WO2008152549A2 - Dispositif pour l'évaluation fonctionnelle d'une épaule - Google Patents

Dispositif pour l'évaluation fonctionnelle d'une épaule Download PDF

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WO2008152549A2
WO2008152549A2 PCT/IB2008/052236 IB2008052236W WO2008152549A2 WO 2008152549 A2 WO2008152549 A2 WO 2008152549A2 IB 2008052236 W IB2008052236 W IB 2008052236W WO 2008152549 A2 WO2008152549 A2 WO 2008152549A2
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score
shoulder
humerus
scores
range
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PCT/IB2008/052236
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English (en)
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WO2008152549A3 (fr
Inventor
Kamiar Aminian
Brian Coley
Alain Farron
Brigitte Jolles-Haeberlin
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Laboratory Of Movement Analysis And Measurement
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Publication of WO2008152549A2 publication Critical patent/WO2008152549A2/fr
Publication of WO2008152549A3 publication Critical patent/WO2008152549A3/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
    • A61B5/1126—Measuring movement of the entire body or parts thereof, e.g. head or hand tremor, mobility of a limb using a particular sensing technique
    • 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
    • A61B5/1121—Determining geometric values, e.g. centre of rotation or angular range of movement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/45—For evaluating or diagnosing the musculoskeletal system or teeth
    • A61B5/4528—Joints
    • 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
    • A61B5/1036—Measuring load distribution, e.g. podologic studies
    • A61B5/1038—Measuring plantar pressure during gait
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/6813—Specially adapted to be attached to a specific body part
    • A61B5/6824—Arm or wrist
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/72—Signal processing specially adapted for physiological signals or for diagnostic purposes
    • A61B5/7235—Details of waveform analysis
    • A61B5/7253—Details of waveform analysis characterised by using transforms
    • A61B5/726—Details of waveform analysis characterised by using transforms using Wavelet transforms

Definitions

  • the present invention relates to a functional assessment of a shoulder and to a method for the functional assessment of the shoulder.
  • the functional assessment of body joints is known in different areas. For example has the importance of recognizing the result of a medical procedure long been recognized in surgery and particularly in orthopaedic surgery.
  • the invention relates to a device for a functional assessment of the shoulder which comprises at least three gryoscopes and at least three accelerometers, of which all are designed to be attached to the humerus of a subject.
  • the gryoscopes and accelerometers are designed to measure the anterior elevation-extension (pitch), abduction-adduction (yaw) and internal- external rotation (roll) of the shoulder.
  • the device according to the invention includes a processing unit which is at least suitable to process the received data of the gryoscopes to estimate the 3D range of angular velocity according to the equation
  • 3D kinematics during movements from body fixed sensors using ambulatory recording device are measured.
  • the clinician could use a device to assess the shoulder's function and to find objective scores of their patients and which not include answering questions and therefore always a high subjective percentage.
  • the processing unit is further suitable to process the received data from the gryoscopes and accelerometers to observe the relationship between humerus acceleration and angular velocities according to the equation
  • the processing unit further suitable to process the received data from the gryoscopes and anthropometries data of the subject to observe the moments of the humerus according to the equation
  • I is the inertia matrix and (JQ the angular velocities.
  • the present invention relates to a method for functionally assessing a shoulder by measuring and scoring angular velocities of a humerus, resulting in a score (RAV), measuring and scoring angular velocities and accelerations of the humerus, resulting in a score (P) and by measuring and scoring the sum of moments of the humerus, resulting in a score (M).
  • RAV angular velocities of a humerus
  • P measuring and scoring angular velocities and accelerations of the humerus
  • M the sum of moments of the humerus
  • the score RAV is a range of angular velocity and is calculated by the difference between the maximum and minimum of angular velocity, preferably in 3 dimensions, measured during one test, according to the equation
  • the score M is based on the angular velocities of the humerus and anthropometrics data of the patient according to the equation
  • I is the inertia matrix and Q) the angular velocities.
  • results according to the invention can be for different assessments.
  • One possibility here is to compare the scores of healthy subjects to other according scores e.g. of pathological subjects.
  • the scores of left handed subjects are compared to right handed subjects. Or with the results it could be determined whether an object is more left- or right-handed.
  • the measurement is done during at least 1 hour, and the score P is estimated at least every second.
  • FIG. 1 positioning of the sensors module according to a preferred embodiment of the invention
  • 1 Inertial sensor
  • 2 ultrasound microphones (markers)
  • 4 humerus
  • Fig. 2 a flow chart of the angles estimation according to a preferred embodiment of the invention
  • Fig. 3 humerus acceleration as a function of its angular velocity a) for a healthy shoulder b) for a pathological shoulder
  • Fig. 5 P parameter for a patient and a control subject
  • Fig. 6 Box plot for the P score (a), RAV score (b) and Mscore (c)
  • Fig. 7 humerus angles for another test according to a preferred embodiment of the invention.
  • a functional assessment of the shoulder is presented.
  • 3D accelerometers and gyroscopes, attached on the humerus were used to differentiate a healthy from a painful shoulder.
  • objective parameters could be found for the assessment of shoulder function based on body fixed inertial sensors and evaluating the effectiveness of these parameters to quantify the difference of kinematics between a healthy and a painful shoulder. By validating such approach, it could be provided to the clinician a system to assess the shoulder's function and to find objective scores of their patients.
  • 10 healthy subjects (25.1 years old ⁇ 4.1) and 10 patients with unilateral pathological shoulder (7 rotator cuff disease (7 rotator cuff repair) / 3 osteoarthritis (3 prosthetic shoulder arthroplasty) : 4 women, 6 men : 62.4 years old ⁇ 10.4) were studied.
  • Nine tests representing some movements of daily activity based on the Simple Shoulder Test were carried out for both shoulders (see table 1) before surgery, 3 and 6 months after surgery. These tests were also carried out twice with one year interval on the same healthy subjects. Each test lasted 20 seconds and was video filmed for further validation of the movements and estimation of the false movements.
  • Table 1 Summary of the 9 tests carried out for painful and healthy shoulders. The subject is in standing position.
  • Figure 1 is an illustration of a) the position of the inertial sensors module including 3D gyroscope and 3D accelerometer and b) of the position of the reference markers for abduction/adduction (yaw), flexion/elevation (pitch) rotation and c) the position of the reference markers for internal and external rotation (roll).
  • the reference markers from the reference system were used for assessing our kinematic system.
  • one module 1 comprising three miniature capacitive gyroscopes (Analog device, ADXRS 250, ⁇ 400 deg/s) and three miniature accelerometers ⁇ Analog device, ADXL 210, ⁇ 5 g) were fixed by a patch on the humerus 4.
  • the sensors measured the anterior elevation- extension, abduction-adduction and internal-external rotation of the shoulder.
  • the signal from the sensors was amplified and low-pass filtered (cutoff frequency: 17 Hz) to remove any electronic noise.
  • the sensors and their conditioning electronics were packaged in a very small box (25x25x13 mm). All signals were digitized at 200Hz sampling rate and recorded by the data logger (Physilog®, BioAGM, CH) carried on the subject's waist.
  • the Simple Shoulder Test (SST) and the Disabilities of the Arm and Shoulder Score (DASH) were filled out by each subject to compare the results with the results of the described embodiment according to the invention.
  • the SST consists of 12 questions with "yes or no" answer.
  • DASH is a 30-item questionnaire designed to evaluate upper extremity-related symptoms and to measure functional status at the level of disability.
  • the SST and DASH scores are both validated scores and patient-reported outcomes measures.
  • Roll Internal and external rotational movements (roll), extension and anterior elevation movements (pitch) and abduction and adduction movements (yaw) were estimated from 3D accelerometers and 3D gyroscopes.
  • Figure 2 shows the flow chart of the 3D angles estimation.
  • the 3D gryoscopes measure the angular velocity for flexion/elevation, int/ext rotation and adduction/abduction.
  • the accelerometers measure the gravity component, and using this feature, it is possible to measure the segment orientation when it is motionless.
  • Drift and DC components of the angular velocities were removed using wavelet transformation and considering the initial and final orientation of the segment based on the acceleration signals.
  • the 3D angles were obtained after integration of the three angular velocities. The angles were estimated from the integral of angular velocity and by considering initial and final orientation from the accelerometers.
  • a Zebris CMS-HS ultrasound-based motion measurement system was used. This system consists of three fixed sonic emitters which send out a burst of ultrasound, and receivers (microphones) placed on body segments. The time taken for the burst to reach each receiver is recorded. Using this delay, the distances between the receiver and each emitter can be calculated from the sound velocity. Knowing the distance from three emitters, the coordinates of the receiver placed on body segment can be computed by triangulation with an absolute accuracy better than 1.0 mm with a sampling rate of 100Hz. In this study, two ultrasound microphones (marker 2 and marker 3) were attached over the same segment of the humerus 4.
  • Spatial marker positions (x, y, z) were recorded and used for calculation of humerus orientation angles. Synchronization between the reference and the Physilog systems was performed by electrical trigger. The angle data obtained by the body-fixed sensors were down sampled to 100Hz for comparison purpose. The flexion/extension and abduction/adduction angles of the humerus were estimated using the spatial coordinates of the microphone markers 2,3 on the humerus 4 (see Fig. Ib)). The internal/external rotation angles of the humerus 4 were estimated using the spatial coordinates of the microphone markers 2,3 on the radius (see Fig. Ic)). Basic movements like anterior flexion-extension, abduction, adduction and internal/external rotation were performed with our system and the reference system on 10 healthy subjects to assess the accuracy of our angles estimation method.
  • the second investigation was to estimate the difference of kinematics between the healthy and the painful shoulder. It was based only on the angular velocities of the humerus 4.
  • the 3D range of angular velocity (RAV) was calculated by the difference between the maximum and the minimum of angular velocity (deg/s) measured by 3D gyroscopes during each test in internal and external rotational
  • the RAVr parameter was estimated as the average of the sum of the RAV in the three axis of rotation.
  • the difference between a healthy and a painful shoulder was expressed as the percentage of RAV of the healthy shoulder (ZlRAVr).
  • the RAV score is defined as the average of the ⁇ RAVr over all 9 tests.
  • RAV score l - lO ⁇ [%] (Equ.3)
  • Figure 3 shows the difference between the healthy and the painful side for one axis and a patient.
  • the surface inside the curve was calculated for both sides.
  • the simplest estimation of this surface was to calculate the area of the rectangle, which circumscribes the curve corresponding to the product of the acceleration range by the angular velocity range.
  • Figure 3 shows in a) a trace representing the humerus acceleration vs. angular velocity for the healthy side of the patient; b) a trace representing the humerus acceleration vs. angular velocity for the painful side.
  • the rectangle, which circumscribes the curve, corresponds to the product of the acceleration range by the angular velocity range (Pr).
  • Pr parameter of a healthy The difference between the Pr parameter of a healthy and a painful side relative by the healthy side was considered as ⁇ Pr parameter.
  • the first score is defined as the average of the ⁇ Pr over all 9 tests.
  • P score 1 (Equ.6)
  • the last step was to estimate the difference of moments M between the healthy and the painful shoulder; it was based on the angular velocities CO of the humerus and the anthropometries data of the patient.
  • M was defined as the moment of the humerus (Equ.7), I as the inertia matrix (Equ.8).
  • Iyaw Ipitch This method was used to evaluate the difference between the healthy and the painful shoulder, calculating the maximum of the norm of the moment (noted by 1 1 1 1 ) during each test for each shoulder.
  • the difference between the healthy and the painful shoulder was expressed as the percentage of the moment of the healthy shoulder.
  • AMr ⁇ - J r (EqU- I l) max ⁇ Mhealth ⁇
  • the M score is defined as the average of the ⁇ Mr over all 9 tests.
  • a subject with a total mobility of his/her shoulder will have a M score, a RAV score and P score of 100% and a patient without any mobility of his/her shoulder will have a M score, a RAV score and a P score of 0%.
  • the Wilcoxon matched pairs signed rank sum test was used as a non-parametric hypothesis test to show if there were significant differences (at a significance level 5%) between baseline vs. 3 months, and baseline vs. 6 months for 10 patients.
  • Figure 4 shows the angles of the basics movements of the reference system Zebris and the inertial sensors a) for Flexion, extension; b) Abduction, adduction; c) Internal external rotation.
  • the dashed line shows the reference system and the solid line the inertial sensors.
  • Table 2 Comparison between humerus angles obtained inertial sensors and reference system for 10 subjects.
  • the error represents the RMS, mean and SD of the difference between reference and our measuring device.
  • V represents the Correlation Coefficient between the two measuring system.
  • the results were very close to those of the reference system presenting a small average error in RMS (5.81°), mean (1.80°) and standard deviation (4.82°) of the difference signal, reflecting accurate and precise estimation respectively; and excellent correlation coefficient (0.99) values reflected highly linear response.
  • Figure 5 al) and bl show the comparison of P parameters between a patient and a control subject for the nine tests realized. It can be observed that for the patient (Fig. 5 (al)) the P parameter is higher for the healthy side than the painful side for all tests. But for the healthy subject (Fig. 5 (bl)) the Pr parameter is approximately equal between the right and the left shoulder for each test. Table 3 shows the P score for a healthy subject. The P score for the healthy subjects ranged from 85% to 97% (mean : 92%), which is twice compared to patients before surgery (table 3,4).
  • Table 3 shows all the results in comparison with the baseline (before surgery).
  • the Wilcoxon matched pairs signed rank sum test indicates that significant differences were found between the P score at baseline vs. the P score at 3 months and the P score at baseline vs. the P score at 6 months (p ⁇ 0.05).
  • Fig. 6(a) shows the improvement of the P score after surgery in comparison to the baseline values and the control subjects.
  • Figure 5 a2) b2) show the comparison of RAV parameters between a patient and a control subject for the nine.
  • the RAV parameter is higher for the healthy side than the painful side for all tests (Fig. 5 (a2)).
  • the ⁇ RAV parameter is approximately similar between the right and the left shoulder for each test.
  • the RAV score for healthy subject ranged from 87% to 99% (mean : 94%). While this score was in average 59% for patients preoperatively (tables 3, 4).
  • Table 4 DASH, SST, P Score, RAV Score and M Score for healthy subjects.
  • SST was 12 and the DASH was 30.
  • brackets difference between the first measurement and the one year measurement ( ⁇ (l-2)) .
  • Figure 5 a3) and b3) show the comparison of moment in Nm (Newton-meter) between a patient and a control subject for the nine.
  • the moments are higher for the healthy side than the painful side for all tests (Fig. 5 (a3)); while the moments are similar between the right and the left shoulder for a healthy subject (Fig. 5 (b3)).
  • the M score for a healthy subject ranged from 82% to 97% (mean : 88%), which is more than twice the average for the patients preoperatively (tables 3, 4).
  • the M score at baseline was significantly lower than the M score at 3 months as well as the M score at 6 months (p ⁇ 0.05).
  • Table 3 shows all the results in comparison with the baseline.
  • the M score average was respectively 59% and 62% at 3 months and 6 months after surgery.
  • Fig. 6(c) shows the improvement of the M score after surgery in comparison to the baseline values and the control subjects.
  • the patient could not understand the real meaning of the questions and could not answer or did a wrong answer.
  • the DASH instrument is a questionnaire. It depends on subjective evaluation of the patients. In some case, the patient doesn't understand the questions or answers wrongly. It depends also of the psychological condition of the patient. Due to the dichotomous response option (yes or no), the SST instrument is likely to have poor sensitivity to differentiate between patients with varying severity of the same condition.
  • the outcome evaluation of shoulder surgery according to the method of the preferred embodiment was based on objectives scores derived from accurate 3D measurement (table 2) of shoulder kinematics on healthy and painful shoulder obtained during specific task. These scores concerns acceleration and angular velocity rather than angles' components. Though angles can be estimated accurately with our system, they have not shown pertinent changes between a healthy and a painful shoulder.
  • FIG. 6 shows the comparison between baseline, 3, 6 months after surgery for the three scores. It is shown a box plot for the P score (a), the RAV score (b) and the M score (c). The boxes contain 50% of the results and lines represent the range. The dashed line show the limit for healthy subjects.
  • Table 3 shows also the results of the Wilcoxon matched pairs signed rank sum test for the clinical scores (DASH, SST). It can be seen while kinematic scores showed significant differences between baseline and follow-up time (p ⁇ 0.02), the clinical scores (DASH, SST) showed no significant differences between baseline and 3 months evaluation but the differences became significant at 6 months evaluation (p ⁇ 0.03). These results suggested that our kinematics scores might be more sensitive to the functional changes than the clinical scores, and were able to express a kinematic improvement from the baseline even at 3 months after surgery.
  • the patient 7 had very bad clinical scores after the surgery. He had an inflammatory capsulite retractile after 6 months. The kinematics scores were also able to show this post-surgery complication because the patient had a lot of pain while performing some movements. The complication of the patient 8 was a chronicle luxation. His clinical scores were improved but the kinematic scores were equal as the baseline, whose show the poor mobility of this patient.
  • the proposed system has also the potential to be used during daily activity before and after shoulder surgery and to provide a valuable outcome.
  • Another preferred embodiment of the invention is to measure the humerus activity in a daily life cycle to find out about the dominant shoulder of a subject.
  • Each module consists of three miniature gyroscopes (Analog device, ADXRS 250, ⁇ 400°/s) which measured the limb angular velocity and three miniature accelerometers (Analog device, ADXL 210, ⁇ 5 g).
  • the inertial module on the humerus measured the anterior elevation-extension, abduction-adduction and internal-external rotation of the shoulder and the module on thorax was used for detecting daily activities (walking, sitting, standing).
  • Each inertial module including the sensors and their conditioning electronics, was packaged in a small box.
  • the signal from the sensors was amplified and low- pass filtered to remove any electronic noise. All signals were digitized and recorded by two synchronized data loggers (Physilogl, BioAGM, CH) carried on the subject's waist. Each subject carried the system during 1 day (8 h). Following completion of recording, the datawere transferred to a computer for further analysis.
  • Body posture allocations (sitting, standing and lying) as well as walking periods were detected by the trunk inertial module.
  • the time of sit-stand or stand-sit transition was detected from the patterns of angular tilt obtained from the gyroscope. Pattern recognition of the vertical acceleration allowed detection of the transition and distinction between standing and sitting positions.
  • the lying position was detected from the inclination of the trunk obtained from the accelerometers. Walking periods were defined as intervals with at least three gait cycles. Walking state was identified by analyzing the vertical accelerometer every five seconds.
  • the parameter Pr was defined which considered the 3D components of acceleration and angular velocity of the humerus obtained from the inertial module fixed on this segment:
  • Pr was estimated every 5 s for the left and the right humerus (Pr Left , Pr R ⁇ ght ). In order to estimate shoulder usage, Pr was compared to a defined threshold (th). If Pr was under th the humerus was considered as motionless; otherwise it was considered as active. The periods where Pr > th were estimated as a percentage of the total monitoring time and were defined as activity. To define the threshold th, we turned on the system in rest position during 1 h to detect the meanvalue of the Pr for the left and right humerus. The mean value for Pr was used to define the optimum th.
  • ALS left shoulder usage
  • ARS right shoulder usage
  • n total time of measurement/5 s.
  • P(i) parameter For each interval i of 5 s, P(i) parameter was defined as
  • th we turned on the system in rest position during 1 h to detect the mean value of the Pr for the left and right humerus.
  • the mean value for Pr Left was 0.859 and the mean value for the PrRight was 0.556. These values corresponded to the average noise of the motion during rest. Activity periods should be several times above this noise level.
  • th we varied th from 1 to 10 per step of 1 for the 31 subjects.
  • the optimum threshold was defined as the value where a difference of 1% was observed in the values of ARSp and ALSp (for the sit and stand postures). We obtained an optimum threshold of 3 which was used to estimate the activity periods.
  • the mean of the P parameter during the daily activity for all right handed subjects was larger for the right shoulder compared to the left shoulder.
  • the tendency was reversed for the left handed subjects on average although a few left handed subjects had higher intensity for the right shoulder.

Abstract

L'invention concerne un dispositif pour l'évaluation fonctionnelle d'une épaule, qui comprend trois gyroscopes, trois accéléromètres tous conçus pour être fixés à l'humérus d'un sujet et pour mesurer l'élévation-extension antérieures (pas), l'abduction-adduction (lacet) et la rotation interne-externe (roulis) de l'épaule; et une unité de traitement permettant au moins de traiter les données provenant des gyroscopes afin d'estimer la plage 3D de vitesse angulaire selon l'équation (I). L'invention concerne de plus un procédé d'évaluation fonctionnelle d'une épaule, qui consiste à mesurer et à évaluer les vitesses angulaires d'un humérus afin d'obtenir un résultat (RAV); les vitesses angulaires et les accélérations de l'humérus afin d'obtenir un résultat (P); et la somme des moments de l'humérus pour obtenir un résultat (M).
PCT/IB2008/052236 2007-06-13 2008-06-06 Dispositif pour l'évaluation fonctionnelle d'une épaule WO2008152549A2 (fr)

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US11596347B2 (en) 2014-06-25 2023-03-07 Canary Medical Switzerland Ag Devices, systems and methods for using and monitoring orthopedic hardware
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US10492686B2 (en) 2014-09-17 2019-12-03 Canary Medical Inc. Devices, systems and methods for using and monitoring medical devices
US11071456B2 (en) 2014-09-17 2021-07-27 Canary Medical Inc. Devices, systems and methods for using and monitoring medical devices
US11020053B2 (en) 2016-03-23 2021-06-01 Canary Medical Inc. Implantable reporting processor for an alert implant
US11540772B2 (en) 2016-03-23 2023-01-03 Canary Medical Inc. Implantable reporting processor for an alert implant
US11191479B2 (en) 2016-03-23 2021-12-07 Canary Medical Inc. Implantable reporting processor for an alert implant
US11045139B2 (en) 2016-03-23 2021-06-29 Canary Medical Inc. Implantable reporting processor for an alert implant
US11638555B2 (en) 2016-03-23 2023-05-02 Canary Medical Inc. Implantable reporting processor for an alert implant
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US10925537B2 (en) 2016-03-23 2021-02-23 Canary Medical Inc. Implantable reporting processor for an alert implant
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