A multi-sensor wearable system for the assessment of diseased gait in real-world conditions.

Introduction: Accurately assessing people's gait, especially in real-world conditions and in case of impaired mobility, is still a challenge due to intrinsic and extrinsic factors resulting in gait complexity. To improve the estimation of gait-related digital mobility outcomes (DMOs) in real-world scenarios, this study presents a wearable multi-sensor system (INDIP), integrating complementary sensing approaches (two plantar pressure insoles, three inertial units and two distance sensors). Methods: The INDIP technical validity was assessed against stereophotogrammetry during a laboratory experimental protocol comprising structured tests (including continuous curvilinear and rectilinear walking and steps) and a simulation of daily-life activities (including intermittent gait and short walking bouts). To evaluate its performance on various gait patterns, data were collected on 128 participants from seven cohorts: healthy young and older adults, patients with Parkinson's disease, multiple sclerosis, chronic obstructive pulmonary disease, congestive heart failure, and proximal femur fracture. Moreover, INDIP usability was evaluated by recording 2.5-h of real-world unsupervised activity. Results and discussion: Excellent absolute agreement (ICC >0.95) and very limited mean absolute errors were observed for all cohorts and digital mobility outcomes (cadence ≤0.61 steps/min, stride length ≤0.02 m, walking speed ≤0.02 m/s) in the structured tests. Larger, but limited, errors were observed during the daily-life simulation (cadence 2.72-4.87 steps/min, stride length 0.04-0.06 m, walking speed 0.03-0.05 m/s). Neither major technical nor usability issues were declared during the 2.5-h acquisitions. Therefore, the INDIP system can be considered a valid and feasible solution to collect reference data for analyzing gait in real-world conditions.

Connecting real-world digital mobility assessment to clinical outcomes for regulatory and clinical endorsement-the Mobilise-D study protocol.

BACKGROUND: The development of optimal strategies to treat impaired mobility related to ageing and chronic disease requires better ways to detect and measure it. Digital health technology, including body worn sensors, has the potential to directly and accurately capture real-world mobility. Mobilise-D consists of 34 partners from 13 countries who are working together to jointly develop and implement a digital mobility assessment solution to demonstrate that real-world digital mobility outcomes have the potential to provide a better, safer, and quicker way to assess, monitor, and predict the efficacy of new interventions on impaired mobility. The overarching objective of the study is to establish the clinical validity of digital outcomes in patient populations impacted by mobility challenges, and to support engagement with regulatory and health technology agencies towards acceptance of digital mobility assessment in regulatory and health technology assessment decisions. METHODS/DESIGN: The Mobilise-D clinical validation study is a longitudinal observational cohort study that will recruit 2400 participants from four clinical cohorts. The populations of the Innovative Medicine Initiative-Joint Undertaking represent neurodegenerative conditions (Parkinson's Disease), respiratory disease (Chronic Obstructive Pulmonary Disease), neuro-inflammatory disorder (Multiple Sclerosis), fall-related injuries, osteoporosis, sarcopenia, and frailty (Proximal Femoral Fracture). In total, 17 clinical sites in ten countries will recruit participants who will be evaluated every six months over a period of two years. A wide range of core and cohort specific outcome measures will be collected, spanning patient-reported, observer-reported, and clinician-reported outcomes as well as performance-based outcomes (physical measures and cognitive/mental measures). Daily-living mobility and physical capacity will be assessed directly using a wearable device. These four clinical cohorts were chosen to obtain generalizable clinical findings, including diverse clinical, cultural, geographical, and age representation. The disease cohorts include a broad and heterogeneous range of subject characteristics with varying chronic care needs, and represent different trajectories of mobility disability. DISCUSSION: The results of Mobilise-D will provide longitudinal data on the use of digital mobility outcomes to identify, stratify, and monitor disability. This will support the development of widespread, cost-effective access to optimal clinical mobility management through personalised healthcare. Further, Mobilise-D will provide evidence-based, direct measures which can be endorsed by regulatory agencies and health technology assessment bodies to quantify the impact of disease-modifying interventions on mobility. TRIAL REGISTRATION: ISRCTN12051706.

An Objective Methodology for the Selection of a Device for Continuous Mobility Assessment.

Continuous monitoring by wearable technology is ideal for quantifying mobility outcomes in "real-world" conditions. Concurrent factors such as validity, usability, and acceptability of such technology need to be accounted for when choosing a monitoring device. This study proposes a bespoke methodology focused on defining a decision matrix to allow for effective decision making. A weighting system based on responses (n = 69) from a purpose-built questionnaire circulated within the IMI Mobilise-D consortium and its external collaborators was established, accounting for respondents' background and level of expertise in using wearables in clinical practice. Four domains (concurrent validity, CV; human factors, HF; wearability and usability, WU; and data capture process, CP), associated evaluation criteria, and scores were established through literature research and group discussions. While the CV was perceived as the most relevant domain (37%), the others were also considered highly relevant (WU: 30%, HF: 17%, CP: 16%). Respondents (~90%) preferred a hidden fixation and identified the lower back as an ideal sensor location for mobility outcomes. Overall, this study provides a novel, holistic, objective, as well as a standardized approach accounting for complementary aspects that should be considered by professionals and researchers when selecting a solution for continuous mobility monitoring.

Developing a toolkit for the assessment and monitoring of musculoskeletal ageing.

The complexities and heterogeneity of the ageing process have slowed the development of consensus on appropriate biomarkers of healthy ageing. The Medical Research Council-Arthritis Research UK Centre for Integrated research into Musculoskeletal Ageing (CIMA) is a collaboration between researchers and clinicians at the Universities of Liverpool, Sheffield and Newcastle. One of CIMA's objectives is to 'Identify and share optimal techniques and approaches to monitor age-related changes in all musculoskeletal tissues, and to provide an integrated assessment of musculoskeletal function'-in other words to develop a toolkit for assessing musculoskeletal ageing. This toolkit is envisaged as an instrument that can be used to characterise and quantify musculoskeletal function during 'normal' ageing, lend itself to use in large-scale, internationally important cohorts, and provide a set of biomarker outcome measures for epidemiological and intervention studies designed to enhance healthy musculoskeletal ageing. Such potential biomarkers include: biochemical measurements in biofluids or tissue samples, in vivo measurements of body composition, imaging of structural and physical properties, and functional tests. This review assesses candidate biomarkers of musculoskeletal ageing under these four headings, details their biological bases, strengths and limitations, and makes practical recommendations for their use. In addition, we identify gaps in the evidence base and priorities for further research on biomarkers of musculoskeletal ageing.

A comfort assessment of existing cervical orthoses.

PURPOSE: Identify location and intensity of discomfort experienced by healthy participants wearing cervical orthoses. METHOD: Convenience sample of 34 healthy participants wore Stro II, Philadelphia, Headmaster, and AspenVista® cervical orthoses for four-hour periods. Participants reported discomfort level (scale 0-6) and location. RESULTS: Participants reported mean discomfort for all orthoses over the four-hour test between 'a little discomfort' and 'very uncomfortable' (mean discomfort score = 1.64, SD = 1.50). Seven participants prematurely stopped tests due to pain and six reported maximum discomfort scores. Significant linear increase in discomfort with duration of wear was found for all orthoses. Significantly less discomfort was reported with Stro II than Headmaster and Philadelphia. Age correlated with greater perceived discomfort. Orthoses differed in the location discomfort was experienced. CONCLUSION: Existing cervical orthoses cause discomfort influenced by design and duration of wear with orthoses' design the more significant factor. This work informed the design of a new orthosis and future orthoses developments. Practitioner Summary: The purpose of this study was to gain greater knowledge about the discomfort caused by wearing of existing neck orthoses in order to inform the design and development of a new neck orthosis. This study gathers empirical data from a surrogate population and concludes that orthosis design is more influential than the duration of wear.

Moving from laboratory to real life conditions: Influence on the assessment of variability and stability of gait.

The availability of wearable sensors allows shifting gait analysis from the traditional laboratory settings, to daily life conditions. However, limited knowledge is available about whether alterations associated to different testing environment (e.g. indoor or outdoor) and walking protocols (e.g. free or controlled), result from actual differences in the motor behaviour of the tested subjects or from the sensitivity to these changes of the indexes adopted for the assessment. In this context, it was hypothesized that testing environment and walking protocols would not modify motor control stability in the gait of young healthy adults, who have a mature and structured gait pattern, but rather the variability of their motor pattern. To test this hypothesis, data from trunk and shank inertial sensors were collected from 19 young healthy participants during four walking tasks in different environments (indoor and outdoor) and in both controlled (i.e. following a predefined straight path) and free conditions. Results confirmed what hypothesized: variability indexes (Standard deviation, Coefficient of variation and Poincaré plots) were significantly influenced by both environment and walking conditions. Stability indexes (Harmonic ratio, Short term Lyapunov exponents, Recurrence quantification analysis and Sample entropy), on the contrary, did not highlight any change in the motor control. In conclusion, this study highlighted an influence of environment and testing condition on the assessment of specific characteristics of gait (i.e. variability and stability). In particular, for young healthy adults, both environment and testing conditions affect gait variability indexes, whereas neither affect gait stability indexes.

Reliability of inertial sensors in the assessment of patients with vestibular disorders: a feasibility study.

BACKGROUND: Vestibular disorders affect an individual's stability, balance, and gait and predispose them to falls. Traditional laboratory-based semi-objective vestibular assessments are intrusive and cumbersome provide little information about their functional ability. Commercially available wearable inertial sensors allow us to make this real life assessments objective, with a detailed view of their functional abilities. Timed Up and Go (TUG) and Postural Sway tests are commonly used tests for gait and balance assessments. Our aim was to assess the feasibility, test-retest reliability and ability to classify fall status in individuals with vestibular disorders using parameters derived from the commercially available wearable system (inertial sensors and the Mobility Lab Software, APDM, Inc.). METHODS: We recruited 27 individuals diagnosed either with unilateral or bilateral vestibular loss on vestibular function testing. Instrumented Timed Up and Go (iTUG) and Postural Sway (iSway) were administered three times during the first session and then repeated at a similar time the following week. To evaluate within and between sessions reliability of the parameters the Intra-Class Correlation coefficient (ICC) was used. Subsequently, the ability of reliable parameters (ICC ≥ 0.8) to classify fallers from non-fallers was estimated. RESULTS: The iTUG test parameters showed good within and between sessions' reliability with mean ICC (between-sessions) values of 0.81 ± 0.17 and 0.69 ± 0.15, respectively. For the iSway test, the relative figures were; 0.76 ± 0.13 and 0.71 ± 0.14, respectively. A retrospective falls classification analysis with past 12 months falls history data yielded an accuracy of 66.70% with an area under the curve of 0.79. Mean Distance from centre of COP (mm) of accelerometer's trajectory (m/s2) from the iSway test was the only significant parameter to classify fallers from non-fallers. CONCLUSIONS: Using a commercially available wearable system a subset of reliable iTUG and iSway parameters were identified and their ability to classify fallers were estimated. These parameters have potential to augment assessments of vestibular patients to enable clinicians and therapists to provide objective, tailored, personalised interventions for their gait and postural control and also to objectively evaluate and monitor the efficiency of their interventions.

To what extent is joint and muscle mechanics predicted by musculoskeletal models sensitive to soft tissue artefacts?

Musculoskeletal models are widely used to estimate joint kinematics, intersegmental loads, and muscle and joint contact forces during movement. These estimates can be heavily affected by the soft tissue artefact (STA) when input positional data are obtained using stereophotogrammetry, but this aspect has not yet been fully characterised for muscle and joint forces. This study aims to assess the sensitivity to the STA of three open-source musculoskeletal models, implemented in OpenSim. A baseline dataset of marker trajectories was created for each model from experimental data of one healthy volunteer. Five hundred STA realizations were then statistically generated using a marker-dependent model of the pelvis and lower limb artefact and added to the baseline data. The STA׳s impact on the musculoskeletal model estimates was finally quantified using a Monte Carlo analysis. The modelled STA distributions were in line with the literature. Observed output variations were comparable across the three models, and sensitivity to the STA was evident for most investigated quantities. Shape, magnitude and timing of the joint angle and moment time histories were not significantly affected throughout the entire gait cycle, whereas magnitude variations were observed for muscle and joint forces. Ranges of contact force variations differed between joints, with hip variations up to 1.8 times body weight observed. Variations of more than 30% were observed for some of the muscle forces. In conclusion, musculoskeletal simulations using stereophotogrammetry may be safely run when only interested in overall output patterns. Caution should be paid when more accurate estimated values are needed.

Assessment of the Sheffield Support Snood, an innovative cervical orthosis designed for people affected by neck muscle weakness.

BACKGROUND: This study aimed at quantifying the biomechanical features of the Sheffield Support Snood, a cervical orthosis specifically designed for patients with neck muscle weakness. The orthosis is designed to be adaptable to a patient's level of functional limitation using adjustable removable supports, which contribute support and restrict movement only in desired anatomical planes. METHODS: The snood was evaluated along with two commercially available orthoses, the Vista and Headmaster, in a series of flexion, extension, axial-rotation and lateral flexion movements. Characterization was performed with twelve healthy participants with and without the orthoses. Two inertial-magneto sensors, placed on the forehead and sternum, were used to quantify the neck's range of motion. FINDINGS: In its less supportive configuration, the snood was effective in limiting movements to the desired planes, preserving free movement in other planes. The Headmaster was only effective in limiting flexion. The range of motion achieved with the snood in its rigid configuration was equivalent (P>0.05, effect size<0.4) to that achieved with the Vista, both in trials performed reaching the maximum amplitude (range of motion reduction: 25%-34% vs 24%-47%) and at maximum speed (range of motion reduction: 24%-29% vs 25%-43%). INTERPRETATION: The Sheffield Support Snood is effectively adaptable to different tasks and, in its most supportive configuration, offers a support comparable to the Vista, but providing a less bulky structure. The chosen method is suitable for the assessment of range of motions while wearing neck orthoses and is easily translatable in a clinical context.

Attenuation of Upper Body Accelerations during Gait: Piloting an Innovative Assessment Tool for Parkinson's Disease.

The objective of the current investigation was to explore whether upper body accelerations obtained during gait provide sensitive measures of postural control in people with Parkinson's disease (PD). Thirteen people with PD (70 ± 11 years) and nineteen age-matched controls (70 ± 7 years) walked continuously for two minutes while wearing three inertial sensors located on their lower back (L5), shoulder level (C7), and head. Magnitude (root mean square (RMS)), attenuation (attenuation coefficient), and smoothness (Harmonic ratios, HR) of the accelerations were calculated. People with PD demonstrated greater RMS, particularly in the mediolateral direction, but similar harmonic ratio of head accelerations compared to controls. In addition, they did not attenuate accelerations through the trunk and neck as well as control participants. Our findings indicate that measuring upper body movement provides unique information regarding postural control in PD and that poor attenuation of acceleration from the pelvis to the head contributes to impaired head control. This information is simple to measure and appears to be sensitive to PD and, consequently, is proposed to benefit researchers and clinicians.

Reliability of gait variability assessment in older individuals during a six-minute walk test.

Gait variability is an important indicator of gait performance. However, the reliability of the parameters used for its quantification, obtained from trunk linear accelerations, has still not been thoroughly investigated. The aim of this study is to assess the reliability of gait variability assessment in healthy older individuals based on lower trunk accelerations during a six-minute walk test and to examine the reliability of the data acquired in shorter periods. Twenty-nine subjects (84±5 years) performed the test while wearing one inertial sensor on the lower trunk. Gait variability parameters (standard deviation and coefficient of variation of the stride duration, and correlation coefficients of accelerations between neighbouring strides) were calculated from the accelerations over 35 rectilinear strides observed during six series of one-minute intervals extracted from the original signal. The reliability of these parameters was assessed using intraclass correlation coefficients (ICC). Results showed no significant changes across the six series for any of the parameters, with very high ICC values (0.93-0.95), indicating a strong reliability of the observed quantities. Therefore, gait variability analysis based on lower trunk acceleration data is a reliable and informative quantity in gait performance assessment in older individuals, and 1min interval is sufficient to ensure reliable results.

Assessment of level-walking aperiodicity.

BACKGROUND: In gait analysis, walking is assumed to be periodic for the sake of simplicity, despite the fact that, strictly speaking, it can only approximate periodicity and, as such, may be referred to as pseudo-periodic. This study aims at: 1) quantifying gait pseudo-periodicity using information concerning a single stride; 2) investigating the effects of walking pathway length on gait periodicity; 3) investigating separately the periodicity of the upper and lower body parts movement; 4) verifying the validity of foot-floor contact events as markers of the gait cycle period. METHODS: Ten young healthy subjects (6 males, 23 +/- 5 years) were asked to perform various gait trials, first along a 20-m pathway that allowed reaching a steady-state condition, and then along an 8-m pathway. A stereophotogrammetric system was used to reconstruct the 3D position of reflective markers distributed over the subjects' body. Foot contact was detected using an instrumented mat. Three marker clusters were used to represent the movement of the whole body, the upper body (without upper limbs), and the lower body, respectively. Linear and rotational kinetic, and gravitational and elastic potential "energy-like" quantities were used to calculate an index J(t) that described the instantaneous "mechanical state" of the analysed body portion. The variations of J(t) in time allowed for the determination of the walking pseudo-period and for the assessment of gait aperiodicity. RESULTS: The suitability of the proposed approach was demonstrated, and it was shown that, for young, healthy adults, a threshold of physiological pseudo-periodicity of walking at natural speed could be set. Higher pseudo-periodicity values were found for the shorter pathway only for the upper body. Irrespective of pathway length, the upper body had a larger divergency from periodicity than the lower body. The error that can be made in estimating the gait cycle duration for the upper body from the heel contacts was shown to be significant. CONCLUSION: The proposed method can be easily implemented in gait laboratories to verify the consistency of a recorded stride with the hypothesis of periodicity.

Biomechanic modeling of sit-to-stand to upright posture for mobility assessment of persons with chronic stroke.

OBJECTIVE: To test the suitability of using biomechanic measures associated with a minimum measured input model (MMIM) approach to assess mobility of people with chronic stroke during the execution of a sit-to-stand (STS) to upright posture motor task. DESIGN: Single group, observational. SETTING: Institutional settings in the United States and Italy. PARTICIPANTS: Twenty-nine subjects with chronic unilateral lower-limb impairments and resultant mobility limitations secondary to stroke. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Manual measurement of lower-limb strength; performance-based tests including repeated chair standing, walking speed, and standing balance; and ground reactions measured with a force platform during STS and upright posture. The ground reactions were fed to a telescopic inverted pendulum model of the musculoskeletal system. Parameters representing the model outputs were compared with performance-based and strength measures to assess, respectively, motor ability and impairment-related changes in subjects' motor strategies. RESULTS: The parameters derived from the model effectively differentiated between motor strategies associated with different performance-based scores, and allowed the identification of relevant difficulties encountered in STS execution. These difficulties could be associated with different strength scores. This was also true for subjects scoring the maximum in both performance-based and strength tests. CONCLUSIONS: The MMIM is a relatively inexpensive and noninvasive approach that enhances mobility assessment of hemiparetic subjects with different motor ability levels. It provides information that correlates well with performance-based and strength scores and, in addition, it allows for subject-specific motor strategy identification.

Sequencing sit-to-stand and upright posture for mobility limitation assessment: determination of the timing of the task phases from force platform data.

The identification of quantitative tools to assess an individual's mobility limitation is a complex and challenging task. Several motor tasks have been designated as potential indicators of mobility limitation. In this study, a multiple motor task obtained by sequencing sit-to-stand and upright posture was used. Algorithms based on data obtained exclusively from a single force platform were developed to detect the timing of the motor task phases (sit-to-stand, preparation to the upright posture and upright posture). To test these algorithms, an experimental protocol inducing predictable changes in the acquired signals was designed. Twenty-two young, able-bodied subjects performed the task in four different conditions: self-selected natural and high speed with feet kept together, and self-selected natural and high speed with feet pelvis-width apart. The proposed algorithms effectively detected the timing of the task phases, the duration of which was sensitive to the four different experimental conditions. As expected, the duration of the sit-to-stand was sensitive to the speed of the task and not to the foot position, while the duration of the preparation to the upright posture was sensitive to foot position but not to speed. In addition to providing a simple and effective description of the execution of the motor task, the correct timing of the studied multiple task could facilitate the accurate determination of variables descriptive of the single isolated phases, allowing for a more thorough description of the motor task and therefore could contribute to the development of effective quantitative functional evaluation tests.