WO2019180029A1 - Dispositif et procédé permettant d'évaluer une asymétrie de la démarche - Google Patents

Dispositif et procédé permettant d'évaluer une asymétrie de la démarche Download PDF

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Publication number
WO2019180029A1
WO2019180029A1 PCT/EP2019/056858 EP2019056858W WO2019180029A1 WO 2019180029 A1 WO2019180029 A1 WO 2019180029A1 EP 2019056858 W EP2019056858 W EP 2019056858W WO 2019180029 A1 WO2019180029 A1 WO 2019180029A1
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acceleration
data
step time
value
asymmetry
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PCT/EP2019/056858
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English (en)
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Richard Peindl
Nahir HABET
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Ao Technology Ag
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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
    • A61B5/112—Gait analysis

Definitions

  • the present invention relates to a device and method for evaluation gait asymmetry.
  • Gait assessment in performance based measures is important when a patient shows gait asymmetry.
  • Such devices and methods for evaluating gait asymmetry should: a) be accurate and reproducible, b) objectively capture clinically meaningful functional information, and c) involve a quick and convenient measurement and report on results.
  • CN 107 616 798 A provides a method for detecting gait asymmetry based on gravitational acceleration.
  • Triaxial acceleration sensors acquire data of a walking user. Based on the changes in the displacement of the center of gravity during movement gait characteristic values are derived.
  • CN 106 908 021 A provides a wearable sensor and discloses a human body step length measuring method using of two inertial sensor units to collect and store the acceleration and angular velocity data of a human body in the walking process, and then uses an algorithm to calculate the user's step length information. The method can be used to estimate the user's gait asymmetry.
  • WO 2016/097746 Al discloses an arrangement for analyzing the biomechanical motion of a wearer comprising an acceleration sensing unit attached to the upper body of the wearer, for example to the ear, for sensing acceleration of the wearer's upper body and generating a series of acceleration values indicative of that motion; and a processor communicatively coupled to the acceleration sensing unit for processing the acceleration values, the processor being configured to gather real-time acceleration values from the acceleration sensing unit and to compare the real-time acceleration data with one or both of: (a) historic acceleration data derived from the acceleration sensing unit and (b) predetermined acceleration features indicative of biomechanical motion quality to form an output indicative of the current state of the biomechanical motion of the wearer.
  • This object can be reached with an IMU to generate kinematic variables which correlate with observed clinical pathology and also provide quantitative data to augment patient-reported outcome measures.
  • MEMS microelectromechanical system
  • IMUs inertial measurement units
  • AHRSs affordable MEMS attitude and heading reference systems
  • AHRSs are IMUs that typically integrate an additional (non-inertial) tri- axial magnetometer and an on-board data processing system that computes continuous local sensor coordinate system attitude and heading information, in the form of orientation quaternions, in addition to 3-D linear acceleration and 3-D angular velocity data.
  • AHRSs are often referred to simply as IMUs.
  • the primary advantages of AHRSs over accelerometer- and gyroscope-based IMUs are: 1) all acceleration and angular velocity data can be collected with regard to a global coordinate system (e.g. North, East, Down (NED), 2) using a local coordinate system initialization procedure, data from a continuously moving sensor coordinate system can be converted to a non-moving, pre-established body coordinate system, and 3) when using multiple AHRSs, all sensor data streams can be transformed into the same global or fixed-local coordinate system.
  • a global coordinate system e.g. North, East, Down (NED)
  • NED North, East, Down
  • AHRSs all sensor data streams can be transformed into the same global or fixed-local coordinate system.
  • commercially available AHRS systems for full body motion analysis can function similarly to reflective marker video motion tracking systems for medical research purposes. As configured for full-body motion capture, however, multiple AHRSs do not lend themselves to use in a busy clinical
  • an inertial measurement unit IMU
  • an attitude and heading reference system AHRS
  • an on-board processing system in an AHRS which provides attitude and heading information versus an IMU which delivers sensor data to an additional device or control unit that computes attitude and heading.
  • attitude determination an AHRS may also form part of an inertial navigation system.
  • the present invention is related to determine a method for employing minimal instrumentation for kinematic and kinetic testing of patients in a busy orthopaedic clinic setting.
  • the gait measures that best indicate the degree of gait abnormality, from a clinical observation standpoint, are those that deal with spatio-temporal and/or kinetic asymmetries of motion. Therefore, the present invention starts to use a single chest-mounted AHRS to quantify vGRF asymmetry and step time asymmetry as measures of perceived kinetic and spatio-temporal gait abnormalities in a cadre of post-surgical lower extremity trauma patients versus matched healthy controls.
  • a validated value of such measurements is the “lift acceleration” as a new measure for assessing gait kinetic asymmetry.
  • the measurements of the device according to the invention are showing that: 1) recovering patients with a lower limb injury spend less single stance time and have a diminished lift acceleration on their injured versus a lesser-injured or uninjured limb, 2) that AHRS vertical acceleration P2P times and P2T lift accelerations correlate well with spatio- temporal and kinetic measures as determined using a Vicon motion capture system wherein chest-mounted AHRS data filtering is important, and 3) step time and lift acceleration asymmetry measures show the relevance of these values in indicating degree of gait abnormality.
  • a device for evaluation gait asymmetry of the gait of a walking user can comprise a sensor package having an inertial measurement unit or an attitude and heading reference system, to be attached at the user, and a control unit connected with the sensor package to receive data from the sensor package, wherein the control unit is configured to determine the highest and lowest vertical displacement value of the center of mass of the walking user, to calculate, based on these highest and lowest vertical displacement values over time, the step time or downward acceleration for each right step and for each left step and to calculate an asymmetry value as a function of the difference of the determined step time or downward accelerations for right steps and for left steps.
  • the device can calculate an acceleration asymmetry value as a percentage from [ ((Right acceleration data - Left acceleration data)
  • This value is an objective value of gait asymmetry compared to the subjective assessment of a traumatologist who monitors a walking user over several gait cycles. Additionally, the value can be determined after only one or two passes of 10 meters without the necessity of the presence of a physician, thus reducing the costs of this automatic assessment of the gait asymmetry.
  • the average value of the downward accelerations for all steps of one kind can be taken from the group encompassing the traditional mean value or the harmonic mean value or the median value.
  • the sensor package of the device can comprise a torso harness adapted to fix the sensor package on the central line of the user.
  • the fixation of the harness on the sternum as a near-bone fixation point has the advantage that no other elements interfere in the monitoring and gathering of the gait movement values.
  • the central line is on the median plane of the body.
  • the control unit can be provided as a separate device, e.g. a computer being connected to a storage to directly store and use the determined measurement values. Then, the connection between the sensor package and the control unit to transmit data is a wireless connection; especially it can be a Bluetooth or wireless lan connection.
  • the device allows to determine a further asymmetry value, the step time asymmetry value which is calculated as [ ((Right step time data - Left step time data)
  • the step time asymmetry can be combined with the gait acceleration asymmetry value, which are preferably both provided as percentage from the value 0 for no presence of an asymmetry.
  • the average value of the step time for all steps of one kind can be taken from the group encompassing the traditional mean value or the harmonic mean value or the median value of this time value.
  • the device determines a combined asymmetry value, which is calculated as ⁇ [ ((Right acceleration data - Left acceleration data)
  • right acceleration data is an average value of the downward accelerations for all right steps of the walking user
  • left acceleration data is an average value of the downward accelerations for all left steps of the walking user
  • max- function relates to the highest downward acceleration value of the entire measurement series
  • right step time data is an average value of the step time for all right steps of the walking user
  • left step time data is an average value of the step time for all left steps of the walking user
  • max-function relates to the highest step time value of the entire measurement series
  • asymmetry value it is possible to base the asymmetry value on the calculation of two different asymmetry values, i.e. the the acceleration asymmetry value as well as the step time asymmetry value giving as a result a combined asymmetry value, which is determined based on a function of the acceleration asymmetry value and of the step time asymmetry value.
  • This function can especially be achieved by the mean average or the harmonic mean. It can be provided in percentage of asymmetry (x 100 as mentioned above) or as a value between 0 (no asymmetry) and 1 (full asymmetry, theoretical case).
  • a method device for evaluation gait asymmetry of the gait of a walking user comprises the steps of providing a sensor package comprising an inertial measurement unit or an attitude and heading reference system, attaching the sensor package at the user, providing a control unit connected with the sensor package to receive data from the sensor package, determining, within the control unit, the highest and lowest vertical displacement value of the center of mass of the walking user, calculating, within the control unit, based on these highest and lowest vertical displacement values over time, the step time or downward acceleration for each right step and for each left step made by the user, and calculating, within the control unit, an asymmetry value as a function of the difference of the determined step time or downward accelerations for right steps and for left steps.
  • Fig. 1 shows an image of a harness with straps and an IMU noting location of the sensor package at the top of the sternum of a user
  • Fig. 2 shows a schematic representation of the temporal (horizontal) and kinetic
  • Fig. 3 depicts within the three row of graphs show: simulated acceleration profiles for increasingly abnormal gait, result of direct double integration of sine series functions of the first row and evaluation of the resultant displacement function, and actual AHRS gait cycle acceleration patterns for several users.
  • IMU inertial measurement unit
  • Tables 1 provides PROMIS measure scores at the time of testing and Tables 2&3 provide kinematic gait test variables for three patients who were selected to illustrate various degrees of gait normalcy / abnormality. Subject 1 demonstrates a normal gait after surgery and recovery.
  • Subject 2 demonstrates a noticeable limp and subject three demonstrates a continuing pathological gait pattern at 82 month post-surgery. However, subjects 2 and 3 routinely utilize an energy storing orthosis on their affected limb and were tested with and without the brace. Tables 2&3 provide data from gait tests without the brace. 50 is the U.S. general modulation mean value. +-10 is 1 standard deviation from said mean.
  • Subject 3 demonstrated significantly more sidedness for vertical accelerations and stance times than subjects 1 or 2 or controls (Table 2) and significantly greater vertical displacement, pitch and roll than all others tested (Table 3). His PROMIS function score, however, is within 1 standard deviation of the mean and pain interference score is just outside of 1 standard deviation (Table 1).
  • Fig. 1 shows an image of a harness with straps 21 and an IMU noting location of the sensor package 20 at the top of the sternum of a user 10 standing on ground 11.
  • the sensor package 20 can be an AHRS or an IMU. It can also comprise a data control unit for an on- board handling of data.
  • the sensor package 20 is preferably connected in a wireless manner 23 with an external control unit 22 like a desktop computer in the room where the tests are conducted.
  • the user 10 is requested to walk 10 meters on a flat ground surface 11 , e.g. 5 meters in one direction and 5 meters back to the starting point, while the sensor package 20 takes a number of measurements and transmits them via the wireless connection (as e.g. Bluetooth or wireless lan) 23 to the control unit 22.
  • the wireless connection as e.g. Bluetooth or wireless lan
  • the attachment of the sensor package 20 with straps 21 on the sternum of the user 10 has the advantage, that it is a central location on the body with no lateral offset when the user 10 is walking forward.
  • the sensor package 20 comprises a power supply, e.g. a battery pack.
  • Fig. 2 is a schematic representation of the temporal (horizontal) and kinetic (vertical) relationships vertical of normal human gait.
  • the user 10 is making one right step 31 and one left step 32 in about 0.8 seconds.
  • the vertical ground reaction force of a walking human is related with vertical acceleration 34, velocity 35 and displacement 36. These three values are shown in this order above the ground reaction force 33.
  • the sensor package 20 comprises a control unit or the external control unit 22 comprising a programmable microprocessor having a computer program configured to calculate, based on the measurement of vertical displacement 36 and vertical velocity step time (P2P) 41 and lift acceleration (P2T) 42.
  • P2P vertical velocity step time
  • P2T lift acceleration
  • the so-called push-off point 43 is denoted as the center of dual stance (DS) and mid-swing (MSw) 44 denotes the point of maximum single leg weight bearing.
  • DS center of dual stance
  • MSw mid-swing
  • Fig.2 is the drawing of the curves measured for a user 10 in health.
  • P2P time intervals 41 are shortened and P2T displacement magnitudes 42 are reduced for injured limbs in patients tested compared to contralateral limb values.
  • troughs 52 in the vertical acceleration curve correspond to initiation of the mid- swing (MSw) phase 44 of each step 31 and 32 and also to maximal excursions in vertical displacement 36 of the center of mass (CoM).
  • peaks 53 on the acceleration curve correspond to mid-dual stance (DS) 43 and to minimal excursions 54 in CoM vertical displacement.
  • DS is actually a temporal range that lasts from heel-strike of one limb to toe-off of the contralateral limb.
  • P2T peak-to- trough
  • This P2T acceleration segment correlates with the terminal dual stance, pre-swing and initial swing phases of a step cycle. Since this P2T acceleration segment 62 is also associated with the upward forces applied to the CoM from push-off for one limb post dual stance to weight bearing by the contralateral limb at midstance in each step 31, 32, this segment is hereafter referred to as“lift acceleration” 62. Thus, the end points of lift acceleration 62 involve significant activities by both limbs of a user 10 for a given step 31 or 32. In abnormal gait, due to lower extremity trauma and surgical repair, both end points are affected and the kinematic and kinetic relationships in Fig. 2 are altered as will be addressed.
  • Patients 1 and 4 were clinically assessed by orthopaedic traumatologists as having normal gait, while patients 2, 3 and 5 were assessed as having progressively mild to excessive gait abnormality. Patients 3 and 5 typically wear a dynamic brace for activities of daily living but were tested without their braces.
  • a modified lOmWalkTest (mlOmWT) (i.e. walk 5 meters, turn and walk five meters) was used due to walkway length constraints.
  • a ten-camera VICON motion capture system (Vicon Motion Systems Ltd, Oxford, UK) was used to record motion data at 100 Hz.
  • the measurement space was about 5.0m L x 2.0m W x2.5m H, and the 3-D residue of marker position tracking was lower than 1 mm after system calibration. All tests were also video- recorded at 60 fps. Accelerating and decelerating steps, at either end of the walkway, were removed from the step time and lift acceleration asymmetry analyses. These were steps on either end of the walkway where peak accelerations were less than 1 std of the remaining step acceleration peaks.
  • a marker triad was placed on the AHRS for Vicon corroboration of AHRS acceleration, angular velocity and orientation data.
  • the mean of the AHRS marker triad data was also used to track the instantaneous position of the AHRS and to provide data as a Vicon clavicle CLAV marker.
  • the midpoint of the CLAV and C7 markers was used to approximate the CoM of the subject’s head, arms and thorax (HAT).
  • the control unit 22 comprises a computer program adapted to 1) determine P2T magnitudes (lift accelerations) and P2P intervals (step times) using AHRS data from the sensor package 20 transmitted via connection 23 and 2) to separate these values for right and left steps.
  • P2T right lift acceleration 162 (see Fig. 3) and left lift acceleration 262 were calculated using sequential maxima and minima from AHRS vertical acceleration data.
  • Vicon vertical acceleration data was determined using double-differentiated position data from a point midway between the Vicon CLAV and C7 markers as an approximation of the HAT CoM vertical acceleration. Step time and lift acceleration data are presented as the mean + sem for all right steps and left steps from four, 5-meter gait segments per subject.
  • a single AHRS as sensor package 20 was located on the upper sternum (i.e. manubrium) of each individual user 10 tested. This location was selected as a single-device, multi-test compromise that could be used for: 1) a 10-meter- walk-test (lOmWT), 2) Timed-Up-and- Go (TUG) tests and 3) the 5-times-Sit-To-Stand (5xSTS) tests in the clinic without repositioning the AHRS between tests. In the latter two tests the head, arms and upper torso (HAT) rotational movements are more pronounced than in gait and measurement of these angular displacement parameters is better served by an upper-torso-mounted AHRS.
  • LEOmWT 10-meter- walk-test
  • TAG Timed-Up-and- Go
  • 5xSTS 5-times-Sit-To-Stand
  • the sternum as opposed to belt-level device locations, positions the AHRS near a bony surface regardless of subject BMI and away from any metallic gait assistive devices that may be required for gait or metal-frame chairs (i.e. used for TUG and 5xSTS tests). Such accessories can affect AHRS magnetometer readings.
  • Vicon CLAV markers and AHRS raw vertical acceleration waveform data were then compared to synchronize the waveforms obtained from the two separately triggered systems.
  • a signal processing function was used which shifts two continuous waveforms in time until an optimal fit (best synchronization) between waveforms is achieved.
  • AHRS P2P vertical acceleration intervals and P2T lift accelerations were compared versus Vicon DS2DS step times and HAT lift accelerations on an individual step basis.
  • the mean estimation error (i.e. AHRS vs Vicon) for N steps + sem for each lower extremity was obtained using the equation:
  • Step time and lift acceleration percent asymmetry data (right vs left) was calculated using the mean step time and mean lift acceleration data as:
  • Vicon and AHRS vertical acceleration data for all gait segments and for all subjects tested were“highly correlated' ' with r > 0.9 in all cases. This indicates that the AHRS provided accurate acceleration data for the Vicon CLAV marker position for the mlOmWT for all patients and controls.
  • Step time and lift acceleration accuracy assessment data can be found in tabular format in Table 5 and 6. Aggregate mean right and left step time deviations for all AHRS P2P vs Vicon DS2DS step time data averaged 8.01% for all patients and 2.98% for all controls. Aggregate deviation for the patient group was significantly affected differences in AHRS and Vicon accuracy assessments. Pt 3 Vicon step time data, using forefoot and hindfoot markers was corroborated with video data. Examination of Pt 3 data showed that peak accelerations for the affected limb were affected by high frequency components that were not adequately filtered; this type of error has been previously reported when using chest- mounted AHRSs for gait analysis. All patients, however, demonstrated shorter step times for trauma affected limbs for Vicon data and for AHRS data with the exception of Pt 3.
  • Lift acceleration aggregate mean deviations for all P2T vs Vicon HAT CoM data averaged 10.92% for all patients and 6.22% for all controls tested. Affected limbs demonstrated lesser lift accelerations in all patients as compared with unaffected or lesser affected limbs using both AHRS and Vicon data. As is the case with all surface mounted sensors, percent error was affected by the fact that the AHRS and HAT CoM are not at the same location.
  • Table 7a and 7b provide asymmetry data for step times and lift accelerations for patients and controls using Vicon and AHRS data.
  • Patient lift acceleration asymmetry ranking agrees with initial subjective traumatologists’ rankings but AHRS step time ranking was less discriminatory.
  • Controls asymmetry data were small regardless of method used for determination.
  • AHRS and Vicon lift acceleration percent asymmetry data agreed with traumatologists’ rankings of relative asymmetry. Again, control values for asymmetry were small in all cases.
  • AHRS e.g. foot, shank, hip, lower back, sternum and upper back
  • the vertical acceleration 62, 162, 262 measured by an AHRS located on the sternum highly correlated (r > 0.9 for all tests using the MATLAB xcorr function) with the vertical acceleration of a Vicon CLAV marker at the same location.
  • Lift acceleration asymmetry also has a direct effect on various types of observable vertical displacement patterns during gait.
  • Fig. 3 illustrates this point to demonstrate the capability of a single AHRS to provide reliable qualitative and quantitative vertical displacement data even when dealing with abnormal gait.
  • Upper body kinetics and kinematics are major observational features of gait analysis separate from lower body spatio-temporal measures.
  • the asymmetry results, particularly for lift acceleration 62, 162, 262 support the previous findings of 10% - 13% asymmetry as being an observational threshold for perceiving gait abnormality by a traumatologist, which represents a subjective point of view.
  • Fig. 3 depicts within the first row of graphs simulated acceleration profiles for increasingly abnormal gait (i.e. left to right) constructed from a multiple sine series.
  • the present invention focus on four parameters to explore the IMU’s potential to distinguish normal from pathologic gait: time in stance phase for each limb,“peak-to-peak” upper body vertical acceleration (i.e. which relates to observable vertical displacement), upper body oscillations in sagittal plane angulation (“pitching”), and upper body oscillations in coronal plane angulation (“rolling”).
  • time in stance phase for each limb “peak-to-peak” upper body vertical acceleration (i.e. which relates to observable vertical displacement)
  • upper body oscillations in sagittal plane angulation (“pitching”) upper body oscillations in coronal plane angulation
  • rolling coronal plane angulation
  • control unit 54 minimal excursion

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Abstract

La présente invention concerne un dispositif permettant d'évaluer une asymétrie de la démarche d'un utilisateur en train de marcher, ledit dispositif comprenant un boîtier de capteur comprenant une unité de mesure inertielle ou un système de référence d'attitude et de cap, à fixer à l'utilisateur, et une unité de commande raccordée au boîtier de capteur pour recevoir des données en provenance du boîtier de capteur, l'unité de commande étant configurée de sorte à déterminer le déplacement vertical (36) le plus haut (71) et le plus bas (72) du centre de masse de l'utilisateur en train de marcher, pour calculer, sur la base de ces valeurs de déplacement vertical (36) le plus haut (71) et le plus bas (72) au fil du temps (39), l'accélération vers le bas pour chaque pas droit (31) et pour chaque pas gauche (32) et pour calculer une valeur d'asymétrie en fonction de la différence du temps de pas déterminé (41) ou des accélérations vers le bas (42) pour les pas droits (31) et pour les pas gauches (32).
PCT/EP2019/056858 2018-03-19 2019-03-19 Dispositif et procédé permettant d'évaluer une asymétrie de la démarche WO2019180029A1 (fr)

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