Use of nonintrusive sensor-based information and communication technology for real-world evidence for clinical trials in dementia

Cognitive function is an important end point of treatments in dementia clinical trials. Measuring cognitive function by standardized tests, however, is biased toward highly constrained environments (such as hospitals) in selected samples. Patient-powered real-world evidence using information and communication technology devices, including environmental and wearable sensors, may help to overcome these limitations. This position paper describes current and novel information and communication technology devices and algorithms to monitor behavior and function in people with prodromal and manifest stages of dementia continuously, and discusses clinical, technological, ethical, regulatory, and user-centered requirements for collecting real-world evidence in future randomized controlled trials. Challenges of data safety, quality, and privacy and regulatory requirements need to be addressed by future smart sensor technologies. When these requirements are satisfied, these technologies will provide access to truly user relevant outcomes and broader cohorts of participants than currently sampled in clinical trials

Automatic discrimination between safe and unsafe swallowing using a reputation-based classifier

<p>Abstract</p> <p>Background</p> <p>Swallowing accelerometry has been suggested as a potential non-invasive tool for bedside dysphagia screening. Various vibratory signal features and complementary measurement modalities have been put forth in the literature for the potential discrimination between safe and unsafe swallowing. To date, automatic classification of swallowing accelerometry has exclusively involved a single-axis of vibration although a second axis is known to contain additional information about the nature of the swallow. Furthermore, the only published attempt at automatic classification in adult patients has been based on a small sample of swallowing vibrations.</p> <p>Methods</p> <p>In this paper, a large corpus of dual-axis accelerometric signals were collected from 30 older adults (aged 65.47 ± 13.4 years, 15 male) referred to videofluoroscopic examination on the suspicion of dysphagia. We invoked a reputation-based classifier combination to automatically categorize the dual-axis accelerometric signals into safe and unsafe swallows, as labeled via videofluoroscopic review. From these participants, a total of 224 swallowing samples were obtained, 164 of which were labeled as unsafe swallows (swallows where the bolus entered the airway) and 60 as safe swallows. Three separate support vector machine (SVM) classifiers and eight different features were selected for classification.</p> <p>Results</p> <p>With selected time, frequency and information theoretic features, the reputation-based algorithm distinguished between safe and unsafe swallowing with promising accuracy (80.48 ± 5.0%), high sensitivity (97.1 ± 2%) and modest specificity (64 ± 8.8%). Interpretation of the most discriminatory features revealed that in general, unsafe swallows had lower mean vibration amplitude and faster autocorrelation decay, suggestive of decreased hyoid excursion and compromised coordination, respectively. Further, owing to its performance-based weighting of component classifiers, the static reputation-based algorithm outperformed the democratic majority voting algorithm on this clinical data set.</p> <p>Conclusion</p> <p>Given its computational efficiency and high sensitivity, reputation-based classification of dual-axis accelerometry ought to be considered in future developments of a point-of-care swallow assessment where clinical informatics are desired.</p

Gait symmetry and regularity in transfemoral amputees assessed by trunk accelerations

<p>Abstract</p> <p>Background</p> <p>The aim of this study was to evaluate a method based on a single accelerometer for the assessment of gait symmetry and regularity in subjects wearing lower limb prostheses.</p> <p>Methods</p> <p>Ten transfemoral amputees and ten healthy control subjects were studied. For the purpose of this study, subjects wore a triaxial accelerometer on their thorax, and foot insoles. Subjects were asked to walk straight ahead for 70 m at their natural speed, and at a lower and faster speed. Indices of step and stride regularity (Ad1 and Ad2, respectively) were obtained by the autocorrelation coefficients computed from the three acceleration components. Step and stride durations were calculated from the plantar pressure data and were used to compute two reference indices (SI1 and SI2) for step and stride regularity.</p> <p>Results</p> <p>Regression analysis showed that both Ad1 well correlates with SI1 (<it>R</it>²up to 0.74), and Ad2 well correlates with SI2 (<it>R</it>²up to 0.52). A ROC analysis showed that Ad1 and Ad2 has generally a good sensitivity and specificity in classifying amputee's walking trial, as having a normal or a pathologic step or stride regularity as defined by means of the reference indices SI1 and SI2. In particular, the antero-posterior component of Ad1 and the vertical component of Ad2 had a sensitivity of 90.6% and 87.2%, and a specificity of 92.3% and 81.8%, respectively.</p> <p>Conclusions</p> <p>The use of a simple accelerometer, whose components can be analyzed by the autocorrelation function method, is adequate for the assessment of gait symmetry and regularity in transfemoral amputees.</p

Approaches of data analysis from multi‐parametric monitoring systems for landslide risk management

In the last decades, several approaches were proposed accounting for early warning systems to manage in real time the risks due to fast slope failures where important elements, such as structures, infrastructures and cultural heritage are exposed. The challenge of these approaches is to forecast the slope evolution, thus providing alert levels suitable for managing infrastructures in order to mitigate the landslide risk and reduce the “response” time for interventions. Three different strategies can be defined in this regard: an Observation‐Based Approach (OBA), a Statistic‐Based Approach (SBA) and a Semi‐Empirical Approach (SEA). These approaches are focused on searching relations among destabilizing factors and induced strain effects on rock mass. At this aim, some experiments are being performed at different scales in the framework of consulting activities and research projects managed by the Research Centre for the Geological Risk (CERI) of the University of Rome “Sapienza”. These experiments are testing different kind of sensors including extensometers, strain gauges, rock‐thermometers, interferometers, optical cams connected to Artificial Intelligence (AI) systems, for detecting changes in rock properties and detecting stressstrain changes, as well as pluviometers, anemometers, hygrometers, air‐thermometers, micro‐ or nano‐ accelerometers and piezometers for detecting possible trigger of deformational events. The results of this Ph.D. thesis demonstrate that the data analysis methods allowed the identification of destabilizing actions responsible for strain effects on rock mass at different dimensional scale and over several time‐window, from short‐ to long‐ period time scale. Furthermore, the three approaches were to be suitable to recognize precursor signals of rock mass deformation and demonstrated the possibility to provide an early warning

A Review of Accelerometry-Based Wearable Motion Detectors for Physical Activity Monitoring

Characteristics of physical activity are indicative of one’s mobility level, latent chronic diseases and aging process. Accelerometers have been widely accepted as useful and practical sensors for wearable devices to measure and assess physical activity. This paper reviews the development of wearable accelerometry-based motion detectors. The principle of accelerometry measurement, sensor properties and sensor placements are first introduced. Various research using accelerometry-based wearable motion detectors for physical activity monitoring and assessment, including posture and movement classification, estimation of energy expenditure, fall detection and balance control evaluation, are also reviewed. Finally this paper reviews and compares existing commercial products to provide a comprehensive outlook of current development status and possible emerging technologies

Validation of seat-off and seat-on in repeated sit-to-stand movements using a single body fixed sensor

The identification of chair rise phases is a prerequisite for quantifying sit-to-stand movements. The aim of this study is to validate seat-off and seat-on detection using a single-body-fixed sensor against detection based on chair switches. A single sensor system with three accelerometers and three gyroscopes was fixed around the waist. Synchronized on-off switches were placed under the chair. Thirteen older adults were recruited from a residential care home and fifteen young adults were recruited among college students. Subjects were asked to complete two sets of five trials each. Six features of the trunk movement during seat-off and seat-on were calculated automatically, and a model was developed to predict the moment of seat-off and seat-on transitions. The predictions were validated with leave-one-out cross-validation. Feature extraction failed in two trials (0.7%). For the optimal combination of seat-off predictors, cross-validation yielded a mean error of 0ms and a mean absolute error of 51ms. For the best seat-on predictor, cross-validation yielded a mean error of -3ms and a mean absolute error of 127ms. The results of this study demonstrate that seat-off and seat-on in repeated sit-to-stand movements can be detected semi-automatically in young and older adults using a one-body-fixed sensor system with an accuracy of 51 and 127ms, respectively. The use of the ambulatory instrumentation is feasible for non-technically trained personnel. This is an important step in the development of an automated method for the quantification of sit-to-stand movements in clinical practice. © 2012 Institute of Physics and Engineering in Medicine

Intraoperative Quantification of MDS-UPDRS Tremor Measurements Using 3D Accelerometry:A Pilot Study

The most frequently used method for evaluating tremor in Parkinson’s disease (PD) is currently the internationally standardized Movement Disorder Society—Unified PD Rating Scale (MDS-UPDRS). However, the MDS-UPDRS is associated with limitations, such as its inherent subjectivity and reliance on experienced raters. Objective motor measurements using accelerometry may overcome the shortcomings of visually scored scales. Therefore, the current study focuses on translating the MDS-UPDRS tremor tests into an objective scoring method using 3D accelerometry. An algorithm to measure and classify tremor according to MDS-UPDRS criteria is proposed. For this study, 28 PD patients undergoing neurosurgical treatment and 26 healthy control subjects were included. Both groups underwent MDS-UPDRS tests to rate tremor severity, while accelerometric measurements were performed at the index fingers. All measurements were performed in an off-medication state. Quantitative measures were calculated from the 3D acceleration data, such as tremor amplitude and area-under-the-curve of power in the 4–6 Hz range. Agreement between MDS-UPDRS tremor scores and objective accelerometric scores was investigated. The trends were consistent with the logarithmic relationship between tremor amplitude and MDS-UPDRS score reported in previous studies. The accelerometric scores showed a substantial concordance (>69.6%) with the MDS-UPDRS ratings. However, accelerometric kinetic tremor measures poorly associated with the given MDS-UPDRS scores (R2 < 0.3), mainly due to the noise between 4 and 6 Hz found in the healthy controls. This study shows that MDS-UDPRS tremor tests can be translated to objective accelerometric measurements. However, discrepancies were found between accelerometric kinetic tremor measures and MDS-UDPRS ratings. This technology has the potential to reduce rater dependency of MDS-UPDRS measurements and allow more objective intraoperative monitoring of tremor

Accelerometric Trunk Sensors to Detect Changes of Body Positions in Immobile Patients

Mobilization, verticalization and position change are mandatory for severely affected neurological patients in early neurorehabilitation in order to improve neurological status and prevent complications. However, with the exception of hospitals and rehabilitation facilities, this activity is not usually monitored and so far the automated monitoring of position changes in immobile patients has not been investigated. Therefore, we investigated whether accelerometers on the upper trunk could reliably detect body position changes in immobile patients. Thirty immobile patients in early neurorehabilitation (Barthel Index 30) were enrolled. Two tri-axial accelerometers were placed on the upper trunk and on the thigh. Information on the position and position changes of the subject were derived from accelerometer data and compared to standard written documentation in the hospital over 24 h. Frequency and duration of different body positions (supine, sidelying, sitting) were measured. Data are presented as mean +/- SEM. Groups were compared using one-way ANOVA or Kruskal-Wallis-test. Differences were considered significant if p < 0.05. Trunk sensors detected 100% and thigh sensors 66% of position changes (p = 0.0004) compared to standard care documentation. Furthermore, trunk recording also detected additional spontaneous body position changes that were not documented in standard care (81.8 +/- 4.4% of all position changes were documented in standard care documentation) (p < 0.0001). We found that accelerometric trunk sensors are suitable for recording position changes and mobilization of severely affected patients. Our findings suggest that using accelerometers for care documentation is useful for monitoring position changes and mobilization frequencies in and outside of hospital for severely affected neurological patients. Accelerometric sensors may be valuable in monitoring continuation of care plans after intensive neurorehabilitation

Rehabilitation Engineering in Parkinson's disease

Impairment of postural control is a common consequence of Parkinson's disease (PD) that becomes more and more critical with the progression of the disease, in spite of the available medications. Postural instability is one of the most disabling features of PD and induces difficulties with postural transitions, initiation of movements, gait disorders, inability to live independently at home, and is the major cause of falls. Falls are frequent (with over 38% falling each year) and may induce adverse consequences like soft tissue injuries, hip fractures, and immobility due to fear of falling. As the disease progresses, both postural instability and fear of falling worsen, which leads patients with PD to become increasingly immobilized. The main aims of this dissertation are to: 1) detect and assess, in a quantitative way, impairments of postural control in PD subjects, investigate the central mechanisms that control such motor performance, and how these mechanism are affected by levodopa; 2) develop and validate a protocol, using wearable inertial sensors, to measure postural sway and postural transitions prior to step initiation; 3) find quantitative measures sensitive to impairments of postural control in early stages of PD and quantitative biomarkers of disease progression; and 4) test the feasibility and effects of a recently-developed audio-biofeedback system in maintaining balance in subjects with PD. In the first set of studies, we showed how PD reduces functional limits of stability as well as the magnitude and velocity of postural preparation during voluntary, forward and backward leaning while standing. Levodopa improves the limits of stability but not the postural strategies used to achieve the leaning. Further, we found a strong relationship between backward voluntary limits of stability and size of automatic postural response to backward perturbations in control subjects and in PD subjects ON medication. Such relation might suggest that the central nervous system presets postural response parameters based on perceived maximum limits and this presetting is absent in PD patients OFF medication but restored with levodopa replacement. Furthermore, we investigated how the size of preparatory postural adjustments (APAs) prior to step initiation depend on initial stance width. We found that patients with PD did not scale up the size of their APA with stance width as much as control subjects so they had much more difficulty initiating a step from a wide stance than from a narrow stance. This results supports the hypothesis that subjects with PD maintain a narrow stance as a compensation for their inability to sufficiently increase the size of their lateral APA to allow speedy step initiation in wide stance. In the second set of studies, we demonstrated that it is possible to use wearable accelerometers to quantify postural performance during quiet stance and step initiation balance tasks in healthy subjects. We used a model to predict center of pressure displacements associated with accelerations at the upper and lower back and thigh. This approach allows the measurement of balance control without the use of a force platform outside the laboratory environment. We used wearable accelerometers on a population of early, untreated PD patients, and found that postural control in stance and postural preparation prior to a step are impaired early in the disease when the typical balance and gait intiation symptoms are not yet clearly manifested. These novel results suggest that technological measures of postural control can be more sensitive than clinical measures. Furthermore, we assessed spontaneous sway and step initiation longitudinally across 1 year in patients with early, untreated PD. We found that changes in trunk sway, and especially movement smoothness, measured as Jerk, could be used as an objective measure of PD and its progression. In the third set of studies, we studied the feasibility of adapting an existing audio-biofeedback device to improve balance control in patients with PD. Preliminary results showed that PD subjects found the system easy-to-use and helpful, and they were able to correctly follow the audio information when available. Audiobiofeedback improved the properties of trunk sway during quiet stance. Our results have many implications for i) the understanding the central mechanisms that control postural motor performance, and how these mechanisms are affected by levodopa; ii) the design of innovative protocols for measuring and remote monitoring of motor performance in the elderly or subjects with PD; and iii) the development of technologies for improving balance, mobility, and consequently quality of life in patients with balance disorders, such as PD patients with augmented biofeedback paradigms

Wearable inertial sensors for human movement analysis

Introduction: The present review aims to provide an overview of the most common uses of wearable inertial sensors in the field of clinical human movement analysis.Areas covered: Six main areas of application are analysed: gait analysis, stabilometry, instrumented clinical tests, upper body mobility assessment, daily-life activity monitoring and tremor assessment. Each area is analyzed both from a methodological and applicative point of view. The focus on the methodological approaches is meant to provide an idea of the computational complexity behind a variable/parameter/index of interest so that the reader is aware of the reliability of the approach. The focus on the application is meant to provide a practical guide for advising clinicians on how inertial sensors can help them in their clinical practice.Expert commentary: Less expensive and more easy to use than other systems used in human movement analysis, wearable sensors have evolved to the point that they can be considered ready for being part of routine clinical routine