Is a Wearable Sensor-Based Characterisation of Gait Robust Enough to Overcome Differences Between Measurement Protocols? A Multi-Centric Pragmatic Study in Patients with Multiple Sclerosis.

Inertial measurement units (IMUs) allow accurate quantification of gait impairment of people with multiple sclerosis (pwMS). Nonetheless, it is not clear how IMU-based metrics might be influenced by pragmatic aspects associated with clinical translation of this approach, such as data collection settings and gait protocols. In this study, we hypothesised that these aspects do not significantly alter those characteristics of gait that are more related to quality and energetic efficiency and are quantifiable via acceleration related metrics, such as intensity, smoothness, stability, symmetry, and regularity. To test this hypothesis, we compared 33 IMU-based metrics extracted from data, retrospectively collected by two independent centres on two matched cohorts of pwMS. As a worst-case scenario, a walking test was performed in the two centres at a different speed along corridors of different lengths, using different IMU systems, which were also positioned differently. The results showed that the majority of the temporal metrics (9 out of 12) exhibited significant between-centre differences. Conversely, the between-centre differences in the gait quality metrics were small and comparable to those associated with a test-retest analysis under equivalent conditions. Therefore, the gait quality metrics are promising candidates for reliable multi-centric studies aiming at assessing rehabilitation interventions within a routine clinical context.

An observational study to assess validity and reliability of smartphone sensor-based gait and balance assessments in multiple sclerosis: Floodlight GaitLab protocol.

Background: Gait and balance impairments are often present in people with multiple sclerosis (PwMS) and have a significant impact on quality of life and independence. Gold-standard quantitative tools for assessing gait and balance such as motion capture systems and force plates usually require complex technical setups. Wearable sensors, including those integrated into smartphones, offer a more frequent, convenient, and minimally burdensome assessment of functional disability in a home environment. We developed a novel smartphone sensor-based application (Floodlight) that is being used in multiple research and clinical contexts, but a complete validation of this technology is still lacking. Methods: This protocol describes an observational study designed to evaluate the analytical and clinical validity of Floodlight gait and balance tests. Approximately 100 PwMS and 35 healthy controls will perform multiple gait and balance tasks in both laboratory-based and real-world environments in order to explore the following properties: (a) concurrent validity of the Floodlight gait and balance tests against gold-standard assessments; (b) reliability of Floodlight digital measures derived under different controlled gait and balance conditions, and different on-body sensor locations; (c) ecological validity of the tests; and (d) construct validity compared with clinician- and patient-reported assessments. Conclusions: The Floodlight GaitLab study (ISRCTN15993728) represents a critical step in the technical validation of Floodlight technology to measure gait and balance in PwMS, and will also allow the development of new test designs and algorithms.

A Multifactorial Model of Multiple Sclerosis Gait and Its Changes Across Different Disability Levels.

OBJECTIVE: Mobility assessment is critical in the clinical management of people with Multiple Sclerosis (pwMS). Instrumented gait analysis provides a plethora of metrics for quantifying concurrent factors contributing to gait deterioration. However, a gait model discriminating underlying features contributing to this deterioration is lacking in pwMS. This study aimed at developing and validating such a model. METHODS: The gait of 24 healthy controls and 114 pwMS with mild, moderate, or severe disability was measured with inertial sensors on the shanks and lower trunk while walking for 6 minutes along a hospital corridor. Twenty out of thirty-six initially explored metrics computed from the sensor data met the quality criteria for exploratory factor analysis. This analysis provided the sought model, which underwent a confirmatory factor analysis before being used to characterize gait impairment across the three disability groups. RESULTS: A gait model consisting of five domains (rhythm/variability, pace, asymmetry, and forward and lateral dynamic balance) was revealed by the factor analysis, which was able to highlight gait abnormalities across the disability groups: significant alterations in rhythm/variability-, asymmetry-, and pace-based features were present in the mild group, but these were more profound in the moderate and severe groups. Deterioration in dynamic balance-based features was only noted in pwMS with a moderate and severe disability. CONCLUSION: A conceptual model of gait for disease-specific mobility assessment in pwMS was successfully developed and tested. SIGNIFICANCE: The new model, built with metrics that represent gait impairment in pwMS, highlighted clinically relevant changes across different disability levels, including those with no clinically observable walking disability. This shows the clear potential as a monitoring biomarker in pwMS.

Wearable sensors can reliably quantify gait alterations associated with disability in people with progressive multiple sclerosis in a clinical setting.

Gait disability in people with progressive multiple sclerosis (MS) is difficult to quantify using existing clinical tools. This study aims to identify reliable and objective gait-based biomarkers to monitor progressive multiple sclerosis (MS) in clinical settings. During routine clinical visits, 57 people with secondary progressive MS and 24 healthy controls walked for 6 minutes wearing three inertial motion sensors. Fifteen gait measures were computed from the sensor data and tested for between-session reliability, for differences between controls and people with moderate and severe MS disability, and for correlation with Expanded Disability Status Scale (EDSS) scores. The majority of gait measures showed good to excellent between-session reliability when assessed in a subgroup of 23 healthy controls and 25 people with MS. These measures showed that people with MS walked with significantly longer step and stride durations, reduced step and stride regularity, and experienced difficulties in controlling and maintaining a stable walk when compared to controls. These abnormalities significantly increased in people with a higher level of disability and correlated with their EDSS scores. Reliable and objective gait-based biomarkers using wearable sensors have been identified. These biomarkers may allow clinicians to quantify clinically relevant alterations in gait in people with progressive MS within the context of regular clinical visits.

Effect of remote ischaemic preconditioning on walking in people with multiple sclerosis: double-blind randomised controlled trial.

BACKGROUND: Remote ischaemic preconditioning (RIPC) is the exposure of body parts to brief periods of circulatory occlusion and reperfusion. Recent studies have also shown that RIPC can improve exercise performance in healthy individuals. OBJECTIVE: This study aimed to assess the effect of RIPC on walking in people with multiple sclerosis (MS). METHODS: This was a double-blind randomised controlled clinical trial. We used three cycles of RIPC delivered by occluding the upper arm with a blood pressure (BP) cuff inflated to a pressure of 30 mm Hg above the systolic BP. In patients in the sham intervention group, the BP cuff was inflated only to 30 mm Hg below diastolic BP. Outcome measures included the Six-Minute Walk Test (6MWT), gait speed, the Borg rate of perceived exertion (RPE) scale, the tolerability of the RIPC using a Numerical Rating Scale for discomfort from 0 to 10, and adverse events. We identified responders meeting the minimal clinically important difference (MCID) established in the literature in each group. RESULTS: Seventy-five participants completed the study (RIPC: 38 and Sham: 37). The distance walked during the 6MWT improved by 1.9% in the sham group and 5.7% in the RIPC group (p=0.012). The number of responders meeting MCID criteria in the RIPC group was significantly greater compared with the sham intervention group. No serious adverse events occurred. CONCLUSION: Single cycle of RIPC resulted in immediate improvement in walking distances during 6MWT in people with MS. TRIAL REGISTRATION NUMBERS: NCT03153553.

Effect of arm swinging on lumbar spine and hip joint forces.

During level walking, arm swing plays a key role in improving dynamic stability. In vivo investigations with a telemeterized vertebral body replacement showed that spinal loads can be affected by differences in arm positions during sitting and standing. However, little is known about how arm swing could influence the lumbar spine and hip joint forces and motions during walking. The present study aims to provide better understanding of the contribution of the upper limbs to human gait, investigating ranges of motion and joint reaction forces. A three-dimensional motion analysis was carried out via a motion capturing system on six healthy males and five patients with hip instrumented implant. Each subject performed walking with different arm swing amplitudes (small, normal, and large) and arm positions (bound to the body, and folded across the chest). The motion data were imported in a commercial musculoskeletal analysis software for kinematic and inverse dynamic investigation. The range of motion of the thorax with respect to the pelvis and of the pelvis with respect to the ground in the transversal plane were significantly associated with arm position and swing amplitude during gait. The hip external-internal rotation range of motion statistically varied only for non-dominant limb. Unlike hip joint reaction forces, predicted peak spinal loads at T12-L1 and L5-S1 showed significant differences at approximately the time of contralateral toe off and contralateral heel strike. Therefore, arm position and swing amplitude have a relevant effect on kinematic variables and spinal loads, but not on hip loads during walking.

Spinal loads and trunk muscles forces during level walking - A combined in vivo and in silico study on six subjects.

During level walking, lumbar spine is subjected to cyclic movements and intricate loading of the spinal discs and trunk musculature. This study aimed to estimate the spinal loads (T12-S1) and trunk muscles forces during a complete gait cycle. Six men, 24-33years walk barefoot at self-selected speed (4-5km/h). 3D kinematics and ground reaction forces were recorded using a motion capturing system and two force plates, implemented in an inverse dynamic musculoskeletal model to predict the spinal loads and trunk muscles forces. Additionally, the sensitivity of the intra-abdominal pressure and lumbar segment rotational stiffness was investigated. Peak spinal loads and trunk muscle forces were between the gait instances of heel strike and toe off. In L4-L5 segment, sensitivity analysis showed that average peak compressive, antero-posterior and medio-lateral shear forces were 130-179%, 2-15% and 1-6%, with max standard deviation (±STD) of 40%, 6% and 3% of the body weight. Average peak global muscles forces were 24-55% (longissimus thoracis), 11-23% (iliocostalis thoracis), 12-16% (external oblique), 17-25% (internal oblique) and 0-8% (rectus abdominus) of body weight whereas, the average peak local muscles forces were 11-19% (longissimus lumborum), 14-31% (iliocostalis lumborum) and 12-17% (multifidus). Maximum±STD of the global and local muscles forces were 13% and 8% of the body weight. Large inter-individual differences were found in peak compressive and trunk muscles forces whereas the sensitivity analysis also showed a substantial variation.

A comparative study on the mechanical behavior of polyurethane PICCs.

PURPOSE: This study describes a comparative analysis of eight commercial polyurethane, single-lumen peripherally inserted central venous catheters (PICCs) from different vendors. The aim was to investigate the mechanical response of the catheters providing objective and quantitative data to support a comparison among them. Such data could help nurses and physicians to select a central venous catheter (CVC) not only on the basis of the expected dwell duration or of the assessment of the vessels at the desired insertion site but also of the chemical and mechanical properties of the CVC and of the projected response of the body to these properties. METHODS: An experimental procedure was defined and tests were performed to assess some main characteristics of the PICC lines, including macro and microgeometric features, chemical and physical properties, and mechanical response. Preliminary measurements were performed to accurately define all geometric characteristics, including length, inner and outer diameters, and any inherent initial curvature of the catheter. Micro-geometric features were investigated using surface roughness analysis, optical microscopy, and scanning electron microscopy. Mechanical properties were studied by means of dynamic mechanical thermal analysis, simple uniaxial tensile tests, and kinking tests. RESULTS: Results are discussed in order to compare the different PICC lines. In particular, they show that polyurethane catheters can have a different mechanical behavior, which might play a role in the onset of pathologic processes and result in an increased risk and incidence of catheter-related complications. CONCLUSIONS: This study provides useful information that can help identifying and facilitate the choice of a PICC.