Background: One of the main challenges after stroke is gait recovery. To provide patients with an individualized rehabilitation program, it is helpful to have real-life objective evaluations at baseline and at regular follow-ups to adjust the program and verify potential improvements. Objectives: To evaluate the accuracy and reliability of a fully stand-alone system of connected insoles (FeetMe® Monitor) against a widely used clinical walkway system (GAITRite®). Methods: Twenty-nine subjects with a stroke that occurred >6 months prior participated in the study. Their comfortable gait over three 8-m trials was evaluated by four raters, on Day 1 and Day 7, using simultaneously FeetMe® Monitor and GAITRite®. Velocity, stride length, cadence, stance, and swing duration were calculated on both sides over three sequences of gait: one single stride, 8 m, and three 8-m trials pooled. The Intra-class Correlation Coefficient (ICC) and the Bland-Altman plot evaluated the construct validity (inter-device) and the reliability (test-retest and inter-rater) of FeetMe® Monitor. Results: Through all gait analysis sequences, the inter-device ICCs were >0.95 for velocity, stride length, and cadence. Ranges of inter-device ICCs were [0.77-0.94] for stance duration for both limbs, and for swing duration [0.32-0.57] on the non-paretic side and [0.75-0.90] on the paretic side. Test-retest and inter-rater ICCs for all parameters were >0.73 for one single stride, >0.88 for 8-m trials and >0.94 for three 8-m trials. Conclusion: FeetMe® Monitor is an accurate and reliable system for measurement of gait velocity, stride length, cadence, and stance duration in chronic hemiparesis.

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.

Background Wearable technology provides an opportunity for new ways of monitoring patient gait remotely, through at-home self-administered six-minute walk tests (6MWTs). The purpose of this study was to evaluate the reliability and repeatability of FeetMe® insoles, a wearable gait assessment device, for measuring the six-minute walking distance (6MWD) during tests conducted independently at home by healthy volunteers. Methods Participants (n=21) performed two 6MWTs at home while wearing the FeetMe® insoles, and two 6MWTs at hospital while wearing FeetMe® insoles and being assessed by a rater. All assessments were performed with a one-week interval between tests, no assistance was provided to the participants at home. Results and conclusion The agreement between the 6MWD measurements made at baseline and at Week 1 was good for all test configurations and was highest for the at-home FeetMe® measurements, with an intraclass correlation coefficient (ICC) of 0.95, standard error of the measurement (SEM) of 15.02 m and coefficient of variation (CV) of 3.33%, compared to ICCs of 0.79 and 0.78, SEMs of 25.65 and 26.65 and CVs of 6.24% and 6.10% for the rater and FeetMe® measurements at hospital, respectively. Our work demonstrates that the FeetMe® system could provide a reliable solution allowing individuals to self-administer 6MWTs independently at home.

The six-minute walk test (6MWT) is widely used to assess functional capacity in patients with various diseases. Use of wearable devices can make this test more accurate and easier to administer, and may even enhance it by providing additional information. The purpose of this study was to evaluate the validity and reliability of FeetMe® insoles for assessing the total six-minute walking distance (6MWD) by comparing the FeetMe® estimates to those obtained by a rater and to the ground truth measured with a surveyor’s wheel. Data were analyzed from healthy volunteers who performed the 6MWT on 10-m and 30-m tracks while wearing FeetMe® insoles (n = 32), and being simultaneously assessed by a rater (n = 33) and followed by an investigator with a surveyor’s wheel. The mean average error (MAE) of the estimates was below 13 m on both tracks for FeetMe®, whereas it ranged from 16.24 m to 38.88 m on the 30-m and 10-m tracks for the rater. Thus, the FeetMe® insoles provided a more precise estimate than the rater, and the precision of the FeetMe® estimates did not vary according to the track length. We conclude that the FeetMe insoles are a reliable and accurate solution for measuring the 6MWD.

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