The present invention relates to assessing the risk of falling for elderly people and, more particularly, to a device upon which a user can step and which measures the dynamic force distribution on the user's feet to calculate the risk of the user falling.
Falls are major threats to the health and independent living of the elderly. It is estimated that 10% of the falls by the elderly are associated with fractures, and some can lead to head injuries and deaths. Falls and their associated injuries, such as hip fractures, are risk factors for placement in nursing homes [MT1997]. Even minor falls can lead to substantial functional impairment of mobility and the daily activities of living in the elderly. They can trigger a negative domino effect leading to complications such as pneumonia, thromboembolism, loss of autonomy, disability, anxiety, depression and an impaired quality of life in the individual, and a burden on the family. Falls in the elderly are costly to the health care system because they often require accident and emergency services, as well as prolonged hospitalization, procedures, operations and rehabilitation services. The burden of falls on the society will increase with the aging population.
Since an average of 20% of the elderly population have accidental falls annually, if at least 10% of them can be warned of an imminent fall risk so they can take proper precautions, great harm to them can be prevented. In particular, severe injuries such as fractures, head injuries and deaths could be reduced from 10% to 3% by taking proper preventive measures. However, current assessment tools for falls and balance require the presence of a clinician for administration of a test and interpretation of the results. Since individuals do not have a practical and objective way to assess their own daily fall risk, they may under-estimate or overestimate their risk of falling. While under-estimation leads to unsafe behaviors and increased falls, over-estimation is also problematic due to creation of an unfounded fear of falling and its downstream effects such as restricted physical activity, social isolation and functional loss.
Balance ability assessment relies on a specific procedure or method that can analyze human balance ability either quantitatively or qualitatively. Currently, there are a wide range of different methods for human balance ability assessment. These can be divided into three categories: observation, scale, and balance testing devices.
The simplest and most typically used method is observation, such as the Romberg test [FB1982, YA2011], one-legged stance test (OLST) [TM2009], and postural stress test [JC1990], etc. In the Romberg test, subjects close their eyes, stand on both feet, and raise their arms forward.
An evaluation person (evaluator) will then give a balance ability assessment based on the degree of body sway. Similar to the Romberg test, in an OLST, the subject instead stands on one leg. The postural stress test is clinically applicable and is used to obtain quantitative measurements. In this method, a destabilizing force is applied to the subject's waist. Balance ability is evaluated based on the subject's ability to remain standing upright.
A more elaborate method is a scale, which includes the Berg balance test [SM2008], Tinetti test [SK2006], and Timed Up and Go test (TUG) [TS2002], etc. The Tinetti test has also been widely used in balance ability assessment and fall prediction for the elderly. In this method, an evaluator will score the subject's performance in a series of different tasks.
The first balance testing device method was introduced by Yuriy V. Terekhov [YT1976] in 1976 and is called stabilometry. This measures the mechanical oscillation of a subject's center of gravity and converts it into electronic signals. A computer is then used to analyze the frequency, amplitude, and duration of oscillation to evaluate the subject's balance ability. Over the years, this method has been improved and developed into different versions, but the basic principle remains the same; they all consist of a pressure test board, computer, and specialized analysis software (see
Balance testing devices have even been adapted for recreational use. For example, the Nintendo Wii Balance Board [RC2010] (see
Fall risk assessment is used to determine if a subject has a low, moderate, or high risk of falling. Mostly performed on older adults, it commonly includes an initial screening, then completion of a set of tasks known as fall assessment tools. Initial screening comprises a series of questions about the subject's overall health, and whether they have a history of falls or problems with balance, standing, or walking; while the fall assessment tools test a subject's strength, balance, and gait.
Initial screening questions include: “Have you fallen in the past year?”; “Do you feel unsteady when standing or walking?”; and “Are you worried about falling?” There are a number of questionnaires that can be used for screening, such as the Patient Fall Questionnaire [NR1984] and the Fall Assessment Questionnaire [LR1993].
Fall assessment tools include the aforementioned TUG test [TS2002], 30-Second Chair Stand Test [KJ2015], and 4-Stage Balance Test [JG2017], etc. In the TUG test, the subject starts in a chair, stands up, then walks approximately 10 feet at a regular pace while the health care provider checks the subject's gait. The 30-Second Chair Stand Test checks strength and balance. First, the subject sits in a chair with their arms crossed over their chest. They then repeat standing up and sitting down for 30 seconds while the health care provider counts how many times this is performed. The 4-Stage Balance Test checks how well a subject can maintain their balance. The subject stands in four different positions, holding each one for 10 seconds. In the first position, the subject stands with their feet side by side. In the second, the subject moves one foot halfway forward. In the third, the subject moves one foot fully in front of the other, so that the toes touch the heel of the other foot. In the fourth position, the subject stands on only one foot. There are many other similar fall assessment tools, such as the Berg Balance Test [KB1989], Elderly Fall Screening Test [JC1998], Dynamic Gait Index [SW2000], and Tinetti Performance Oriented Motility Test [MT1986].
There are also scale methods for fall assessment, such as the Gait Abnormality Rating Scale (GMRS) [LW1990, JV1996] and Morse Fall Scale [JM1989]. GMRS, for example, includes variables that are intended to provide a description of test subject's gait associated with an increased risk of falling, such as step and arm movements, guardedness, weaving, waddling, staggering, percentage of time in the swing phase of the gait cycle, foot contact, hip range of motion, knee range of motion, elbow extension, shoulder extension, shoulder abduction, arm-heel-strike synchrony, head held forward, shoulder held elevated and upper trunk flexed forward.
Among the various human balance ability assessment methods, because an evaluator is required for both the observation and scale methods, balance ability evaluation is subjective. At the same time, fall assessment tools also require a health care provider to administer the assessment, meaning that the results are also subjective. As such, because no evaluator or health care provider is needed, a balance tester is much more objective. While the tread force detector in balance testers mostly relies on an array of electronic force sensors (see
In one aspect of the present invention, there is provided a human balance sensor for assessing the risk of the user falling, comprising:
In a preferred embodiment, the light given by the light source is invisible or more preferably an infrared light. The light source may be any light-emitting device that can give an invisible light (i.e. not visible by human naked eyes) at a fixed wavelength, particularly give infrared light at a fixed wavelength. It is advantageous to the assessment because it can minimize the noise detected during the entire process, so as to improve the accuracy of the measurement.
In another embodiment, the human balance sensor further comprises a wave guide or an optical wave guide to block unwanted light from entering the transparent glass plate or minimize the unwanted effect caused by noise. This could improve the accuracy in assessment.
In another aspect of the invention, there is provided a human balance sensor for assessing the risk of the user falling, comprising:
Similarly, the human balance sensor of this aspect may also comprise an invisible light source as described above, and an optical wave guide.
In a further aspect, the invention pertains to a method of using the human balance sensor as described herein to assess the risk of a user failing.
Compared to “A device for measuring plantar pressure under the sole of the foot”, R. P. Bettes and T. Duckworth, here are some major differences in hardware design:
In order to be objective when assessing human balance ability, the present invention uses a comprehensive physical system for balance evaluation, called “Balance Sensor,” which has a special sensing unit for collecting force distribution information under human feet. The sensing unit does not rely on an electronic force sensor array, but instead operates on the optical principle of Frustrated Total Internal Reflection (FTIR). Widely used to develop haptic sensors for robots [HM1992, NN1990, SB1988_1, SB1988_2], the present invention extends the principle far beyond robotics and takes advantage of the abundant haptic information available and applies it to investigate human balance ability. Although a sensing unit based on FTIR has a much simpler structure than an electronic force sensor array, it is more sensitive and can reach much higher force distribution resolution. Furthermore, its fabrication cost is very low.
As the sensing unit of the Balance Sensor is based on an optical principle, the final signal collecting device is a camera. Force distribution under the feet is recorded in images; hence, force distribution variation information is encoded in a video format (see
Once the collected data is in video format, cutting-edge computer vision and AI technology can be leveraged for analysis, thereby greatly enhancing the Balance Sensor's ability to obtain human balance information. This is another major advantage compared with traditional balance testing devices. If the data analysis results need to be discrete, then algorithms are used to map the original video data to these discrete results, which is a classification solution. One method is to extract certain features manually from the original videos and then set a rule-based algorithm to classify different videos or train a machine learning model to classify them. Another method is to simply use the original video data to train a deep learning algorithm such as a 3D convolutional neural network (CNN) to generate a classification model. If the data analysis results are continuous, then a functional relationship is established between the original video data and the final continuous results. When this is the case, it is a regression process. As with the previous method, features can be extracted manually and a regression model can be trained accordingly, or deep learning methods can be used to perform regression. In both scenarios, however, it is better to first compress the original video data to extract useful information and discard redundant information before analysis. This is because there is always a large volume of video data and it allows for the reduction of the model size and improved processing efficiency. In terms of data compression, there are multiple available methods, such as compressive sensing and autoencoding.
Alternatively, there is another option to analyze the Balance Sensor's data. Since the relationship between pressure value and pixel intensity is fixed, this pressure-pixel relationship can be calibrated through experiments, so as to transform the original images into real pressure distribution information. This calibration work has been completed. [SW2019, SW2020] With the real pressure distribution variation information, dynamic analysis of the human body can be conducted. Specifically, a dynamic model can be established for the specific motion of a human body during testing. This model comprises multiple differential equations associated with the pressure distribution variation process under the feet. With this information, a series of definite conditions can be set according to the physical properties of the human body, so that differential equations can be solved to obtain detailed body motion processes. A novel differential equation-solving algorithm has been developed based on a Generative Adversarial Tri (GAT) model, which is able to solve nonlinear differential equations with any feasible definite condition. With detailed body motion processes, further balance ability assessment or fall assessment can be realized.
There are two possible application scenarios. (1) To qualitatively identify whether the subject is normal, sick, or drunk. For example, it may be necessary to perform a physical examination of a patient, identify whether a subject has a specific neural disease, or use it to identify a drunk driver. (2) To quantitatively score the balance ability or fall likelihood of a subject. For example, as part of athlete selection, pilot selection, or during the falling assessment of an elderly patient.
The foregoing and other objects and advantages of the present invention will become more apparent when considered in connection with the following detailed description and appended drawings in which like designations denote like elements in the various views, and wherein:
The major component of the Balance Sensor of the present invention is based on the principle of Frustrated Total Internal Reflection (FTIR), as shown in
The different pixel intensities derive from different diffused light intensities at each point of contact. Different diffused light intensities are caused only by different contact pressure since the surface properties of the latex sheet and the glass plate are identical everywhere. Therefore, the haptic image captured by the camera is actually a force distribution image of the tread force under foot. Moreover, because the camera can record video with a high frame rate, the pressure distribution information can be recorded over time with a high frame rate. A schematic diagram of the Balance Sensor device of the present invention is shown in
Eq1 are nonlinear ordinary differential equations that have no analytical solution. Even though only a numerical solution is needed, the equations still lack initial conditions. However, other definite conditions can be exploited in order to solve Eq51. Since during experiments, the user or tester doesn't fall, θ1 and θ2 must always oscillate around 0. The angular velocities {dot over (θ)}1 and {dot over (θ)}2 also must always oscillate around 0. Since all of θ1, θ2, {dot over (θ)}1, {dot over (θ)}2 don't diverge, their integrals over the whole experimental period (0, T) are all considered to be 0. In this way, definite conditions are obtained as shown in Eq3.
The present invention uses a novel method to solve the ordinary differential equation, the so called Generative Adversarial Tri-model (GAT) model. The GAT method combines an analytical approach with a neuro network to numerically solve nonlinear ordinary differential equations with non-initial conditions such as Eq3 as follows:
First Eq1 is transformed into 4 first-order differential equations, as shown in Eq4, where u1=θ1, u2=θ2, u3={dot over (θ)}1, u4={dot over (θ)}2 Specifically, four neural networks are used to represent θ1|(t), θ2(t), {dot over (θ)}1(t), {dot over (θ)}2(t), respectively. Their network structures are the same, as shown in
The flow chart of the GAT model is shown in
Furthermore, an approximate solution is worked out and then this approximate solution is used as the first initialization of the GAT model. In this way, the convergence of the HAN model is made faster and better. Specifically, for Eq4, the nonlinear terms in the equations are first discarded so that Eq4 can be converted into linear differential equations Eq5. For Eq5, since it is linear, its numerical solutions can be worked out through the finite difference method with the help of definite conditions Eq3. Then the numerical solutions of Eq5 are used as the first initialization of the HAN model. This greatly accelerates the convergence of the HAN model. The multiple differential equations solved by this method are associated with the pressure distribution variation process under the feet of the user.
There are lots of different coordinates of the center of pressure (COP)-based measurements that can be used to evaluate human balance ability or conduct fall assessment. Time-domain “distance” measures [TP1996] include mean distance of the COP from the origin, root mean square distance of the COP from the origin, total length of the COP path, mean velocity of the COP [MG1990], etc. Time-domain “area” measures include 95% confidence circle area which is the area of a circle with a radius equal to the one-side 95% confidence limit of the RD time series, 95% confidence ellipse area which is expected to enclose approximately 95% of the points on the COP path, etc. There are also time-domain “hybrid” measures. For example, sway area estimates the area enclosed by the COP path per unit of time [AH1980]. The mean frequency is the rotational frequency, in revolutions per second or Hz, of the COP if it had travelled the total excursions around a circle with a radius of the mean distance [FH1989]. The fractal dimension is a unitless measure of the degree to which a curve fills the metric space which it encompasses.
Apart from time-domain measures, there are also frequency-domain measures. A variety of qualitative and quantitative methods have been used to characterize the frequency distribution of the displacement of the COP [ID1983, TP1993], such as power spectral moments, total power, 50% power frequency, 95% power frequency, centroidal frequency, frequency dispersion, etc. There are also some statistical measures, like Romberg ratios, the phase plane parameter of Riley, etc.
It is worth pointing out that in 1981, the International Society of Posturography suggested the use of two COP-based measures, mean velocity of the COP and root mean square distance of the COP from origin, in their recommendations for standardizing force platform-based evaluation of postural steadiness [ID1983].
Since COP can be calculated from the pressure distribution under the user's feet obtained by the Balance Sensor of the present invention, all of the above COP-based measures can be adopted in the applications of the Balance Sensor. Moreover, pressure distribution has much more abundant information than a single COP position. With the pressure distribution under the user's feet, pedography analysis can be used. Pedography is a functional diagnostic tool, which can provide accurate, reliable information for the analysis of foot function and the diagnosis of foot pathologies. Foot deformities and malfunction can be detected during analysis of barefoot pressure distribution. This extra pathological information will greatly facilitate balance ability and fall assessment.
In addition, in the above COP-based measurements and assessments, COP can be replaced with center of gravity (COG). In this way, a series of COG-based measures can be created. Moreover, since the motion of the COG is the real physical motion of the human body and COP can be considered as the control of the human body in order to keep balance, a comparison of the variation of COP and COG can be used to analyze the balance control ability of the human body, which is a direct indicator of human balance ability and the degree of tendency to fall. As a result, a more accurate assessment is obtained.
The COP measurement, pedography analysis and COG measurement abilities of balancing can be integrated to develop fall assessment software. The core part of the software is a regression model generated through machine learning, which outputs the fall probability of the tester. This regression model is fused by two parts. One is based on a support vector machine. Those COP-based measurements, pedography analysis results and COG-based measurements are extracted and fed into this support vector machine. This support vector machine outputs a fall probability of the user or tester. Another part is based on use of a deep convolutional neural network, which will directly take the video data from the Balance Sensor as an input and output another fall probability of the tester. Then a weighted average of the two fall probabilities is taken from the support vector machine and the deep neural network as the final evaluation result of the fall assessment software.
The diagram of the regression model is shown in
The assessment results are displayed on the screen 29 on the Balance Sensor and/or are announced by voice from a speaker, not shown. Furthermore, the results can also be transmitted via WiFi or Bluetooth to mobile devices 25 and/or other computers (not shown) for display and recording.
The rectangular box 22 of the sensing unit may have a size, e.g., of about 60×43×10 cm3, as shown in
The graphical user interface (GUI) of the Balance Sensor is shown in
On the right side of the GUI of
The procedure to turn on the Balance Sensor is as follows:
Product setup procedure:
Experiments were conducted to test the measurement of human balancing using the sensor of the present invention. The test involved five recruited testers in total. Measurements of each of them were taken for 10 seconds with the Balance Sensor while the testers were in their normal states. The COP variations with time in a 2D plane for these 5 testers are shown in the first row of
It can be seen in
The cited references in this application are incorporated herein by reference in their entirety and are as follows:
I. DIRECTIONS, “Standardization in platform stabilometry being a part of posturography,” Agressologie, vol. 24, no. 7, pp. 321-326, 1983. While the invention is explained in relation to certain embodiments, it is to be understood that various modifications thereof will become apparent to those skilled in the art upon reading the specification. Therefore, it is to be understood that the invention disclosed herein is intended to cover such modifications as fall within the scope of the appended claims.
This application is a U.S. National Stage Application under 35 U.S.C. § 371 of International Patent Application No. PCT/CN2022/098354, filed Jun. 13, 2022, and claims the benefit of priority under 35 U.S.C. Section 119(e) of U.S. provisional patent application U.S. 63/210,596 filed on Jun. 15, 2021, the entire content of which is incorporated by reference for all purpose. The International Application was published in English on Dec. 22, 2022 as International Publication No. WO 2022/262669 A1.
Filing Document | Filing Date | Country | Kind |
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PCT/CN2022/098354 | 6/13/2022 | WO |
Number | Date | Country | |
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63210596 | Jun 2021 | US |