State improvement promotion system

Abstract

The state improvement promotion system propagates ultrasonic vibration or low-frequency vibration so as to transmit vibration energy to the entire target region in the brain in a state where a subject wears a vibration energy supply unit on the head, thereby reflecting an effect of physical movement of the subject produced by an operation function improving device.

Description

State improvement promotion system

[0001] The present invention relates to a state improvement promotion system, and is particularly suitable for application to promote the improvement of microcirculation in the intracranial tissue of a subject and the improvement of dementia in the subject by physical stimulation such as ultrasonic vibration or low-frequency vibration.

[0002] With the progress of the aging society in Japan, the number of dementia patients in the country is on the increase. In particular, as disease types of dementia, cerebrovascular dementia and Alzheimer's dementia account for the majority of all dementia, and there are also many patients presenting both symptoms.

[0003] As a method for dealing with cerebrovascular dementia, drug treatments for hypertension, lipid metabolism disorders, and diabetes, as well as efforts such as promoting exercise, smoking cessation, overeating prohibition, and stress reduction are common, but at present, there is still no developed treatment method for cerebrovascular dementia itself using pharmaceuticals.

[0004] In recent years, a treatment method for dementia has been proposed in which low-output pulsed ultrasound (LIPUS: Low-intensity Pulsed Ultrasound) is irradiated onto the brain for the purpose of bringing about angiogenesis and neuron increase in the human brain (see Patent Document 1).

[0005] This treatment therapy for dementia is a treatment therapy in which the expression of endothelial nitric oxide synthase (eNOS) is enhanced through a mechanism via physical stimulation to the caveolin-1 / β-integrin complex present in the vascular endothelial cell membrane by irradiation with low-output pulsed ultrasound, and as a result, reduction of amyloid-β accumulation downstream, suppression of microglial activity, angiogenesis, and remyelination are induced, and the decline of cognitive function is suppressed by a complex action mechanism.

[0006] Japanese Patent Publication No. 2018-181991

[0007] By the way, in recent years, when performing treatment and rehabilitation of a subject having a dysfunction of the cerebrovascular system or the physical system by using a wearable motion assistance device capable of controlling and assisting motion based on a bioelectric potential accompanying voluntary muscle activity according to the intention of the subject, many cases where the functions of these subjects have been improved have been reported.

[0008] Based on signals from the subject's own nervous system, the wearable movement assist device functions to move the body, which has impaired motor function. As a result, the subject moves their musculoskeletal system of their own volition, and sensory information flows from inside and outside the body to the nervous system, creating a bidirectional biofeedback loop between the nervous system and the musculoskeletal system.

[0009] It is believed that repeating this process strengthens synaptic connections in the brain, nervous system, and muscular system, promoting relearning and functional regeneration, and thereby accelerating the improvement of physical function in subjects with brain, nervous system, or muscular system diseases.

[0010] By applying the dementia treatment method described in Patent Document 1 mentioned above to subjects using such a wearable motion assistance device, it is expected that the decline in cognitive function can be further suppressed.

[0011] This invention was made with the above points in mind, and aims to propose a condition improvement promotion system that can significantly improve microcirculation in brain tissue and alleviate dementia compared to conventional methods.

[0012] To solve these problems, the present invention provides a vibration energy supply unit attached to the outer surface of the subject's head and supplying vibration energy of ultrasonic vibration or low-frequency vibration with a vibration frequency of 100 Hz or less; a vibration control unit that drives and controls the vibration energy supply unit so that the vibration energy of ultrasonic vibration or low-frequency vibration is propagated throughout the target area in the subject's brain; and a motion function enhancement device that promotes the effect of the subject's physical movement based on the repetition of a bidirectional biofeedback loop established between the nervous system and the musculoskeletal system, wherein the vibration control unit is configured to reflect the effect of the subject's physical movement by the motion function enhancement device when driving and controlling the vibration energy supply unit.

[0013] In this condition improvement promotion system, when the subject wears a vibration energy supply unit on their head and ultrasonic or low-frequency vibrations are transmitted to the entire target area in the brain, the effects of the subject's physical movement using a motor function enhancement device are reflected. This allows for the dilation of peripheral blood vessels, mainly in the head, improving blood flow and enabling a complex mechanism of action in the brain. This improves microcirculation in brain tissue and can alleviate dementia.

[0014] Furthermore, in the present invention, the device for improving operational function comprises a drive unit that provides power to a subject, a signal detection unit that detects the subject's bioelectric potential signal, a biosignal processing unit that acquires the subject's nerve transmission signal and myoelectric potential signal from the bioelectric potential signal detected by the signal detection unit, a voluntary control unit that uses the nerve transmission signal and myoelectric potential signal acquired by the biosignal processing unit to generate a command signal for the drive unit to generate power according to the subject's will, and a drive current generation unit that generates a current corresponding to the nerve transmission signal and a current corresponding to the myoelectric potential signal, respectively, based on the command signal generated by the voluntary control unit, and supplies them to the drive unit.

[0015] In this condition improvement promotion system, when a subject repeatedly performs voluntary movements using a motor function enhancement device, the system corrects the difference between the motor commands from the brain and nervous system and the actual movement phenomena, thereby improving the motor function of the subject's brain, nerves, and muscles. As a result, it becomes possible to obtain the effects of physical movement on the subject, such as dilation of peripheral blood vessels, mainly in the head, and improved blood flow.

[0016] Furthermore, in the present invention, the motion function enhancement device is used to be integrated with the subject and includes a motion mechanism unit having a drive unit that drives actively or passively in conjunction with the subject's physical movements, a signal detection unit that detects changes in ion current transmitted from the subject's brain and nervous system to the muscle system as biopotential signals appearing on the skin surface, a joint detection unit that detects physical quantities around the joints associated with the subject's physical movements based on the output signal from the drive unit, a voluntary control unit that controls the drive unit to produce motion phenomena that reflect the subject's intention to move based on the biopotential signals and physical quantities around the joints, and stores the reference parameters of each phase, which is a series of minimum motion units constituting the subject's motion patterns classified as tasks, in a data storage unit, and by comparing the physical quantities around the joints with the reference parameters stored in the data storage unit, the subject's task phases The system includes an autonomous control unit that estimates the phase and controls the drive unit to generate power corresponding to the phase, and a synthesis control unit that stores the control ratios of the voluntary control unit and the autonomous control unit set for each task phase in the data storage unit and synthesizes the control states of the voluntary control unit and the autonomous control unit so that the control ratio corresponds to the phase. The synthesis control unit compensates for the physical impedance of the entire system consisting of the entire device and the subject based on physical quantities around the joints, in accordance with the physical characteristics of the entire system, including the subject's physical characteristics and gravity, and also provides feedback adjustment of the synthesized control state at the same time as correcting the difference with motion commands from the brain and nervous system, based on a bio-self-control loop interactively promoted between the subject's body and the motion mechanism, so as to minimize the difference between the subject's intention to move and the motion phenomenon.

[0017] In this condition improvement promotion system, when a subject repeatedly performs voluntary movements using the movement mechanism of the motor function improvement device, the motor function of the subject's brain, nerves, and muscles is improved by correcting the difference between the movement commands from the brain and nervous system and the actual movement phenomena. As a result, it becomes possible to obtain the effects of physical movement on the subject, such as dilation of peripheral blood vessels, mainly in the head, and improved blood flow.

[0018] Furthermore, in this invention, when forming a biological self-regulation loop, the smallest motor control unit for realizing voluntary movements generated by the subject's will is set as a minimal voluntary motor control unit consisting of the brain and nervous system, synaptic connections, and the muscular system. A biological self-regulation loop is then established for each minimal voluntary motor control unit that forms a coordinated bodily movement to realize the motor phenomenon, using a motion mechanism.

[0019] As a result, in the condition improvement promotion system, by explicitly incorporating the influence of disease site and disease cause into the functional improvement and treatment process based on the fundamental theory of the bio-self-regulation loop by the movement mechanism, the minimal voluntary movement control unit in the motor function improvement device also affects other minimal voluntary movement control units, causing them to work in sync with the movement mechanism. This strengthens and adjusts the function of each minimal voluntary movement control unit in sync with the movement mechanism to achieve the target movement, thereby improving the function of the brain, nervous system, and muscular system.

[0020] Furthermore, the present invention further includes a scattering induction unit attached to the contact portion of the vibration energy supply unit with the outer surface of the subject's head, which induces scattering of ultrasonic vibrations or low-frequency vibrations. Multiple vibration energy supply units are mounted so as to be arranged around the subject's head, and the control unit drives and controls each of the ultrasonic vibrations and low-frequency vibrations from each vibration energy supply unit so as to create a phase difference.

[0021] As a result, the condition improvement acceleration system uses multiple ultrasonic vibrations and low-frequency vibrations transmitted into the subject's brain with a phase difference, which allows the vibrational energy to be transmitted throughout the entire target area of ​​the brain without resonance.

[0022] Furthermore, the present invention further includes a vibration receiving unit that receives ultrasonic vibrations and low-frequency vibrations transmitted through a contact area with the outer surface of the subject's head, and the control unit constantly monitors the vibration energy intensity of the ultrasonic vibrations and low-frequency vibrations received by the vibration receiving unit to keep it below a predetermined level while driving and controlling the vibration generating unit when the intensity is above a predetermined level.

[0023] As a result, the condition improvement acceleration system ensures safety by constantly monitoring to prevent excessive vibrational energy from the ultrasonic and low-frequency vibrations transmitted into the subject's brain, thereby preventing adverse effects on the subject's brain from the application of this device.

[0024] Furthermore, in this invention, the vibration energy of the ultrasonic vibration or low-frequency vibration generated by the vibration energy supply unit is set to a vibration generation sound pressure of 0.1 to 1.5 [MPa], with a maximum irradiation time of 20 minutes per use for the subject, and when used repeatedly, with an interval of 5 minutes between irradiations, the total irradiation time per day is set to a maximum of 60 minutes.

[0025] As a result, the condition improvement promotion system sets the sound pressure generated by the piezoelectric vibrator in the vibration energy supply unit to a range that provides appropriate tissue amplitude to the brain. Furthermore, by setting limits on the irradiation time for each use, as well as setting upper limits on the time interval when repeated use and the total time per day, it becomes possible to sustain the effects of improving microcirculation in the brain tissue and suppressing cognitive decline in the subject for a relatively long period after use.

[0026] Furthermore, in this invention, the vibrational energy of ultrasonic vibrations or low-frequency vibrations generated by the vibrational energy supply unit is diffused omnidirectionally while scattering from the supply direction, stimulating vascular cells with ultrasonic and low-frequency vibrations and promoting the expression of eNOS, VEGF, and bFGF.

[0027] As a result, the condition improvement promotion system allows the vibrational energy of ultrasonic or low-frequency vibrations to be scattered omnidirectionally from the direction of irradiation, thereby enhancing the expression of eNOS (endothelial nitric oxide synthase), VEGF (vascular endothelial growth factor), and bFGF (basic fibroblast growth factor), and achieving improvements in the microcirculation of the brain tissue and dementia in the subject.

[0028] Furthermore, in the present invention, the vibration energy supply units are mounted so as to be arranged in multiple locations around the head of the subject, and the control unit drives and controls each of the multiple vibration energy supply units to supply vibration energy of ultrasonic vibration or low frequency vibration in a non-focused manner and diffused in an inverse tapered shape that gradually expands in the direction of radiation, and to supply the energy sequentially between the multiple vibration energy supply units at predetermined time intervals.

[0029] As a result, in the condition improvement promotion system, when unfocused vibrational energy is sequentially supplied between multiple vibrational energy supply units, the irradiation wave or reflected wave of unfocused vibrational energy generated from one vibrational energy supply unit is attenuated, so that even if it overlaps with the unfocused vibrational energy generated from the next vibrational energy supply unit, it does not result in excessive vibrational stimulation. This makes it possible to provide the brain with appropriate tissue amplitude and treat dementia.

[0030] Furthermore, in this invention, the vibration energy of ultrasonic vibration or low-frequency vibration supplied by the vibration energy supply unit has a widening angle of 50° to 100° for the expanding inverse tapered inclined surface, and a vibration generation sound pressure of 0.1 to 1.5 [MPa], and is supplied continuously to the subject for 15 to 60 minutes.

[0031] As a result, in the condition improvement promotion system, the angle of the expanding inverse tapered inclined surface in the vibration energy of ultrasonic vibrations or low-frequency vibrations supplied from the vibration energy supply unit is set to a range that can be transmitted to the entire brain, and the sound pressure generated by the piezoelectric vibrator is set to a range that provides appropriate tissue amplitude to the brain. By setting a limit on the irradiation time for each use on the subject and repeating the process, the effect of improving microcirculation in the subject's brain tissue and the effect of suppressing cognitive decline can be sustained for a relatively long period after use.

[0032] According to the present invention, when efficiently transmitting vibrational energy throughout the target area in the brain, the effects of the subject's physical movement using a motion function device are reflected, causing peripheral blood vessels, mainly in the head, to dilate and improve blood flow. This allows for the activation of complex mechanisms within the brain, thereby improving microcirculation in brain tissue and realizing a condition improvement promotion system capable of alleviating dementia.

[0033] This is an external perspective view showing the configuration of the state improvement acceleration system according to this embodiment. This is a conceptual diagram showing the circuit configuration of the control system in the state improvement acceleration system shown in Figure 1. This is a conceptual diagram for explaining the basic theory of the bio-self-regulation loop according to the present invention. This is a conceptual diagram for explaining the minimum voluntary movement control unit. This is a conceptual diagram showing the transition state when the basic theory of the bio-self-regulation loop described above is applied to a subject. This is a schematic diagram showing the external configuration of the motion function improvement device including the waist-type motion mechanism in this embodiment. This is a schematic diagram showing the main configuration of the motion function improvement device in Figure 6. This is a schematic diagram showing the operating state and range of motion of the motion function improvement device in Figure 6. This is a block diagram showing the configuration of the control system of the motion function improvement device in Figure 6. This is a conceptual diagram showing an example of each task and each phase stored in the data storage unit. This is a diagram showing the state in which the motion function improvement device is attached to a subject. This is a diagram showing the state in which the motion function improvement device is attached to a subject. This is a conceptual diagram showing the circuit configuration of the control system in the state improvement acceleration device when the scattering induction unit of another embodiment is applied. This is a conceptual diagram showing the circuit configuration of the control system in the state improvement acceleration device when the scattering induction unit of another embodiment is applied.

[0034] An embodiment of the present invention will be described in detail below with reference to the drawings.

[0035] (1) Diagram 1 of the configuration of the condition improvement promotion system according to this embodiment is a schematic external view of the condition improvement promotion system 1 according to this embodiment. The condition improvement promotion system 1 includes a pair of vibration energy supply units 2 for attachment to the outer surface of the subject's head, a control unit 3 for driving and controlling each of the vibration energy supply units 2, and a motion function improvement device 4 for promoting the effects of the subject's physical movement based on the repetition of a bidirectional biofeedback loop established between the nervous system and the musculoskeletal system.

[0036] A pair of vibration energy supply units 2, a control unit (vibration control unit) 3, and an action function enhancement device 4 are connected to each other via wired or wireless communication. When the control unit 3 drives and controls the vibration energy supply units 2, it is configured to reflect the effect of the subject's physical movement on the action function enhancement device 4.

[0037] The pair of vibration energy supply units 2 consist of piezoelectric resonators (such as piezoelectric ceramic resonators, piezoelectric single crystal resonators, polymer piezoelectric film resonators, etc.) or magnetostrictive resonators (such as ferrite magnetostrictive resonators) that generate ultrasonic vibrations and low-frequency vibrations with a vibration frequency of 100 Hz or less.

[0038] Each of these pair of vibration energy supply units 2 is equipped with a scattering induction unit 5 at the contact point with the outer surface of the subject's head to induce scattering of ultrasonic vibrations and low-frequency vibrations generated from each piezoelectric vibrator (or magnetostrictive vibrator) (Figure 2, described later).

[0039] The subject attaches a pair of vibration energy supply units 2 in the condition improvement promotion system 1 to the left and right temporal bones (temples), which are the thinnest parts of the skull, so that the scattering induction units 5 are in contact with each other. By selecting the temporal bones (temples) as the contact site with the outer surface of the head, it is possible to relatively improve the transmission efficiency of ultrasonic vibrations and low-frequency vibrations to the brain.

[0040] The scattering induction unit 5 consists of a thin, plate-like encapsulated body containing fine particles made of ultrasonic scatterers having predetermined scattering characteristics, dispersed in a liquid (e.g., water), gel, or polymer medium.

[0041] Here, scattering refers to the phenomenon where, when ultrasonic waves are incident on an irregular interface or a minute reflector, the reflected waves spread out in all directions. The ultrasonic scatterer can be any fine particle capable of inducing forward scattering of ultrasonic vibrations and low-frequency vibrations generated from the vibration energy supply unit (piezoelectric transducer or magnetostrictive transducer), and can be of various sizes, shapes, and materials.

[0042] As a result, in the state improvement promotion system 1, when the subject wears the vibration energy supply unit 2 on the head, by applying a relatively flexible object as the scattering induction unit 5 inserted between the vibration energy supply unit 2 and the contact part of the outer surface of the head, it becomes possible to reduce the discomfort of the subject's head.

[0043] Thus, in the state improvement promotion system 1, in the state where the subject wears the vibration energy supply unit 2 on the head via the scattering induction unit 5, ultrasonic vibration or low-frequency vibration is scattered and irradiated, so that vibration energy is propagated to the entire target area in the brain. At the same time, by reflecting the effect of the subject's body movement by the motion function improvement device, a complex action mechanism can work in the brain in a state where the peripheral blood vessels are dilated centered on the head and the blood flow is improved, improving the microcirculation of the brain tissue and making it possible to improve dementia.

[0044] (2) Driving control method for a pair of vibration energy supply units Fig. 2 shows the circuit configuration of the control system in the state improvement promotion system 1. The state improvement promotion system 1 includes a general control unit 10 that controls the entire device, which is composed of an MCM (Multi-Chip Module) equipped with a CPU (Central Processing Unit), a memory, etc. in the control unit 3, and a storage unit 11 that reads and writes various data under the control of the general control unit 10.

[0045] The general control unit 10 drives and controls each vibration energy supply unit 2 so that vibration energy of ultrasonic vibration and low-frequency vibration is propagated to the entire target area in the subject's brain.

[0046] According to experiments, as the condition setting of the vibration energy of ultrasonic vibration and low-frequency vibration generated by the vibration energy supply unit 2, the vibration generation sound pressure is 0.1 to 1.5 [MPa], the irradiation time for one use for the subject is at most 20 minutes, and when used repeatedly, the irradiation is set with a 5-minute interval and a total of 60 minutes per day as the upper limit.

[0047] Thus, in the state improvement promotion system 1, the sound pressure generated by the piezoelectric vibrator (or magnetostrictive vibrator) in the vibration energy supply unit 2 is set within a range that gives an appropriate tissue amplitude to the brain, and the irradiation time for one use is limited, and the time sense when repeated and the total time per day are also set with an upper limit. As a result, the effect of improving the microcirculation of the tissue in the subject's brain and the effect of suppressing the decline of cognitive function can be maintained for a relatively long period of more than three months after use.

[0048] As a state improvement promotion function by irradiating the vibration energy of ultrasonic vibration and low-frequency vibration generated by the vibration energy supply unit 2, the vibration energy of the ultrasonic vibration and low-frequency vibration is diffused omnidirectionally while scattering from the irradiation direction, and the blood vessel cells in the subject's brain are stimulated by the ultrasonic / low-frequency vibration. Therefore, it becomes possible to promote the expression of eNOS (endothelial nitric oxide synthase), VEGF (vascular endothelial growth factor), and bFGF (basic fibroblast growth factor).

[0049] Thus, in the state improvement promotion system 1, by diffusing the vibration energy of ultrasonic vibration and low-frequency vibration omnidirectionally while scattering from the irradiation direction, it becomes possible to enhance the expression of eNOS (endothelial nitric oxide synthase), VEGF (vascular endothelial growth factor), and bFGF (basic fibroblast growth factor), and to realize the effect of improving the microcirculation of the tissue in the subject's brain and the effect of improving dementia.

[0050] Further, in the state improvement promotion system 1, the overall control unit 10 drives and controls the ultrasonic vibration and low-frequency vibration from the pair of vibration energy supply units 2 so that a phase difference occurs, whereby the vibration energy transmitted through the subject's brain can be propagated to the entire target area in the brain without resonance.

[0051] Furthermore, the state improvement promotion system 1 is provided with a vibration receiving unit 12 that receives ultrasonic vibration and low-frequency vibration transmitted through the contact part with the outer surface of the subject's head in the vicinity of the pair of vibration energy supply units 2.

[0052] The central control unit 10 constantly monitors the vibration energy intensity of the ultrasonic vibrations and low-frequency vibrations received by the vibration receiving unit 12 to maintain it below a predetermined level, while driving and controlling the vibration energy supply unit 2 if the intensity of the vibration energy is above a predetermined level.

[0053] As a result, the condition improvement promotion system 1 can ensure safety by constantly monitoring to prevent excessive vibrational energy from the ultrasonic vibrations and low-frequency vibrations transmitted into the subject's brain, thereby preventing adverse effects on the subject's brain caused by the application of this device.

[0054] Furthermore, while the vibration energy of ultrasonic vibrations and low-frequency vibrations from the pair of vibration energy supply units 2 is being irradiated, the control unit 10 may, when the intensity of the vibration energy of ultrasonic vibrations and low-frequency vibrations received by the vibration receiving unit 12 is above a predetermined level, constantly monitor and drive the vibration energy supply units 2 to keep it below that predetermined level, and at the same time appropriately change the phase difference between the ultrasonic vibrations and low-frequency vibrations for both vibration energy supply units 2.

[0055] (3) Basic theory of the biological self-regulation loop using a motor function improvement device As a method to improve the motor function of the brain, nervous system, and muscular system of subjects, experimental research is being conducted from a medical perspective to elucidate information processing that focuses on the brain. However, brain research alone is difficult to target because it is separated from the motor system.

[0056] The human motor system consists of the central nervous system (brain and spinal cord), the peripheral nervous system, and the musculoskeletal system. While these systems are interconnected and act as an information transmission system when dealing with the flow of information from the central nervous system to the periphery, this alone is not enough to achieve proper motor control.

[0057] In other words, while efferent nerve information is transmitted to muscle fibers involved in muscle contraction, information after contraction is not returned to the brain, even though it is transmitted from the brain through the spinal cord to the muscle fibers via motor nerves. For this reason, simply analyzing the "motor unit" composed of motor nerves and muscle fibers makes it virtually impossible to elucidate the mechanisms of improving motor function or to create technologies for improving motor control.

[0058] For this reason, some research attempts to improve function by using robotic technology to move the joints and muscles of the legs and hands through external motion input. However, it has also been reported that simply applying external force to move the joints and muscles of the legs and hands does not lead to functional improvement.

[0059] In this invention, as shown in Figure 3, a motion mechanism having a drive unit that operates actively or passively in conjunction with the subject's physical movements is used to demonstrate that when a subject performs a specific action, command signals (efferent nerve signals) that attempt to move according to their motor intention, and sensory signals (afferent nerve signals) generated by the successful movement, travel back and forth between the central system (brain and spinal cord) and the peripheral system (motor nerves, muscle system, and sensory nerves), thereby improving and reconstructing the physical functions necessary for voluntary movement.

[0060] The method for improving the function of the operating mechanism according to the present invention includes a voluntary control step for causing the operating mechanism to move in accordance with the subject's intention to move, an autonomous control step for generating a preset ideal power, and an impedance control step (including gravity compensation control) for reducing the feeling of difficulty in movement due to the load and viscous friction of the operating mechanism itself. As a result, the subject can feel as if the operating mechanism is an extension of their own body, and a functional fusion and integration between the subject and the operating mechanism can be achieved.

[0061] Furthermore, in this method for improving operational function, the synthesis control step, which synthesizes control states from voluntary control steps and autonomous control steps to achieve a control ratio corresponding to the phase of the task, not only executes the impedance control step described above, but also, based on a bio-self-regulation loop interactively promoted between the subject's body and the motor mechanism, corrects the difference with movement commands from the brain and nervous system, while simultaneously providing feedback adjustment to the synthesized control state, so as to minimize the difference between the subject's intention to move and the actual movement.

[0062] This biological self-regulation loop is formed when, in sync with the transmission of nervous system commands from the brain through the spinal cord to muscle fibers via motor nerves, causing muscle contraction, proprioceptors called muscle spindles and tendon spindles in the muscles and tendons are activated. This activation information is then fed back to the central nervous system (spinal cord and brain) via sensory nerves as information about muscle contraction, and this feedback information is used to strengthen and regulate synaptic connections between nerves and between nerves and muscles. This cycle is repeated, forming the loop.

[0063] In this way, in the method for improving motor function, when the subject repeatedly performs voluntary movements using the motor mechanism, it becomes possible to improve the motor function of the subject's brain, nerve, and muscle systems by correcting the difference between the movement commands from the brain and nervous system and the actual movement phenomena.

[0064] One of the features of the present invention is that, in forming a biological self-regulation loop, a minimal voluntary motor control unit consisting of the cranial nervous system (brain and spinal cord), synaptic connections (synaptic connections between nerves and synaptic connections between nerves and muscles), and the muscular system (muscle fibers (extrafusal muscle fibers to which α motor neurons connect and intrafusal muscle fibers to which γ motor neurons connect), tendon fibers, muscle spindles, tendon spindles, etc.) can be configured as the smallest motor control unit for realizing voluntary movements that arise from a person's will in order to establish a biological self-regulation loop.

[0065] In other words, the minimal voluntary movement control unit is the control unit that realizes the smallest voluntary movement, formed through pathways such as the cranial nervous system (brain, spinal cord, motor nerves), muscle fibers, movement (response), muscle spindles / tendon spindles, and the cranial nervous system (sensory nerves, spinal nerves, brain), as shown in Figure 4.

[0066] Multiple minimal voluntary movement control units, each forming a specific joint movement, are configured in conjunction with other minimal voluntary movement control units that interact with the aforementioned unit, thereby achieving the desired overall movement.

[0067] In this process, the synaptic connections between nerves and between nerves and muscles within the minimal voluntary movement control units are adjusted and strengthened within the overall regulatory system, such as the group of minimal voluntary movement control units related to the target overall movement, and the unconscious adjustment of postural balance.

[0068] Furthermore, by using the movement mechanism (such as the lower limb type, single-joint type, waist type, hand type, and finger type described later) in joint movements driven by muscle groups (so-called flexion and extension muscle groups) composed of minimal voluntary movement control units (units), and in more complex and coordinated movements composed of each joint system, it becomes possible to accommodate everything from the smallest units to higher-order complex body systems, thereby achieving improvements in the function of the brain, nervous system, and muscular system.

[0069] In fact, when the minimal voluntary movement control unit is considered a unit that promotes synaptic plasticity, neural plasticity, and muscle plasticity—basic neural functions for improving the function of the brain, nervous system, and muscular system—the process of activating the subject's self-healing ability according to the disease or symptoms (such as flaccidity, stiffness, tremors, rigidity, ataxia, and co-contraction) will differ for each of these minimal voluntary movement control units.

[0070] Therefore, the unit components of the minimal voluntary movement control unit for improving motor function of the brain, nerves, and muscles differ for each disease or symptom, and the relevant parts and ranges of other minimal voluntary movement control units that the said minimal voluntary movement control unit is involved in also differ. Thus, by using it as the smallest unit when making various adjustments to the movement mechanism section 20 (Figures 6 to 8 described later) in the motor function improvement device 4 according to the subject's condition (such as tuning parameters to realize movement according to the subject's intention to move and establish a biological self-control loop), it becomes possible to construct a treatment control strategy.

[0071] In the method for improving motor function according to the present invention, by detecting nerve-derived signals linked to voluntary will obtained from pathways affected by the disease site and cause of the disease, the method focuses on the minimal voluntary motor control units involved in those pathways and performs functional improvements on each minimal voluntary motor control unit that constitutes the target overall voluntary movement.

[0072] For voluntary movement to be achieved in humans, the starting point is the expression of the intention to move voluntarily in the cerebrum. The neural signals of this intention are transmitted from the brain to the spinal cord, motor nerves, and muscle fibers, ultimately resulting in the achievement of the target movement. However, this flow is too broad, from the expression of intention to the generation of movement. Therefore, it is difficult to explicitly grasp the influence of disease sites and causes on voluntary movement, from the brain and nervous system through synaptic connections to the muscular system, including sensory nerves in muscle fibers and muscle spindles and the gamma loop formed by gamma motor neurons. It is also difficult to explicitly perform treatment that takes the influence of disease sites and causes into account. For this reason, in actual clinical practice, training is limited to the repetition of simple movements.

[0073] Therefore, by explicitly incorporating minimal voluntary movement control units that reflect the influence of the disease site and cause into the functional improvement treatment process based on the basic theory of the biological self-regulation loop by the movement mechanism unit 20 (Figures 6 to 8), the effects extend to other minimal voluntary movement control units, causing them to work in sync with the movement of the movement mechanism unit 20. To achieve the target movement, each minimal voluntary movement control unit strengthens and adjusts the function of its unit components in sync with the movement of the movement mechanism unit, thereby enabling functional improvement of the brain, nervous system, and muscular system as a new method different from conventional approaches.

[0074] Figures 5(A) to 5(E) show the transition states when the basic theory of the biological self-regulation loop described above is applied to the subject. Starting from the state before treatment when the movement mechanism 20 is not attached (Figure 5(A)), in the initial stages of treatment, sensory nerve information from the musculoskeletal system is fed back to the central nervous system (brain and spinal cord) through joint movement using the movement mechanism 20 (Figure 5(B)).

[0075] Subsequently, in the state after initial treatment when the motor mechanism 20 is not attached (Figure 5(C)), some feedback sensation from sensory nervous system information remains. However, by continuing treatment using the motor mechanism 20 (Figure 5(D)), the difference between the subject's intention to move and the actual movement phenomenon, based on the motor commands from the central nervous system, is corrected based on a bio-self-regulation loop that is interactively promoted between the subject's body and the motor mechanism 20.

[0076] Furthermore, even when the motor mechanism 20 is not attached after continuous treatment, the motor function of the subject's brain, nerves, and muscles can be improved by correcting the difference between the motor commands from the central nervous system and the actual motor phenomena, thereby activating the subject's self-healing ability (Figure 5(E)).

[0077] (4) Configuration of the motion function improvement device in this embodiment (4-1) Configuration of the motion mechanism (waist type: hardware) Figures 6(A) and (B) show the motion function improvement device 4 including the waist type motion mechanism 20 in this embodiment. Figures 7(A) and (B) show the main components of the motion mechanism 20 in Figure 6, excluding the thigh cuff, belt, etc. The motion function improvement device 4 is a device that assists the work and movements of the subject, and detects bioelectric potential signals, the movement angle of the subject's hip joint, and the absolute angle of the torso, and operates to apply driving force from the drive unit based on these detected signals.

[0078] When a subject wearing the motion function enhancement device 4 lifts and carries a relatively heavy object of their own volition, the bioelectric potential signals on the skin surface of the latissimus dorsi or gluteus maximus muscles and the driving torque corresponding to the movement angle of the subject's hip joint are applied as assisting force from the motion mechanism 20. Therefore, the subject can lift and carry the object using the combined force of their own muscle strength and the driving torque from the drive mechanism (actuator).

[0079] Furthermore, the motion enhancement device 4 can assist not only with transporting tasks such as lifting an object and walking, but also with tasks such as ascending and descending stairs while the subject is carrying luggage.

[0080] In the motion mechanism 20 of the motion function improvement device 4, a lumbar frame 30 is attached to the back of the subject's waist, extending in the left-right direction. The lumbar frame 30 is, for example, a hollow member made of CFRP (carbon fiber reinforced plastic) and has a rounded shape that conforms to the shape of the back and both sides of the human waist.

[0081] The lumbar frame 30 is configured such that a first lumbar frame 30A, which is attached to the back of the subject's lumbar region from left to right, and a second lumbar frame 30B, which is attached above the first lumbar frame 30A and extends from left to right, are connected via a support column 31.

[0082] The first lumbar frame 30A and the second lumbar frame 30B are attached to the subject's waist by attachment belts 32 and 33 that are passed across the subject's ventral side. When attached, the first lumbar frame 30A and the second lumbar frame 30B are attached in a forward-leaning posture such that both ends are lower than the back side, that is, both ends are positioned lower than the longitudinal center (the part located on the back side of the subject).

[0083] Left-side frame 40 and right-side frame 41 are fixed to both ends of the first lumbar frame 30A and the second lumbar frame 30B.

[0084] Furthermore, on the outer side opposite to the mounting side of the operating mechanism 20, a battery 42 is detachably housed in the central part of the first waist frame 30A, and wiring connected to the battery 42 is inserted into the internal space.

[0085] The support column 31 is a member that connects the longitudinal center of the first waist frame 30A and the longitudinal center of the second waist frame 30B in the vertical direction. The support column 31 is, for example, a hollow member made of reinforced resin, and sensor wiring is inserted through its interior. A control device 80 (Figure 9, described later) that controls the operation of the operating mechanism 20 is also provided inside the support column 31.

[0086] The support column 31 holds the various components constituting the first waist frame 30A and the second waist frame 30B in place, preventing them from rotating, thereby ensuring the strength of the monocoque structure. In addition, a mounting belt 32 corresponding to the first waist frame 30A and a mounting belt 33 corresponding to the second waist frame 30B are attached to the support column 31, respectively.

[0087] The left-side frame 40 is fixed by joining the left end of the first lumbar frame 30A and the left end of the second lumbar frame 30B on the left side of the subject's hip joint. The right-side frame 41 has a structure that is substantially symmetrical to the left-side frame 40 and is fixed by joining the right end of the first lumbar frame 30A and the right end of the second lumbar frame 30B.

[0088] The left side frame 40 houses an actuator and a brake mechanism (neither shown), and is provided with a minus button 43 for inputting a reduction in the driving force of the actuator. This minus button 43 lights up when the power supply of the function enhancement device is turned on.

[0089] The right-side frame 41 houses an actuator and a brake mechanism (neither of which are shown), and is provided with a plus button 44 for inputting an increased driving force for the actuator, and a power button 45 for switching the power of the function enhancement device 1 on and off. The plus button 44 and power button 45 light up when the power of the function enhancement device 4 is turned on.

[0090] In this way, the lumbar frame (first lumbar frame 30A and second lumbar frame 30B), the support column 31, and the side frames (left side frame 40 and right side frame 41) are assembled to form a single integrated structure, thereby realizing a monocoque structure in which the frame itself bears the stress.

[0091] In Figures 6(A) and (B), the thigh fixation part 50 consists of a left thigh fixation part 50L that fixes the left thigh of the subject and a right thigh fixation part 50R that fixes the right thigh of the subject.

[0092] The left thigh fixing portion 50L consists of a stay portion 51L connected to an actuator in the left side frame 40 and a belt portion 52L attached to the stay portion 51L, and is rotatably mounted relative to the left side frame 40 in a side view.

[0093] Furthermore, the right thigh fixing portion 50R is composed of a stay portion 51R connected to an actuator in the right side frame 41 and a belt portion 52R attached to the stay portion 51R, and is provided so as to be rotatable in a side view relative to the right side frame 41.

[0094] In addition, in the left thigh fixing section 50L and the right thigh fixing section 50R, the stay sections 51L and 51R are designed to an optimal length based on the average length of a human thigh, and the subject's thigh is fixed by the belt sections 52L and 52R.

[0095] The attachment belt 32 is an attachment belt that is passed across the abdominal side when attaching the first lumbar frame 30A to the subject, and serves as the main attachment point for the operating mechanism 20 to the waist of the human body.

[0096] The attachment belt 33 is an attachment belt that is passed across the abdominal side when attaching the second lumbar frame 30B to the subject. The attachment belt 33 is used to fix the motion mechanism 20 to the human body above the attachment belt 33 in order to efficiently transmit the reaction force generated by the movement of the legs to the abdomen or waist of the subject when the subject wearing the motion mechanism 20 lifts a relatively heavy object from a bent-knee position.

[0097] The battery 42 is located on the outside of the central part of the first waist frame 30A, on the side opposite to the mounting side of the operating mechanism 20, and supplies power to the control device, actuator, brake mechanism (not shown), minus button 43, plus button 44, and power button 45.

[0098] The biosignal detection unit 60, which has a biopotential sensor, is attached to the back of the subject's waist and is a detection unit that detects biopotential signals associated with muscle activity when the subject tries to raise their torso or when they try to maintain the angle of their torso.

[0099] The bioelectric potential sensors of the biosignal detection unit 60 are connected to the ends of wiring that extends from holes in the support column 31 to the outside of the support column, and there are three of them. The bioelectric potential sensors are attached to the back of the subject's waist and detect bioelectric potential signals generated when the subject moves the muscles of their trunk.

[0100] The biopotential signal detected by the biosignal detection unit 60 is input to the control device. The biopotential sensor may be attached to the subject's back using tape or the like, or it may be attached using gel or the like. One of the three sensors is used to measure the reference signal, and the remaining two sensors are used to measure the biopotential signal.

[0101] In fact, in the motion function improvement device 4, the motion mechanism 20 is attached to the subject's waist from the rear. The motion function improvement device 4 is a device that generates assisting force to help the movement of the thighs relative to the waist when the subject stands up from a bent-over position (half-crouching posture) as shown in Figure 8(A) as shown in Figure 8(B). Such movements of the subject include, for example, standing up from a half-crouching posture, lifting an object from a half-crouching posture, and movements during transfer assistance.

[0102] Figure 8(C) is a diagram (left side view) showing the range of motion of the operating mechanism 20 in the motion function improvement device 4. The left thigh fixing part 50L can rotate 130° clockwise and 30° counterclockwise from the reference position shown in Figure 8(C), with the left side frame 40 as the center of rotation. Through this movement, the motion function improvement device 4 generates an assisting force to support the movement of the thigh relative to the waist when the subject moves from a bent-over position as shown in Figure 8(A) to a standing position as shown in Figure 8(B). The range of motion of the right thigh fixing part 50R is similar.

[0103] In this embodiment, the waist-type motion function improvement device 4 has a control system 70 as shown in Figure 9, which will be described later. As a result, the motion function improvement device 4 also functionally includes a voluntary control step for performing actions according to the subject's intention to move, an autonomous control step for generating a preset ideal power, and an impedance control step (including gravity compensation control) for reducing the feeling of difficulty in movement due to the load and viscous friction of the motion mechanism 20 itself.

[0104] As a result, in the waist-type motion function improvement device 4, the subject can feel as if the motion mechanism 20 is an extension of their own body, making it possible to achieve functional fusion and integration between the subject and the motion mechanism 20.

[0105] In fact, the motion function improvement device 4 can generate an assisting force to support the movement of the thighs relative to the waist when the subject moves from a crouched position as shown in Figure 8(A) to a standing position as shown in Figure 8(B). This assisting force is generated when the drive unit (actuator) is driven based on bioelectric potential signals, which are detected by the biosignal detection unit 60, and are associated with muscle activity when the subject tries to raise their torso or when they try to maintain the angle of their torso.

[0106] Therefore, it is possible to provide a highly convenient motor function improvement device 4 that can provide the necessary assistive force in the necessary direction according to the subject's will. Furthermore, it is possible to provide a motor function improvement device 4 that can minimize the amount of power (muscle strength) that the subject must generate themselves, and that can prevent situations that impair the subject's convenience.

[0107] Furthermore, the control device 80 (Figure 9) is configured to determine that the subject is walking if it determines that the signal levels of the biological signals in the subject's left and right thighs are not equal, while determining that the subject is stationary if it determines that the signal levels are equal.

[0108] Furthermore, when the control device 80 determines that the subject is in a stationary state, if it determines that both the left and right hip joint angles are greater than a predetermined specified angle, it determines that the subject is walking. On the other hand, if it determines that the angles are less than or equal to the specified angle, it determines that the subject is in a posture with their upper body lowered forward.

[0109] Furthermore, in the motion function enhancement device 4, the synthesis control step, which synthesizes the control states from the voluntary control step and the autonomous control step to achieve a control ratio corresponding to the phase of the task, not only executes the impedance control step described above, but also, based on a bio-self-control loop interactively promoted between the subject's body and the motion mechanism, corrects the difference with motion commands from the brain and nervous system, and simultaneously provides feedback adjustment to the synthesized control state, so as to minimize the difference between the subject's intention to move and the actual movement.

[0110] As a result, with the motor function improvement device 4, when the subject repeatedly performs voluntary movements using the movement mechanism 20, it becomes possible to improve the motor function of the subject's brain, nerve, and muscle systems by correcting the difference between the movement commands from the brain and nervous system and the actual movement phenomena.

[0111] Furthermore, in the motor function improvement device 4, when forming a biological self-control loop, the smallest motor control unit for realizing voluntary movements generated by the subject's will is set as a minimal voluntary motor control unit consisting of the brain and nervous system, synaptic connections, and the muscular system. The motor mechanism unit 20 is used to establish a biological self-control loop for each minimal voluntary motor control unit that forms a coordinated bodily movement to realize a motor phenomenon.

[0112] As a result, in the motor function improvement device 4, by explicitly incorporating the influence of disease site and disease cause into the process of functional improvement and treatment based on the basic theory of the bio-self-regulation loop by the motor mechanism, the effect extends to other minimal voluntary movement control units, causing them to work in sync with the operation of the motor mechanism 20. This strengthens and adjusts the function of each minimal voluntary movement control unit in sync with the operation of the motor mechanism to achieve the target movement, thereby improving the function of the brain, nervous system, and muscular system.

[0113] (4-2) Control System in the Motion Function Improvement Device Figure 9 is a block diagram showing the configuration of the control system 70 of the motion function improvement device 4. As shown in Figure 9, the control system 70 of the motion function improvement device 4 includes a control device 80 that is in charge of overall control of the entire system, a data storage unit 81 in which various data are stored in a database that can be read and written according to the commands of the control device 80, and drive units 82L and 82R that are driven actively or passively in conjunction with the lower limb movements of the subject.

[0114] Furthermore, the control system 70 is equipped with a joint detection unit 90 having a potentiometer 83, an absolute angle sensor 84, and a torque sensor 85, which detects physical quantities around the joints associated with the subject's body movements based on output signals from the drive units 82L and 82R.

[0115] The joint detection unit 90 detects the absolute angle, rotation angle, angular velocity, angular acceleration, and drive torque between the rotor-side frame and the stator-side frame of the drive units 82L and 82R in the operating mechanism unit 20 as physical quantities around the joint.

[0116] The potentiometer 83 is located coaxially with the output shaft of the actuators in the drive units 82L and 82R, and detects the joint angle corresponding to the lower limb movement of the subject by detecting the rotation angle of the output shaft.

[0117] The absolute angle sensor 84 is mounted on the lower limb frame and measures the absolute angle of the subject's thigh relative to the vertical direction. This absolute angle sensor 84 consists of an accelerometer and a gyroscope and is used in sensor fusion, a method of extracting new information using data from multiple sensors.

[0118] To calculate the absolute angle of the thigh, a first-order filter is used to remove the effects of translational motion and temperature drift in each sensor. This first-order filter is calculated by weighting and adding the values ​​obtained from each sensor.

[0119] If θabs(k) is the absolute angle of the thigh with respect to the vertical, ω is the angular velocity obtained by the gyro sensor, dt is the sampling period, and α is the acceleration obtained by the accelerometer, then θabs(t) can be expressed as shown in equation (1) below.

[0120] Furthermore, the torque sensor 85 detects the current value supplied to the drive units 82L and 82R, and detects the drive torque by multiplying this current value by a torque constant specific to the actuator.

[0121] A biosignal detection unit 60, equipped with biopotential sensors (electrode groups), is positioned on the body surface of the subject (mainly the body surface of the thigh) based on the joints associated with the subject's lower limb movements. This unit detects changes in ion current transmitted from the subject's brain and nervous system to the muscle system as biopotential signals appearing on the skin surface.

[0122] The biosignal detection unit 60 is a detection unit that measures nerve action potentials emitted from the brain to the legs to move the subject's legs, and muscle action potentials generated when skeletal muscles generate muscle force, and has electrodes that detect weak potentials generated at the periphery of the body system. In this embodiment, the biopotential sensor is attached so as to be detachably attached to the surface of the subject's skin by means of, for example, an adhesive seal that covers the area around the electrodes.

[0123] The data storage unit 81 stores data necessary for performing various calculations in the control device 80. Bioelectric potential signals detected by the biosignal detection unit 60 are stored in the data storage unit 81. Joint angle (θknee, θhip) data detected by the absolute angle sensor 84 of the joint circumference detection unit 90 is input to the data storage unit 81.

[0124] The control device 80 is composed of, for example, a CPU (Central Processing Unit) chip having memory, and includes a discretionary control unit 100, an autonomous control unit 101, and a composite control unit 102.

[0125] The voluntary control unit 100 controls the drive units 82L and 82R based on bioelectric signals and physical quantities around the joints, so that the movement phenomena reflect the subject's intention to move. Specifically, the voluntary control unit 100 supplies a command signal to the current control unit 105 corresponding to the detection signal from the biosignal detection unit 60.

[0126] The discretionary control unit 100 generates a command signal by applying a predetermined command function f(t) or gain P to the biosignal detection unit 60. This gain P is a preset value or function and can be adjusted by an external input.

[0127] The knee joint angle data detected by the potentiometer 83, the absolute angle data of the thigh relative to the vertical direction detected by the absolute angle sensor 84, the drive torque detected by the torque sensor 85, and the bioelectric potential signal detected by the biosignal detection unit 60 are input to the data storage unit 81.

[0128] The autonomous control unit 101 stores the reference parameters for each phase, which is a series of minimum operating units that constitute the operation pattern of the subject classified as a task, in the data storage unit 81. By comparing the physical quantities around the joints with the reference parameters stored in the data storage unit 81, it estimates the phase of the subject's task and controls the drive unit to generate power corresponding to that phase.

[0129] The autonomous control unit 101 compares the knee joint angle data detected by the joint detection unit (potentiometer 83) 90 with the knee joint angle of a reference parameter stored in the data storage unit 81, and estimates the phase of the subject's movement based on the comparison result.

[0130] Then, when the autonomous control unit 101 obtains the control data for the estimated phase, it generates a command signal corresponding to the control data for this phase and supplies this command signal to the current control unit 105 to generate power in the drive units 82L and 82R.

[0131] Furthermore, the autonomous control unit 101 receives a gain adjusted by an external input, generates a command signal corresponding to this gain, and outputs it to the current control unit 105. The current control unit 105 controls the current that drives the actuators of the drive units 82L and 82R, thereby controlling the torque and rotation angle of the actuators, and applying assisting force from the actuators to the knee joint of the subject.

[0132] In this manner, the autonomous control unit 101 identifies phases corresponding to the subject's task based on the physical quantities detected by the joint detection unit (potentiometer 83, absolute angle sensor 84, and torque sensor 85) 90, and generates power corresponding to each phase in the drive units 82L and 82R.

[0133] The combined control unit 102 combines the control signals from the voluntary control unit 100 and the autonomous control unit 101, and the current control unit 105 amplifies the drive current corresponding to the combined control signal and supplies it to the actuators of the drive units 82L and 82R. The torque of these actuators is transmitted to the knee joint of the subject as an assist force via the lumbar frame 30.

[0134] Figure 10 shows an example of each task and phase stored in the data storage unit 81. Tasks for classifying the subject's movements include, for example, Task A, which has data for standing up from a seated position to a standing position; Task B, which has data for walking after the subject has stood up; Task C, which has data for sitting down from a standing position to a seated position; and Task D, which has data for climbing stairs from a standing position to going up and down stairs. These tasks are stored in the data storage unit 81.

[0135] Furthermore, each task has multiple phase data sets. For example, task B, which involves walking, has phase B containing motion data (such as joint angles, trajectory of the center of gravity, torque fluctuations, and changes in bioelectric signals) when swinging the right leg forward from a standing position with the center of gravity on the left leg; phase B containing motion data when landing and shifting the center of gravity from a position with the center of gravity on the right leg; phase B containing motion data when swinging the left leg forward from a standing position with the center of gravity on the right leg; and phase B containing motion data when landing and shifting the center of gravity from a position with the left leg in front of the right leg.

[0136] Thus, by analyzing typical human movements, it becomes clear that typical movement patterns, such as the angles of each joint and the movement of the center of gravity, are determined for each phase. Therefore, for each phase that constitutes a large number of basic human movements (tasks), typical joint angle displacements and center of gravity movement states are empirically determined and stored in the data storage unit 81. In addition, multiple assist patterns are assigned to each phase, and different assists are provided for each assist pattern even within the same phase.

[0137] In the above configuration, the function enhancement device 4 detects the change in ion current transmitted from the subject's brain and nervous system to the muscle system as a bioelectric potential signal appearing on the skin surface using the bioelectric signal detection unit 60, and operates to apply driving force from the drive units (actuators) 82L and 82R based on this detected signal.

[0138] When a subject wearing the motion mechanism 20 attempts to perform lower limb movements of their own volition, the motion mechanism 20 provides a driving torque as an assisting force corresponding to the bioelectric potential signals generated. In other words, the assisting force is a force that generates torque acting around each joint in the frame mechanism of the motion mechanism 20 (corresponding to the subject's knee and hip joints, respectively) as the axis of rotation.

[0139] Therefore, the subject can perform walking movements while supporting their weight with the combined force of their own muscle strength and the driving torque from the drive units 82L and 82R. In addition to walking, the motion function improvement device 4 can also assist with movements that correspond to the subject's will, such as when the subject stands up from a seated position in a chair, or sits down in a chair from a standing position, and when the subject goes up or down stairs. In particular, when muscle strength is weak, it is difficult to go up stairs or stand up from a chair, but a subject wearing the motion mechanism unit 20 can perform these movements without worrying about muscle weakness because driving torque is applied according to their own will.

[0140] The composite control unit 102 stores the control ratios of the discretionary control unit 100 and the autonomous control unit 101 set for each phase of each task in the data storage unit 81, and combines the control states of the discretionary control unit 100 and the autonomous control unit 101 so that the control ratio corresponds to the phase.

[0141] In other words, when a subject attempts to move their body, their intention to move is transmitted as a weak ionic current from the brain to the spinal cord, nerves, muscle spindles, and muscles, causing the musculoskeletal system, which has joints, to move. At that time, when a weak bioelectric signal is detected from the surface of the subject's skin, the voluntary control unit 100 controls the actuators to move the joints according to the subject's intention.

[0142] Furthermore, since the motion mechanism 20 is fastened in close contact with the subject's leg (biological part), the driving force of the drive units 82L and 82R is transmitted to the subject as an assisting force to rotate the joint. As a result, the subject's body moves due to the assisting force of the motion mechanism 20, and signals from Ia afferent neurons from muscle spindles return to the brain via nerves and the spinal cord.

[0143] As a result, an interactive biofeedback system is established between the subject, the brain, and the motor function enhancement device 4, consisting of two signal transmission systems: "brain → spinal cord → motor nerves → [musculoskeletal system + motor mechanism unit 20]" and "motor mechanism unit 20 → musculoskeletal system (muscle spindles) → sensory nerves → spinal cord → brain". This is bidirectional voluntary control from the brain and the motor mechanism unit 20, making it possible to further enhance the effectiveness of neurorehabilitation-based training for the recovery of nervous system function.

[0144] Thus, the motor function enhancement device 4 is configured to sense bioelectric potential signals from the brain to the periphery after decision-making regarding movement and utilize them for actuator control. However, it attempts to capture bioelectric potential signals corresponding to brain activity from the periphery, specifically muscle activity. This makes it possible to provide real-time feedback to the brain and nervous system sensed in the periphery. Therefore, by performing rehabilitation with the subject wearing the motor mechanism unit 20, functional recovery in the bidirectional signal transmission system can be promoted.

[0145] Furthermore, in cases of severe motor dysfunction, where bioelectric signals cannot be detected, voluntary control does not function. Therefore, the control ratio is switched to enable autonomous control, which controls the drive units 82L and 82R based on a phase-by-phase control program derived from the analysis results of basic human movement patterns and operating mechanisms.

[0146] In this hybrid control system, where voluntary and autonomous control coexist, the amplitude and characteristics of bioelectric signals change according to the state of motor function, even in cases of complete paralysis or the progression of neurological and muscular diseases. Therefore, rehabilitation can be effectively carried out for these conditions as well.

[0147] Furthermore, the synthesis control unit 102 compensates for the physical impedance of the entire system, consisting of the entire apparatus and the subject, based on the physical quantities around the joints, in accordance with the physical characteristics of the entire system, including the human characteristics of the subject, and gravity.

[0148] In other words, the synthesis control unit 102 uses the equation of motion data (Mi) and known parameters (Pk) read from the data storage unit 81 to construct the target equation of motion in the calculation environment, and is configured to allow the input of the estimated drive torque (Te), the estimated joint torque (ΔT), and the joint angle θ into the equation of motion.

[0149] Here, the equation of motion data (Mi) is used to construct the equation of motion for the entire system consisting of the motion function improvement device 4 and the subject, while the known parameters (Pk) consist of dynamic parameters such as the weight of each part of the motion function improvement device 4, the moment of inertia around the joints, the viscosity coefficient, and the Coulomb friction coefficient.

[0150] The joint detection unit 90 includes not only the potentiometer 83, absolute angle sensor 84, and torque sensor 85 mentioned above, but also a relative force detection unit 110, a joint torque estimation unit 111, and a muscle torque estimation unit 112. The relative force detection unit 110 detects the relative force (ΔF) acting on the operating mechanism unit (frame mechanism) 20, that is, the force determined relatively by the relationship between the force generated by the drive units 82L and 82R and the muscle strength of the subject.

[0151] The joint torque estimation unit 111 estimates the joint moment (ΔT) around each joint of the subject from the difference between the relative force data (ΔF) detected by the relative force detection unit 110 multiplied by a preset coefficient and the drive torque (Te) detected by the torque sensor 85. Since the resultant force of the drive torque (Te) of the drive units 82L and 82R and the subject's muscle torque (Tm) acts as the joint moment (ΔT) on the subject's leg, the subject can move their leg with less muscle force than when the motion mechanism unit (frame mechanism) 20 is not attached.

[0152] The muscle torque estimation unit 112 estimates the muscle torque (Tm) due to the subject's muscle force based on the drive torque (Te) detected by the torque sensor 85 and the joint moment (ΔT) estimated by the joint torque estimation unit 111. The muscle torque (Tm) is determined to enable parameter identification even when the subject is generating muscle force, and is advantageous when performing parameter identification in the subject's operating state.

[0153] The synthesis control unit 102 performs calculations that take into account the drive torque (Te), joint data (θ), and joint moment (ΔT) obtained from the joint detection unit 90, as well as the muscle torque (Tm), to identify unknown dynamic parameters (Pu) such as the weight of each part of the subject, the moment of inertia around each joint, the viscosity coefficient, and the Coulomb friction coefficient, and averages them after repeating the process multiple times (for example, 10 times).

[0154] Next, the synthesis control unit 102 reads the estimated ratio of muscle torque (Tm) to biopotential (Tm / BES) and a predetermined setting gain (Gs) from the data storage unit 81. If the setting gain (Gs) is outside the acceptable error range (Ea), it corrects the biopotential (BES) to obtain a corrected biopotential (BES'), and makes the ratio of muscle torque (Tm) to corrected biopotential (BES') (Tm / BES') approximately equal to the setting gain (Gs).

[0155] As a result, it is possible to prevent a decrease in the accuracy of identifying the unknown dynamic parameters (Pu) of the subject, as well as to prevent situations in which the assist force generated by the drive units 82L and 82R is too small or too large.

[0156] The synthesis control unit 102 is configured to read control method data (Ci) from the data storage unit 81, drive torque (Te), joint torque (ΔT), and joint angle θ obtained from the joint detection unit 90, as well as identification parameters (Pi) which are the result of identifying unknown dynamic parameters (Pu), and corrected biopotential (BES').

[0157] Furthermore, the synthesis control unit 102 configures a predetermined control unit on the computing environment using control method data (Ci), and by reflecting the drive torque (Te), joint torque (ΔT), joint angle θ, identification parameter (Pi), and biopotential (BES') in this synthesis control unit 102, it is possible to send a control signal Ur for driving control of the drive units 82L and 82R. The current control unit 105 drives the drive units 82L and 82R in accordance with the control signal Ur from the synthesis control unit 102.

[0158] Furthermore, the motion enhancement device 4 is designed to control the assist force based on impedance adjustment in order to eliminate the interference with natural control caused by the physical characteristics of the device itself, namely the viscoelasticity around the joints and the inertia of the frame. In other words, the motion enhancement device 4 calculates the parameters of the joints and compensates for the moment of inertia, viscosity, and elasticity with the drive units (actuators) 82L and 82R, thereby improving the assist rate in walking motion and reducing discomfort for the subject.

[0159] In this way, the motion enhancement device 4 makes it possible to indirectly change and adjust the characteristics of the subject by changing the characteristics of the entire system, which includes the subject in addition to the device itself. For example, by adjusting the drive torque so as to suppress the influence of the inertia term and viscous friction term of the entire system, it becomes possible to maximize the subject's ability to perform quick movements such as reflexes. Furthermore, it is also possible to suppress the influence of the subject's own inertia term and viscous friction term, making it possible to make the subject walk faster than their original period or move more smoothly (with less viscous friction) than before the device was attached.

[0160] Furthermore, the functional enhancement device 4, while attached to the subject, can use the composite control unit 102 to identify the subject's unique dynamic parameters, and the control device 80 can control the drive units 82L and 82R based on the equation of motion obtained by substituting the identified dynamic parameters. Therefore, it can exert effects according to the control method used by the control device 80, regardless of individual differences or fluctuating factors such as the subject's physical condition.

[0161] Furthermore, since the control device 80 can control the drive units 82L and 82R based on the equation of motion which also incorporates the muscle torque (Tm) estimated by the joint detection unit 90, dynamic parameters can be identified even when muscle force is being generated from the subject, and the above effects can be achieved without requiring the subject to wait for the identification of these dynamic parameters.

[0162] By adjusting the gain between the bioelectric potential (BES) detected by the bioelectric signal detection unit 60 and the muscle torque (Tm) detected by the joint detection unit 90 to a preset gain (Gs), it is possible to prevent situations in which the detection results from the bioelectric signal detection unit 60 have poor or excessive sensitivity.

[0163] As a result, it is possible to prevent a decrease in the accuracy of identifying the subject's dynamic parameters, as well as to prevent situations where the assist force generated by the drive units 82L and 82R is too small or too large. Moreover, with the operational function improvement device 4 of this embodiment, calibration can be performed even when muscle force is being generated by the subject, and the subject does not need to wait for the calibration to be performed.

[0164] Since the control device 80 can be subjected to at least one of gravity compensation and inertia compensation using dynamic parameters identified by the composite control unit 102, it is possible to prevent situations where the weight of the device itself becomes a burden on the subject, or where the inertia of the device itself causes discomfort to the subject during operation.

[0165] In addition, the synthesis control unit 102, based on a biological self-regulation loop interactively facilitated between the subject's body and the motion mechanism unit 20, corrects the difference with motion commands from the brain and nervous system, and simultaneously provides feedback adjustment to the synthesized control state, so as to minimize the difference between the subject's intention to act and the actual motion.

[0166] As a result, with the motor function improvement device 4, when the subject repeatedly performs voluntary movements using the movement mechanism 20, it becomes possible to improve the motor function of the subject's brain, nerve, and muscle systems by correcting the difference between the movement commands from the brain and nervous system and the actual movement phenomena.

[0167] Furthermore, in the motor function improvement device 4, when forming a biological self-control loop, the smallest motor control unit for realizing voluntary movements generated by the subject's will is set as a minimal voluntary motor control unit consisting of the brain and nervous system, synaptic connections, and the muscular system. The motor mechanism unit 20 is used to establish a biological self-control loop for each minimal voluntary motor control unit that forms a coordinated bodily movement to realize a motor phenomenon.

[0168] As a result, in the motor function improvement device 4, by explicitly incorporating the influence of disease site and disease cause into the process of functional improvement and treatment based on the basic theory of the bio-self-regulation loop by the motor mechanism, the effect extends to other minimal voluntary movement control units, causing them to work in sync with the operation of the motor mechanism 20. This strengthens and adjusts the function of each minimal voluntary movement control unit in sync with the operation of the motor mechanism 20 in order to achieve the target movement, thereby improving the function of the brain, nervous system, and muscular system.

[0169] For example, in subjects with progressive diseases (slowly progressive neuromuscular diseases), motor function normally gradually declines over time, but using the motor function improvement device 4 yields a functional improvement effect that was previously unthinkable (Figure 11). Furthermore, while it is generally accepted that normal daily life and conventional exercise therapy cause muscle breakdown, leading to an increase in blood CK levels, an indicator of muscle breakdown in the blood, the motor function improvement device 4 actually results in a decrease in CK levels (Figure 12).

[0170] (5) Role of the Functional Improvement Device in the Condition Improvement Promotion System of the Present Invention In the condition improvement promotion system 1 of this embodiment, when the subject wears the vibration energy supply unit 2 on their head, the vibration energy is transmitted from the ultrasonic low-frequency vibration to the entire target area in the brain, thereby activating a complex mechanism of action in the brain, improving the microcirculation of brain tissue and making it possible to improve dementia.

[0171] In this condition improvement promotion system 1, when the control unit (vibration control unit) 3 drives and controls the vibration energy supply unit, the subject repeatedly performs voluntary movements using the movement mechanism 20 of the movement function improvement device 4. This corrects the difference between the movement commands from the brain and nervous system and the actual movement phenomena, thereby improving the motor function of the subject's brain, nerves, and muscles. As a result, it becomes possible to obtain the effects of physical movement on the subject, such as dilation of peripheral blood vessels, mainly in the head, and improved blood flow.

[0172] In this way, the condition improvement promotion system 1 reflects the effect of the subject's physical movement using the motion function improvement device 4, dilating peripheral blood vessels mainly in the head to improve blood flow. When the vibration energy of the ultrasonic and low-frequency vibrations generated by the vibration energy supply unit 2 is scattered from the supply direction and diffused in all directions, it becomes possible to further promote the expression of eNOS (endothelial nitric oxide synthase), VEGF (vascular endothelial growth factor), and bFGF (basic fibroblast growth factor) when vascular cells are stimulated by the ultrasonic and low-frequency vibrations.

[0173] Therefore, the condition improvement promotion system 1 can activate a complex mechanism of action in the brain through the vibrational energy of ultrasound and low-frequency vibrations propagated throughout the entire target area, while reflecting the effect of the subject's physical movement using the motor function improvement device 4. This improves microcirculation in the brain tissue of the subject and further enhances the effect of improving dementia. Since the subject can simultaneously experience both the effect of the propagation of vibrational energy of ultrasound and low-frequency vibrations acting on their head and the effect of improving motor function through the movement of their lower limbs, it is possible to obtain a synergistic effect that combines both effects.

[0174] (6) Other Embodiments In the embodiments described above, a thin plate-shaped encapsulated body containing fine particles made of ultrasonic scatterers having predetermined scattering characteristics, dispersed in a liquid, gel, or polymer medium, was used as the scattering induction unit 5 that induces the scattering of ultrasonic and low-frequency vibrations generated from the vibration energy supply unit 2. However, the present invention is not limited to this, and in short, various scattering induction units may be applied as long as they can be propagated throughout the entire target area in the subject's brain and have a structure that can be attached to the contact area with the outer surface of the subject's head.

[0175] For example, as shown in Figure 13, where the corresponding parts in Figure 2 are denoted by the same reference numerals, the scattering induction unit 120 consists of a thin plate-shaped encasing body containing point-like scattering bodies 121, which are made up of bubbles, scattered in a liquid medium. The control unit 10 adjusts the scattering characteristics of ultrasonic vibrations and low-frequency vibrations by controlling either the arrangement and / or distribution state of the point-like scattering bodies 121 in the scattering induction unit 120 to a desired state.

[0176] As a result, the condition improvement acceleration system 1 can adjust the scattering characteristics of the scattering induction part 120 that comes into contact with the contact area on the outer surface of the subject's head to a desired state, making it possible to optimize the propagation state of vibrational energy throughout the target area in the brain.

[0177] As another example, as shown in Figure 14, where the corresponding parts in Figure 2 are denoted by the same reference numerals, the scattering induction unit 130 consists of a thin plate-shaped encasing filled with magnetic fluid 131. The central control unit 10 adjusts the scattering characteristics of ultrasonic vibrations and low-frequency vibrations by controlling either or both of the arrangement and distribution state of the ferromagnetic fine particles contained in the magnetic fluid 131 in the scattering induction unit 130 to a desired state.

[0178] The magnetic fluid 131 is a colloidal solution in which magnetic iron oxide nanoparticles are extremely stably dispersed in a liquid, and is a composite material consisting of magnetic nanoparticles (for example, magnetite (Fe3O4) or maghemite (γ-Fe2O3)) as the dispersed phase (solute), a solvent as the dispersion medium (solvent), and ions or surfactants as dispersants.

[0179] The magnetic fluid 131 has the characteristic that, in the absence of an external magnetic field, the magnetic moments of the magnetic particles rotate randomly in the liquid, canceling each other out and resulting in no magnetization of the fluid as a whole. However, in the presence of an external magnetic field, the magnetic moments of each nanoparticle are oriented in the direction of the magnetic field lines, causing it to behave as if it were magnetized.

[0180] Taking advantage of these magnetic fluid properties, the central control unit 10 controls the particle size, particle size distribution, shape, and aggregate size of the ferromagnetic fine particles contained in the magnetic fluid 131 in the scattering induction unit 130, thereby controlling either the arrangement and distribution state of the ferromagnetic fine particles or both to a desired state, and adjusting the scattering characteristics of ultrasonic vibrations and low-frequency vibrations.

[0181] As a result, the condition improvement promotion system 1 can adjust the scattering characteristics of the scattering induction part 130 that comes into contact with the contact area on the outer surface of the subject's head to a desired state, making it possible to optimize the propagation state of vibrational energy throughout the target area in the brain.

[0182] Furthermore, in the above-described embodiment, the driving control method of the vibration energy supply unit 2 by the central control unit 10 in order to bring about the effect of improving microcirculation in the brain tissue and suppressing the decline of cognitive function in the condition improvement promotion system 1 is described as a case in which the vibration energy supply unit 2 is mounted so as to be arranged in multiple locations around the head of the subject, and a scattering induction unit is attached to the contact area of ​​the vibration energy supply unit 2 with the outer surface of the subject's head to induce scattering of ultrasonic and low-frequency vibrations, and the central control unit 10 drives and controls each vibration energy supply unit 2 so as to create a phase difference in ultrasonic and low-frequency vibrations. However, the present invention is not limited to this, and various driving control methods may be applied as long as it is possible to propagate the vibration energy that passes through the brain to the entire target area in the brain without resonance.

[0183] For example, multiple vibration energy supply units 2 may be mounted around the head of the subject, and the control unit 10 may drive and control each of the multiple vibration energy supply units 2 to supply ultrasonic vibration or low-frequency vibration energy in a non-focused manner and diffuse in an inverse taper shape that gradually expands in the direction of radiation, and to supply the energy sequentially between the multiple vibration energy supply units 2 at predetermined time intervals.

[0184] As a result, in the condition improvement promotion system 1, when unfocused vibration energy is sequentially supplied between multiple vibration energy supply units 2, the irradiation wave or reflected wave of unfocused vibration energy generated from one vibration energy supply unit is attenuated, so that even if it overlaps with the unfocused vibration energy generated from the next vibration energy supply unit, it does not result in excessive vibration stimulation, making it possible to provide the brain with an appropriate tissue amplitude and treat dementia.

[0185] In this case, the vibration energy of ultrasonic vibration or low-frequency vibration supplied by the vibration energy supply unit 2 is such that the angle of the expanding inverse tapered inclined surface is 50° to 100°, and the vibration generation sound pressure is 0.1 to 1.5 [MPa], and is supplied continuously to the subject for 15 to 60 minutes.

[0186] As a result, in the condition improvement promotion system 1, the angle at which the expanding inverse tapered inclined surface of the ultrasonic vibration or low-frequency vibration supplied from the vibration energy supply unit 2 spreads is set to a range that can be transmitted to the entire brain, and the sound pressure generated by the piezoelectric vibrator is set to a range that provides an appropriate tissue amplitude to the brain. By setting a limit on the irradiation time for each use on the subject and repeating the process, the effect of improving microcirculation in the brain tissue and the effect of suppressing cognitive decline in the subject can be sustained for a relatively long period after use.

[0187] Furthermore, in this embodiment, we have described a case in which the left and right temporal regions (temples) are selected as contact points with the outer surface of the subject's head in the condition improvement promotion system 1, and vibration energy supply units 2 are attached to each of them. However, the present invention is not limited to this, and the number of vibration energy supply units 2 can be freely set to one, three or more, not just two. For example, in addition to the left and right temporal regions (temples), the boundary between the occipital region and the crown (foramen magnum) may also be selected as a contact point with the outer surface of the subject's head.

[0188] Furthermore, although the above-described embodiment described the case in which a waist-type motion mechanism 20 was applied as the motion function improvement device 4, the present invention is not limited to this, and can be broadly applied to motion function improvement devices equipped with motion mechanisms adapted to the joint area where the subject's body can move, such as those equipped with a lower body (lower limb type) motion mechanism or a single-joint type motion mechanism.

[0189] For example, a device for improving motor function may be configured that includes a hand-type motion mechanism and a control system equipped with the functional configuration of the basic theory of the voluntary control step, autonomous control step, impedance control step, and bio-self-regulation loop described above. This hand-type motion mechanism may be configured to be directly attached to the subject's hand or to be fixed to a table.

[0190] Furthermore, even if the device does not have a detailed configuration like the motion function improvement device 4 in this embodiment, a motion function improvement device with a relatively simple configuration may be used, as long as it has a motion mechanism adapted to the joint area of ​​the subject's body that is capable of movement.

[0191] For example, a simple operational function improvement device (not shown) may be applied, comprising: a drive unit that provides power to a subject; a signal detection unit that detects the subject's biopotential signal; a biosignal processing unit that acquires the subject's nerve transmission signal and myoelectric signal from the biopotential signal detected by the signal detection unit; a voluntary control unit that uses the nerve transmission signal and myoelectric signal acquired by the biosignal processing unit to generate a command signal for the drive unit to generate power according to the subject's will; and a drive current generation unit that generates a current corresponding to the nerve transmission signal and a current corresponding to the myoelectric signal, respectively, based on the command signal generated by the voluntary control unit, and supplies them to the drive unit.

[0192] 1... Condition Improvement Promotion System, 2... Vibration Energy Supply Unit, 3... Control Unit, 4... Operation Function Improvement Device, 5, 120, 130... Scattering Induction Unit, 10... Overall Control Unit, 11... Memory Unit, 12... Vibration Receiving Unit, 20... Operation Mechanism Unit, 30... Waist Frame, 30A... First Waist Frame, 30B... Second Waist Frame, 31... Support Column, 32, 33... Mounting Belt, 40... Left Side Frame, 41... Right Side Frame, 42... Battery, 43... Minus Button, 44... Plus Button, 45... Power Button, 50... Thigh Fixing Unit, 50L... Left Thigh Fixing Unit 50R...Right thigh fixing part, 51L, 51R...Stay part, 52L, 52R...Belt part, 60...Biosignal detection part, 70...Control system, 80...Control device, 81...Data storage part, 82L, 82R...Drive part, 83...Potentiometer, 84...Absolute angle sensor, 85...Torque sensor, 90...Joint circumference detection part, 100...Voluntary control unit, 101...Autonomous control unit, 102...Composite control unit, 105...Current control unit, 110...Relative force detection unit, 111...Joint torque estimation unit, 112...Muscle torque estimation unit, 121...Point scatterer, 131...Magnetic fluid.

Claims

1. A condition improvement promotion system comprising: a vibration energy supply unit attached to the outer surface of the subject's head and supplying vibration energy of ultrasonic vibration or low-frequency vibration with a vibration frequency of 100 Hz or less; a vibration control unit that drives and controls the vibration energy supply unit so that the vibration energy of the ultrasonic vibration or low-frequency vibration is propagated throughout a target area in the subject's brain; and a motion function improvement device for promoting the effects of the subject's physical movement based on the repetition of a bidirectional biofeedback loop established between the nervous system and the musculoskeletal system, wherein when the vibration control unit drives and controls the vibration energy supply unit, it reflects the effects of the subject's physical movement by the motion function improvement device.

2. The function improvement device is characterized by comprising: a drive unit that provides power to the subject; a signal detection unit that detects the biopotential signal of the subject; a biosignal processing unit that acquires the nerve transmission signal and myoelectric signal of the subject from the biopotential signal detected by the signal detection unit; a voluntary control unit that uses the nerve transmission signal and myoelectric signal acquired by the biosignal processing unit to generate a command signal for the drive unit to generate power according to the subject's will; and a drive current generation unit that generates a current corresponding to the nerve transmission signal and a current corresponding to the myoelectric signal, respectively, based on the command signal generated by the voluntary control unit, and supplies them to the drive unit, thereby promoting the improvement of the condition according to claim 1.

3. The motion function enhancement device includes: an motion mechanism unit used to be integrated with the subject and having a drive unit that actively or passively drives in conjunction with the subject's physical movements; a signal detection unit that detects changes in ion current transmitted from the subject's brain and nervous system to its muscle system as biopotential signals appearing on the skin surface; a joint detection unit that detects physical quantities around the joints associated with the subject's physical movements based on the output signal from the drive unit; a voluntary control unit that controls the drive unit to produce a motion phenomenon that reflects the subject's intention to move, based on the biopotential signals and the physical quantities around the joints; and an autonomous control unit that stores reference parameters for each phase, which is a series of minimum motion units constituting the subject's motion patterns classified as tasks, in a data storage unit, estimates the phase of the subject's task by comparing the physical quantities around the joints with the reference parameters stored in the data storage unit, and controls the drive unit to generate power corresponding to that phase. The state improvement promotion system according to claim 1, wherein the data storage unit stores the control ratios of the voluntary control unit and the autonomous control unit set for each phase of each task, and the synthesis control unit synthesizes the control states of the voluntary control unit and the autonomous control unit so that the control ratio corresponds to the phase, and the synthesis control unit compensates the physical impedance of the entire system consisting of the entire device and the subject based on the physical quantities around the joints, in accordance with the physical characteristics of the entire system including the physical characteristics of the subject and gravity, and, based on a bio-self-control loop interactively promoted between the subject's body and the motion mechanism, corrects the difference with motion commands from the brain and nervous system, and simultaneously feedback adjusts the synthesized control state so that the difference between the subject's intention to move and the motion phenomenon is minimized.

4. The state improvement promotion system according to claim 3, characterized in that, when forming the biological self-regulation loop, the smallest motor control unit for realizing voluntary movements generated by the subject's will is set as a minimal voluntary motor control unit consisting of the brain and nervous system, synaptic connections, and the muscular system, and the biological self-regulation loop is established for each minimal voluntary motor control unit that forms a coordinated bodily movement to realize the motor phenomenon using the movement mechanism.

5. The condition improvement promotion system according to any one of claims 1 to 3, further comprising a scattering induction unit attached to the contact portion of the vibration energy supply unit with the outer surface of the subject's head, which induces scattering of the ultrasonic vibration or the low-frequency vibration, wherein the vibration energy supply unit is mounted so as to be arranged in multiple locations around the subject's head, and the vibration control unit drives and controls the ultrasonic vibration and the low-frequency vibration from each of the vibration energy supply units so as to create a phase difference.

6. The condition improvement promotion system according to claim 5, further comprising a vibration receiving unit that receives the ultrasonic vibrations or low-frequency vibrations transmitted through a contact area with the outer surface of the head of the subject, wherein the vibration control unit constantly monitors the vibration energy intensity of the ultrasonic vibrations or low-frequency vibrations received by the vibration receiving unit to maintain it below a predetermined level when the intensity of the vibration energy is above a predetermined level, while driving and controlling the vibration energy supply unit.

7. The condition improvement promotion system according to claim 1 or 2, characterized in that the vibration energy of the ultrasonic vibration or low-frequency vibration generated by the vibration energy supply unit has a vibration generation sound pressure of 0.1 to 1.5 [MPa], the irradiation time for a single use on the subject is set to a maximum of 20 minutes, and when used repeatedly, the irradiation is set to a maximum of 60 minutes per day with an interval of 5 minutes between irradiations.

8. The condition improvement promoting system according to claim 1 or 2, characterized in that the vibration energy of the ultrasonic vibration or low-frequency vibration generated by the vibration energy supply unit is diffused omnidirectionally while scattering from the supply direction, stimulating vascular cells with ultrasonic and low-frequency vibrations and promoting the expression of eNOS, VEGF, and bFGF.

9. The condition improvement promotion system according to any one of claims 1 to 3, characterized in that the vibration energy supply units are mounted so as to be arranged in multiple locations around the head of the subject, and the vibration control unit drives and controls each of the multiple vibration energy supply units to supply the vibration energy of the ultrasonic vibration or the low-frequency vibration in a non-focused and inversely tapered manner that gradually expands in the direction of radiation, and to supply the vibration energy sequentially between the multiple vibration energy supply units at predetermined time intervals.

10. The condition improvement acceleration system according to claim 9, characterized in that the vibration energy of the ultrasonic vibration or low-frequency vibration supplied by the vibration energy supply unit has a spreading angle of 50° to 100° for the expanding inverse tapered inclined surface and a vibration generation sound pressure of 0.1 to 1.5 [MPa], and is supplied continuously to the subject for 15 to 60 minutes.

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