wedges spaced along the length or width of the sole and may include two front wedges and two rear wedges. The foot support may have a part which pivots relative to a sole body with means to limit movement. Movement of the wedges may be constrained to sliding using cooperating grooves and rails. A motor may act as an actuator and sensor can be used to detect environmental parameters such as pressure, temperature or force and the actuator can be controlled based on the data. An upper padded sole may be provided and the sole can form part of a shoe or footwear.

Description

Technical Field The present disclosure relates to a sole, such as an insole, an outsole, or a sole insert, and a footwear including the same. Associated systems, apparatus, methods, and corresponding computer programs are also disclosed. Background An orthosis, or orthotic device, is an externally applied device used to compensate for impairments of the structure and function of the neuro-muscular and skeletal systems. Examples include a foot orthosis, which encompasses - and so seeks to support, align, or offload - the whole or part of the foot. There is a need for advances in orthoses and related areas to improve end-user (e.g., patient) outcomes. Summary According to a first aspect of the present disclosure, there is provided a sole comprising: at least one foot support element; and at least one wedge member actuatable to push against at least part of the or the respective foot support element to lift the or the respective foot support element. The or each wedge member may be arranged underneath the or the respective foot support element. An underside of the or each foot support element may include at least one slope. The or each wedge member may be actuatable to push against at least part of the or each slope of the or the respective foot support element to lift the or the respective foot support element. The underside of the or each foot support element may include multiple slopes. The sole may include multiple wedge members that are actuatable to push against the respective slopes of the or the respective foot support element to lift the or the respective foot support element. The sole may include multiple wedge members that are actuatable to push against the same foot support element to lift the same foot support element. The multiple wedge members may include: wedge members spaced apart along a width of the sole; and / or wedge members spaced apart along a length of the sole. The multiple wedge members may include two front wedge members and two rear wedge members. The front wedge members may be spaced apart from each other along a width of the sole. The rear wedge members may be spaced apart from each other along a width of the sole. Each front wedge member may be spaced apart from a respective one of the rear wedge members along a length of the sole. The sole may include a sole body. The or each foot support element may be liftable relative to the sole body. The at least one foot support element may include a pivotable foot support element that is pivotally coupled to the sole body. The pivotable foot support element may be arranged at or near a heel region of the sole body. The sole body may include a pivot stop structure configured to limit a maximum pivot angle of the pivotable foot support element relative to the sole body. The at least one foot support element may include at least one vertically liftable foot support element that is laterally constrained by the sole body. The at least one foot support element may include a row of vertically liftable foot support elements. Each of the vertically liftable foot support elements may be laterally constrained by the sole body. The or each vertically liftable foot support element may be arranged at a metatarsophalangeal region of the sole body. The or each wedge member may be movingly coupled to the or the respective foot support element so that, in use, actuation of the or each wedge member guides a movement of the or the respective foot support element during the lifting of the or the respective foot support element. The or each wedge member may include: a groove that is slidably coupled to a rail of the or the respective foot support element; or a rail that is slidably coupled to a groove of the or the respective foot support element. Multiple of the at least one wedge member may be combined to form a unitary structure. The sole may comprise an actuator configured to be operable to push the at least one wedge member against the at least part of the or the respective foot support element to lift the or the respective foot support element. The actuator may be configured to be operable to move the at least one wedge member away from the or the respective foot support element to lower the or the respective foot support element. The actuator may include a motor configured to drive the at least one wedge member. In other embodiments, the actuator may include a different type of drive element to drive the at least one wedge member. The sole may include at least one sensor configured to sense an environmental parameter when the sole is in contact with the sole of a foot. The sole may include a processor configured to, in use, receive sensor data from the at least one sensor and generate output data corresponding to the sensed environmental parameter. The at least one sensor may include, but is not limited to, at least one pressure sensor, at least one temperature sensor and / or at least one force sensor. The processor may be configured to, in use, control the actuator based on the output data. The sole may include a transmitter for transmitting the output data to an external device. The sole may include at least one position detector for detecting a position of the or each foot support element and / or the or each wedge member. The sole may include a controller configured to, in use, perform a calibration routine to move the or each foot support element and / or the or each wedge member to a predefined position in response to position detection data by the or each position detector. The sole may include a hard stop structure arranged to limit a horizontal displacement of the at least one wedge member. The sole may include an upper insole, optionally wherein the upper sole is padded or cushioned. The sole may be an insole, an outsole, or a sole insert. According to a second aspect of the present disclosure, there is provided a footwear comprising a sole according to any of the preceding aspects and embodiments. According to a third aspect of the present disclosure, there is provided a method of using a sole comprising at least one foot support element and at least one wedge member, the method comprising the step of: actuating the at least one wedge member to push against at least part of the or the respective foot support element to lift the or the respective foot support element. The sole may include a plurality of foot support elements, the method further comprising the step of: individually actuating one or more corresponding wedge members to push against at least part of each of the plurality of foot support elements to lift each of the plurality of foot support elements. The method may further comprise the step of: performing a calibration routine to move the or each foot support element and / or the or each wedge member to a predefined position in response to position detection data detected by at least one position detector. According to a fourth aspect, there is provided an apparatus comprising a processor and memory including computer program code, the memory and computer program code configured to, with the processor, enable the apparatus to at least perform the method of the third aspect. According to a fifth aspect, there is provided a system comprising a sole according to the first aspect and an external device. The external device may be a server or a user device such as a mobile device. The system may comprise a plurality of external devices including a server and a user device. According to a sixth aspect, there is provided an apparatus as substantially described herein with reference to, and as illustrated by, the accompanying drawings. The optional features described in relation to the first aspect are also applicable to the second aspect, the third aspect, the fourth aspect, the fifth aspect, and / or the sixth aspect where compatible. The steps of any method disclosed herein do not have to be performed in the exact order disclosed, unless explicitly stated or understood by the skilled person. Corresponding computer programs for implementing one or more steps of the methods disclosed herein are also within the present disclosure and are encompassed by one or more of the described examples. Accordingly, one or more methods disclosed herein may be computer-implemented. One or more of the computer programs may, when run on a computer, cause the computer to configure any apparatus, including a battery, circuit, controller, or device disclosed herein or perform any method disclosed herein. One or more of the computer programs may be software implementations, and the computer may be considered as any appropriate hardware, including a digital signal processor, a microcontroller, and an implementation in read only memory (ROM), erasable programmable read only memory (EPROM) or electronically erasable programmable read only memory (EEPROM), as nonlimiting examples. The software may be an assembly program. One or more of the computer programs may be provided on a computer readable medium, which may be a physical computer readable medium such as a disc or a memory device, or may be embodied as a transient signal. Such a transient signal may be a network download, including an internet download. The present disclosure includes one or more corresponding aspects, examples or features in isolation or in various combinations whether or not specifically stated (including claimed) in that combination or in isolation. Corresponding means for performing one or more of the discussed functions are also within the present disclosure. Throughout the present specification, descriptors relating to movement or displacement such as "push against" or "move away", and descriptors relating to position or location such as "forward" or "rearward", as well as any adjective and adverb derivatives thereof, are used in the sense of the movement of features relating to those presented in the drawings. However, such descriptors are not intended to be in any way limiting to an intended use of the described or claimed invention. The above summary is intended to be merely exemplary and non-limiting. It will be appreciated that the use of the terms "first" and "second", and the like, in this patent specification is merely intended to help distinguish between similar features and is not intended to indicate the relative importance of one feature over another feature, unless otherwise specified. Within the scope of this patent application it is expressly intended that the various aspects, embodiments, examples and alternatives set out in the preceding paragraphs, and the claims and / or the following description and drawings, and in particular the individual features thereof, may be taken independently or in any combination. That is, all embodiments and all features of any embodiment can be combined in any way and / or combination, unless such features are incompatible. The applicant reserves the right to change any originally filed claim or file any new claim accordingly, including the right to amend any originally filed claim to depend from and / or incorporate any feature of any other claim although not originally claimed in that manner. Brief description of drawings Preferred embodiments of the invention will now be described, by way of non-limiting examples, with reference to the accompanying drawings in which: Figure 1 shows in schematic form a sole according to an example of the disclosure; Figure 2 shows a drawing of a sole according to another example of the disclosure; Figure 3 shows perspective (Figure 3(a)) and side-on (Figure 3(b)) drawings of a foot support element and wedge members according to another example of the disclosure; Figure 4 shows side-on view drawings of the example of Figure 3 in a retracted state (Figure 4(a)) and an extended state (Figure 4(b)); Figure 5 shows perspective view drawings of a main structure of a sole (Figure 5(a)) and a toe region compartment of the sole (Figure 5(b)) according to another example of the disclosure; Figure 6 shows side-on views (Figures 6(a)-(b)) and a perspective view (Figure 6(c)) of a heel region of a sole according to another example of the disclosure; Figure 7 shows simplified cross-sectional diagrams representing different configurations of the sole according to other examples of the disclosure; Figure 8 shows simplified diagrams representing a heel wedge from a posterior view (Figure 8(a)) and from a top-down view (Figure 8(b)) according to another example of the disclosure; Figures 9(a)-(f) show photographs of a sole according to another example of the disclosure; Figure 10 shows photographs (Figures 10(a)-(b)) and diagrams (Figure 10(c)) of sensors and a sensor arrangement according to examples of the disclosure; Figure 11 shows photographs of a controller (Figure 11(a)) and a battery management system and a charging circuit (Figure 11(b)) according to examples of the disclosure; Figure 12 shows photographs of a sole according to another example of the disclosure; Figures 13(a)-(d) show perspective (Figures 13(a)-(c)) and side-on (Figure 13(d)) drawings of a sole according to another example of the disclosure; Figure 14 shows drawings of the sole of Figure 13 from additional perspectives; Figure 15 shows in schematic form a system according to an example of the disclosure; Figures 16(a)-(d) show diagrams of an external device according to an example of the disclosure; Figure 17 shows a photograph of a portion of a mobile application according to an example of the disclosure; and Figure 18 shows a flow diagram for a method of using a sole comprising at least one foot support element and at least one wedge member according to an example of the disclosure. Detailed Description Figure 1 shows in schematic form a sole 100 according to an example of the disclosure. The sole 100 comprises at least one foot support element 101 and at least one wedge member 102, the sizes and positions of which are non-limiting in the context of the disclosure. The at least one wedge member 102 is actuatable to push against at least part of the or the respective foot support element 101 to lift the or the respective foot support element 101. The inventors have discovered that the relatively limited volume of a sole presents challenges in designing an effective offloading device. As devised by the inventors, however, the sole 100 affords advantageous pressure offloading characteristics due to the at least one foot support element 101 and the at least one wedge member 102 providing strength and support within such a volume. In turn, a sole according to Figure 1 can provide improved end-user (e.g., patient) outcomes over alternative designs investigated by the inventors, particularly designs where weaker, less supportive parts are used (e.g., a compressible member such as an air-filled bladder) to lift a foot support element instead of at least one wedge member. These improved end-user outcomes include the possible prevention (or otherwise better management) of ulceration or other possible musculoskeletal conditions arising from altered foot posture and altered distribution of pressure. These latter conditions, especially those that arise due to a significant increase in pressure on specific areas of the plantar aspect of the foot, can include (and so are not limited to): rheumatic conditions, such as pressure lesions in rheumatoid arthritis (that can include even possible ulceration) and offloading of rheumatoid nodules; metatarsalgia (many pathologies that affect the ball of the foot); first metatarsophalangeal joint arthritis; midfoot conditions arising from altered function of the foot. The metatarsophalangeal joints in rheumatoid arthritis can undergo severe degeneration which may be managed by appropriate offloading to reduce the daily stresses that these structures undergo during walking. Figure 2 shows a computer aided design (CAD) drawing of a sole 200 according to another example of the disclosure. Like the sole shown schematically in Figure 1, the sole 200 comprises at least one foot support element 201 - two in this example - and at least one wedge member 202 - a plurality in this example - that is actuatable as described above. Compared with the sole shown schematically in Figure 1, in the example sole of Figure 2 each wedge member 202 is arranged underneath a respective foot support element 201. To assist the understanding of this arrangement, certain foot support elements have been omitted from Figure 2. Furthermore, although each foot support element 201 is shown as resembling a platform, similar or dissimilar structural forms may be used in addition or in the alternative. For example, a top surface of a foot support element 202 may be substantially level, or substantially unlevel (e.g., curved or undulating). Where a plurality of foot support elements 202 is present, each foot support element 202 may have a different or same structural form to each other foot support element 202. Figure 3 shows perspective (Figure 3(a)) and side-on (Figure 3(b)) drawings of a foot support element 301 and at least one wedge member 302a-d according to another example of the disclosure. Although four wedge members 302a-d are present in this example, in other examples different numbers of wedge members, such as one two, three, five, etc., are actuated to push against part of the foot support element 301. An underside of the support element 301 includes at least one slope 303a-c, four (not all of which are visible) in this example, each wedge member 302a-d being actuatable to push against at least part of the respective slope of the foot support element 301 to lift the foot support element 301. It should be appreciated, then, that in some examples of the disclosure the underside of the or each foot support element 301 includes multiple slopes 303a-c, and the sole includes multiple wedge members 302a-d that are actuatable to push against the respective slopes 303a-c of the or the respective foot support element 301 to lift the or the respective foot support element 301. As apparent from Figure 2 and later figures, the multiple wedge members 302a-d may include wedge members spaced apart along a width of the sole, and / or wedge members spaced apart along a length of the sole. Where multiple slopes and / or multiple wedge members are present, a uniform lifting action may be realised by the multiple wedge members (when actuated) across a greater area of the underside of a foot support element than if only one wedge member is present (for example). This may improve overall support for the foot support element, such that unintended slanting etc. of the foot support element is avoided during use. It should be understood that intentional slanting of the foot support element may be performed in some cases. Revisiting Figure 3(a), the multiple wedge members 302a-d may include two front wedge members 302a-b and two rear wedge members 302c-d. The front wedge members 302a-b may be spaced apart from each other along a width of the sole, the rear wedge members 302c-d spaced apart from each other along a width of the sole, each front wedge member 302a-b spaced apart from a respective one of the rear wedge members 302c-d along a length of the sole. As can be seen from Figure 2 and later figures, other spacings are nonetheless possible in accordance with the teachings of this disclosure. In some examples the or each wedge member 302a-d is movingly coupled to the or the respective foot support element 301 so that, in use, actuation of the or each wedge member 302a-d guides a movement of the or the respective foot support element 301 during the lifting of the or the respective foot support element 301. In these examples, the or each wedge member 302a-d may include: a groove that is slidably coupled to a rail of the or the respective foot support element; or a rail 304 that is slidably coupled to a groove of the or the respective foot support element 301. Figure 4 shows side-on view drawings of the example of Figure 3 in a retracted state (Figure 4(a)) and an extended state (Figure 4(b)), to inform understanding of the lifting principle as used herein. The retracted state - see Figure 4(a) - may correspond to an initial arrangement or positioning of a foot support element 301 and at least one wedge member 302a, 302c. When the at least one wedge member 302a, 302c is actuated to push (i.e., to the left) against at least part of the foot support element 301, the foot support element 301 moves along a slope of the or each wedge member 302a, 302c to be forced upwards to a higher, lifted position. For instance, the only slope of the or each wedge member, or one of a plurality of slopes of the or each wedge member. The at least part of the foot support element may be an underside slope(s) 303a, 303c, as in this example, although in different examples other contact points or areas of the foot support element may be pushed, such as an edge. The lifted position is exemplified in the extended state - see Figure 4(b) - that may correspond to an advanced arrangement or positioning of the foot support element 301 and the at least one wedge member 302a, 302c. The foot support element 301 may thereafter remain at the higher position due to friction between a slope 303a and a corresponding slope of a wedge member 302a, or the foot support element and a rail 304 of a wedge member, for example. As shown in Figure 4, a foot support element 301 having a height of 11mm is lifted by 5mm or 45% of the retracted height, it being understood this height and extent of lifting are mere examples only. The extent to which the foot support element 301 is lifted may be dependent upon factors including: how far along a slope of a wedge member a foot support element 301 is lifted; and whether a wedge member(s) 302a, 302c, as pushed against a foot support element, is at the end of its travel. Figure 5 shows perspective view drawings of a main structure 505 of a sole 500 (Figure 5(a)) and a toe region compartment 506 of the sole 500 (Figure 5(b)) according to another example of the disclosure. The main structure 505 and the toe region compartment 506 exemplify a sole that includes a sole body, in which cases the or each foot support element is liftable relative to the sole body. In alternative examples the sole body may be the main structure 505 alone, which has been formed to include a toe region, or a set of structures that collectively define the sole body. As shown, the main structure 505 houses a plurality of wedge members 502, their respective locations clarified with respect to the example sole shown in Figure 2 (such that these figures complement one another by showing soles at differing degrees of assembly). The purpose of the toe compartment region 506 is discussed below. The main structure 505 may be characterised as comprising a forward region 507 and a heal region 508. The forward region 507 comprises a row of multiple wedge members 502 grouped together and combined (e.g., interconnected) to form unitary structures. With reference to the discussion of Figure 1-4, each unitary structure is actuatable to push against a respective foot element, an example of which is shown in the corresponding region of Figure 2. In some examples the at least one foot support element may include at least one vertically liftable foot support element that is laterally constrained by the sole body, thereby minimising unintended horizontal displacement of the at least one foot support element when pushed by one or more wedge members. In these examples, the at least one foot support element may include a row of vertically liftable foot support elements, each of which is laterally constrained by the sole body. Additionally, or in the alternative, the or each vertically liftable foot support element is arranged at a metatarsophalangeal region of the sole body. Figure 6 shows side-on views (Figures 6(a)-(b)) and a perspective view (Figure 6(c)) CAD drawings of a heel region 608 of a sole according to another example of the disclosure. Following the discussion with reference to Figure 4, the heel region 608 shown in Figures 6(a)-(b) shows a foot support element 601 and a plurality of wedge members 602 in a retracted state (Figure 6(a)), wherein the foot support element 601 and the plurality of wedge members 602 are in an initial arrangement, and in an extended state (Figure 6(b)) that corresponds to the plurality of wedge members 602 having lifted the foot support element 601. Whereas the example of Figure 4 concerned a foot support element remaining substantially level after lifting, however, the foot support element 601 of Figure 6 includes a pivotable foot support element 609 that is pivotally coupled to the sole body so as to tilt (about the pivot axis indicated by the dashed line) during lifting. This difference between the examples of Figures 4 and 6 is emphasised in Figure 6(c) that shows the foot support element 601 'over-pivoted' to a relatively large angle that reveals the wedge members 602 underneath. According to the example of Figure 6 the pivotable foot support element 609 is arranged at or near a heel region 608 of the sole body, however, this is not essential and in other examples the pivotable foot support element 609 is arranged elsewhere on the sole body. Figure 6 also shows a pivot stop structure 610 that forms part of the sole body, the pivot stop structure 609 configured to limit a maximum pivot angle of the pivotable foot support element relative to the sole body when pushed by at least one wedge member. See Figure 6(b) in this regard. In this or alternative examples, the sole may include a hard stop structure 611 arranged to limit a horizontal displacement of the at least one wedge member 602. Building on the detailed description so far, the sole body, the forward region and the heel region may be understood further from the following non-limiting examples: Sole body The main frame, or structure which encloses the entire system including mechanical, electrical and control systems is shown in Figure 5(a). The overall height dedicated for the mechanical structure and mechanical actuation is 12mm, enabling it to be embedded within a shoe sole. A frontal compartment below the toe region (Figure 5(b)) is designed to provide space for batteries and other electrical components. Forward region The mechanism of the forefoot is based on a wedge design that is pushed forward in order to lift an upper platform. In an example, multiple wedges are interconnected into one component. The lower component (cf. Figure 3(a)) has four wedges around the four corners of the component. This is placed below the upper component (platform) (cf. Figure 3(a)) which has four slope edges which rest against the lower wedges. Figure 3(b) shows the side views of the lower and upper components. Figure 4(a) shows the retracted setting and as the lower component is pushed forward (to the left) it forces the upper component upwards, thus achieving the required platform rise. The force that pushes the lower component forward may be provided by a DC motor that has a threaded shaft or employing other means of pushing the lower component forward, such as a linear actuator. The threaded shaft may be connected to a nut embedded within the lower wedge so that as the shaft rotates, the nut and lower component move accordingly. A groove and slide (or rail) within the component act as a track (or a member that is functionally comparable to a rail) and prevent the upper platform and the bottom wedges from disassembling if the mechanism is tilted upside down. Furthermore, the same features provide a downward force when the system is retracted. The components and features may be designed in a manner in which all these features can be 3D printed or else injection moulded without any supports and with minimal, if any, post processing. The components are housed within a structure that acts as a frame as shown in Figure 5. The relative location of the motors and platform regions is shown in a later figure. Benefits of the designed mechanism may include one or more of: 1. Providing a required rise. 2. Providing a flexible (variable) height. 3. Lifting a platform evenly (such that the platform remains horizontal) 4. A relatively compact size. 5. The mechanism does not slide into the metatarsophalangeal joints region. 6. Actuation by a single acting driving source (e.g., a motor and a screw drive). 7. Complex double threaded screw drives may be avoided. 8. Being strong enough to support the pressure and transfer the forces without breaking. In some examples this mechanism may be called a one-direction double-wedge design. Heel region The heel region is required to tilt to a certain angle. The heel region may rotate around a pivot axis (shown by the dashed line in Figure 6(c)) and the actuation is also achieved using a wedge-based design and, optionally, motor driven actuation. The designed layout enables the motor and wedge to be located below the same heel region. Figures 6(a)-(b) show a cross section of the heel mechanism in the retracted and extended positions. In the retracted position, the wedge is located to the right and the heel platform rests directly onto the outer structure. As the wedge component is pushed forward by the motor driven shaft, the wedge forces the platform upwards up to the maximum extension as shown in Figure 6(b). The force on the wedge component is applied by the motor driven threaded shaft acting against an embedded nut within the wedge structure. Figure 6(c) shows the heel platform open (blue part) exposing the wedge component (green part). Hard stops and mounting locations for limit switches may be provided. The solution provided by the heel actuation design also makes the best use of the limited space while providing the required strength and support. Figure 7 shows simplified cross-sectional diagrams representing different configurations of at least one foot support element and at least one wedge member according to other examples of the disclosure. Specifically, these diagrams indicate how relevant regions of the sole may be activated to provide corrections to a patient's foot (for example), thereby preventing (or otherwise better managing) ulceration or other possible musculoskeletal conditions as discussed above with reference to Figure 1. More specifically, Figure 7 shows in abstract form forefoot regions of a sole, where from left to right: the first (light blue or dashed-line) box in each diagram represents the elevated region in the insole proximal to the 1st metatarsophalangeal joint (MPJ): the second (yellow or dotted-line) box in each diagram represents the elevated region in the insole proximal to the 2nd-4th MPJs; and the third (dark green or hatched) box in each diagram represents the elevated region in the insole proximal to the 5th MPJ. Thus, the simplified cross-sectional diagrams relate to a right foot looking from behind, and 'proximal' in medical terms in this instance means nearer to the body. The relative height of each box represents the degree of forefoot region activation / correction, which may be exaggerated for ease of understanding. Figure 8 shows simplified diagrams representing a heel wedge from a posterior view (Figure 8(a)) and from a top-down view (Figure 8(b)) according to another example of the disclosure. The heel wedge is in an activated state - compare with the extended state discussion of the wedge members shown in Figures 4 and 6 - as best seen in Figure 8(a). The heel wedge may be activated to control heel eversion and thus foot posture; this serves to alter gait pattern. The heel wedge may be used on its own or in combination with any or all the forefoot adaptations shown diagrammatically in Figure 7. Figures 9(a)-(f) show photographs of a sole 900 according to another example of the disclosure. The sole 900 is shown at various states of assembly and, for brevity, where like numerals are present for representative features, the reader is referred to the preceding discussion for a description of the feature in question. The sole 900 also comprises an actuator 912 (e.g., an electromechanical actuator) configured to be operable to push the at least one wedge member against the at least part of the or the respective foot support element 901 to lift the or the respective foot support element 901. In related examples, the actuator 912 may be configured to be operable to move the at least one wedge member away from the or the respective foot support element to lower the or the respective foot support element, and / or may include a motor 913 configured to drive the at least one wedge member. With reference to the discussion of the forward and heel regions, a DC motor (or other means of linear actuation) that has a threaded shaft may provide the necessary force to pushes the lower (wedge member) component forward and thereby lift a foot support element (e.g., a platform). Although in that example the threaded shaft was connected to a nut embedded within the lower wedge so that as the shaft rotates, the nut and lower component move accordingly, variations thereto and alternative designs are encompassed by the disclosure. For example, the nut may instead be embedded within the DC motor (or another type of motor or electromechanical drive unit) and the threaded shaft may be integral with the wedge member. The sole 900 also comprises - see at least Figure 9(3) - at least one sensor 913 configured to sense an environmental parameter when the sole is in contact with the sole of a foot, and a processor 914 configured to, in use, receive sensor data from the at least one sensor 913 and generate output data corresponding to the sensed environmental parameter. Figure 10 shows photographs (Figures 10(a)-(b)) and a diagram (Figure 10(c)) of sensors 1013 and a sensor arrangement according to examples of the disclosure. The photograph of Figure 10(a) shows a force sensing resistor, FSR, for sensing pressure and the photograph of Figure 10(b) shows a thermistor for sensing temperature. As such, the at least one sensor may include at least one pressure sensor, at least one temperature sensor and / or at least one force sensor. Other sensor types may be utilised instead or in addition depending upon the environmental parameter(s) of interest. The at least one sensor 1013 may be placed at any suitable location on or within a sole. In some examples more than one sensor (e.g., an FSR and a thermistor) may be colocated to provide complementary sensor data at the same or substantially the same location. An example of this is shown in Figure 10(c) where, optionally, a suitable (e.g., specifically designed) adaptor 1014 may be provided to equalize pressure across the FSR (or other type of pressure sensor). In an example of the disclosure, a sole comprises four FSRs as shown in Figure 10(a) to sense the pressure exerted on different parts of the sole. Each sensor works by exhibiting a lower resistance for an increase in pressure. Each FSR's resistance may vary upwards from 50 kfl. Where relatively high resistance values are obtained that correspond to a pressure range of interest, a corresponding number (e.g., four) operational amplifiers may be used to increase the sensors' output. An additional filter may be used on each operational amplifier to smooth the input voltage. The operational amplifiers increase the sensitivity of a resultant sensor circuit and filter out noise. A voltage reference integrated circuit may be used to power the operational amplifiers. In the same or a different example of the disclosure, to measure temperature, four thin film negative temperature coefficient, NTC, thermal resistors, shown in Figure 10(b), may be used. The output of these thermal resistors may be connected to a voltage divider directly connected to a microcontroller (processor). The temperature sensors may be rated 10 kfl and may measure between -30 to +120 degrees Celsius. In an example, sensor values are read 1050 times per second, and an average value is computed using the last 350 readings. Higher or lower sensor value read frequencies and / or wider or narrower reading ranges (or a range prior to a predefined number of last readings) may be used in other examples. The average value may then be sent to a mobile app in accordance with the discussion below. Such an approach enables each meaningful change in pressure and temperature to be captured and at the same time the mobile app is not overloaded with, e.g., noisy data. Where a sole includes at least one sensor and a processor as described above, the processor may be configured to, in use, control the actuator based on the output data. In this way the sole may realise advantages in full or partial automation over, e.g., a manual adjustment of the actuator, particularly where a real-time (or a near real-time) response to environmental changes are detected. Figure 11 shows photographs of a controller 1115 (Figure 11(a)) and a battery management system 1116 and a charging circuit 1117 (Figure 11(b)) according to examples of the disclosure. The controller 1115 may be an ESP32 micro controller that is embedded in the middle of a sole. The controller 1115 is configured to collect data from, e.g., four pressure and four temperature sensors and transmit this data over Bluetooth (or another data exchange standard) to an external (e.g., a mobile) device. From the external device, this data may be uploaded to the cloud where various calculations and conversions may take place. Alternatively, the various calculations and conversions may be performed by a processor on board the external device. Irrespective of where the transmitted data is processed, an app on-board the external device may make a request for all or part of the processed data for displaying to an enduser. In an example a sole incorporates four DC motors, which are used to drive a sliding mechanism that varies the pressure on various parts of the foot. The DC motors are connected to four switched-mode motor drivers, which are controlled by the controller 1115. The end-user can increase or decrease the height of each sliding mechanism, and hence the pressure exerted on the respective part of the foot in steps of 1mm (or some other step size) at a time. The various electrical and electromechanical components of a sole may be powered by a single LiPo battery which produces a nominal voltage of 4.2 volts, with 2000 mAh capacity and a maximum draining current of 2C (4000mAh). The sole may be designed and configured to operate at 240 mA with a maximum of 700 mAh when operating a motor under load. This can be achieved by including a 1000 pF capacitor in parallel with the supply input of the controller 1115. The controller 1115 normally operates at 240 mA but at times (e.g., millisecond bursts) it can draw 800 mA, which is taken care of the Included capacitor. For safety reasons a battery management system (BMS) 1116, shown in Figure 11(b), may be included. This limits the battery charging voltage and cuts power if the battery's voltage falls below 2.5 Volts. With the BMS 1116, a charging circuit or module 1117 may also be provided which enables a user to charge a sole using, for example, a USB type C cable. The battery's remaining capacity may be displayed on the app on-board the external device. This can be achieved in part by using a voltage divider connected to the battery and controller 1115. The data read by the voltage divider is then compared with a table of predefined (e.g., factory) calibrated values stored in memory (e.g., onboard the sole or the external device). The above discussion is exemplary of a sole including a transmitter for transmitting the output data to an external device. When a user connects with the controller 1115 via Bluetooth (for example), the controller 1115 may start a calibration process where each pad (foot support element) is lowered to its minimum position. This process advantageously starts each session of adjusting each pad to a desired height with zeroed parameters. Also, each motor is provided with an optical shaft encoder (or some other position detector), which is used to measure the number of motor shaft rotations. Moreover, the optical shaft encoder is used to check if the motor has started in the first place, and whether one of the motors stalled because of a limit switch failure, due to a jammed mechanism, or some other error or. In such a case, the motor is stopped to prevent overheating and the user is notified immediately. Another optional feature is limit switch detection upon each controller 1115 boot-up. If a limit switch is on during boot-up, an LED (e.g., a blue LED) will start flashing on micro controller 1115 and the user is notified of the problem upon Bluetooth connection. This process will stop the calibration process from starting and gives the user access to individual control of each motor to rectify the problem. The user may also be notified when the problem is solved. The above discussion is exemplary of a sole that includes at least one position detector for detecting a position of the or each foot support element and / or the or each wedge member. In such cases, the controller 1115 may be configured to, in use, perform a calibration routine to move the or each foot support element and / or the or each wedge member to a predefined position in response to position detection data by the or each position detector. Figure 12 shows photographs of a sole 1200 according to another example of the disclosure. The sole 1200 may be considered a fully assembled sole capable of realising one or more of the preceding advantages. Attention is drawn in this figure to the sensors 1213 (top panel), configured and arranged in accordance with the above examples, and the sole as inserted into a footwear 1216 (bottom panel) such as a boot or shoe (e.g., a diabetic shoe). Thus, in some examples, the sole 1200 is an insole, an outsole, or a sole insert, and / or comprised by a footwear 1216. Figures 13(a)-(d) show perspective (Figures 13(a)-(c)) and side-on (Figure 13(d)) CAD drawings of a sole 1300 according to another example of the disclosure. As with Figures 9(a)-(f), where like numerals are present for representative features, the reader is referred to the preceding discussion for a description of the feature in question. The sole 1300 includes an upper insole 1317 (e.g., a top insole) that may be padded or cushioned. The upper insole 1317 is generally designed for use as a custom orthosis that complements the underlying sole 1300; e.g., by providing a surface that further conforms to the sole of an end-user's foot. A protocol for designing a custom upper insole orthosis may follow: 1. 3D scanning of the foot. 2. Import of the scanned foot into appropriate (e.g., Paromed CADCAM) software. 3. Design of the orthosis that incorporate a D-filler pad, a heel rim, and a 3 to 5 mm forefoot extension, which follows the contour of the sole. 4. Manufacturing (e.g., milling or 2D or 3D printing) of the orthosis. The upper insole may be made from Ethylene Vinyl Acetate (EVA) of dual density ShoreASO for the hindfoot / arch region and ShoreA 30 for the forefoot, or ShoreA 40 for the hindfoot / arch region and ShoreA 20 for the forefoot. Any other low-density EVA material may be used, typically ranging from ShoreA 20 to ShoreA 30. Figure 14 shows CAD drawings of the sole 1300 of Figure 13 from additional perspective views, where the indication of a foot 1318 facilitates understanding of the placement of the upper insole 1317. In view of the above, a sole in accordance with the disclosure may solve one or more of the following offloading issues: 1. The effectiveness of a known insole may be unverified due to the cost of a verification system and any associated time constraints. 2. It is assumed that a patient's walking style is always the same and on even ground whereas, from the inventors' own investigations, variability during walking is significant, both through patient posture issues and changing terrain. Furthermore, a sole in accordance with the disclosure may: replace pressure mapping technology in a clinic; replace a clinician / doctor / orthotist; provide a constant measurement of pressure and temperature; apply an algorithm, e.g., a specifically adapted artificial intelligence, AI, to constantly adjust itself; and / or exemplify the concept of 'doctor in the shoe'. The following discussion elaborates on these points. Due to the issues outlined above, known offloading insoles often do not work and the delay in healing is then blamed on other factors such as the neuropathy, poor glucose control or the poor state of the patient's circulatory system. A sole in accordance with the disclosure may address either or both above-mentioned issues (and / or related issues) by providing a constant output of plantar pressure characteristics and changing its shape to offload high areas of pressure. Thus, some salient characteristics of the sole may be: Constant monitoring of peak pressure areas which serves as a personalized 'inshoe' pressure mapping system which can be viewed on a mobile app. Real-Time shape alteration to offload the identified areas of high pressure in the forefoot. Utilizing an algorithm (e.g., an AI or a fusion algorithm) to determine an effective 'shape strategy' to employ at a certain time to reduce high pressure areas, and to increase efficiency through the algorithm 'learning' the walking style of the end user. Live alerts through a mobile app should there be repetitive high-pressure areas which cannot be effectively offloaded. A sole may consist of two distinct parts: a lower robotized structure that can be commercially mass-produced according to shoe size, which may be cost-effective from a manufacturing standpoint and enable updating both hardware and software components; and an upper part that can be moulded / manufactured by a clinician in order to customize the device according to a patient. This is advantageous since a perfect replica of the patient's foot sole is required to maximise contact area so as to redistribute pressure over a larger area. Various techniques can be utilized in order to manufacture this insole component, such as CADCAM and / or vacuum forming, using low-density Etylene Vinyl Acetate (EVA), or similar, typically (so not exclusively) Shore 20A to Shore 30A as indicated above. Moreover: - A forefoot component may be composed of two layers, namely a lower 3D printed structure utilizing Thermoplastic Poly Urethane (TPU), at a density of 15% -which is effective in reducing pressure - covered with a low-density shockabsorbing material. Pressure and temperature sensors may be placed under particular regions of interest in the forefoot. Fusion of temperature and pressure sensor data for offloading the diabetic foot may improve the sensitivity and / or specificity with which areas at high risk of ulceration are detected. E.g., when areas of high pressure cause local tissue damage, an inflammatory reaction takes place, which increases local temperature. An increase in both temperature and pressure parameters could be an indication that the areas are at a high risk of ulceration. The lower portion of the sole may consist of a further two layers: a base that comes in contact with the shoe; and a higher layer that comes in contact with an EVA insole. This latter higher layer may be divided into regions suitably hinged to allow movement on the heel (to change foot posture substantially) and three regions in the front, under the 1st metatarsal, the central (2nd-4th) metatarsals and the 5th metatarsal. Where such regions are not co-located with sensors, they will be suitably proximal. Activation of the regions can be achieved through an electromagnet situated underneath each component, with each magnet providing a repelling force on each hinged component which, in turn, would have a small 1mm magnet attached to provide a magnetic pole that can be repelled. A lithium ion or similar battery pack and microcontroller that includes WIFI or Bluetooth connectivity to the mobile phone may be placed in the central region between the heel and the front regions of the insole, or else, through a thin wire, an external battery pack attached to the outside of the shoe or other convenient location. Also, software updates may be received through the mobile app every time the software requires updating. Figure 15 shows in schematic form a system 1519 according to an example of the disclosure. The system 1519 comprises a sole 1500, an external device 1520 and, optionally, one or more servers 1521. The external device may be a computer device, a mobile device, a user device, and may share computing resources for processing data as described herein with the one or more servers 1521. Figures 16(a)-(d) show diagrams of an external device 1620 according to an example of the disclosure. In this example, the external device is a mobile device comprises a display showing exemplary modes of an application ('app') 1622 for controlling a sole. According to these modes: a 'Calibration' (pressure analysis) mode - see in particular Figure 16(b) -determines an improved (e.g., optimum) offloading strategy through software; an 'Activate' mode - see in particular Figure 16(c) - activates a sole in a nonweightbearing situation, and monitor gait to determine if the sole is being effective or not; and an 'Adjust' mode - see in particular Figure 16(d) - enables adjustment of regions activated by software or a health professional (for example). A calibration procedure may involve a sole according to the disclosure being placed in each of a patient's shoes, a user pressing CALIBRATE on the app 1622; the patient walking a number of steps while wearing the shoes; once the patient has sat down, the soles are removed from the shoes; the user presses ACTIVATE so that the soles activate one or more regions thereon; the soles are placed back in the patient's shoes and measure pressure during subsequent use; the patient or user presses ADJUST if they not entirely satisfied with the results. As such, a sole according to the disclosure may be generally configured as a user-adjustable device aimed for clinicians who determine the most effective design for an offloading device; a fully-autonomous device that allows for calibration (pressure analysis), determination of optimum offloading strategy by software, continuous activation of insole in a weightbearing situation, monitoring of gait to determine if the device is being effective or not, and continuous adjustment of regions activated when necessary; or a device embedded inside the sole of the foot, thereby improving its utility before a wider range of end-users (those concerned or involved with sports injury, diabetes, rheumatology, geriatrics, musculo-skeletal problems, and other areas). Accordingly, a sole according to the disclosure has tremendous commercial and social applications and the capability to significantly reduce ulceration rates and hence unwarranted amputation. Figure 17 shows a photograph of a portion of a mobile application 1722 according to an example of the disclosure. Specifically, the mobile application 1722 is for connecting to a sole and is shown displaying: pressure and temperature data for the 1st MPJ and the 2nd-4* MPJs; and a user interface that allows a user to adjust corresponding foot support elements and wedge members of a sole. The reader is referred to Figure 10 and the discussion thereof for further details on this aspect of the disclosure. In other words, where a sole device connects to a mobile application, the maximum pressure and temperature at each region may be displayed, which facilitates the gradual upward or downward activation of each region. Data may be passed directly to a webserver, where various calculations are performed, and each trial stored for later retrieval by an operator. Figure 18 shows a flow diagram for a method 1830 of using a sole comprising at least one foot support element and at least one wedge member according to an example of the disclosure. The method 1830 comprises actuating 1831 the at least one wedge member to push against at least part of the or the respective foot support element to lift the or the respective foot support element. The method may further comprise one or both of: wherein the sole includes a plurality of foot support elements, individually actuating 1832 one or more corresponding wedge members to push against at least part of each of the plurality of foot support elements to lift each of the plurality of foot support elements; and performing 1833 a calibration routine to move the or each foot support element and / or the or each wedge member to a predefined position in response to position detection data detected by at least one position detector. Thereby, individual (e.g., independent) control of each of a plurality of wedge members or can be realised, providing tailored offloading for a plurality of regions on the sole of a foot. 5 It will also be appreciated that the above numerical values are merely intended to help illustrate the working of the invention and are not necessarily limiting on the scope of the invention. 10 The listing or discussion of an apparently prior-published document or apparently prior-published information in this specification should not necessarily be taken as an acknowledgement that the document or information is part of the state of the art or is common general knowledge. 15 Preferences and options for a given aspect, feature or parameter of the invention should, unless the context indicates otherwise, be regarded as having been disclosed in combination with any and all preferences and options for all other aspects, features and parameters of the invention. One or more aspects / examples of the present disclosure may or may not address one or more of the background issues.

Claims

1. A sole comprising:at least one foot support element; andat least one wedge member actuatable to push against at least part of the or the respective foot support element to lift the or the respective foot support element.

2. The sole of claim 1, wherein the or each wedge member is arranged underneath the or the respective foot support element.

3. The sole of claim 1 or claim 2, wherein an underside of the or each foot support element includes at least one slope, and wherein the or each wedge member is actuatable to push against at least part of the or each slope of the or the respective foot support element to lift the or the respective foot support element.

4. The sole of claim 3, wherein the underside of the or each foot support element includes multiple slopes, and wherein the sole includes multiple wedge members that are actuatable to push against the respective slopes of the or the respective foot support element to lift the or the respective foot support element.

5. The sole of any preceding claim, wherein the sole includes multiple wedge members that are actuatable to push against the same foot support element to lift the same foot support element, wherein the multiple wedge members include: wedge members spaced apart along a width of the sole; and / or wedge members spaced apart along a length of the sole.

6. The sole of Claim 5, wherein the multiple wedge members include two front wedge members and two rear wedge members, the front wedge members spaced apart from each other along a width of the sole, the rear wedge members spaced apart from each other along a width of the sole, each front wedge member spaced apart from a respective one of the rear wedge members along a length of the sole.

7. The sole of any preceding claim, wherein the sole includes a sole body, wherein the or each foot support element is liftable relative to the sole body.

8. The sole of claim 7, wherein the at least one foot support element includes a pivotable foot support element that is pivotally coupled to the sole body.

9. The sole of claim 8, wherein the pivotable foot support element is arranged at or near a heel region of the sole body.

10. The sole of claim 8 or claim 9, wherein the sole body includes a pivot stop structure configured to limit a maximum pivot angle of the pivotable foot support element relative to the sole body.

11. The sole of any of claims 7 to 10, wherein the at least one foot support element includes at least one vertically liftable foot support element that is laterally constrained by the sole body.

12. The sole of claim 11, wherein the at least one foot support element includes a row of vertically liftable foot support elements, each of which is laterally constrained by the sole body.

13. The sole of claim 11 or claim 12, wherein the or each vertically liftable foot support element is arranged at a metatarsophalangeal region of the sole body.

14. The sole of any preceding claim, wherein the or each wedge member is movingly coupled to the or the respective foot support element so that, in use, actuation of the or each wedge member guides a movement of the or the respective foot support element during the lifting of the or the respective foot support element.

15. The sole of claim 14, wherein the or each wedge member includes: a groove that is slidably coupled to a rail of the or the respective foot support element; or a rail that is slidably coupled to a groove of the or the respective foot support element.

16. The sole of any preceding claim, wherein multiple of the at least one wedge member are combined to form a unitary structure.

17. The sole of any preceding claim, wherein the sole comprises an actuator configured to be operable to push the at least one wedge member against the at least part of the or the respective foot support element to lift the or the respective foot support element.

18. The sole of claim 17, wherein the actuator is configured to be operable to move the at least one wedge member away from the or the respective foot support element to lower the or the respective foot support element.

19. The sole of claim 17 or claim 18, wherein the actuator includes a motor configured to drive the at least one wedge member.

20. The sole of any preceding claim including:at least one sensor configured to sense an environmental parameter when the sole is in contact with the sole of a foot; anda processor configured to, in use, receive sensor data from the at least one sensor and generate output data corresponding to the sensed environmental parameter.

21. The sole of claim 20, wherein the at least one sensor includes at least one pressure sensor, at least one temperature sensor and / or at least one force sensor.

22. The sole of claim 20 or claim 21 when dependent on claim 17 or any claim dependent on claim 17, wherein the processor is configured to, in use, control the actuator based on the output data.

23. The sole of any of claims 20 to 22 including a transmitter for transmitting the output data to an external device.

24. The sole of any preceding claim including at least one position detector for detecting a position of the or each foot support element and / or the or each wedge member.

25. The sole of claim 24 including a controller configured to, in use, perform a calibration routine to move the or each foot support element and / or the or each wedge member to a predefined position in response to position detection data by the or each position detector.

26. The sole of any preceding claim including a hard stop structure arranged to limit a horizontal displacement of the at least one wedge member.

27. The sole of any preceding claim including an upper insole, optionally wherein the upper sole is padded or cushioned.

28. The sole of any preceding claim, wherein the sole is an insole, an outsole, or a sole insert.

29. A footwear comprising the sole of any preceding claim.

30. A method of using a sole comprising at least one foot support element and at least one wedge member, the method comprising the step of:5 actuating the at least one wedge member to push against at least part of the orthe respective foot support element to lift the or the respective foot support element.

31. The method of claim 30, wherein the sole includes a plurality of foot support elements, the method further comprising the step of:10 individually actuating one or more corresponding wedge members to push againstat least part of each of the plurality of foot support elements to lift each of the plurality of foot support elements.

32. The method of claim 31, further comprising the step of:15 performing a calibration routine to move the or each foot support element and / orthe or each wedge member to a predefined position in response to position detection data detected by at least one position detector.

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