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Abstract Details

Study for the Validation of the FeetMe® Integrated Sensor Insole System Compared to GAITRite® System to Assess the Characteristics of the Gait in Patients with Multiple Sclerosis
Multiple Sclerosis
P14 - Poster Session 14 (8:00 AM-9:00 AM)
9-019
To determine statistical agreement and precision of gait velocity in multiple sclerosis (MS) patients, measured by a shoe insole device with integrated motion and pressure sensors (FeetMe®) vs reference system (GAITRite®), in 25FWT. 
The complete and objective gait assessment in MS patients is an unmet need, with important biases in the usual way of assessing gait disorder (NRL examination/EDSS). GAITRite® measures different visuospatial gait parameters; however, its use is very limited because of high price, time constraint, material problems, required space and human resources.
Observational, cross-sectional, prospective, single-centre study conducted between October-2018 and March-2019. Patients 18-55 years, with MS (McDonald-2010), EDSS 0–6.5 and relapse free ≥30 days at baseline. GAITRite®/FeetMe® devices used. Primary endpoint was gait velocity (cm/second) (velocity-1/velocity-2 formulas). Secondary endpoints included were ambulation time (seconds), gait cadence (steps/min) and stride length (cm), among others.
205 patients included (ITT population). At baseline, mean (SD) age was 41.5 (8.0) years, 66.8% women, 82.9% RRMS, EDSS 3.1 (2.0). Mean (SD) velocity-1 was 98.9 (35.9) for GAITRite®, 103.3 (32.3) FeetMe® with 0.83 intraclass coefficient correlation (ICC) and 0.84 Pearson correlation, while for velocity-2 were 98.6 (36.1) and 104.1 (33.2), respectively, with 0.87 ICC and 0.88 Pearson correlation. These results indicate a very strong agreement between devices on the same subjects. Mean (SD) ambulation time difference between devices was 0.1 (2.9). Cadence-1 and cadence-2 differences between devices were 0.04 (9.4) and -2.8 (9.3), respectively. Mean (SD) stride length difference was -7.0 (41.2). A high correlation was obtained between devices in velocity, ambulation time, cadence, and stride length.

Agreement between devices was almost perfect (ICC≥0.8). To our knowledge, this is the first validated medical device that would allow a portable monitoring of the gait of MS patients, being potentially able to assess disease activity, progression and treatment response.
Authors/Disclosures

PRESENTER 		No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
No disclosure on file
MARIA JOSE MORENO JIMENEZ No disclosure on file
Basilio Hernandez (GRIFOLS SA) No disclosure on file
Guillermo Izquierdo Ayuso, MD (Servicio De Neurologia) Dr. Izquierdo Ayuso has received personal compensation in the range of $500-$4,999 for serving as a Consultant for Bayer, Biogen Idec, Novartis, Sanofi, Merck Serono, Roche, Actelion and Celgene. Dr. Izquierdo Ayuso has received personal compensation in the range of $500-$4,999 for serving on a Scientific Advisory or Data Safety Monitoring board for Genzyme, Novartis, Sanofi Aventis, Alexion.