Pilot Test of a New Personal Health System Integrating Environmental and Wearable Sensors for Telemonitoring and Care of Elderly People at Home (SMARTA Project).

BACKGROUND: The increase in life expectancy is accompanied by a growing number of elderly subjects affected by chronic comorbidities, a health issue which also implies important socioeconomic consequences. Shifting from hospital or community dwelling care towards a home personalized healthcare paradigm would promote active aging with a better quality of life, along with a reduction in healthcare-related costs. OBJECTIVE: The aim of the SMARTA project was to develop and test an innovative personal health system integrating standard sensors as well as innovative wearable and environmental sensors to allow home telemonitoring of vital parameters and detection of anomalies in daily activities, thus supporting active aging through remote healthcare. METHODS: A first phase of the project consisted in the definition of the health and environmental parameters to be monitored (electrocardiography and actigraphy, blood pressure and oxygen saturation, weight, ear temperature, glycemia, home interaction monitoring - water tap, refrigerator, and dishwasher), the feedbacks for the clinicians, and the reminders for the patients. It was followed by a technical feasibility analysis leading to an iterative process of prototype development, sensor integration, and testing. Once the prototype had reached an advanced stage of development, a group of 32 volunteers - including 15 healthy adult subjects, 13 elderly people with cardiac diseases, and 4 clinical operators - was recruited to test the system in a real home setting, in order to evaluate both technical reliability and user perception of the system in terms of effectiveness, usability, acceptance, and attractiveness. RESULTS: The testing in a real home setting showed a good perception of the SMARTA system and its functionalities both by the patients and by the clinicians, who appreciated the user interface and the clinical governance system. The moderate system reliability of 65-70% evidenced some technical issues, mainly related to sensor integration, while the patient's user interface showed excellent reliability (100%). CONCLUSIONS: Both elderly people and clinical operators considered the SMARTA system a promising and attractive tool for improving patients' healthcare while reducing related costs and preserving quality of life. However, the moderate reliability of the system should prompt further technical developments in terms of sensor integration and usability of the clinical operator's user interface.

Instrumented Version of the Modified Dynamic Gait Index in Patients With Neurologic Disorders.

BACKGROUND: Gait instability is common in adults with neurologic disorders and the modified Dynamic Gait Index (mDGI) was recently introduced to assess dynamic balance. However, instrumental assessment is needed to provide quantitative measures. OBJECTIVE: To develop and validate an instrumented version of the mDGI. DESIGN: Cross-sectional study. SETTING: Clinical setting. PARTICIPANTS: Thirty adults with neurologic disorders (10 with multiple sclerosis, 10 with Parkinson disease, and 10 with stroke) and 20 healthy volunteers. METHODS: Participants were assessed with the Timed Up and Go test (TUG) and with the mDGI. During the assessment of mDGI, data were collected by a single Inertial Measurement Unit (IMU) positioned on the sternum. Principal component analysis (PCA) was performed on the instrumented data extracting eight PC scores (ImPC) describing dynamic balance. The instrumented overall score (ImDGI) was then calculated as the sum of the mPCs. PCA revealed two components associated with stride features and regularity (ImDGI_Gait_Pattern) and trunk movements (ImDGI_Trunk_Sway). Spearman coefficients were calculated between mDGI and ImDGI, whereas Mann-Whitney (U) and Kruskal-Wallis (H) tests assessed differences between groups and neurologic conditions. MAIN OUTCOME MEASUREMENTS: ImDGI. RESULTS: ImDGI did not show ceiling effects, and good correlations were found between ImDGI and mDGI (r = .84), and TUG (r = .84) for people with neurologic disorders (P < .001). Significant differences among pathologies (H test(2) =12.5, P = .002) and between healthy participants and adults with neurologic disorders (U test = 47.0, P = .001) were found. ImDGI_Trunk_Sway discriminated between people using or not using walking aids and among the three pathologies (H(2) = 10.0, P = .007). CONCLUSIONS: The ImDGI test seems to provide valid measures to objectively assess dynamic balance in neurologic conditions and possibly quantify balance deficits also in adults with neurologic disorders.

Evaluation of the Tinetti score and fall risk assessment via accelerometry-based movement analysis.

Gait and balance disorders are among the main predisposing factors of falls in elderly. Clinical scales are widely employed to assess the risk of falling, but they require trained personnel. We investigate the use of objective measures obtained from a wearable accelerometer to evaluate the fall risk, determined by the Tinetti clinical scale. Seventy-nine patients and eleven volunteers were enrolled in two rehabilitation centers and underwent a full Tinetti test, while wearing a triaxial accelerometer at the chest. Tinetti scores were assessed by expert physicians and those subjects with a score ≤18 were considered at high risk. First, we analyzed 21 accelerometer features by means of statistical tests and correlation analysis. Second, one regression and one classification problem were designed and solved using a linear model (LM) and an artificial neural network (ANN) to predict the Tinetti outcome. Pearson's correlation between the Tinetti score and a subset of 9 features (mainly related with standing and walking) was 0.71. The misclassification error of high risk patient was 0.21 and 0.11, for LM and ANN, respectively. The work might foster the development of a new generation of applications meant to monitor the time evolution of the fall risk using low cost devices at home.

Responsiveness of gait analysis parameters in a cohort of 71 CMT subjects.

Detection of worsening in the slowly progressive Charcot-Marie-Tooth disease (CMT) is difficult. As previous clinical scales showed low responsiveness, novel outcome measures are under study, including innovative approaches such as quantitative muscle MRI and instrumented movement analysis. Since gait analysis proved able to reliably quantify CMT locomotor deficits, we aimed to explore whether it can be a sensitive-to-change outcome measure in CMT studies. Clinical and biomechanical evaluations were performed in 71 CMT subjects at baseline and after a mean (±sd) of 28.9 ± 9.5 months. Locomotor tasks included natural walking, ascending and descending steps. Instrumented analysis of such tasks provided indexes related to muscle strength (kinetic parameters) and joint movement (kinematic parameters). Parameter responsiveness was expressed as Standardized Response Mean (SRM). Considering the whole CMT group, several parameters showed moderate responsiveness; subgrouping subjects according to disease severity allowed reaching high responsiveness (SRM >0.80). CMT Examination Score showed moderate responsiveness (SRM 0.53) in the minimally affected group; kinematic parameters were more responsive in this group, whereas kinetic parameters in the most severely affected one. Biomechanical parameters can represent suitable outcome measures for CMT by showing moderate-to-high responsiveness. These data suggest that appropriate selection of patient population and outcome measures is crucial for clinical trials' design.

Performance comparison between wrist and chest actigraphy in combination with heart rate variability for sleep classification.

The concurrent usage of actigraphy and heart rate variability (HRV) for sleep efficiency quantification is still matter of investigation. This study compared chest (CACT) and wrist (WACT) actigraphy (actigraphs positioned on chest and wrist, respectively) in combination with HRV for automatic sleep vs wake classification. Accelerometer and ECG signals were collected during polysomnographic studies (PSGs) including 18 individuals (25-53 years old) with no previous history of sleep disorders. Then, an experienced neurologist performed sleep staging on PSG data. Eleven features from HRV and accelerometry were extracted from series of different lengths. A support vector machine (SVM) was used to automatically distinguish sleep and wake. We found 7 min as the optimal signal length for classification, while maximizing specificity (wake detection). CACT and WACT provided similar accuracies (78% chest vs 77% wrist), larger than what yielded by HRV alone (66%). The addition of HRV to CACT reduced slightly the accuracy, while improving specificity (from 33% to 51%, p < 0.05). On the contrary, the concurrent usage of HRV and WACT did not provide statistically significant improvements over WACT. Then, a subset of features (3 from HRV + 1 from actigraphy) was selected by reducing redundancy using a strategy based on Spearman's correlation and area under the ROC curve. The usage of the reduced set of features and SVM classifier gave only slightly reduced classification performances, which did not differ from the full sets of features. The study opens interesting possibilities in the design of wearable devices for long-term monitoring of sleep at home.

Trunk motion analysis: a systematic review from a clinical and methodological perspective.

INTRODUCTION: This systematic literature review aims to check the current state of affairs of non-gait-related optoelectronic trunk movement analysis; results have been analyzed from a clinical and a methodological perspective. EVIDENCE ACQUISITION: Extensive research was performed on all papers published until December 31st, 2015, dealing with trunk movement analysis assessed by optoelectronic systems, excluding those related to gait. The research was performed on the 14th of January 2016 on three databases: Scopus, Science Direct and Pubmed. A reference search and expert consultation were also performed. EVIDENCE SYNTHESIS: Out of a total number of 8431 papers, 45 were deemed relevant: they included 1334 participants, 57.9% healthy, with age range 8-85. Few studies considered the whole trunk, and none focused on each vertebra independently: the trunk was almost always divided into three segments. Thirteen studies included 20 or more markers. Most of the papers focused mainly on the biomechanics of various movements; the lumbar area and low back pain were the most studied region and pathology respectively. CONCLUSIONS: This study has shown the relative scarcity of current literature focusing on trunk motion analysis. In clinical terms, results were sparse. The only quite well represented group of papers focused on the lumbar spine and pathologies, but the scarcity of individuals evaluated make the results questionable. The use of optoelectronic systems in the evaluation of spine movement is a growing research area. Nevertheless, no standard protocols have been developed so far. Future research is needed to define a precise protocol in terms of number and position of markers along the spine and movements and tasks to be evaluated.

Automatic vs. clinical assessment of fall risk in older individuals: A proof of concept.

Falling in elderly is a worldwide major problem because it can lead to severe injuries, and even sudden death. Fall risk prediction would provide rapid intervention, as well as reducing the over burden of healthcare systems. Such prediction is currently performed by means of clinical scales. Among them, the Tinetti Scale is one of the better established and mostly used in clinical practice. In this work, we proposed an automatic method to assess the Tinetti scores using a wearable accelerometer. The balance and gait characteristics of 13 elderly subjects have been scored by an expert clinician while performing 8 different motor tasks according to the Tinetti Scale protocol. Two statistical analysis were selected. First, a linear regression study was performed between the Tinetti scores and 8 features (one feature for each task). Second, the generalization quality of the regression model was assessed using a Leave-One SubjectOut approach. The multiple linear regression provided a high correlation between the Tinetti scores and the features proposed (adj. R(2) = 0.948; p = 0.003). Moreover, six of the eight features added statistically significantly to the prediction of the scores (p <; 0.05). When testing the generalization capability of the model, a moderate linear correlation was obtained (R(2) = 0.67; p <; 0.05). The results suggested that the automatic method might be a promising tool to assess the falling risk of older individuals.

The influence of somatosensory and muscular deficits on postural stabilization: Insights from an instrumented analysis of subjects affected by different types of Charcot-Marie-Tooth disease.

Charcot-Marie-Tooth (CMT) disease is the most common hereditary neuromuscular disorder. CMT1 is primarily demyelinating, CMT2 is primarily axonal, and CMTX1 is characterized by both axonal and demyelinating abnormalities. We investigated the role of somatosensory and muscular deficits on quiet standing and postural stabilization in patients affected by different forms of CMT, comparing their performances with those of healthy subjects. Seventy-six CMT subjects (CMT1A, CMT2 and CMTX1) and 41 healthy controls were evaluated during a sit-to-stand transition and the subsequent quiet upright posture by means of a dynamometric platform. All CMT patients showed altered balance and postural stabilization compared to controls. Multivariate analysis showed that in CMT patients worsening of postural stabilization was related to vibration sense deficit and to dorsi-flexor's weakness, while quiet standing instability was related to the reduction of pinprick sensibility and to plantar-flexor's weakness. Our results show that specific sensory and muscular deficits play different roles in balance impairment of CMT patients, both during postural stabilization and in static posture. An accurate evaluation of residual sensory and muscular functions is therefore necessary to plan for the appropriate balance rehabilitation treatment for each patient, besides the CMT type.

Assessment of postural stabilization in three task oriented movements in people with multiple sclerosis.

PURPOSE: In accordance with the Task Oriented Approach, clinicians need assessment procedures providing information on the execution of multiple tasks. Instrumented task assessment can add information regarding sensory-motor strategies, difficult to assess purely by clinical observation. It has been shown that People with Multiple Sclerosis (PwMS) have difficulties in maintaining upright balance, but little is known about their ability to achieve a stable posture after the execution of tasks related to activities of daily living. The aim of the present study was to assess postural stabilization in a population of PwMS. METHODS: Twenty Healthy Subjects (HS) and twenty PwMS were assessed in three tasks leading to a quiet erect posture: sit-to-stand, taking a step forward, bending forward. Antero-posterior ground reaction force was measured by a force platform and interpolated by a model providing information on the initial instability after task execution (Transitional_Sway), the time required to dissipate this initial instability (Stabilization_Time), and their stability in quiet upright posture (Static_Sway). RESULTS: PwMS had statistically significant altered performance in comparison to HS: their instability after task execution (Transitional_Sway) was higher in bending and sit-to-stand (p < 0.05), their stabilization time (Stabilization_Time) was longer in bending and step forward (p < 0.05). Static_Sway was higher in all tasks (p < 0.05) indicating imbalance also in quiet upright posture.

A multiple-task gait analysis approach: kinematic, kinetic and EMG reference data for healthy young and adult subjects.

Standard clinical gait analysis protocols usually limit to test self-selected speed gait: this approach is generally valid and permits time and cost saving. Yet, the literature evidences suggest that some pathologies (especially at onset or subclinical level) may not primarily affect plain gait, but more demanding locomotor tasks. In the present study we therefore propose a multiple-task gait analysis protocol including: self-selected, increased and decreased speed gait; walking on toes; walking on heels; step ascending and step descending, and apply it to 40 healthy subjects (20 aged 6-17, 20 aged 22-72) thus building extensive reference data set. Published studies already report normative data for some of these tasks, but inhomogeneously (due to different collecting methods and biomechanical models, population characteristics, nature of data). We verify a good correlation between our results and those presented by Schwartz et al. (2008) [12] in their study providing extensive data on the effect of walking speed on the gait of healthy children. In discussing the results, the rationale and effectiveness of each task is confirmed, and we supply an electronic addendum with comprehensive kinematic, kinetic and electromyographic normative data for the considered population, along with a set of reference parameters and related statistical analysis, as a premise for further applications on pathological subjects.

An experimental paradigm to assess postural stabilization: no more movement and not yet posture.

A ground reaction based method is proposed to evaluate the hypothesis that a stabilization phase occurs in transitions towards erect posture, following the macroscopic movement and preceding the quiet final erect posture, whose aim is to control and dissipate the residual inertial unbalancing forces occurring at the transition end. The experimental protocol considers three tasks leading to the final erect posture: taking a step forward (F), sit-to-stand (S), and bending the trunk forward (B), The method mainly consists of the fitting of a negative exponential function on the instability time profile following the end of the transition movement. The model parameters Y(0), T, and Y(inf), respectively, quantify the initial instability rate, a time duration related to the stabilization, and the final asymptotic instability rate. Results from a sample of 40 adult able bodied subjects demonstrated that a postural stabilization phase actually occurs: Y(inf) is smaller (0.010, 0.010, and 0.008 m/s(2) for, respectively, F, S, and B tasks) than Y(0) (0.081, 0.137, and 0.057 m/s(2)). Tis in the order of seconds (0.95, 0.51, and 1.00 s). No trial with large values of both Y(0) and T was observed, evidencing that large initial instability rates are quickly controlled and reduced. The Y(0) and T parameters distribution are discussed according to the possible underlying active and/or passive stabilization mechanisms. The test-retest reliability overall figure (mean ICC 0.45 for 12 indexes) increased, when dropping the indexes related to the less reliable B task, to values (mean ICC 0.56 for eight indexes) comparable to published posturographic data.