Supplementary Material for: Assessment of Postural Sway in Individuals with Multiple Sclerosis Using a Novel Wearable Inertial Sensor

Balance impairment is common in individuals with multiple sclerosis (MS). However, objective assessment of balance usually requires clinical expertise and/or the use of expensive and obtrusive measuring equipment. These barriers to the objective assessment of balance may be overcome with the development of a lightweight inertial sensor system. In this study, we examined the concurrent validity of a novel wireless, skin-mounted inertial sensor system (BioStamp®, MC10 Inc.) to measure postural sway in individuals with MS by comparing measurement agreement between this novel sensor and gold standard measurement tools (force plate and externally validated inertial sensor). A total of 39 individuals with MS and 15 healthy controls participated in the study. Participants with MS were divided into groups based on the amount of impairment (MS_Mild: EDSS 2–4, <i>n</i> = 19; MS_Severe: EDSS ≥6, <i>n</i> = 20). The balance assessment consisted of two 30-s quiet standing trials in each of three conditions: eyes open/firm surface, eyes closed/firm surface, and eyes open/foam surface. For each trial, postural sway was recorded with a force plate (Bertec) and simultaneously using two accelerometers (BioStamp and Xsens) mounted on the participant’s posterior trunk at L5. Sway metrics (sway area, sway path length, root mean square amplitude, mean velocity, JERK, and total power) were derived to compare the measurement agreement among the measurement devices. Excellent agreement (intraclass correlation coefficients >0.9) between sway metrics derived from the BioStamp and the MTx sensors were observed across all conditions and groups. Good to excellent correlations (<i>r</i> >0.7) between devices were observed in all sway metrics and conditions. Additionally, the acceleration sway metrics were nearly as effective as the force plate sway metrics in differentiating individuals with poor balance from healthy controls. Overall, the BioStamp sensor is a valid and objective measurement tool for postural sway assessment. This novel, lightweight and portable sensor may offer unique advantages in tracking patient’s postural performance

Supplementary Material for: Use of Mobile Devices to Measure Outcomes in Clinical Research, 2010–2016: A Systematic Literature Review

<b><i>Background:</i></b> The use of mobile devices in clinical research has advanced substantially in recent years due to the rapid pace of technology development. With an overall aim of informing the future use of mobile devices in interventional clinical research to measure primary outcomes, we conducted a systematic review of the use of and clinical outcomes measured by mobile devices (mobile outcomes) in observational and interventional clinical research. <b><i>Method:</i></b> We conducted a PubMed search using a range of search terms to retrieve peer-reviewed articles on clinical research published between January 2010 and May 2016 in which mobile devices were used to measure study outcomes. We screened each publication for specific inclusion and exclusion criteria. We then identified and qualitatively summarized the use of mobile outcome assessments in clinical research, including the type and design of the study, therapeutic focus, type of mobile device(s) used, and specific mobile outcomes reported. <b><i>Results:</i></b> The search retrieved 2,530 potential articles of interest. After screening, 88 publications remained. Twenty-five percent of the publications (<i>n</i> = 22) described mobile outcomes used in interventional research, and the rest (<i>n</i> = 66) described observational clinical research. Thirteen therapeutic areas were represented. Five categories of mobile devices were identified: (1) inertial sensors, (2) biosensors, (3) pressure sensors and walkways, (4) medication adherence monitors, and (5) location monitors; inertial sensors/accelerometers were most common (reported in 86% of the publications). Among the variety of mobile outcomes, various assessments of physical activity were most common (reported in 74% of the publications). Other mobile outcomes included assessments of sleep, mobility, and pill adherence, as well as biomarkers assessed using a mobile device, including cardiac measures, glucose, gastric reflux, respiratory measures, and intensity of head-related injury. <b><i>Conclusion:</i></b> Mobile devices are being widely used in clinical research to assess outcomes, although their use in interventional research to assess therapeutic effectiveness is limited. For mobile devices to be used more frequently in pivotal interventional research – such as trials informing regulatory decision-making – more focus should be placed on: (1) consolidating the evidence supporting the clinical meaningfulness of specific mobile outcomes, and (2) standardizing the use of mobile devices in clinical research to measure specific mobile outcomes (e.g., data capture frequencies, placement of device). To that aim, this manuscript offers a broad overview of the various mobile outcome assessments currently used in observational and interventional research, and categorizes and consolidates this information for researchers interested in using mobile devices to assess outcomes in interventional research