WO2020226183A1 - Procédé d'acquisition d'indice d'aide au diagnostic pour l'arthrose du genou, indice, programme d'aide au diagnostic, et dispositif pouvant être porté - Google Patents

Procédé d'acquisition d'indice d'aide au diagnostic pour l'arthrose du genou, indice, programme d'aide au diagnostic, et dispositif pouvant être porté Download PDF

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Publication number
WO2020226183A1
WO2020226183A1 PCT/JP2020/018726 JP2020018726W WO2020226183A1 WO 2020226183 A1 WO2020226183 A1 WO 2020226183A1 JP 2020018726 W JP2020018726 W JP 2020018726W WO 2020226183 A1 WO2020226183 A1 WO 2020226183A1
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knee osteoarthritis
acceleration
index
acquiring
diagnostic support
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PCT/JP2020/018726
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English (en)
Japanese (ja)
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友 岩間
武雄 名倉
健吾 原藤
直道 荻原
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学校法人慶應義塾
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Priority to JP2021518410A priority Critical patent/JPWO2020226183A1/ja
Publication of WO2020226183A1 publication Critical patent/WO2020226183A1/fr

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/103—Detecting, measuring or recording devices for testing the shape, pattern, colour, size or movement of the body or parts thereof, for diagnostic purposes
    • A61B5/11—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb

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  • the present invention relates to an evaluation method for measuring the severity and progression of knee osteoarthritis.
  • a method that can easily evaluate the severity of knee osteoarthritis, prognosis prediction, etc., an evaluation index, a program for calculating the evaluation index, and a small wearable without the need for an expensive measuring device or a dedicated measurement environment. Inspection equipment. It also relates to a new index of knee osteoarthritis that reflects knee pain.
  • Osteoarthritis of the knee is a degenerative disease that accompanies aging, and is a disease in which the cartilage of the knee joint wears, causing pain during walking and causing gait disturbance as it progresses.
  • the number of patients is increasing, and it is said that there are an estimated 25 million patients in Japan.
  • knee osteoarthritis is the most common among arthropathy, and it is said that about 80% of people over the age of 60 have some kind of knee osteoarthritis by roentgenology.
  • the knee has two joints, the tibial femur joint formed by the femur and tibia, and the patellofemur joint formed by the femur and patella.
  • the frequency of knee osteoarthritis is predominantly osteoarthritis of the femoral tibial joint.
  • medial osteoarthritis (so-called O-leg) is the main cause.
  • Knee osteoarthritis can be broadly divided into two treatment methods: conservative treatment and surgical treatment when it progresses.
  • Conservative treatment includes lifestyle guidance, drug therapy such as painkillers and intra-articular injection, exercise therapy such as quadriceps femoris strength training, and equipment therapy using knee supporters.
  • Surgical treatment includes artificial joint replacement. There is a technique.
  • osteoarthritis is diagnosed by the presence or absence of tenderness by palpation, the range of motion of joints, X-ray images, etc., but there is not necessarily a correlation between the deformity of the knee joint by X-ray images and the symptoms. Some people have few symptoms such as pain despite the progress of knee joint deformity, while others complain of strong pain even though there is almost no knee joint deformity. Early diagnosis and treatment of knee osteoarthritis are important because the symptoms can be improved or the progression can be delayed if appropriate treatment is given. If accurate diagnosis of knee osteoarthritis can be made at an early stage, conservative treatment will suppress the progression of knee osteoarthritis and will not interfere with activities of daily living.
  • KAM external knee varus moment
  • Patent Document 1 discloses that KAM is measured by a device attached to a lower leg equipped with a plurality of sensors.
  • Non-Patent Document 2 reports a method of estimating KAM by installing a plurality of small acceleration sensors on the pelvis, thighs, and lower legs, installing a small floor reaction force meter on the sole, and combining wearable devices. ..
  • biomarkers present in blood, urine, etc. are being searched for.
  • Patent Document 1 is a large-scale device like a robot suit worn on the lower leg, and cannot be used on a daily basis in outpatient clinics. Further, the measurement method described in Non-Patent Document 2 requires a plurality of acceleration sensors, requires a combination of floor reaction force meters, and further, complicated calculation processing is required for the data obtained from the acceleration sensors. It has not been widely used because it is necessary.
  • hyaluronic acid and glycosaminoglycan which are used as biomarkers, fluctuate drastically due to various factors such as diurnal fluctuations and diet, and cannot be said to be effective markers.
  • the X-ray image does not necessarily correlate with the disease symptom and cannot be used as an effective index for measuring the grade of knee osteoarthritis. Therefore, it has been desired to develop an objective index that can be easily measured and can accurately diagnose knee osteoarthritis. If an index that correlates with pain can be obtained, it can be used as an objective index for screening effective drugs and improving assistive devices. Furthermore, it becomes possible to select the optimal treatment method for the patient, specifically, the drug and the orthosis, and it is possible to select the treatment method suitable for each individual patient.
  • the present invention relates to a method for supporting the diagnosis of knee osteoarthritis, an index for evaluating the severity and progression of knee osteoarthritis in place of KAM, an evaluation method, a program and a device used for measurement.
  • a method for acquiring a diagnostic support index for knee osteoarthritis in which acceleration of the trunk and / or lower limbs during walking is measured, and a lateral acceleration peak width value immediately after heel contact is extracted.
  • a method for acquiring a diagnostic support index which comprises calculating an average value of peak width values of lateral acceleration and acquiring a value that supports the diagnosis of knee osteoarthritis from the average value.
  • This is a method for acquiring a diagnostic support index for knee osteoarthritis.
  • the rising position of acceleration in the vertical direction is determined to be when the heel touches, and the peak width value of the lateral acceleration immediately after the heel touches is extracted.
  • An index of the severity of knee osteoarthritis which is the average value of the peak width values of lateral acceleration synchronized with the rising position of longitudinal acceleration in the trunk and / or lower limbs during walking.
  • a program that supports the diagnosis of knee osteoarthritis which records the acceleration in the trunk and / or lower limbs during walking measured by an acceleration sensor, and sets the rising position of the vertical acceleration to the heel contact.
  • a diagnosis support program for knee osteoarthritis which comprises extracting the peak width of the lateral acceleration immediately after the heel touches down and calculating the average value of the peak width of the lateral acceleration.
  • a wearable device for knee osteoarthritis which includes an acceleration sensor, a microprocessor, a memory, and a display, and the program according to (9) or (10) is stored in the memory.
  • a wearable device for knee osteoarthritis which is equipped with an acceleration sensor, a microprocessor, and a memory, and is measured by an acceleration sensor on an external device equipped with the program according to (9) or (10).
  • the wearable device according to (11) or (12) which comprises a member to be attached to the sacral portion or the lower leg.
  • FIG. 1A is a diagram schematically showing an example of the measurement method of the present invention.
  • FIG. 1B is a diagram showing actual measurement values measured by a sensor installed in the sacral region.
  • the figure which shows that the peak width value of the acceleration in a lateral direction is extracted by judging the heel contact time from a single acceleration sensor by the data which synchronized with the acceleration sensor and the floor reaction force meter.
  • the severity and progression of knee osteoarthritis can be easily evaluated without the need for an expensive measuring device and a dedicated measuring room.
  • the lateral acceleration value by the measurement method shown below can be continuously measured in daily medical care such as outpatient clinics and clinics, and can be used for diagnosis, evaluation of treatment policy, and the like. Further, by attaching the measuring device, it is possible to measure for a long time without burdening the patient. As a result, it becomes possible to monitor the daily life of the patient and analyze the correlation between pain and movement, which can be useful for treatment.
  • KAM is used as an index for measuring the progression and severity of knee osteoarthritis, but this measurement method can not only be an index equivalent to KAM, but also the progression of knee osteoarthritis. It is an index that more reflects the severity of the disease. Therefore, instead of measuring KAM, which requires an expensive measuring device and a dedicated measuring room, it can be used for confirmation of drug effectiveness, clinical trials, evaluation of improvement of equipment, and the like. Further, while KAM measures the force at which the knee bends, that is, torque, this measuring method is a method of measuring acceleration, that is, movement that correlates with pain. Therefore, it can be a parameter for measuring knee osteoarthritis more sensitively. As a result, it is highly possible that knee osteoarthritis can be diagnosed at an early stage and the prognosis can be predicted. If accurate diagnosis of knee osteoarthritis is possible at an early stage, activities of daily living can be maintained by conservative treatment.
  • an existing acceleration sensor is used to measure the acceleration of the trunk and lower limbs during walking, but the measurement is specialized for the examination of knee osteoarthritis.
  • the device can have the following configuration.
  • the knee osteoarthritis measuring device is a microprocessor, a measurement value or a program having a built-in program that extracts the peak width of lateral acceleration at the time of heel contact measured by an acceleration sensor and an acceleration sensor and calculates the average thereof. It is possible to provide a memory for storing the data and a display capable of displaying the result and the like.
  • the time when the heel touches down is identified from the rise of the vertical acceleration measured by the acceleration sensor, and the identified lateral acceleration when the heel touches down is stored in the built-in memory, and from the peak width value stored in the memory.
  • the average value is calculated by the processor.
  • the calculated average value is displayed on the display, from which the doctor can judge the degree of knee osteoarthritis of the patient. Further, when the measured lateral acceleration value exceeds the reference value, it can be programmed to show the value and to show the suspicion of knee osteoarthritis or the like on the display.
  • the wearable device can monitor daily activities not only during outpatient treatment but also at home. There is no system that can monitor daily activities, and it is an epoch-making device. Furthermore, since it can be easily measured, it is possible to follow up for a long period of time to see what kind of effect the therapeutic agent or various interventions have.
  • this evaluation method based on the acceleration value correlates with the degree of progression of knee osteoarthritis, it can be used as a criterion when applying surgery, and the therapeutic effect of drugs and the effect of assistive devices are evaluated. It can be used as an objective index.
  • TSND151 three-dimensional acceleration sensors
  • ATR-Promotions three-dimensional acceleration sensors
  • the acceleration sensors are attached to six places, but it may be attached to at least one place for measurement.
  • the heel contact state may be determined by a sensor different from the sensor that measures the lateral acceleration.
  • KAM affixed 46 reflection markers in the gait analysis room, and performed gait analysis by the conventional method using eight infrared cameras (Oqus, Qualisys) and two floor reaction force meters (Bertec, Columbus). It was calculated using Visual 3D (C-motion Company).
  • the measurement was performed on 38 knees (16 females, 3 males, age 68.9 ⁇ 6.5 years, BMI 22.1 ⁇ 2.7 kg / m 2 ) of 19 patients with medial knee osteoarthritis.
  • Fig. 1 (A) schematically shows the case where the acceleration sensor is attached to the sacral region.
  • An acceleration sensor is attached near the sacral bone, and the acceleration is measured in three directions: the vertical direction (vertical direction, Az), the traveling direction (Ax), and the direction perpendicular to the traveling direction (horizontal direction, Ay, LM Axis).
  • the sensor attached near the sacrum will be referred to as the sacral sensor, and the sensor attached to the lower leg will be referred to as the lower leg sensor.
  • the measured value of the lateral acceleration is shown in FIG. 1 (B).
  • the peak width of the lateral acceleration generated when the heel touches down (Fig. 1 (B), Peak range of Acc indicated by a thick arrow) correlates with the peak value of KAM. showed that.
  • the peak width refers to the amount of change in acceleration until the next peak value in which the peak value of positive acceleration outward with respect to the stance limb is continuous at the initial stage of stance. Patients with medial knee osteoarthritis tend to walk while swinging from side to side, but the amount of change in lateral acceleration is regarded as the peak width.
  • the peak value of KAM including patients with medial knee osteoarthritis and healthy subjects and the acceleration value in the lateral direction were measured.
  • the correlation between the lateral acceleration value and the KAM peak value in the sacral sensor (FIG. 2 (A)) and the lower leg sensor (FIG. 2 (B)) is shown.
  • Pearson's correlation analysis was used, and P ⁇ 0.05 was considered significant.
  • Both the sacral sensor and the lower leg sensor showed a significant correlation between the lateral acceleration value and the KAM peak value.
  • r 0.60 (P ⁇ 0.01), which was more strongly correlated with the KAM value than the measured values (0.43, P ⁇ 0.01) of the sacral sensor.
  • Non-Patent Documents 3 and 4 a KAM peak value of 4.2% body weight x height or more is severe knee osteoarthritis.
  • This value corresponds to 30,000 or more in the lateral acceleration peak width value obtained from the lower leg sensor, and is in good agreement with the comprehensive findings obtained by other diagnostic methods such as X-ray images.
  • the report that the acceleration at the time of heel contact in the trunk and limbs correlates with the peak value of KAM is a new finding that has never existed before.
  • the sensors attached to the femur and sternum also showed a correlation with the KAM value, although there was no significant difference. Even in these places, there is a possibility that accurate measurement can be performed by the method of fixing the acceleration sensor, such as attaching the acceleration sensor so that it is fixed more closely to the body.
  • the peak width value of acceleration is relatively large, and it is possible to judge when the heel touches down only by the value of the acceleration sensor in the lateral direction.
  • walking is slow, so it is difficult to determine when the heel touches the ground without using a motion capture system.
  • measurement using a motion capture system makes the device large-scale, making it difficult to use in daily medical care and clinics. Therefore, we investigated a method to determine when the heel touches the ground with a single accelerometer without using a motion capture system.
  • the rise of the vertical component of the acceleration sensor may be estimated to be when the heel touches the ground, and the peak width value of the horizontal component immediately after that may be measured.
  • the lateral acceleration value correlates with the conventionally used evaluation values such as KAM and lateral thrust, and is a measurement value that better reflects the patient's movement, a new knee osteoarthritis is replaced with these measurement values. It can be used as a diagnostic index for osteoarthritis. Furthermore, since it can be a new index that reflects the correlation with pain, it can be used as an objective index for drug discovery development, improvement of equipment, and the like.

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Abstract

La présente invention permet l'évaluation de la gravité de l'arthrose du genou en mesurant l'accélération dans la direction latérale à l'aide d'un capteur d'accélération fixé au torse ou à une jambe lorsque le talon touche le sol. Ce dispositif pouvant être porté, ayant un capteur d'accélération, facilite l'évaluation de l'arthrose du genou.　La présente invention peut fournir un indice et un dispositif pour l'arthrose du genou, qui facilitent la mesure sans nécessiter de dispositif de mesure coûteux ni de salle de mesure spéciale, et l'indice peut être un indice objectif non seulement pour réaliser un traitement optimal sur un patient, mais également pour un criblage de découverte de médicament et une amélioration d'un instrument d'aide.
PCT/JP2020/018726 2019-05-08 2020-05-08 Procédé d'acquisition d'indice d'aide au diagnostic pour l'arthrose du genou, indice, programme d'aide au diagnostic, et dispositif pouvant être porté WO2020226183A1 (fr)

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022250098A1 (fr) * 2021-05-28 2022-12-01 京セラ株式会社 Dispositif de traitement d'informations, appareil électronique, système de traitement d'informations, procédé de traitement d'informations et programme

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JP2004261525A (ja) * 2003-03-04 2004-09-24 Microstone Corp 変形性膝関節症の判定方法および判定装置
JP2005342254A (ja) * 2004-06-03 2005-12-15 Matsushita Electric Ind Co Ltd 歩行周期検出装置
JP2012179114A (ja) * 2011-02-28 2012-09-20 Hiroshima Univ 測定装置、測定方法、及び、測定プログラム
JP2017202236A (ja) * 2016-05-13 2017-11-16 花王株式会社 歩行分析方法及び歩行分析装置

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2004261525A (ja) * 2003-03-04 2004-09-24 Microstone Corp 変形性膝関節症の判定方法および判定装置
JP2005342254A (ja) * 2004-06-03 2005-12-15 Matsushita Electric Ind Co Ltd 歩行周期検出装置
JP2012179114A (ja) * 2011-02-28 2012-09-20 Hiroshima Univ 測定装置、測定方法、及び、測定プログラム
JP2017202236A (ja) * 2016-05-13 2017-11-16 花王株式会社 歩行分析方法及び歩行分析装置

Non-Patent Citations (2)

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Title
DEGUCHI, NAOKI ET AL.: "Significance of performing motion analysis using an accelerometer in knee osteoarthritis, Comparison between HTO patients and healthy subjects", ABSTRACTS OF THE 48TH CONGRESS OF JAPANESE SOCIETY OF PHYSICAL THERAPY, vol. 40, no. 2, May 2013 (2013-05-01) *
INOUE, YOSHIKATSU ET AL.: "Evaluation of varus osteoarthritic knee by an ultra-small accelerometer", THE JOURNAL OF TOKYO MEDICAL UNIVERSITY, vol. 65, no. 3, 2007, pages 263 - 269 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2022250098A1 (fr) * 2021-05-28 2022-12-01 京セラ株式会社 Dispositif de traitement d'informations, appareil électronique, système de traitement d'informations, procédé de traitement d'informations et programme

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