Improved ankle-foot-orthosis

Abstract

Disclosed is an orthosis comprising a foot support element, a connecting element, and a bracing element. The connecting element connects the supporting portion and the bracing element. The orthosis is an ankle-foot-orthosis. The connecting element extends from a lateral side of the foot support element towards a lower end of the bracing element. A lower end of the connecting element is located next to the foot supporting element. The connection element comprises a connecting element lower section extending from the lower end of the connecting element. The connecting element comprises an connecting element upper section. An upper end of the connecting element upper section is located next to the bracing element. The foot support element and the connecting element are made from at least one composite material. The at least one composite material is at least one fibre-reinforced polymer. The connecting element upper section comprises a lower stiffness against bending about the ankle-joint axis than the connecting element lower section.

Description

Improved Ankle-Foot-Orthosis[1] The present invention relates to the field of ankle-foot-orthoses.[2] Ankle-foot-orthoses (AFOs) are used inter alia to treat patients with foot drop, partial paralysis of the lower limbs as well as patients experiencing ankle or foot problems. Ankle- foot-orthoses typically lift the foot when the leg is raised and do thus prevent the foot from being dragged. Further, the risk of tripping over low obstacles because of the foot drop is decreased. Additionally, ankle-foot-orthoses support normal gait. Some AFOs can suitably store mechanical energy during gait and release the stored energy in the terminal stance and pre swing phase of gait.[3] Choo YJ, Chang MC. Commonly Used Types and Recent Development of Ankle-Foot Orthosis: A Narrative Review. Healthcare. 2021; 9(8): 1046. https: / / doi.org / 10.3390 / healthcare9081046 discusses different types of ankle-foot- orthoses.[4] Choo et al. discusses inter alia carbon fibre composite AFOs (CCAFOs). CCAFOs comprise a higher energy storage capacity and, according to Choo, provide a function superior to other orthoses, such as orthoses made from thermoplastic polymers.[5] WO 2020 / 120396 Al discloses an orthosis for a lower limb, with a foot part, which has a sole for supporting a foot, and with at least one leg rail, which extends from the foot part and, in the fitted state, extends along a lower leg and has devices for supporting and / or securing the leg rail on the lower leg, wherein the orthosis is assigned at least one sensor for detecting orthosis parameters, which sensor is coupled to a control device, and the foot part is assigned at least one device coupled to the control device and / or materials for changing the stiffness of the sole.[6] EP 2 276 432 Al discloses a connecting element between two orthopedic components, in particular prosthesis or orthosis components, which are rigidly coupled to one another and comprise a top part and a bottom part. The connecting element has a laminar structure, and at least one sensor is arranged in the connecting element in order to determine an effective moment or an effective force.[7] EP 2 858 605 Al discloses an ankle-foot-orthosis with a foot part, which has a sole for receiving a foot, and with a shin part which, when fitted in place, bears on the frontal aspect of a shin and is connected to the foot part via a medially extending spring, wherein the spring, behind an ankle area, forms a hinge area that allows a movement of the shin part relative to the foot part in the anterior-posterior direction.[8] While the prior art approaches may be satisfactory in some regards, they have certain shortcomings and disadvantages.[9] Common CCAFOs allow for normal bending of the ankle-joint. However, common CCAFOs may show accelerated wear and tear in case of excessive bending, for example when squatting. Care is also often advised when climbing stairs to apply the load to the whole sole of the orthosis and to avoid unsymmetrical loads. With some orthoses, climbing ladders is not advised, with others, it is advised to imperatively place the center of the foot on the rung. According to the best knowledge of the inventors, current CCAFOs exclude sportive activities involving jumps, fast step sequences or sudden movements.

[0010] In summary, common CCAFOs show increased wear and tear when the sole of the CCAFO is exposed to uneven loads, and / or when the ankle is bend more than during normal walking.

[0011] It is therefore an object of the invention to overcome or at least alleviate the shortcomings and disadvantages of the prior art.

[0012] More particularly, it is an object of the present invention to provide an improved ankle-foot-orthosis.

[0013] It is an optional objective of the present invention to provide an ankle-foot-orthosis comprising an increased movement range without increased wear effects.

[0014] It is another optional objective of the present invention to provide an ankle-foot- orthosis comprising an increased movement range while providing a relatively high stiffness against bending about the ankle-joint axis.

[0015] In a first embodiment, an orthosis is disclosed. The orthosis comprises a foot support element, a connecting element and a bracing element.

[0016] The foot support element may comprise a sole-like shape. The foot support element may be configured for supporting a foot of the user, particularly from a lower side of the foot of the user.

[0017] The bracing element may be a leg brace. The bracing element may be configured for being attached and / or fitted to a lower limb of the user, particularly to a lower leg of the user. The lower limb and / or the lower leg may be the lower limb and / or lower leg next to the foot of the user. In other words, if the orthosis is configured for supporting a left foot of the user, the bracing element may be configured for being attached and / or fitted to the left leg and / or the left lower leg. If the orthosis is configured for supporting a right foot of the user, the bracing element may be configured for being attached and / or fitted to the right leg and / or the tight lower leg.

[0018] The connecting element connects the foot support element and the bracing element.

[0019] The connecting element may form a mechanical connection of the foot support element and the bracing element. The connecting element may be a link, such as a fixed link.

[0020] The connecting element may be flexible. In particular, the connecting element be generally flexible against bending about an ankle-joint axis.

[0021] In other words, the connecting element may comprise a stiffness against bending about the ankle-joint axis and further be configured for being bent about the ankle-joint axis repeatedly.

[0022] In a use configuration in which the orthosis is worn by the user, when the foot support element is located under a foot of the user, the bracing element may be located in front of a lower limb, particularly in front of a lower leg, of the user.

[0023] The use configuration may be a configuration in which the orthosis is worn by the user. In other words, the use configuration may be a configuration in which the foot support element is located under the foot of the user and the bracing element is located next to the corresponding lower leg of the user.

[0024] The orthosis may be an ankle-foot-orthosis.

[0025] In the use configuration, the foot support element may be configured for supporting at least a section of the foot of the user.

[0026] In the use configuration, the foot support element may configured for lifting at least the section of the foot of the user when the bracing element is raised.

[0027] The orthosis may be configured for storing energy during at least a first phase of gait by elastic deformation and for delivering a propulsive force during at least a second phase of gait.

[0028] In some embodiments, in the use configuration, the connecting element may not enclose a heel of the foot of the user.

[0029] The connecting element, particularly a connecting element lower section, may extend from a section of the foot support element located below an outer side of an ankle of the user in the use configuration.

[0030] The connecting element lower section may be a lower section of the connecting element.

[0031] The connecting element may extend from the foot support element towards the bracing element around an outer half of a front side of a lower section of the lower limb of the user.

[0032] The section of the foot support element located below an outer side of an ankle of the user in the use configuration may be located next to at least one of a base of a fifth and a fourth base of a metatarsal or between these bases.

[0033] In other words, the section of the foot support element located below an outer side of the ankle of the user in the use configuration may be located below at least one of or between a Tuberositas ossis metatarsale V and a caput metatarsale V.

[0034] In a substantially unbiased configuration of the orthosis, the foot support element and the bracing element may include an angle of 70° to 90°, particularly of 80° to 90°.

[0035] The orthosis may be a in a substantially unbiased configuration when it is exposed to gravity only or when it is worn by a user, but the user does not perform a flexion of an ankle-joint of the leg at which the orthosis is worn.

[0036] The foot support element may comprise a generally sole-like shape defining a first axis along a longer dimension of the foot support element. The bracing element may define a second axis along a longer dimension of the bracing element.

[0037] In particular, the second axis may be defined by a longer dimension of a central section of the bracing element, such as a section of the bracing element extending from a lower end to an upper end of the bracing element in a middle of the bracing element in an orientation of the orthosis corresponding the use configuration.

[0038] Terms like "upper", "lower", "medial" and "lateral" may correspond to a general orientation of the orthosis corresponding to an orientation in the substantially unbiased state.

[0039] The first axis and the second axis may include the angle of 70° to 90°, particularly 80° to 90°, in the substantially unbiased configuration.

[0040] The bracing element may be curved at least around a line which line includes an angle of less than 20°, such as less than 15° with respect to the second axis.

[0041] When the term "curved" is used in the present application, this is intended to generally specify a presence of curvature, such as a curvature obtained by bending a flexible material about at least one axis.

[0042] When the term "twisted" is used in the present application, this is intended to generally specify a presence of twist, such as a twist obtained by twisting a flexible materialabout at least one axis. In other words, the term twisted may refer to a shape obtained when applying a torque resulting in torsion to the flexible material.

[0043] A section may be twisted and curved, e.g. in a case where the two corresponding deformations are superposed.

[0044] The foot support element may comprise a lateral side substantially parallel to the first axis. The lateral side may be a side next to an outer side of the foot of the user in the use configuration.

[0045] The connecting element may comprise an at least partially curved shape.

[0046] The connecting element may extend from the lateral side of the foot support element towards a lower end of the bracing element.

[0047] The connecting elements may comprise a section curved by at least 60°, particularly at least 75°, such as 85° around the second axis.

[0048] A lower end of the connecting element may be located next to the foot supporting element. For example, the lower end of the connecting element may merge into the foot supporting element.

[0049] The connecting element may comprise a connecting element lower section extending from the lower end of the connecting element. The connecting element lower section may be a lower section of the connecting element.

[0050] The connecting element lower section may be curved by an angle of at least 75°, particularly at least 80°, such as at least 85° around the first axis.

[0051] In the use configuration, the connecting element lower section may extend along an outer side of the foot of the user.

[0052] The connecting element lower section may comprise an angle of twist of at most 15°, particularly at most 10°, such as at most 5°, in the substantially unbiased state.

[0053] The connecting element lower section may be substantially not twisted.

[0054] The connecting element lower section may be substantially straight in an orthogonal projection on a plane comprising the first axis and the second axis.

[0055] The connecting element may comprise a connecting element upper section. The connecting element upper section may be an upper section of the connecting element. An upper end of the connecting element upper section may be located next to the bracing element.

[0056] In particular, the connecting element upper section may merge into the bracing element.

[0057] The connecting element upper section may extend at least 5 mm, particularly at least 10 mm from the upper end towards a center of the connecting element.

[0058] The connecting element upper section may extend from the upper end of the connecting element towards the center of the connecting element about a length of at least 2%, preferably at least 4%, and still more preferably at least 6% of a length of the connecting element.

[0059] When reference is made to the length of the connecting element, a length along a coordinate running through middles of cross-sections of the connecting element may be meant.

[0060] The connecting element upper section may comprise an angle of twist of at most 15°, particularly at most 10°, such as at most 5°, in the substantially unbiased state.

[0061] The connecting element upper section may be substantially untwisted.

[0062] The connecting element may comprise a connecting element middle section. The connecting element middle section may be a middle section of the connecting element. The connecting element middle section may extend between the connecting element upper section and the connecting element lower section.

[0063] The connecting element middle section may be curved around the second axis by at least 60°, particularly at least 75°, such as 85°.

[0064] The connecting element middle section may be twisted in the substantially unbiased state. In other words, the connecting element middle section may comprise a shape corresponding to a deformation of, e.g., a flat or bent element resulting from twisting the element.

[0065] The connecting element middle section may comprise an angle of twist of at least 10°, particularly at least 20°, such as 30°, in the substantially unbiased state.

[0066] The bracing element may comprise a curved, plate-like shape. The bracing element may comprise a first section and a second section.

[0067] The first section may extend from the lower end of the bracing element towards an upper end of the bracing element.

[0068] The first section may extend at least 70 mm, preferably at least 100 mm, and still more preferably at least 130 mm and most preferably at least 150 mm from the lower end of the bracing element towards the upper end of the bracing element.

[0069] The first section may extend at along at least 35%, preferably at least 50%, still more preferably at least 65%, such as at least 75% of a length of the bracing element in a direction parallel to the second axis from the lower end of the bracing element.

[0070] The first section of the bracing element may merge into the connecting element upper section.

[0071] The first section may comprise a width of at least 10mm, preferably at least 15 mm, and still more preferably at least 20 mm.

[0072] The second may comprise two outer end portions of the bracing element connecting an upper end and the lower end of the bracing element.

[0073] The second section may further comprise the upper end of the bracing element.

[0074] The second section may comprise a width of at least 10 mm, preferably at least 15 mm between edges of the bracing element at the outer ends and the first section.

[0075] The second section of the bracing element may enclose the first section of the bracing element towards the upper end, particularly towards the upper end and the outer ends of the bracing element.

[0076] The second section may comprise a portion extending at least 5 mm, preferably at least 10 mm, and still more preferably at least 15 mm further from a middle line of the bracing element than at least one other portion of the second section. In other words, said portion of the second section may comprise width of at least 5 mm, preferably at least 10 mm and still more preferably at least 15 mm in a direction orthogonal to the middle line of the bracing element.

[0077] The bracing element may be configured for being connected to a fastening component configured for fastening the bracing element to the lower leg of the user.

[0078] The fastening component may for example comprise one or more belts and / or one or more a hook-and-loop fasteners for fastening and / or affixing the bracing element to the lower leg of the user. The fastening component may also comprise a cushioning.

[0079] The orthosis may comprise the fastening component.

[0080] The foot support element may comprise a foot support middle section. The foot support middle section may be a middle section of the foot support element.

[0081] The foot support middle section may extend from a section of the lateral side of the foot support element.

[0082] The connecting element, particularly the connecting element lower section, may extend from the foot support middle section.

[0083] The lower end of the connecting element may extend from the foot support middle section.

[0084] The foot support middle section may comprise the section of the foot support element located below an outer side of an ankle of the user in the use configuration.

[0085] The section of the foot support element located below an outer side of an ankle of the user in the use configuration may be located next to at least one of a base of a fifth and a fourth base of a metatarsal or between these bases.

[0086] The foot support middle section may be spaced apart from a rear end of the foot support element by at least 5%, particularly at least 10% of a length of the foot support element parallel to the first axis.

[0087] The rear end may be a heel end of the foot support element.

[0088] The foot support middle section may be spaced apart from the rear end of the foot support element by at least 10 mm, particularly at least 15 mm.

[0089] The foot support middle section may be spaced apart from a front end of the foot support element by at least 40%, particularly at least 50%, such as at least 60% of a length of the foot support element parallel to the first axis.

[0090] The front end of the foot support section may be a toe end.

[0091] The foot support middle section may be spaced apart from the front end of the foot support element by at least 80 mm, particularly at least 100 mm, such as at least 120 mm.

[0092] The foot support middle section may extend at least 10 mm, preferably at least 15 mm, at still more preferably at least 20 mm from the lateral side to the medial side of the foot support section.

[0093] The foot support middle section may extend from the lateral side to the medial side of the foot support section about a length of at least 30%, preferably at least 45%, still more preferably about at least 60% of a distance between the lateral side and the medial side.

[0094] The foot support middle section may extend from the lateral side to the medial side. The foot support middle section may comprise a section of the lateral side as well as a section of the medial side.

[0095] The foot support element may comprise a foot support front section extending from the foot support middle section towards the front end of the foot support element. The foot support front section may be a front section of the foot support element.

[0096] The foot support front section may extend from the front end of the foot support element along at least 35%, preferably at least 40%, still more preferably at least 45% of a length of the foot support element towards the front end of the foot support element.

[0097] The foot support front section may extend from the front end of the foot support element towards the front end of the foot support element along a length of at least 80 mm, particularly at least 100 mm, such as at least 120 mm.

[0098] The foot support front section may be at least partially extending along the foot support middle section on a medial side thereof.

[0099] The foot support element may comprise a foot support rear section extending from the foot support middle section towards the rear end of the foot support element.

[0100] The foot support front section may extend from the front end of the foot support element along at least 35%, preferably at least 40%, still more preferably at least 45% of a length of the foot support element towards the rear end of the foot support element.

[0101] The foot support front section may extend from the front end of the foot support element towards rear end of the foot support element along a length of at least 10 mm, particularly at least 15 mm.

[0102] The foot support rear section may be at least partially extending along the foot support middle section on a medial side thereof.

[0103] The foot support element and the connecting element may be made from at least one composite material.

[0104] The first section of the bracing element may be made from at least one composite material.

[0105] The foot support element, the connecting element and the bracing element may be made from at least one composite material.

[0106] The foot support element, the connecting element and the first section of the bracing element, particularly also the second section of the bracing element, may be integrally formed.

[0107] In other words, these elements and section(s) may be made of a single piece or formed into a single piece.

[0108] The at least one composite material may be at least one fibre-reinforced polymer.

[0109] The at least one fibre-reinforced polymer may comprise a polymer matrix and fibres of at least one material.[HO] The fibres may be arranged in a plurality of layers.

[0111] The at least one fibre-reinforced polymer may comprise a polyester resin-based matrix or an epoxy resin-based matrix.

[0112] Use of a polyester resin-based matrix may be optionally advantageous because of better availability and / or a higher cost-efficiency.

[0113] Use of an epoxy resin-based material may optionally advantageously contribute to improved mechanical properties of the material.

[0114] The fibre-reinforced polymer may comprise glass fibres and carbon fibres.

[0115] The foot support element, the connecting element and the first section of the bracing element may comprise an outer layer comprising glass fibres.

[0116] However, in some embodiments, at least one layer inside the outer layer may also comprise glass fibres, particularly in layers of the foot support element.

[0117] The foot support element, the connecting element and the first section of the bracing element may each comprise a plurality of layers of carbon fibres.

[0118] The second section of the bracing element may be made from the least one fibre- reinforced polymer.

[0119] For example, the second section of the bracing element may be made from glassfibre reinforced polymer. In other words, in the example, a fibre-reinforcement of the polymer of the second section only comprises layers of glass fibres and essentially no other fibres.

[0120] The connecting element upper section may comprise a lower stiffness against bending about the ankle-joint axis than the connecting element lower section.

[0121] In other words, the stiffness against bending about the ankle-joint axis may correspond to a stiffness against bending the bracing element towards the front of the foot support element. In still other words, said stiffness may be a stiffness against bending resulting from a flexion of the ankle of the user in the use configuration.

[0122] The stiffness may be indicated in a bending torque per bending angle around the ankle-joint axis.

[0123] The ankle-joint axis may be substantially perpendicular to the first and the second axis.

[0124] The connecting element upper section may comprise a lower second area moment than the connecting element lower section.

[0125] The second area moment may be a second area moment against bending about a bending axis substantially parallel to a horizontal tangent line of surface the connecting element, wherein the point of tangency is at a center of the respective section of the connecting element, such as at a center between the two substantially vertical edges of the surface. The surface may be the surface proximal to a lower limb of the user or a surface opposite to the lower limb of the user.

[0126] In other words, the point of tangency may be proximal to a centroid of a horizontal cross-section of the respective section of the connecting element.

[0127] In other words, said bending axis may be perpendicular to a length of the connecting element.

[0128] The connecting element upper section may comprise a lower thickness than the connecting element lower section. For example, the connecting element upper section may comprise a lower number of fibre-layers than the connecting element lower section.

[0129] The connecting element middle section and the connecting element lower section may comprise a higher stiffness against bending about the ankle-joint axis than the connecting element upper section.

[0130] The connecting element upper section may comprise a lower second area moment than the connecting element middle section.

[0131] The connecting element upper section may comprise a lower thickness than the connecting element middle section. For example, the connecting element upper section may comprise a lower number of fibre-layers than the connecting element lower section.

[0132] Cross-sections of the connecting element may comprise a generally line-like shape. Said cross-sections may comprise a length I of the cross-section and a width w of the crosssection, and wherein l>5*w, particularly wherein l>10*w.

[0133] Cross-sections of the connecting element upper section may be (a) substantially straight or (b) curved, comprising a curvature with a radius of curvature Ru>30mm, particularly Ru>40mm, such as Ru>50mm.

[0134] End portions of cross-sections of the connecting element lower section may be more curved than center portions of these cross-sections, particularly comprising a curvature with a radius of curvature RL-I of 1.5-8 mm, such as 2-6 mm.

[0135] Center portions of cross-sections of the connecting element lower section may be (a) substantially straight or (b) curved, comprising a curvature with a radius of curvature RL-2>10mm, particularly RL-2>20mm, such as RL-2>30mm.

[0136] End portions of cross-sections of the connecting element lower section may be more curved than the center-portions of these cross-sections. Ends of the end portions may comprise an orthogonal distance dL of 1.5-4 mm, particularly 2-3 mm with respect to straight lines extending the center portion towards the ends of the cross-sections of the connecting element lower section.

[0137] End portions of cross-sections of the connecting element middle section may be more curved than center portions of these cross-sections, particularly comprising a curvature with a radius of curvature RM-I of 1.5-8 mm, such as 2-6 mm.

[0138] Center portions of cross-sections of the connecting element middle section may be (a) substantially straight or (b) curved, comprising a curvature with a radius of curvature RM-2>10mm, particularly RM-2>20mm, such as RM-2>30mm.

[0139] The end portions of cross-sections of the connecting element middle section may be more curved than the center-portions of these cross-sections. Ends of the end portions may comprise an orthogonal distance dn of 1.5-4 mm, particularly 2-3 mm with respect to straight lines extending the center portion towards the ends of the cross-sections of the connecting element middle section.

[0140] The connecting element middle section may comprise a shape resulting in a higher second area moment than a substantially unbent ribbon-shaped strip of material comprising a same width, thickness and / or length, particularly further comprising a same twist.

[0141] The connecting element lower section may comprise a shape resulting in a higher second area moment than a straight line comprising a same width, thickness and / or length.

[0142] In other words, the second area moment resulting from the shape may be higher than a second area moment of a piece of material comprising similar dimensions but being unbent.

[0143] In cases where the middle section is twisted, the piece of material comprising similar dimensions but being unbent may comprise a same twist.

[0144] The foot support middle section may comprise a higher stiffness than the foot support front section.

[0145] The foot support middle section may comprise a higher stiffness than the foot support rear section.

[0146] The foot support middle section may comprise a higher number of layers of carbon fibres than at least one of the foot support front section and the foot support rear section.

[0147] The foot support middle section may comprise a higher thickness than at least one of the foot support front section and the foot support rear section.

[0148] The second section of the bracing element may comprise a lower stiffness than the first section of the bracing element.

[0149] The second section of the bracing element may comprise a lower thickness than the first section of the bracing element, such as a thickness of at most 50% of the thickness of the first section of the bracing element.

[0150] The orthosis may be configured, in the use configuration, for repeated bending about the ankle-joint axis by an angle of at least 35°, preferably at least 40° and still more preferably at least 45°.

[0151] The orthosis may comprise a stiffness against bending about the ankle-joint axis of at least 0.7 Nm / °, particularly at least 0.9 Nm / °.

[0152] As set out above, the stiffness may be a stiffness against bending resulting from flexion of the ankle-joint. The stiffness may for example be measured by pushing the bracing element towards the foot support front section when the foot support front section is located on a substantially flat surface.

[0153] The orthosis may comprise a stiffness against bending about the ankle-joint axis of at least 0.7 Nm / ° and may be configured, in the use configuration, for repeated bending about the ankle-joint axis by an angle of at least 35°, preferably at least 40° and still more preferably at least 45°.

[0154] The orthosis may comprise a stiffness against bending about the ankle-joint axis of 0.7 Nm / ° to 2 Nm / °, particularly 0.75 Nm / ° to 1.5 Nm / ° and may be configured, in the use configuration, for repeated bending about the ankle-joint axis by an angle of at least 35°, preferably at least 40° and still more preferably at least 45°. Thus, optionally advantageously, a more rigid orthosis for high energy storage and high propulsive forces may be provided that still allows the user to perform most movements.

[0155] The orthosis may comprise a stiffness against bending about the ankle-joint axis of 0.3 to 0.7 Nm / °, particularly 0.35 Nm / ° to 0.6 Nm / °.

[0156] The orthosis may comprise a stiffness against bending about the ankle-joint axis of 0.35 Nm / ° to 0.6 Nm / ° and may be configured, in the use configuration, for repeated bending about the ankle-joint axis by an angle of at least 35°, preferably at least 40° and still more preferably at least 45°. Thus, optionally advantageously, a more flexible orthosis for limited mechanical support may be provided, which may allow the user to perform most movements.

[0157] When the orthosis is bent about the ankle-joint axis, for orthosis-bending angles above 10°, particularly above 5°, a ratio of a bending angle of the connecting element upper section to a bending angle of the foot support element about the ankle-joint axis may amount to at most 1: 1, particularly to at most 2:3.

[0158] In other words, a bending angle with respect to the substantially unbiased state of the orthosis, that is, an orthosis bending angle, may be provided by the connecting element upper section and the foot support element. Said orthosis bending angle may comprise a bending angle resulting from elastic deformation of the connecting element upper section and the foot support element. A bending angle resulting from elastic deformation of the connecting element upper section may amount to at most 50%, particularly at most 40% of the orthosis bending angle for orthosis bending angles above 10°, particularly above 5°. A bending angle resulting from elastic deformation of the foot support element may amount to at least 50%, particularly at least 60% of the orthosis bending angle for orthosis bending angles above 10°, particularly above 5°.

[0159] The person skilled in the art will easily understand that, not-withstanding the above, other sections of the orthosis may also comprise an elastic deformation during bending about the ankle-joint axis.

[0160] When bent about the ankle-joint axis, for orthosis-bending angles below 5°, a ratio of a bending angle of the connecting element upper section to a bending angle of the foot support element about the ankle-joint axis may amount to at most 1 :2, particularly to at most 1 :2.5.

[0161] Thus, optionally advantageously, strain of the connecting element lower section may be limited, particularly in cases where the orthosis comprises a stiffness against bending about the ankle-joint axis of 0.7 Nm / ° to 2 Nm / °, particularly 0.75 Nm / ° to 1.5 Nm / °, where strain of the connecting element lower section may be a limiting factor for durability of the orthosis. Hence, optionally advantageously, durability of the orthosis may be increased by means of the above repartition of the bending angle.

[0162] The orthosis may further comprise a sensor system.

[0163] The sensor system may comprise at least one or a plurality of strain gauge(s).

[0164] The at least one strain gauge(s) may be at least two strain gauges.

[0165] The at least one strain gauge(s) may be located at the bracing element.

[0166] The at least one strain gauge(s) may be located at a lower end of the bracing element.

[0167] The at least one strain gauge(s) may be located at a side of the bracing element facing a leg of the user in the use configuration.

[0168] The at least one strain gauge(s) may be located on an outside sensor layer of the fibre-reinforced polymer or between the outside sensor layer and a first layer below the outside sensor layer of the fibre-reinforced polymer.

[0169] The outside sensor layer may comprise glass fibres.

[0170] The outside sensor layer may be a protective layer. For example, the protective layer may comprise a lacquer, a gel coat or a thermoplastic polymer. Thus, optionally advantageously, a durability of the sensor system and / or cleanability of the orthosis may be improved.

[0171] The outside sensor layer may be located on a section of an outer side of the outer layer. In other words, the outer layer may be outer layer of fibres, and the outside sensor layer may be a layer located outside the outer layer of fibres.

[0172] The sensor system may comprise at least one inertial measurement unit configured for sensing at least a translatory acceleration and an orientation.

[0173] The inertial measurement unit may be configured for determining a translatory movement and / or derivatives thereof in all three spatial directions and for determining rotatory movements and / or derivatives thereof around all three spatial axes. In other words, the inertial measurement unit may be a 6-degrees-of-freedom inertial measurement unit.

[0174] The sensor system may comprise a data processing unit configured for processing data generated by the sensor system.

[0175] For example, the data processing unit may be configured for processing at least one signal obtained from the strain gauge(s) and / or the inertial measurement unit.

[0176] The data processing unit may be located at the bracing element, particularly at the side of the bracing element facing the leg of the user in the use configuration.

[0177] The data processing unit may be configured for transmitting data based on the data generated by the sensor system.

[0178] The sensor system, may be configured for transmitting data by wireless transmission, particularly according to Bluetooth Low Energy-standard. In particular, the data processing unit may be configured for transmitting data by wireless transmission, particularly according to Bluetooth Low Energy-standard.

[0179] The data processing unit may comprise a data transmission component configured for wireless data transmission. For example, wherein the data processing unit may be configured for data transmission according to a Bluetooth Low Energy-standard.

[0180] Data transmission by the sensor system allows for processing and / or storage on another data processing system, hence optionally advantageously allowing for further processing, such as further analysis or storage over an extended time.

[0181] The data processing unit may comprise at least one or a plurality of analog-to- digital converter(s). The analog-to-digital converter(s) may for example be configured for converting at least one signal obtained from strain gauge(s).

[0182] The analog-to-digital converter(s) may comprise a resolution of at least 12 bit. Thus, optionally advantageously, sufficiently accurate reconstruction of a bending angle occurring and / or forces acting in use of the orthosis may be enabled to allow for analysis of an interaction of the user and the orthosis.

[0183] The analog-to-digital converter(s) may comprise a sampling frequency of at least 35 Hz, particularly at least 50 Hz. Thus, optionally advantageously, a temporal resolution may be sufficient for a meaningful analysis of interaction of user and orthosis.

[0184] The data processing unit may comprise a distance of at most 50 mm to the strain gauge(s), particularly at most 20 mm, such as at most 10 mm.

[0185] The data processing unit may comprise a distance of at most 50 mm to the inertial measurement unit, particularly at most 20 mm, such as at most 10 mm.

[0186] The data processing unit and the inertial measurement unit may be integrated. In other words, the data processing unit and the inertial measurement unit may be arranged on a same circuit board, such as a same printed circuit board, or they may be provided in a same circuit packaging.

[0187] Also disclosed are a method, a system, a use and a computer program product. Advantages and details discussed in the context of the orthosis may respectively apply also in the context of the method and / or the use.

[0188] In a second embodiment, a system is disclosed.

[0189] The system comprises the orthosis. The system further comprises a computer device. The computer device is configured for receiving data from the sensor system, particularly from the data processing unit.

[0190] The computer device may be configured for data transmission according to the Bluetooth Low Energy-standard.

[0191] The computer device may be configured for storing the data received from the sensor system.

[0192] The system may be configured for determining a strain of a portion of the orthosis based on the processed signal obtained from the at least one strain gauge(s).

[0193] The system may be configured for determining at least one of a bending torque of the orthosis about the ankle-joint-axis and a force transmitted by the bracing element based on the determined strain of the portion of the orthosis.

[0194] The system, particularly the data processing unit and / or the computer device, may be configured for compensating a thermal drift of the strain gauge(s). In other words, a divergence of a signal of the strain gauge(s) corresponding to the substantially unbiased state of the orthosis caused by thermal effects, e.g., a change of ambient temperature, may be compensated by the data processing unit and / or the computer device.

[0195] The system, particularly the data processing unit and / or the computer device, may be configured for determining the thermal drift of the strain gauge(s) based on the at least one signal obtained from the strain gauge(s) in the substantially unbiased state of the orthosis. Thus, optionally advantageously, measurement accuracy may be improved and, for example, a setup with less than four strain gauges may not be necessary.

[0196] The system, particularly the computer device, may be configured for determining forces resulting from an ankle pronation and / or supination. In other words, the system may be configured for determining a bending strain of the orthosis about an axissubstantially parallel to the first axis, that is, the axis substantially parallel to the longer dimension of the foot support element. Thus, optionally advantageously, for example, analysis of the interaction of the user and the orthosis may be facilitated, allowing e.g. for selection of an appropriate insole and / or design of an individualized insole.

[0197] The system, particularly the computer device, may be configured for determining forces resulting from ankle flexion and / or ankle extension. Thus, optionally advantageously, an interaction of the user and the orthosis with respect to ankle flexion and / or extension may be enabled, allowing e.g. for identification of an optimal position of the orthosis in a flexed ankle configuration and an extended ankle configuration. Thus, optionally advantageously, a selection of suitable shim and / or design or adaption of an individualized shim under heel may be facilitated.

[0198] Determining the forces resulting from ankle flexion and / or extension, particularly in combination with the forces resulting from pronation and / or supination, may optionally advantageously facilitate selection of an orthosis comprising an appropriate stiffness and / or selection of a stiffness for an individualized orthosis.

[0199] The system may be configured for determining a phase of gait of the user based on the data sensed by the inertial measurement unit of the sensor system.

[0200] The inertial measurement unit may be a first inertial measurement unit. The system may further comprise at least one wearable sensor component. The wearable sensor component may comprise a second inertial measurement unit. The second inertial measurement unit may be configured for sensing at least a second translatory acceleration and a second orientation. Further, the wearable sensor component may be configured for transmitting at least the second translatory acceleration and the second orientation to the computer device.

[0201] The wearable sensor component may be configured for being worn at a leg or foot of the user opposite to the lower limb of the user with which the orthosis is used.

[0202] The system may be configured for determining the phase of gait of the user based on the data sensed by the first inertial measurement unit of the sensor system and the data sensed by the second inertial measurement unit.

[0203] The system, particularly the computer device, may be configured for outputting the phase of gait of the user. Thus, optionally advantageously, analysis of the interaction of the user and the orthosis may be facilitated.

[0204] The system, particularly the computer device, is configured for determining for a plurality of time intervals the strain of the portion of the orthosis, particularly the at leastone of the bending torque and the force transmitted by the bracing element, and the phase of gait.

[0205] The system, particularly the computer device, may be configured for determining for the plurality of time intervals the force transmitted by the bracing element and the phase of gait.

[0206] The time intervals may comprise a duration of at most 0.1 s, preferably at most 0.05 s. Thus, optionally advantageously, a temporal resolution suitable for showing all relevant interactions during gait may be provided, thus further facilitating analysis of the interaction of the user and the orthosis.

[0207] The at least one wearable sensor component may be a first wearable sensor component. The first wearable sensor component may be configured for being worn at a leg of the user opposite to the lower limb of the user with which the orthosis is used.

[0208] The system may further comprise a second wearable sensor component. The second wearable sensor component may comprise a third inertial measurement unit. The third inertial measurement unit may be configured for sensing at least a third translatory acceleration and a third orientation. The second wearable sensor component may be configured for transmitting at least the third translatory acceleration and the third orientation to the computer device.

[0209] The second wearable sensor component may for example be integrated into an insole, a shoe. The second wearable sensor component may also be attached to a belt to be strapped onto a foot of the user. In other words, the second wearable sensor component may be designed to be securely fastened or attached to the user's foot using a flexible belt or strap.

[0210] The second wearable sensor component may be configured for being worn at a foot of the user opposite to the lower limb of the user with which the orthosis is used.

[0211] The system, particularly the sensor system, may comprise an additional inertial measurement unit. The additional inertial measurement unit may be configured for sensing an additional translatory acceleration and an additional orientation.

[0212] The additional sensor component may be configured for being worn at a foot of the lower limb of the user with which the orthosis is used.

[0213] The sensor system of the orthosis may comprise the additional inertial measurement unit. The sensor system may be configured for transmitting the additional translatory acceleration and the additional orientation to the computer device.

[0214] The system may comprise an additional wearable sensor component comprising the additional inertial measurement unit. The additional wearable sensor component may be configured for transmitting the additional translatory acceleration and the additional orientation to the computer device.

[0215] The system, particularly the computer device, may be configured for determining an angle of flexion of an ankle of the user opposite to the lower limb of the user with which the orthosis is used.

[0216] The system, particularly the computer device, may be configured for determining an angle of flexion of an ankle of the user with which the orthosis is used.

[0217] The system, particularly the computer device, may be configured for determining a gait symmetry of a left lower limb and right lower limb of the user.

[0218] In a third embodiment, a method for making an orthosis is disclosed. The method comprises forming a fibre-reinforced polymer to obtain the foot support element, the connecting element and the first section of the bracing element, and obtaining an orthosis as disclosed above.

[0219] The method may comprise forming a fibre-reinforced polymer comprising carbon fibres and glass fibres to obtain the foot support element, the connecting element and the bracing element.

[0220] In a fourth embodiment, a method for treatment of at least one of foot drop, ankle problems and foot problems comprising providing an orthosis according to any of the orthosis embodiments to a user is disclosed.

[0221] In a fifth embodiment, a method is disclosed. The method comprises the computer device receiving sensor data from the orthosis comprising the sensor system, particularly as discussed above. Further, the method comprises the computer device processing the sensor data and thus generating a processing result. The method also comprises outputting the processing result.

[0222] The sensor data may relate to at least one or a plurality of strain gauge(s) located at the orthosis.

[0223] The sensor data may comprise strain data, wherein the strain data may be based on a processed signal obtained from the strain gauge(s). For example, the sensor data may be obtained by the data processing unit based on the at least one signal obtained from the strain gauge(s).

[0224] The sensor data may also relate at least one inertial measurement unit located at the orthosis. The sensor data may also comprise the acceleration and / or the orientation.

[0225] The method may comprise the computer device receiving sensor data from the at least one wearable sensor component comprising another inertial measurement unit, such as a second and / or a third inertial measurement unit discussed above. In particular, the method may comprises receiving said sensor data from a system as discussed above.

[0226] Further, the method may comprise processing the data received from the at least one wearable sensor component as well as the sensor data.

[0227] The computer device receiving the sensor data from the orthosis comprising the sensor system may further comprise the computer device receiving sensor data from at least two inertial measurement units, such as the inertial measurement unit and the additional inertial measurement unit.

[0228] The method may comprise the computer device receiving the sensor data by wireless transmission, particularly according to a Bluetooth Low Energy-standard.

[0229] The method may comprise the computer device receiving the sensor data from a processing unit of the orthosis.

[0230] The at least one strain gauge(s) may be at least two strain gauges.

[0231] Processing the sensor data may comprise the computer device determining a strain of a portion of the orthosis based the strain data.

[0232] Processing the sensor data may also comprise determining at least one of a bending torque of the orthosis about the ankle-joint-axis and a force transmitted by the bracing element based on the determined strain of the portion of the orthosis.

[0233] Additionally or alternatively, processing the sensor data may further comprise compensating a thermal drift of the strain gauge(s), particularly based on the at least one signal obtained from the strain gauge(s) in a substantially unbiased state of the orthosis.

[0234] Processing the sensor data may comprise the computer device determining forces resulting from an ankle pronation and / or supination. As discussed above, thus, optionally advantageously, for example, analysis of the interaction of the user and the orthosis may be facilitated, allowing e.g. for selection of an appropriate insole and / or design of an individualized insole.

[0235] Processing the sensor data comprises the computer device determining forces resulting from ankle flexion and / or ankle extension. Thus, optionally advantageously, asdiscussed above, an interaction of the user and the orthosis with respect to ankle flexion and / or extension may be enabled.

[0236] Processing the sensor data may comprise the computer device determining a phase of gait of the user based on the the sensor data relating to the inertial measurement unit(s), particularly the above-discussed acceleration(s) and / or orientation(s).

[0237] In a sixth embodiment, a use of an orthosis according to any of the orthosis embodiments for treatment of at least one of foot drop, ankle problems and foot problems of a user is disclosed.

[0238] In a seventh embodiment, a use of the above-disclosed system for selecting an insole and / or a shim for an ankle-foot-orthosis for the user is disclosed.

[0239] In an eighth embodiment, a use of the above-disclosed system for designing an individualized insole and / or a shim for use with the ankle-foot-orthosis for the user is disclosed.

[0240] In a nineth embodiment, a use of the above-disclosed system for selecting a stiffness of the ankle-foot-orthosis for the user is disclosed.

[0241] In a tenth embodiment, a use of the above-disclosed system for designing a stiffness of the ankle-foot-orthosis for the user is disclosed.

[0242] In an eleventh embodiment, a computer program product is disclosed.

[0243] The computer program product comprises instructions which, when the program is executed by a computer device, cause the computer device to carry out a method, such as the method of the fifth embodiment.

[0244] In a twelfth embodiment, a method, comprising providing the orthosis and the computer program product.

[0245] The method may further comprise providing the at least one wearable sensor component comprising the second inertial measurement unit. In other words, the method may comprise providing the first wearable sensor component.

[0246] The method may further comprises providing the second wearable sensor component comprising a third inertial measurement unit.

[0247] The method may comprise further providing the additional inertial measurement unit.

[0248] The following embodiments also form part of the invention.Orthosis embodiments

[0249] Below, embodiments of an orthosis will be discussed. The orthosis embodiments are abbreviated by the letter "O" followed by a number. Whenever reference is herein made to the "orthosis embodiments", these embodiments are meant.01. Orthosis, wherein the orthosis comprises- a foot support element, a connecting element, and a bracing element, wherein the connecting element connects the supporting portion and the bracing element.02. The orthosis according to 01, wherein in a use configuration in which the orthosis is worn by the user, when the foot support element is located under a foot of the user, the bracing element is located in front of a lower limb, particularly in front of a lower leg, of the user.03. The orthosis according to any of the preceding embodiments, wherein the orthosis is an ankle-foot-orthosis.04. The orthosis according to any of the preceding embodiments, wherein in the use configuration, the foot support element is configured for supporting at least a section of the foot of the user, particularly wherein the foot support element is configured for lifting at least the section of the foot of the user when the bracing element is raised.05. The orthosis according to the any of the preceding embodiments, wherein the orthosis is configured for storing energy during at least a first phase of gait by elastic deformation and for delivering a propulsive force during at least a second phase of gait.06. The orthosis according to any of the preceding embodiments, wherein in the use configuration, the connecting element does not enclose a heel of the foot of the user.07. The orthosis according to any of the preceding embodiments, wherein the connecting element, particularly a connecting element lower section, extends from a section of the foot support element located below an outer side of an ankle of the user in the use configuration.08. The orthosis according to any of the preceding embodiments, wherein the connecting element extends from the foot support element towards the bracing element around an outer half of a front side of a lower section of the lower limb of the user.09. The orthosis according to any of the two preceding embodiments, wherein the section of the foot support element located below an outer side of an ankle of the user in the use configuration is located next to at least one of a base of a fifth and a fourth base of a metatarsal or between these bases.In other words, the section of the foot support element located below an outer side of the ankle of the user in the use configuration may be located below at least one of or between a Tuberositas ossis metatarsale V and a caput metatarsale V.010. The orthosis according to any of the preceding embodiments, wherein in a substantially unbiased configuration of the orthosis, the foot support element and the bracing element include an angle of 70° to 90°, particularly of 80° to 90°.Oil. The orthosis according to any of the preceding embodiments, wherein the foot support element comprises a generally sole-like shape defining a first axis along a longer dimension of the foot support element, and wherein the bracing element defines a second axis along a longer dimension of the bracing element.012. The orthosis according to any of the two preceding embodiments, wherein the first axis and the second axis include the angle of 70° to 90°, particularly 80° to 90°, in the substantially unbiased configuration.013. The orthosis according to any of the preceding embodiments with the features of 3a, wherein the bracing element is curved at least around a line which line includes an angle of less than 20°, such as less than 15° with respect to the second axis.014. The orthosis according to any of the preceding embodiments, particularly with the features of Oil, wherein the foot support element comprises a lateral side substantially parallel to the first axis.015. The orthosis according to any of the preceding embodiments, wherein the connecting element comprises an at least partially curved shape.016. The orthosis according to any of the preceding embodiments, particularly with the features of 014, wherein the connecting element extends from the lateral side of the foot support element towards a lower end of the bracing element.017. The orthosis according to the preceding embodiment, wherein the connecting elements comprises a section curved by at least 60°, particularly at least 75°, such as 85° around the second axis.018. The orthosis according to any of the preceding embodiments with the features of 016, wherein a lower end of the connecting element is located next to, particularly merges into, the foot supporting element, and wherein the connection element comprises aconnecting element lower section extending from the lower end of the connecting element, particularly wherein the connecting element lower section is curved by an angle of at least 75°, particularly at least 80°, such as at least 85° around the first axis.019. The orthosis according to the preceding embodiment, wherein in the use configuration, the connecting element lower section extends along an outer side of the foot of the user.020. The orthosis according to any of the preceding embodiments with the features of 015, wherein the connecting element lower section comprises an angle of twist of at most 15°, particularly at most 10°, such as at most 5°, in the substantially unbiased state.021. The orthosis according to the preceding embodiment, wherein the connecting element lower section is substantially not twisted.022. The orthosis according to any of the preceding embodiments with the features of 015, wherein the connecting element lower section is substantially straight in an orthogonal projection on a plane comprising the first axis and the second axis.023. The orthosis according to any of the preceding embodiments, particularly with the features of 015, wherein the connecting element comprises an connecting element upper section, wherein an upper end of the connecting element upper section is located next to the bracing element, particularly wherein the connecting element upper section merges into the bracing element.024. The orthosis according to the preceding embodiment, wherein the connecting element upper section extends at least 5 mm, particularly at least 10 mm from the upper end towards a center of the connecting element.025. The orthosis according to any of the two preceding embodiments, wherein the connecting element upper section extends from the upper end of the connecting element towards the center of the connecting element about a length of at least 2%, preferably at least 4%, and still more preferably at least 6% of a length of the connecting element.026. The orthosis according to any of the preceding embodiments with the features of 023, wherein the connecting element upper section comprises an angle of twist of at most 15°, particularly at most 10°, such as at most 5°, in the substantially unbiased state.027. The orthosis according to the preceding embodiment, wherein the connecting element upper section is substantially untwisted.028. The orthosis according to any of the preceding embodiments, particularly with the features of at least one of 015 and 023, wherein the connecting element comprises a connecting element middle section, wherein the connecting element middle sectionextends between the connecting element upper section and the connecting element lower section.029. The orthosis according to the preceding embodiment, particularly with the features of 017, wherein the connecting element middle section is curved around the second axis by at least 60°, particularly at least 75°, such as 85°.030. The orthosis according to any of the preceding embodiments with the features of 028, wherein the connecting element middle section is twisted in the substantially unbiased state.031. The orthosis according to the preceding embodiment, wherein the connecting element middle section comprises an angle of twist of at least 10°, particularly at least 20°, such as 30°, in the substantially unbiased state.032. The orthosis according to any of the preceding embodiments, wherein the bracing element comprises a curved, plate-like shape, wherein the bracing element comprises a first section and a second section.033. The orthosis according to the preceding embodiment, wherein the first section extends from the lower end of the bracing element towards an upper end of the bracing element.034. The orthosis according to any of the two preceding embodiments, wherein the first section extends at least 70 mm, preferably at least 100 mm, and still more preferably at least 130 mm and most preferably at least 150 mm from the lower end of the bracing element towards the upper end of the bracing element.035. The orthosis according to any of the three preceding embodiments, wherein the first section extends at along at least 35%, preferably at least 50%, still more preferably at least 65%, such as at least 75% of a length of the bracing element in a direction parallel to the second axis from the lower end of the bracing element.036. The orthosis according to any of the preceding embodiments with the features of 032, particularly with the features of 023, wherein the first section of the bracing element merges into the connecting element upper section.037. The orthosis according to any of the preceding embodiments with the features of 032, wherein the first section comprises a width of at least 10mm, preferably at least 15 mm, and still more preferably at least 20 mm.038. The orthosis according to any of the preceding embodiments with the features of 032, wherein the second comprises two outer end portions of the bracing element connecting an upper end and the lower end of the bracing element.039. The orthosis according to the preceding embodiment, wherein the second section further comprises the upper end of the bracing element.040. The orthosis according to any of the two preceding embodiments, wherein the second section comprises a width of at least 10 mm, preferably at least 15 mm between edges of the bracing element at the outer ends and the first section.041. The orthosis according to any of the preceding embodiments with the features of 038, wherein the second section of the bracing element encloses the first section of the bracing element towards the upper end, particularly towards the upper end and the outer ends of the bracing element.042. The orthosis according to any of the preceding embodiments with the features of 038, wherein the second section comprises a portion extending at least 5 mm, preferably at least 10 mm, and still more preferably at least 15 mm further from a middle line of the bracing element than at least one other portion of the second section.043. The orthosis according to any of the preceding embodiments, wherein the bracing element is configured for being connected to a fastening component configured for fastening the bracing element to the lower leg of the user.044. The orthosis according to the preceding embodiment, wherein the orthosis comprises the fastening component.045. The orthosis according to any of the preceding embodiments, wherein the foot support element comprises a foot support middle section.046. The orthosis according to any of the preceding embodiments with the features of 045, wherein the foot support middle section extends from a section of the lateral side of the foot support element.047. The orthosis according to any of the preceding embodiments with the features of 045, particularly with the features of 018, wherein the connecting element, particularly the connecting element lower section, extends from the foot support middle section.048. The orthosis according to any of the preceding embodiments with the features of 045, wherein the lower end of the connecting element extends from the foot support middle section.049. The orthosis according to any of the preceding embodiments with the features of 07 and 045, wherein the foot support middle section comprises the section of the foot support element located below an outer side of an ankle of the user in the use configuration, particularly wherein the section of the foot support element located belowan outer side of an ankle of the user in the use configuration is located next to at least one of a base of a fifth and a fourth base of a metatarsal or between these bases..050. The orthosis according to any of the preceding embodiments with the features of 046, wherein the foot support middle section is spaced apart from a rear end of the foot support element by at least 5%, particularly at least 10% of a length of the foot support element parallel to the first axis.051. The orthosis according to any of the preceding embodiments with the features of 046, wherein the foot support middle section is spaced apart from the rear end of the foot support element by at least 10 mm, particularly at least 15 mm.052. The orthosis according to any of the preceding embodiments with the features of 046, wherein the foot support middle section is spaced apart from a front end of the foot support element by at least 40%, particularly at least 50%, such as at least 60% of a length of the foot support element parallel to the first axis.053. The orthosis according to any of the preceding embodiments with the features of 046, wherein the foot support middle section is spaced apart from the front end of the foot support element by at least 80 mm, particularly at least 100 mm, such as at least 120 mm.054. The orthosis according to any of the preceding embodiments with the features of 046, wherein the foot support middle section extends at least 10 mm, preferably at least 15 mm, at still more preferably at least 20 mm from the lateral side to the medial side of the foot support section.055. The orthosis according to any of the preceding embodiments with the features of 046, wherein the foot support middle section extends from the lateral side to the medial side of the foot support section about a length of at least 30%, preferably at least 45%, still more preferably about at least 60% of a distance between the lateral side and the medial side.056. The orthosis according to any of the preceding embodiments with the features of 046, wherein the foot support middle section extends from the lateral side to the medial side, particularly wherein the foot support middle section comprises a section of the lateral side as well as a section of the medial side.057. The orthosis according to any of the preceding embodiments with the features of 045, wherein the foot support element comprises a foot support front section extending from the foot support middle section towards the front end of the foot support element.058. The orthosis according to the preceding embodiment, wherein the foot support front section extends from the front end of the foot support element along at least 35%,preferably at least 40%, still more preferably at least 45% of a length of the foot support element towards the front end of the foot support element.059. The orthosis according to any of the two preceding embodiments, wherein the foot support front section extends from the front end of the foot support element towards the front end of the foot support element along a length of at least 80 mm, particularly at least 100 mm, such as at least 120 mm.060. The orthosis according to any of the preceding embodiments with the features of 057, wherein the foot support front section is at least partially extending along the foot support middle section on a medial side thereof.061. The orthosis according to any of the preceding embodiments with the features of 045, wherein the foot support element comprises a foot support rear section extending from the foot support middle section towards the rear end of the foot support element.062. The orthosis according to the preceding embodiment, wherein the foot support front section extends from the front end of the foot support element along at least 35%, preferably at least 40%, still more preferably at least 45% of a length of the foot support element towards the rear end of the foot support element.063. The orthosis according to any of the two preceding embodiments, wherein the foot support front section extends from the front end of the foot support element towards rear end of the foot support element along a length of at least 10 mm, particularly at least 15 mm.064. The orthosis according to any of the preceding embodiments with the features of 061, wherein the foot support rear section is at least partially extending along the foot support middle section on a medial side thereof.065. The orthosis according to any of the preceding embodiments, wherein the foot support element and the connecting element are made from at least one composite material.066. The orthosis according to any of the preceding embodiments with the features 032, wherein the first section of the bracing element is made from at least one composite material.067. The orthosis according to the two preceding embodiments, wherein the foot support element, the connecting element and the bracing element are made from at least one composite material.068. The orthosis according to any of the preceding embodiments, wherein the foot support element, the connecting element and first section of the bracing element,particularly the first section and the second section of the bracing element, are integrally formed.069. The orthosis according to any of the preceding embodiments with the features of 065, wherein the at least one composite material is at least one fibre-reinforced polymer.070. The orthosis according to the preceding embodiment, wherein the at least one fibre- reinforced polymer comprises a polymer matrix and fibres of at least one material.071. The orthosis according to any of the two preceding embodiments, wherein the fibres are arranged in a plurality of layers.072. The orthosis according to any of the three preceding embodiments, wherein the at least one fibre-reinforced polymer comprises a polyester resin-based matrix or an epoxy resin-based matrix.073. The orthosis according to any of the preceding embodiments with the features of 069, particularly 070, wherein the fibre-reinforced polymer comprises glass fibres and carbon fibres.074. The orthosis according to any of the preceding embodiments with the features of 065, particularly with the features of 068, wherein the foot support element, the connecting element and the first section of the bracing element comprise an outer layer comprising glass fibres.075. The orthosis according to any of the preceding embodiments of 065, particularly with the features of 068, wherein the foot support element, the connecting element and the first section of the bracing element each comprise a plurality of layers of carbon fibres.076. The orthosis according to any of the preceding embodiments with the features of 065, particularly with the features of 068, wherein the second section of the bracing element is made from the least one fibre-reinforced polymer, and wherein further, the second section of the bracing element is made from glass-fibre reinforced polymer.077. The orthosis according to any of the preceding embodiments with the features of 023 and 018, wherein the connecting element upper section comprises a lower stiffness against bending about the ankle-joint axis than the connecting element lower section.078. The orthosis according to any of the preceding embodiments with the features of 023 and 018, wherein the connecting element upper section comprises a lower second area moment than the connecting element lower section.079. The orthosis according to any of the preceding embodiments with the features of 023 and 018, wherein the connecting element upper section comprises a lower thickness than the connecting element lower section. Olla. The orthosis according to any ofthe preceding embodiments with the features of 023 and 028, wherein the connecting element middle section and the connecting element lower section comprise a higher stiffness against bending about the ankle-joint axis than the connecting element upper section.080. The orthosis according to any of the preceding embodiments with the features of 023 and 028, wherein the connecting element upper section comprises a lower second area moment than the connecting element middle section.081. The orthosis according to any of the preceding embodiments with the features of 023 and 028, wherein the connecting element upper section comprises a lower thickness than the connecting element middle section.082. The orthosis according to any of the preceding embodiments, particularly with the features of 077, wherein cross-sections of the connecting element comprise a generally line-like shape, particularly wherein said cross-sections comprise a length I of the crosssection and a width w of the cross-section, and wherein l>5*w, particularly wherein l>10*w.083. The orthosis according to any of the preceding embodiments with the features of at least one of 077 and Olla, wherein cross-sections of the connecting element upper section are (a) substantially straight or (b) curved, comprising a curvature with a radius of curvature Ru>30mm, particularly Ru>40mm, such as Ru>50mm.084. The orthosis according to any of the preceding embodiments particularly with the features of 077, wherein end portions of cross-sections of the connecting element lower section are more curved than center portions of these cross-sections, particularly comprising a curvature with a radius of curvature RL -i of 1.5-8 mm, such as 2-6 mm.085. The orthosis according to any of the preceding embodiments particularly with the features of 077, wherein- center portions of cross-sections of the connecting element lower section are (a) substantially straight or (b) curved, comprising a curvature with a radius of curvature RL-2>10mm, particularly RL-2>20mm, such as RL-2>30mm.086. The orthosis according to any of the preceding embodiments particularly with the features of 077, wherein the end portions of cross-sections of the connecting element lower section are more curved than the center-portions of these cross-sections, and wherein ends of the end portions comprise an orthogonal distance di_ of 1.5-4 mm, particularly 2-3 mm with respect to straight lines extending the center portion towards the ends of the cross-sections of the connecting element lower section.087. The orthosis according to any of the preceding embodiments, particularly with the features of Olla, wherein end portions of cross-sections of the connecting element middle section are more curved than center portions of these cross-sections, particularly comprising a curvature with a radius of curvature RM-I of 1.5-8 mm, such as 2-6 mm.088. The orthosis according to any of the preceding embodiments, particularly with the features of Olla, wherein center portions of cross-sections of the connecting element middle section are (a) substantially straight or (b) curved, comprising a curvature with a radius of curvature RM-2>10mm, particularly RM-2>20mm, such as RM-2>30mm.089. The orthosis according to any of the preceding embodiments, particularly with the features of Olla, wherein the end portions of cross-sections of the connecting element middle section are more curved than the center-portions of these cross-sections, and wherein ends of the end portions comprise an orthogonal distance dm of 1.5-4 mm, particularly 2-3 mm with respect to straight lines extending the center portion towards the ends of the cross-sections of the connecting element middle section.090. The orthosis according to any of the preceding embodiments, particularly with the features of 082, wherein the connecting element middle section comprises a shape resulting in a higher second area moment than a straight line comprising a same width, thickness and / or length.091. The orthosis according to any of the preceding embodiments, particularly with the features of 082, wherein the connecting element lower section comprises a shape resulting in a higher second area moment than a straight line comprising a same width, thickness and / or length.092. The orthosis according to any of the preceding embodiments with the features of 045 and 057, wherein the foot support middle section comprises a higher stiffness than the foot support front section.093. The orthosis according to any of the preceding embodiments with the features of 045 and 061, wherein the foot support middle section comprises a higher stiffness than the foot support rear section.094. The orthosis according to any of the two preceding embodiments and with the features of 075, wherein the foot support middle section comprises a higher number of layers of carbon fibres than at least one of the foot support front section and the foot support rear section.095. The orthosis according to any of the three preceding embodiments and with the features of 075, wherein the foot support middle section comprises a higher thickness than at least one of the foot support front section and the foot support rear section.096. The orthosis according to any of the preceding embodiments, particularly with the features of 076, wherein the second section of the bracing element comprises a lower stiffness than the first section of the bracing element.097. The orthosis according to any of the preceding embodiments, particularly with the features of 092, wherein the second section of the bracing element comprises a lower thickness than the first section of the bracing element, such as a thickness of at most 50% of the thickness of the first section of the bracing element.098. The orthosis according to any of the preceding embodiments, particularly with the features of 077 and / or Olla, wherein the orthosis is configured, in the use configuration, for repeated bending about the ankle-joint axis by an angle of at least 35°, preferably at least 40° and still more preferably at least 45°.099. The orthosis according to any of the preceding embodiments, particularly with the features of 077 and / or Olla, wherein the orthosis comprises a stiffness against bending about the ankle-joint axis of at least 0.7 Nm / °, particularly at least 0.9 Nm / °.0100. The orthosis according to the two preceding embodiments, wherein the orthosis comprises a stiffness against bending about the ankle-joint axis of at least 0.7 Nm / ° and is configured, in the use configuration, for repeated bending about the ankle-joint axis by an angle of at least 35°, preferably at least 40° and still more preferably at least 45°.0101. The orthosis according to any of the preceding embodiments with the features of 098, wherein the orthosis comprises a stiffness against bending about the ankle-joint axis of 0.7 Nm / ° to 2 Nm / °, particularly 0.75 Nm / ° to 1.5 Nm / ° and is configured, in the use configuration, for repeated bending about the ankle-joint axis by an angle of at least 35°, preferably at least 40° and still more preferably at least 45°.0102. The orthosis according to any of the preceding embodiments but the preceding two embodiments, particularly with the features of 077 and / or Olla, wherein the orthosis comprises a stiffness against bending about the ankle-joint axis of 0.3 to 0.7 Nm / °, particularly 0.35 Nm / ° to 0.6 Nm / °.0103. The orthosis according to the preceding embodiment and with the features of 098, wherein the orthosis comprises a stiffness against bending about the ankle-joint axis of 0.35 Nm / ° to 0.6 Nm / ° and is configured, in the use configuration, for repeated bending about the ankle-joint axis by an angle of at least 35°, preferably at least 40° and still more preferably at least 45°.0104. The orthosis according to any of the preceding embodiments with the features of 023, particularly with the features of 065 and 077, wherein, when bent about the ankle- joint axis, for orthosis-bending angles above 10°, particularly above 5°, a ratio of a bending angle of the connecting element upper section to a bending angle of the foot support element about the ankle-joint axis amounts to at most 1: 1, particularly to at most 2:3.0105. The orthosis according to any of the preceding embodiments with the features of 023, particularly with the features of 065 and 077 and 0104, wherein, when bent about the ankle-joint axis, for orthosis-bending angles below 5°, a ratio of a bending angle of the connecting element upper section to a bending angle of the foot support element about the ankle-joint axis amounts to at most 1 :2, particularly to at most 1 :2.5.0106. The orthosis according to any of the preceding embodiments, wherein the orthosis further comprises a sensor system.0107. The orthosis according to the preceding embodiment, wherein the sensor system comprises at least one or a plurality of strain gauge(s).0108. The orthosis according to the preceding embodiment, wherein the at least one strain gauge(s) are at least two strain gauges.0109. The orthosis according to any of the preceding embodiments with the features of 0107, wherein the at least one strain gauge(s) are located at the bracing element.0110. The orthosis according to any of the preceding embodiments with the features of 0107, wherein the at least one strain gauge(s) are located at a lower end of the bracing element.0111. The orthosis according to any of the two preceding embodiments, wherein the at least one strain gauge(s) are located at a side of the bracing element facing a leg of the user in the use configuration.0112. The orthosis according to any of the preceding embodiments with the features of 0107 and with the features of 069, wherein the at least one strain gauge(s) are located on an outside sensor layer of the fibre- reinforced polymer or between the outside sensor layer and a first layer below the outside sensor layer of the fibre-reinforced polymer.0113. The orthosis according to the preceding embodiment, wherein the outside sensor layer comprises glass fibres.0114. The orthosis according to any of the two preceding embodiments, wherein the outside sensor layer is a protective layer.0115. The orthosis according to the preceding embodiment and with the features of 074, wherein the outside sensor layer is located on a section of an outer side of the outer layer.0116. The orthosis according to any of the preceding embodiments with the features of 0106, wherein the sensor system comprises at least one inertial measurement unit configured for sensing at least a translatory acceleration and an orientation.0117. The orthosis according to any of the preceding embodiment with the features of 0106, particularly with the features of 0116, wherein the sensor system comprises a data processing unit configured for processing at least one signal obtained from the strain gauge(s) and / or the inertial measurement unit.0118. The orthosis according to the preceding embodiment, particularly with the features of 0110, wherein the data processing unit is located at the bracing element, particularly at the side of the bracing element facing the leg of the user in the use configuration.0119. The orthosis according to any of the two preceding embodiments, wherein the data processing unit is configured for transmitting data based on the data generated by the sensor system.0120. The orthosis according to the preceding embodiment, wherein the sensor system, particularly the data processing unit, is configured for transmitting data by wireless transmission.0121. The orthosis according to the preceding embodiment, wherein the data processing unit comprises a data transmission component configured for wireless data transmission.0122. The orthosis according to any of the preceding embodiments with the features of 0120, wherein the data processing unit is configured for data transmission according to a Bluetooth Low Energy-standard.0123. The orthosis according to any of the preceding embodiments with the features of 0117, wherein the data processing unit comprises at least one or a plurality of analog-to- digital converter(s).0124. The orthosis according to the preceding embodiment, wherein the analog-to-digital converter(s) comprise a resolution of at least 12 bit.0125. The orthosis according to any of the preceding embodiments with the features of 0123, wherein the analog-to-digital converter(s) comprise a sampling frequency of at least 35 Hz, particularly at least 50 Hz.0126. The orthosis according to any of the preceding embodiments with the features of 0117, wherein the data processing unit comprises a distance of at most 50 mm to the strain gauge(s), particularly at most 20 mm, such as at most 10 mm.0127. The orthosis according to any of the preceding embodiments with the features of 0117, wherein the data processing unit comprises a distance of at most 50 mm to the inertial measurement unit, particularly at most 20 mm, such as at most 10 mm.0128. The orthosis according to the preceding embodiment, wherein the data processing unit and the inertial measurement unit are integrated.System embodiments

[0250] Below, embodiments of a system will be discussed. The system embodiments are abbreviated by the letter "S" followed by a number. Whenever reference is herein made to the "system embodiments", these embodiments are meant.51. A system, comprising an orthosis according to any of the orthosis embodiments, particularly with the features of 0117, wherein the system further comprises a computer device, wherein the computer device is configured for receiving data from the sensor system, particularly from the data processing unit.52. The system according to the preceding embodiment, wherein the computer device is configured for data transmission according to the Bluetooth Low Energy-standard.53. The system according to any of the preceding embodiments with the features of SI, wherein the computer device is configured for storing the data received from the sensor system.54. The system according to any of the preceding system embodiments, wherein the system is configured for determining a strain of a portion of the orthosis based on the processed signal obtained from the at least one strain gauge(s).55. The system according to the preceding embodiment, wherein the system is configured for determining at least one of a bending torque of the orthosis about the ankle- joint-axis and a force transmitted by the bracing element based on the determined strain of the portion of the orthosis.56. The system according to any of the preceding embodiments with the features of S4, wherein the system, particularly the data processing unit and / or the computer device, is configured for compensating a thermal drift of the strain gauge(s).57. The system according to the preceding embodiment, wherein the system, particularly the data processing unit and / or the computer device, is configured for determining the thermal drift of the strain gauge(s) based on the at least one signal obtained from the strain gauge(s) in the substantially unbiased state of the orthosis.58. The system according to any of the preceding embodiments with the features of S4, wherein the system, particularly the computer device, is configured for determining forces resulting from an ankle pronation and / or supination.59. The system according to any of the preceding embodiments with the features of S4, wherein the system, particularly the computer device, is configured for determining forces resulting from ankle flexion and / or ankle extension.510. The system according to any of the preceding system embodiments, wherein the orthosis further comprises the features of 0116 or any embodiment dependent thereon, wherein the system is configured for determining a phase of gait of the user based on the data sensed by the inertial measurement unit of the sensor system.511. The system according to any of the preceding system embodiments, wherein the inertial measurement unit is a first inertial measurement unit, wherein the system further comprises at least one wearable sensor component, wherein the wearable sensor component comprises a second inertial measurement unit, wherein the second inertial measurement unit is configured for sensing at least a second translatory acceleration and a second orientation, and wherein the wearable sensor component is configured for transmitting at least the second translatory acceleration and the second orientation to the computer device.512. The system according to the preceding embodiment, wherein the wearable sensor component is configured for being worn at a leg or foot of the user opposite to the lower limb of the user with which the orthosis is used.513. The system according to any of the preceding system embodiments with the features of S10 and Sil, wherein the system is configured for determining the phase of gait of the user based on the data sensed by the first inertial measurement unit of the sensor system and the data sensed by the second inertial measurement unit.514. The system according to any of the preceding embodiments with the features of S10, wherein the system, particularly the computer device, is configured for outputting the phase of gait of the user.515. The system according to any of the preceding embodiments with the features of S10 and S4, particularly S5, wherein the system, particularly the computer device, is configured for determining for a plurality of time intervals the strain of the portion of the orthosis, particularly the at least one of the bending torque and the force transmitted by the bracing element, and the phase of gait.S16. The system according to the preceding embodiment, wherein the system, particularly the computer device, is configured for determining for the plurality of time intervals the force transmitted by the bracing element and the phase of gait.517. The system according to any of the preceding embodiments with the features of S15, wherein the time intervals comprise a duration of at most 0.1 s, preferably at most 0.05 s.518. The system according to any of the preceding embodiments with the features of Sil, wherein the at least one wearable sensor component is a first wearable sensor component, wherein the system further comprises a second wearable sensor component, wherein the second wearable sensor component comprises a third inertial measurement unit, wherein the third inertial measurement unit is configured for sensing at least a third translatory acceleration and a third orientation, and wherein the second wearable sensor component is configured for transmitting at least the third translatory acceleration and the third orientation to the computer device.519. The system according to the preceding embodiment, wherein the first wearable sensor component is configured for being worn at a leg of the user opposite to the lower limb of the user with which the orthosis is used, and wherein the second wearable sensor component is configured for being worn at a foot of the user opposite to the lower limb of the user with which the orthosis is used.520. The system according to any of the preceding system embodiments, wherein the system, particularly the sensor system, comprises an additional inertial measurement unit, wherein the additional inertial measurement unit is configured for sensing an additional translatory acceleration and an additional orientation.521. The system according to the preceding embodiment, wherein the additional sensor component is configured for being worn at a foot of the lower limb of the user with which the orthosis is used.522. The system according to the preceding embodiment, wherein the sensor system of the orthosis comprises the additional inertial measurement unit, and wherein the sensor system is configured for transmitting the additional translatory acceleration and the additional orientation to the computer device.523. The system according to the first but last embodiment, wherein the system comprises an additional wearable sensor component comprising the additional inertial measurement unit, and wherein the additional wearable sensor component is configured for transmitting the additional translatory acceleration and the additional orientation to the computer device.524. The system according to any of the preceding system embodiments with the features of S18, wherein the system, particularly the computer device, is configured for determining an angle of flexion of an ankle of the user opposite to the lower limb of the user with which the orthosis is used.525. The system according to any of the preceding system embodiments with the features of S20, wherein the system, particularly the computer device, is configured for determining an angle of flexion of an ankle of the user with which the orthosis is used.526. The system according to the preceding two embodiments, wherein the system, particularly the computer device, is configured for determining a gait symmetry of a left lower limb and right lower limb of the user.Method embodiments

[0251] Below, embodiments of a method will be discussed. The method embodiments are abbreviated by the letter "M" followed by a number. Whenever reference is herein made to the "method embodiments", these embodiments are meant.Ml. A method for making an orthosis, wherein the method comprises forming a fibre- reinforced polymer to obtain the foot support element, the connecting element and the first section of the bracing element, and obtaining an orthosis according to 069.M2. The method for making an orthosis according to the preceding embodiment, wherein the method comprises forming a fibre-reinforced polymer comprising carbon fibres and glass fibres to obtain the foot support element, the connecting element and the bracing element, and obtaining an orthosis according to 073.M3. A method for treatment of at least one of foot drop, ankle problems and foot problems, comprising providing an orthosis according to any of the orthosis embodiments to a user.M4. A method comprising a computer device receiving sensor data from an orthosis comprising a sensor system, particularly according to 0106 or any embodiment dependent thereon,- the computer device processing the sensor data and thus generating a processing result, and- outputting the processing result.M5. The method according to the preceding embodiment, wherein the sensor data relate to at least one or a plurality of strain gauge(s) located at the orthosis and the sensor data comprise strain data, the strain data being based on a processed signal obtained from the strain gauge(s).M6. The method according to any of the two preceding embodiments, wherein the sensor data relate at least one inertial measurement unit located at the orthosis.M7. The method according to any of the preceding embodiments with the features of M4, wherein the method further comprises the computer device further receiving sensor data from at least one wearable sensor component comprising another inertial measurement unit, such as a second and / or a third inertial measurement unit, particularly from a system according to Sil or any embodiment dependent thereon, and processing the data received from the at least one wearable sensor component as well as the sensor data.M8. The method according to any of the preceding embodiments with the features of M4, wherein the computer device receiving the sensor data from the orthosis comprising the sensor system comprises receiving sensor data from at least two inertial measurement units, such as the inertial measurement unit and the additional inertial measurement unit according to S20 or any embodiment dependent thereon.M9. The method according to any of the preceding method embodiments with the features of M4, wherein the method comprises the computer device receiving the sensor data by wireless transmission, particularly according to a Bluetooth Low Energy-standard.MIO. The method according to any of the preceding method embodiments with the features of M4, wherein the method comprises the computer device receiving the sensor data from a processing unit of the orthosis.Mil. The method according to any of the preceding method embodiments with the features of M5, wherein the at least one strain gauge(s) are at least two strain gauges.M12. The method according to any of the preceding method embodiments with the features of M5, wherein processing the sensor data comprises the computer device determining a strain of a portion of the orthosis based the strain data.M13. The method according to the preceding embodiment, wherein processing the sensor data further comprises determining at least one of a bending torque of the orthosis about the ankle-joint-axis and a force transmitted by the bracing element based on the determined strain of the portion of the orthosis.M14. The method according to any of the preceding method embodiments with the features of M5, particularly with the features of M12, wherein processing the sensor data comprises compensating a thermal drift of the strain gauge(s), particularly based on the at least one signal obtained from the strain gauge(s) in a substantially unbiased state of the orthosis.M15. The method according to any of the preceding method embodiments with the features of M5, particularly with the features of M12, wherein processing the sensor data comprises the computer device determining forces resulting from an ankle pronation and / or supination.M16. The method according to any of the preceding method embodiments with the features of M5, particularly with the features of M12, processing the sensor data comprises the computer device determining forces resulting from ankle flexion and / or ankle extension.M17. The method according to any of the preceding method embodiments with the features of M6, wherein processing the sensor data comprises the computer device determining a phase of gait of the user based on the the sensor data relating to the inertial measurement unit(s).Use embodiments

[0252] Below, embodiments of a method will be discussed. The use embodiments are abbreviated by the letter "U" followed by a number. Whenever reference is herein made to the "use embodiments", these embodiments are meant.Ul. Use of an orthosis according to any of the orthosis embodiments for treatment of at least one of foot drop, ankle problems and foot problems of a user.U2. Use of a system according to SI, particularly according to S8 and / or S9, for selecting an insole and / or a shim for an ankle-foot-orthosis for the user.U3. Use of a system according to SI, particularly according to S8 and / or S9, for designing an individualized insole and / or a shim for use with the ankle-foot-orthosis for the user.U4. Use of a system according to SI, particularly according to S9 or S9 and S8, for selecting a stiffness of the ankle-foot-orthosis for the user.U5. Use of a system according to SI, particularly according to S9 or S9 and S8, for designing a stiffness of the ankle-foot-orthosis for the user.Computer program product embodiments

[0253] Below, embodiments of a computer program product will be discussed. These embodiments are abbreviated by the letter "C" followed by a number. Whenever reference is herein made to the "computer program product embodiments", these embodiments are meant.Cl. A computer program product comprising instructions which, when the program is executed by a computer device, cause the computer device to carry out the method according to M4 or any method embodiment dependent thereon.M18. A method, comprising providing an orthosis according to any of the orthosis embodiments, particularly according to 0117 or any embodiment dependent thereon, and a computer program product according to Cl.M19. The method according to the preceding embodiment, wherein the method comprises further providing at least one wearable sensor component comprising a second inertial measurement unit, particularly with the features of the wearable sensor component disclosed in Sil.M20. The method according to the preceding embodiment, wherein the method comprises further providing a second wearable sensor component comprising a third inertial measurement unit, particularly with the features of the second wearable sensor component disclosed in S18.M21. The method according to any of the preceding method embodiments with the features of M18, wherein the method comprises further providing an additional inertial measurement unit, particularly with the features of the additional inertial measurement unit disclosed in S20.

[0254] Exemplary features of the invention are further detailed in the figures and the below description of the figures.Brief description of the figuresFig. la-2b show views of an orthosisFig. 3 shows an orthosis according to the prior artFig. 4 shows a net of an orthosisFigs. 5a-5b show side views of an orthosisFigs. 6a-6f show cross-sections of the orthosis and enlarged sections thereofFig. 7 shows a set of measurements generated using an orthosisFig. 8 shows another side view of an orthosisFigs. 9a-9c show cross-sections of the orthosis together with geometric axesFig. 10 shows a view of an orthosis comprising a sensor systemFig. 11 shows a view of a system comprising the orthosisFig. 12 shows a diagram of elastic deformation of portions of the orthosis when bentDetailed figure description

[0255] For the sake of clarity, some features may only be shown in some figures, and others may be omitted. However, also the omitted features may be present, and the shown and discussed features do not need to be present in all embodiments.

[0256] Figs. 3 shows an orthosis 10 known from the prior art. It comprises a foot support element 20 configured for supporting a foot of a user and a bracing element 40 with a fastening component 60 configured for being fastened around a lower limb of the user, such as a shank of the user and a connecting element 30 connecting the foot support element and the bracing element. The shown orthosis 10 from the prior art is generally flexible, but orthoses from the prior art do normally either provide a high stiffness against bending around an ankle-axis, but only a limited movement range, or provide only a very limited stiffness. The stiffness may however be relevant for some users in order to provide ideal treatment and / or support.

[0257] Also, orthoses from the prior art often show increased wear when the user flexes the ankle-joint, e.g., when squatting. Further, loads of the front of the foot sole, as well as sudden loads, e.g., during jumps, often lead to increased wear or failure of known orthosis 10.

[0258] Figs, la, lb, 2a, 2b, 5a and 5b show an embodiment of an orthosis 10. Fig. 4 shows a net of the orthosis 10. The orthosis 10 comprises a foot support element comprising a foot support rear section 22, a foot support front section 23, and a foot support middle section 24, as can be seen e.g. in Figs 4, 5a.

[0259] The foot support element 20 further comprises a rear end 26, which may be a heel end, and a front end 27, which may be a toe end. Further, the foot support element 20 comprises a lateral side 29 which is oriented towards a lateral side of the foot of the user when worn by the user, and a medial side 28, which is oriented towards an inner side of a foot of the user when the orthosis 10 is worn by the user.

[0260] The orthosis 10 further comprises a connecting element 30. The connecting element 30 comprises a connecting element lower section 32, a connecting element upper section 34 and a connecting element middle section 36.

[0261] In Fig. 4 and Fig. 5a, sections with higher and lower stiffness are indicated. In the example embodiment shown in these Figures, the connecting element lower section 32 and the connecting element middle section 36 comprise a higher stiffness against bending than the connecting element upper section 34. In other words, the connecting elementupper section 34 comprises a lower stiffness against bending than the connecting element lower section 32 and the connecting element middle section 36.

[0262] Similarly, the foot support middle section 24 comprises a higher stiffness than the foot support rear section 22 and the foot support front section 23.

[0263] Sections of the foot support element 20 as well as the connecting element 30 with a lower stiffness are also indicated by dashed circles and ellipses in Fig. 5a. Likewise, in Fig. 4, sections of the foot support element 20 and the connecting element 30 comprising a higher stiffness are indicated in plain white in Fig. 4, while sections thereof comprising a lower stiffness are indicated by diagonal hatching.

[0264] Thus, when the orthosis 10 is bent about the ankle-joint-axis, at a given bending angle, the sections comprising a higher stiffness may optionally advantageously show a lower strain in comparison to the sections comprising a lower stiffness. In other words, the connecting element upper section 34 shows a higher strain, i.e., a higher deformation, than the connecting element lower section 32. The strain of the connecting element lower section 32 caused by bending about the ankle-joint-axis is thus reduced.

[0265] For thin, substantially flat components, bending strain around an axis parallel to the surface of a component generally results in tension-compression stress and strain. Bending strain around an axis that is not parallel to the surface of a component generally also results in transverse stress and transverse strain, that is, in shear stress and shearing.

[0266] When the orthosis 10 is bent about the ankle-joint-axis, in the example of Figs. 4 and 5a, the connecting element upper section 34 is mainly bent abound an axis parallel to its surface. The connecting element upper section 34 is thus mainly exposed to bending strain. In contrast thereto, the connecting element lower section 32 is bent around an axis that is not parallel to their surface. The strain of the connecting element lower section 32 may instead comprise a significant shearing component.

[0267] Similarly, the foot support rear section 22 and the foot support front section 23 are mainly exposed to bending strain when the orthosis 10 is bent about the ankle-joint-axis and the foot support middle section 24 is exposed to multiaxial stress, comprising a significant shear stress component.

[0268] Hence, with the above-discussed adapted stiffness, optionally advantageously, shearing of the sections of the orthosis, particularly of the connecting element lower section, may be reduced.

[0269] In cases where the orthosis 10 is made from at least one fibre-reinforced polymer, the fibre layers are typically oriented substantially parallel to the surfaces of the orthosis.Available fibre-reinforced polymers are more susceptible to wear from shearing, than from bending, as shearing may result in delamination of the fibre-reinforced polymer. Delamination of fibre-reinforced polymers may result in a total loss of structural integrity.

[0270] With ankle-foot-orthoses 10 made from fibre-reinforced polymer and comprising a connecting element 30, e.g., in a shape as shown in Fig. 3, a limit for a permissible moving range, more particularly a bending range around the ankle-joint-axis, is often strain of the connecting element lower section 32, as well as sometimes the strain of the foot support middle section 24 and / or the connecting element middle section 36, as discussed above.

[0271] Hence, optionally advantageously, by modifying stiffnesses of the sections of the connecting element 30 and / or the foot support element 20, shearing of the connecting element 30 and / or the foot support element 20 may be reduced. Thus, optionally advantageously, an improved performance of the orthosis 10 may be achieved. For example, the orthosis may optionally comprise a higher movement range, a higher stiffness against bending about the ankle-joint-axis and / or a higher wear-resistance.

[0272] When an increased stiffness against bending of the overall orthosis 10, e.g., for obese users, is desired, the sections of the orthosis 10 are exposed to higher stress. In these cases, the transverse load of the connecting element lower section 32 may be particularly relevant, as the resulting stress is not necessarily homogenous in the section and may increase a risk of failure. Thus, reducing the strain of the connecting element lower section 32 as well as the connecting element middle section 36 and the foot support middle section 24 may optionally provide further advantages in orthoses 10 comprising a higher overall stiffness, such as a stiffness above 0.7 Nm / °, particularly 0.75° / Nm.

[0273] A similar advantage may optionally be achieved when higher permissible movement ranges, such as bending about about the ankle-joint axis by an angle of at least 35°, preferably at least 40° and still more preferably at least 45°, are desired.

[0274] Hence, orthoses 10 according to the invention may optionally advantageously provide a better performance to the user, e.g., due to a wider range of permissible movements, and / or an increased wear-resistance.

[0275] Fig. 12 further shows a division of a bending angle of the orthosis 10 about the ankle-joint-axis to a bending of the connecting element upper section 34 (indicated by the full line) and a bending of the foot support element 20 (dashed line). The diagram in Fig. 12 relates to an orthosis 10 comprising a stiffness above 0.7 Nm / ° against bending about the ankle-joint-axis.

[0276] As can be seen, in the example of such a comparably stiff orthosis, more than 50% of the bending angle are provided by an elastic deformation of the foot support element20 and less than 50 % of the bending angle are provided by an elastic deformation of the connection element upper section 34. Optionally advantageously, designing the orthosis to comprise this division of bending elongations between the connecting element upper section 34 and the foot support element 20 may further improve the performance to the user, e.g., due to a wider range of permissible movements, and / or an increased wearresistance. This may for example be achieved by means of the above-discussed geometry and / or an adapted thickness and orientation of the fibre layers of a fibre-reinforced polymer from which the orthosis 10 in Fig. 12 is made.

[0277] However, in embodiments of the orthosis 10 comprising a different stiffness, such as a lower stiffness, also different divisions of the angles have been observed to yield satisfying results with respect to the performance to the user. Further, optionally advantageously, orthoses with increased stiffness and a wide range of permissible movements can be provided.

[0278] The terms "higher stiffness" and "lower stiffness" may relate to a stiffness against bending about the ankle-joint-axis.

[0279] Adapting of the stiffness and thus the strain of the connecting element lower section 32, middle section 36 and upper section 34 with respect to bending of the section and / or the orthosis 10 may be performed, e.g., by means of different thicknesses of the sections. Thicker sections will then typically comprise a higher stiffness in comparison, thinner sections comprise a lower stiffness in comparison.

[0280] The adapting may also be achieved by an adapted orientation of fibre-layers in the at least one fibre-reinforced polymer, resulting in a higher or lower stiffness of corresponding sections.

[0281] Further, the stiffness and / or the strain with respect to bending of a section can be modified by use of different fibre-types. For example, certain carbon-fibres comprise a higher elasticity module.

[0282] Additionally or alternatively, a higher stiffness of a section can also be obtained by increasing the second area moment of the respective section against bending. For example, the connecting element upper section 34 may comprise a lower second area moment than the connecting element lower section 32 and / or the connecting element middle section 36.

[0283] The second area moment may be the second area moment against bending about a bending axis substantially parallel to a horizontal tangent line of surface the connecting element, wherein the point of tangency is at a center of the respective section of the connecting element, such as at a center between the two substantially vertical edges ofthe surface. The surface may be the surface proximal to a lower limb of the user or a surface opposite to the lower limb of the user.

[0284] In other words, the point of tangency may be proximal to a centroid of a horizontal cross-section of the respective section of the connecting element.

[0285] In other words, the second area moment may be a second area moment against bending the respective section of the connecting element towards or away from centroid of the lower limb of the user at a given horizontal plane, i.e., a given orthogonal distance to a plane defined by the foot support section in the substantially configuration.

[0286] The bending axis may be perpendicular to a length of the connecting element.

[0287] An example of the bending axis of the connecting element lower section 58, the bending axis of the connecting element middle section 56 and the bending axis of the connecting element upper section 54 is show in Figs. 9a, 9b and 9c. While the axes shown in Figs 9a, 9b and 9c comprise an offset with respect to the surface of the sections of the connecting element for improved intelligibility, the axes may also be the above-discussed tangents.

[0288] The person skilled in the art will easily understand that in the use configuration, the sections of the connecting element 30 may not be bent or not exclusively bent about these axes, but that the above-discussed bending axis of the sections of the connecting element 30 serve for more concisely describing the second area moment to which reference is made.

[0289] The second area moment may be a second area moment against bending about a bending axis substantially perpendicular to a center of a section of a face surface, that is, a section of an outside surface, of the connecting element. In particular, said bending axis may be perpendicular to a length at the center section of the face.

[0290] In other words, the second area moment may be the second area moment against bending about a horizontal axis substantially orthogonal to at least one longer axis of a horizontal cross-section of the connecting element 30 when the orthosis 10 is placed upright. The second area moment can be adapted by suitable geometries of the connecting element 30 and / or the foot support element 20. Fig. 5b shows a sideview of the orthosis 10 together with several cross-sections. Figs. 6a-6f show cross-sections of the connecting element 30 and the bracing element 40. Cross-sections C-C and D-D show an adapted shape resulting in an increased second area moment against bending of the connecting element lower section 32 and the connecting element middle section 36. In the example of Figs. 6d and 67, outer ends of the cross-section are bent and comprise a curvature radius that is small compared to a curvature of a center portion of the connecting elementlower section 32 and the connecting element middle section 36. Hence, ends of these sections protruding from a center line of the cross-section increase the second area moment against bending, particularly against bending about an axis perpendicular to an axis perpendicular to a center of a face surface of the sections.

[0291] The connecting element middle section 36 and the connecting element lower section 32 shown in Figs. 6c-6f comprise a shape resulting in a higher second area moment than a straight line comprising a same width, thickness and / or length. Thus, if the connecting element upper section 34 is substantially straight and strip-shaped, as shown e.g. in Fig. 6b, the geometry of the connecting element middle section 36 and the connecting element lower section 32 may optionally advantageously result in a higher second area moment than a strip comprising a same width, thickness and / or length but being substantially straight or comprising a curvature with a radius of curvature of at least Ru>30mm, particularly Ru>40mm, such as Ru>50mm. The bracing element comprises a first section 42 and a second section 44. The first section 42 comprises a higher stiffness than the second section 44. In the example of Figs 4 and 6a, the stiffness of the first section is increased by different thicknesses and by using carbon fibres in the first section 42 and only glass fibres in the second section 44. Thus, optionally advantageously, the second section 44 can comfortably fit to a user's lower limb, while the first section 42 can transmit forces to support a gait of the user. Optionally advantageously, to support force transmission, the lower first section of the bracing element 42 may extend towards the lower end 46 of the bracing element 40. In the example of Fig. 4, the second section of the bracing element 44 extends around the first section 42 of the bracing element and comprises an upper end 47 as well as outer ends 48, 48b of the orthosis 10.

[0292] Further, in the example of the shown orthosis 10, a surface of the foot support element 20, the connecting element 30 and the bracing element 40 comprises a layer of glass fibre. Glass fibre may comprise a lower Young's modulus than carbon fibre and may thus allow for higher strain before failing and / or delaminating. Hence, optionally advantageously, a greater flexibility and thus a better durability of upper layers of the material can be provided.

[0293] In an example embodiment, the orthosis 10 comprises an outer layer of glass fibre at least on the connecting element, the foot support element and the first section of the bracing element. Strain at an outer portion of a component is normally larger than at an inner portion. Common glass fibres normally resist higher strains than carbon fibres.

[0294] Thus, optionally advantageously, a durability of the outer layer may be increased. Also, optionally advantageously, a splinter protection in case of failure of the inner carbon fibres may be provided.

[0295] Fig. 8 shows a first axis 50 extending substantially along a length of the foot support element 20 and a second axis 52 extending along a length of the bracing element 40. The ankle-axis (not shown) around which the orthosis 10 is bent in use is orthogonal to these two axes.

[0296] Fig. 7 shows a strain sensed at the bracing element 40 during different gait phases and with different modifications to a shoe of the user.

[0297] The strain shown in the example of Fig. 7 is sensed by a sensor system 70 of the orthosis 10. The sensor system 70 comprises one or more strain gauge(s) 72a, 72b.

[0298] In the example of Fig. 7, the strain gauge(s) 72a, 72b are placed at the lower end of the bracing element 46, and above the connecting element upper section 34. As set out above, the connecting element upper section 34 may be a section exposed to a maximum stress and strain of the connecting element 30.

[0299] As the strain gauge(s) 72a, 72b are not placed at a section of maximum strain, optionally advantageously, variations of the material surface due to placing the strain gauge(s) 72a, 72b may have a lower impact on the resistance to wear. Further, a connection of the strain gauge(s) 72a, 72b to a data processing unit may optionally advantageously experience lower mechanical loads.

[0300] However, strain at the lower end of the bracing element 46 may still be considerably above strain at other locations of the orthosis 10. Thus, optionally advantageously, the strain gauge(s) 72a, 72b are located at a position where the sensed strain is still significant and hence allows for less error-prone sensor results.

[0301] Further, in the example of Fig. 7, the data processing unit configured for processing data of the strain gauge(s) 72a, 72b is placed at an inner side of the bracing element 40, i.e., a side facing a lower limb of the user in the use configuration. Optionally advantageously, more space may be available at the bracing element 40, thus allowing to place the data processing unit geometrically within the orthosis 10 or with only a limited additional thickness, hence increasing a wear in comfort. Further, being placed next to the bracing element 40, a more durable connecting of the data processing element and a remainder of the orthosis 10 may be obtained.

[0302] In the example of Fig. 7, the sensor system 70 and the data processing unit are placed next to each other, e.g., at most 5 cm, particularly at most 2 cm spaced apart. Thus, tear and wear of the electric connection due to strain may be reduced.

[0303] Fig. 10 shows an example of the orthosis comprising the sensor system 70. The sensor system 70 in the example of Fig. 10 comprises two strain gauges 72a, 72b and an inertial measurement unit 74a.

[0304] The inertial measurement unit 74a and the data-processing unit are integrated in the example of Fig. 10. In other words, they are packaged together. Different from Fig. 10, the inertial measurement unit 74a and the data-processing unit may also be located at a side of the bracing element facing the leg of the user in the use configuration.

[0305] The data processing unit in Fig. 10 is configured for processing at least one signal obtained from the strain gauges 72a, 72b. Further, the data processing unit receives and processes data from the inertial measurement unit. For example, the data processing unit may forward, store, convert and / or agglomerate the data from the inertial measurement unit. Also, the data processing unit may process raw data from the inertial measurement unit, e.g., to obtain acceleration data and / or orientation data.

[0306] The data processing unit is configured for transmitting the data to a computer device 80.

[0307] Fig. 11 shows another example of a system comprising the orthosis 10 of Fig. 10 as well as two wearable sensor components comprising a second and third inertial measurement unit 74c, 74d and an additional inertial measurement unit 74b.

[0308] Further, in Fig. 11, the data processing unit transmits the data to the computer device 80. The computer device may for example be a personal computer, a laptop computer, a smartphone or a wearable device such as a smart watch. These devices may optionally comprise a higher processing power compared to systems integrated to or worn with the orthosis 10.

[0309] In the example of Fig. 11, the system is configured for determining forces from ankle flexion and extension. Thus, optionally advantageously, a selection and / or individual adaption of a shim to place under the heel in a show may be facilitated in order to provide for an improved interaction of the orthosis 10 and the foot and lower limb of the user.

[0310] With continued reference to the example of Fig. 11, the system is further configured for determining forces from ankle pronation and / or supination, i.e., orientation of a foot of the user in medial-lateral direction. Thus, optionally advantageously, a selection and / or individual adaption of a shim to place under the heel in a shoe may be facilitated to provide for avoiding excessive pronation and / or supination.

[0311] Further, determining the forces from ankle flexion and extension, and optionally from ankle pronation and / or supination, may optionally advantageously allow for selectingan appropriate stiffness of the orthosis 10 for improved support of the user. For example, an orthosis 10 from a set of orthoses 10 with different stiffnesses may be selected, or an orthosis 10 comprising an individualized stiffness may be selected or designed based on the determined forces.

[0312] As can be seen, in the example of Fig. 11, there are two inertial measurement units 74a, 74b associated with a leg of the user with which the orthosis 10 is worn. Thus, an angle of flexion of the ankle may optionally advantageously be directly determined based on a difference of orientations of the two inertial measurement units 74a, 74b, instead of indirectly determining the flexion angle based on strains of the orthosis 10, e.g., by means of inferred bending angles. Thus, optionally advantageously, an uncertainty of the determined angle of flexion of the ankle may be reduced.

[0313] Further, in Fig. 11, two wearable sensor components comprising the second and third inertial measurement unit 74c, 74d are shown. Thus, an ankle-flexion angle of a side opposite to a side where the orthosis 10 is worn may be determined. Hence, optionally advantageously, further measures such as a symmetry of gait with the orthosis 10 may be determined and a more differentiated selection and / or adaption of the orthosis 10 may be enabled.

[0314] The computer device 80 may comprise one or more processing units configured to carry out computer instructions of a program (i.e. machine readable and executable instructions). The processing unit(s) may be singular or plural. For example, the computer device 80 may comprise at least one of CPU, GPU, DSP, APU, ASIC, ASIP or FPGA. The computer device 80 may comprise memory components, such as, main memory (e.g. RAM), cache memory (e.g. SRAM) and / or secondary memory (e.g. HDD, SDD). The computer device 80 may comprise volatile and / or non-volatile memory such an SDRAM, DRAM, SRAM, Flash Memory, MRAM, F-RAM, or P-RAM. The computer device 80 may comprise internal communication interfaces (e.g. busses) configured to facilitate electronic data exchange between components of the computer device 80, such as, the communication between the memory components and the processing components. The computer device 80 may comprise external communication interfaces configured to facilitate electronic data exchange between the computer device 80 and devices or networks external to the computer device 80. For example, the computer device 80 may comprise network interface card(s) that may be configured to connect the computer device 80 to a network, such as, to the Internet. The computer device 80 may be configured to transfer electronic data using a standardized communication protocol. The computer device 80 may be a centralized or distributed computing system.

[0315] The computer device 80 may comprise user interfaces, such as:output user interface, such as: o screens or monitors configured to display visual data (e.g. displaying graphical user interfaces of the questionnaire to the user), o speakers configured to communicate audio data (e.g. playing audio data to the user), input user interface, such as: o camera configured to capture visual data (e.g. capturing images and / or videos of the user), o microphone configured to capture audio data (e.g. recording audio from the user), o keyboard configured to allow the insertion of text and / or other keyboard commands (e.g. allowing the user to enter text data and / or other keyboard commands by having the user type on the keyboard) and / or o trackpad, mouse, touchscreen, joystick - configured to facilitate the navigation through different graphical user interfaces of the questionnaire.

[0316] To put it simply, the computer device 80 may be a processing unit configured to carry out instructions of a program. The computer device 80 may be a system-on-chip comprising processing units, memory components and busses. The computer device 80 may be a personal computer, a laptop, a pocket computer, a smartphone, a tablet computer. The computer device 80 may be a server, a server system, a portion of a cloud computing system or a system emulating a server, such as a server system with an appropriate software for running a virtual machine. The computer device 80 may be a processing unit or a system-on-chip that may be interfaced with a personal computer, a laptop, a pocket computer, a smartphone, a tablet computer and / or user interfaces (such as the upper-mentioned user interfaces).

[0317] The data processing unit may comprise a subsystem configured for data processing. The data processing unit may comprise a micro-controller. The data processing unit may also comprise a micro-processor.

[0318] The data processing unit may also comprise a portion of a circuit, such as an integrated circuit (IC) or a printed circuit board (PCB). The data processing unit may be a processing unit or a system-on-chip that may be interfaced with the orthosis and / or the sensor system.

[0319] The data processing unit may also comprise further means of data processing, such as, processor units and / or hardware accelerators. The data processing unit may comprise memory components, such as, main memory (e.g. RAM), cache memory (e.g. SRAM) and / or secondary memory (e.g. flash memory, HDD, SDD). The data processing unit may comprise busses configured to facilitate data exchange between components of the data processing unit, and / or to facilitate data exchange between the data processing unit and other components of the sensor system.

[0320] While in the above, a preferred embodiment has been described with reference to the accompanying drawings, the skilled person will understand that this embodiment was provided for illustrative purpose only and should by no means be construed to limit the scope of the present invention, which is defined by the claims.

[0321] Whenever a relative term, such as "about", "substantially" or "approximately" is used in this specification, such a term should also be construed to also include the exact term. That is, e.g., "substantially straight" should be construed to also include "(exactly) straight".

[0322] Whenever steps were recited in the above or also in the appended claims, it should be noted that the order in which the steps are recited in this text may be accidental. That is, unless otherwise specified or unless clear to the skilled person, the order in which steps are recited may be accidental. That is, when the present document states, e.g., that a method comprises steps (A) and (B), this does not necessarily mean that step (A) precedes step (B), but it is also possible that step (A) is performed (at least partly) simultaneously with step (B) or that step (B) precedes step (A). Furthermore, when a step (X) is said to precede another step (Z), this does not imply that there is no step between steps (X) and (Z). That is, step (X) preceding step (Z) encompasses the situation that step (X) is performed directly before step (Z), but also the situation that (X) is performed before one or more steps (Yl), ..., followed by step (Z). Corresponding considerations apply when terms like "after" or "before" are used.10 Orthosis20 Foot support element22 Foot support rear section23 Foot support front section24 Foot support middle section26 Rear end of the foot support element27 Front end the foot support elementMedial sideLateral side of the foot support elementConnecting elementConnecting element lower sectionConnecting element upper sectionConnecting element middle sectionBracing elementFirst section of the bracing elementSecond section of the bracing elementLower endUpper end a, 48b Outer endsFirst axisSecond axisBending axis connecting element upper sectionBending axis connecting element middle sectionBending axis connecting element lower sectionFastening componentSensor system a, 72b Strain gauge(s) a, 74b, 74c, 74d Inertial measurement unit(s)Computer device

Claims

Claims1. Orthosis, wherein the orthosis comprises- a foot support element, a connecting element, and a bracing element, wherein the connecting element connects the supporting portion and the bracing element, wherein the orthosis is an ankle-foot-orthosis, particularly wherein the orthosis is configured for storing energy during at least a first phase of gait by elastic deformation and for delivering a propulsive force during at least a second phase of gait, wherein the connecting element extends from a lateral side of the foot support element towards a lower end of the bracing element, wherein a lower end of the connecting element is located next to, particularly merges into, the foot supporting element, and wherein the connection element comprises a connecting element lower section extending from the lower end of the connecting element, wherein the connecting element comprises an connecting element upper section, wherein an upper end of the connecting element upper section is located next to the bracing element, wherein the foot support element and the connecting element are made from at least one composite material, wherein the at least one composite material is at least one fibre-reinforced polymer, wherein particularly the fibre-reinforced polymer comprises glass fibres and carbon fibres, wherein the connecting element upper section comprises a lower stiffness against bending about the ankle-joint axis than the connecting element lower section.

2. The orthosis according to the preceding claim, wherein the connecting element comprises a connecting element middle section, wherein the connecting element middle section extends between the connecting element upper section and the connecting element lower section, wherein the connecting element middle section and the connecting element lower section comprise a higher stiffness against bending about the ankle-joint axis than the connecting element upper section, wherein particularly, the connecting element upper section is substantially untwisted.

3. The orthosis according to any of the preceding claims, wherein the bracing element comprises a curved, plate-like shape, wherein the bracing element comprises a first section and a second section,wherein the bracing element is configured for being connected to a fastening component configured for fastening the bracing element to the lower leg of the user, wherein the second section of the bracing element is made from the least one fibre- reinforced polymer, and wherein further, the second section of the bracing element is made from glass-fibre reinforced polymer.

4. The orthosis according to any of the preceding claims, wherein the foot support element comprises a foot support middle section, wherein the foot support middle section extends from a section of the lateral side of the foot support element, wherein the lower end of the connecting element extends from the foot support middle section, and wherein the foot support element comprises a foot support front section extending from the foot support middle section towards the front end of the foot support element.

5. The orthosis according to any of the preceding claims, wherein the foot support element, the connecting element and the first section of the bracing element comprise an outer layer comprising glass fibres.

6. The orthosis according to any of the preceding claims, wherein the connecting element upper section comprises a lower second area moment than the connecting element lower section.

7. The orthosis according to any of the preceding claims, wherein the connecting element lower section comprises a shape resulting in a higher second area moment than a straight line comprising a same width, thickness and / or length.

8. The orthosis according to any of the preceding claims, wherein end portions of cross-sections of the connecting element lower section are more curved than center portions of these cross-sections, particularly comprising a curvature with a radius of curvature K -i of 1.5-8 mm, such as 2-6 mm, and- center portions of cross-sections of the connecting element lower section are (a) substantially straight or (b) curved, comprising a curvature with a radius of curvature RL-2>10mm, particularly RL-2>20mm, such as RL-2>30mm.

9. The orthosis according to any of the preceding claims, wherein the end portions of crosssections of the connecting element lower section are more curved than the center-portions of these cross-sections, and wherein ends of the end portions comprise an orthogonal distance di_ of 1.5-4 mm, particularly 2-3 mm with respect to straight lines extending the center portion towards the ends of the cross-sections of the connecting element lower section.

10. The orthosis according to any of the preceding claims, wherein cross-sections of the connecting element upper section are (a) substantially straight or (b) curved, comprising a curvature with a radius of curvature Ru>30mm, particularly Ru>40mm, such as Ru>50mm.

11. The orthosis according to any of the preceding claims, wherein the connecting element middle section comprises a shape resulting in a higher second area moment than a straight line comprising a same width, thickness and / or length.

12. The orthosis according to any of the preceding claims, wherein end portions of cross-sections of the connecting element middle section are more curved than center portions of these cross-sections, particularly comprising a curvature with a radius of curvature RM-I of 1.5-8 mm, such as 2-6 mm, and center portions of cross-sections of the connecting element middle section are (a) substantially straight or (b) curved, comprising a curvature with a radius of curvature RM-2>10mm, particularly RM-2>20mm, such as RM-2>30mm.

13. The orthosis according to any of the preceding claims, wherein the orthosis is configured, in a use configuration, for repeated bending about the ankle-joint axis by an angle of at least 35°, preferably at least 40° and still more preferably at least 45°.

14. The orthosis according to any of the preceding claims, wherein the orthosis further comprises a sensor system, wherein the sensor system comprises at least one or a plurality of strain gauge(s), and wherein the at least one strain gauge(s) are located at the bracing element.

15. The orthosis according to the preceding claim, wherein the at least one strain gauge(s) are located on an outside sensor layer of the fibre-reinforced polymer or between the outside sensor layer and a first layer below the outside sensor layer of the fibre- reinforced polymer, wherein the outside sensor layer comprises glass fibres and / or wherein the outside sensor layer is a protective layer.

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