Evaluation of the Validity and Reliability of Connected Insoles to Measure Gait Parameters in Healthy Adults

Damien Jacobs, Leila Farid, Sabine Ferré, Kilian Herraez, Jean-Michel Gracies, Emilie Hutin, Damien Jacobs, Leila Farid, Sabine Ferré, Kilian Herraez, Jean-Michel Gracies, Emilie Hutin

Abstract

The continuous, accurate and reliable estimation of gait parameters as a measure of mobility is essential to assess the loss of functional capacity related to the progression of disease. Connected insoles are suitable wearable devices which allow precise, continuous, remote and passive gait assessment. The data of 25 healthy volunteers aged 20 to 77 years were analysed in the study to validate gait parameters (stride length, velocity, stance, swing, step and single support durations and cadence) measured by FeetMe® insoles against the GAITRite® mat reference. The mean values and the values of variability were calculated per subject for GAITRite® and insoles. A t-test and Levene's test were used to compare the gait parameters for means and variances, respectively, obtained for both devices. Additionally, measures of bias, standard deviation of differences, Pearson's correlation and intraclass correlation were analysed to explore overall agreement between the two devices. No significant differences in mean and variance between the two devices were detected. Pearson's correlation coefficients of averaged gait estimates were higher than 0.98 and 0.8, respectively, for unipedal and bipedal gait parameters, supporting a high level of agreement between the two devices. The connected insoles are therefore a device equivalent to GAITRite® to estimate the mean and variability of gait parameters.

Keywords: FeetMe®; GAITRite®; IMU; gait; gait variability; insoles; pressure sensor; validation.

Conflict of interest statement

We wish to draw the attention of the Editor to the following facts: FeetMe® was a partner in this study with the following interests during the study: Damien Jacobs, Leila Farid and Sabine Ferré were employees of the FeetMe company, Kilian Herraez was an intern at FeetMe and Emilie Hutin received consultancy fees from FeetMe, which may be considered as potential conflicts of interest, and FeetMe provided significant financial contributions to this work. Gracies reports no disclosures and no link of interest with the FeetMe company. We confirm that the manuscript has been read and approved by all named authors and that there are no other persons who satisfied the criteria for authorship but are not listed. We further confirm that the order of authors listed in the manuscript has been approved by all of us.

Figures

Figure A1
Figure A1
FeetMe® Monitor solution includes the insoles, and the mobile application to collect data and to transfer to the web platform. The web platform shows the gait parameters and the pressure measurements.
Figure 1
Figure 1
Detection of HS and TO events by the insoles and GAITRite®.
Figure 2
Figure 2
Bland–Altman plots of insole-based parameters including HS, TO and stride length. The solid line is the bias, and the dashed lines are the lower and upper limits of the 95th CI of differences.
Figure 3
Figure 3
Linear regression of average estimates of unipedal gait parameters for velocity, stride length, stance and swing duration and cadence between GAITRite® mat and the insoles (solid lines). The dashed lines represent the confidence region. The values of the slope and the coefficient of determination, r², are provided in the legends.
Figure 4
Figure 4
Linear regression of estimates of variability (coefficient of variation) of unipedal gait parameters for velocity, stride length, stance and swing duration and cadence between GAITRite® mat and the insoles (solid lines). The dashed lines represent the confidence region. The values of the slope and the coefficient of determination, r², are provided in the legends.
Figure 5
Figure 5
Linear regression of average estimates and estimates of variability of bipedal gait parameters with step duration and single support duration between GAITRite® mat and the insoles (solid lines). The dashed lines represent the confidence region. The values of the slope and the coefficient of determination, r², are provided in the legends.

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