Study for the validation of the FeetMe® integrated sensor insole system compared to GAITRite® system to assess gait characteristics in patients with multiple sclerosis

To determine the concordance and statistical precision in gait velocity in people with multiple sclerosis (pwMS), measured with FeetMe® (insoles with pressure and motion sensors) compared with GAITRite® (classic reference system of gait analysis) in the timed 25-Feet Walk test (T25WT). This observat...

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Vydáno v:PloS one Ročník 18; číslo 2; s. e0272596
Hlavní autoři: Granja Domínguez, Anabel, Romero Sevilla, Raúl, Alemán, Aurora, Durán, Carmen, Hochsprung, Anja, Navarro, Guillermo, Páramo, Cristina, Venegas, Ana, Lladonosa, Ana, Ayuso, Guillermo Izquierdo
Médium: Journal Article
Jazyk:angličtina
Vydáno: United States Public Library of Science 2023
Public Library of Science (PLoS)
Témata:
Accelerometers
Autoimmune diseases
Biology and Life Sciences
Clinical medicine
Correlation
Correlation coefficient
Correlation coefficients
Cross-Sectional Studies
Engineering and Technology
Female
Gait
Humans
Insoles
Male
Medicine and Health Sciences
Motion sensors
Multiple sclerosis
Multiple Sclerosis - complications
Patients
Physical Sciences
Population
Prospective Studies
Reference systems
Sensors
Social Sciences
Statistical analysis
Topography
Velocity
Walking
Spain
ISSN:1932-6203, 1932-6203
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Popis
Shrnutí:To determine the concordance and statistical precision in gait velocity in people with multiple sclerosis (pwMS), measured with FeetMe® (insoles with pressure and motion sensors) compared with GAITRite® (classic reference system of gait analysis) in the timed 25-Feet Walk test (T25WT). This observational, cross-sectional, prospective, single center study was conducted between September-2018 and April-2019 in pwMS aged 18-55 years, with Expanded Disability Status Scale (EDSS) 0-6.5 and relapse free ≥30 days at baseline. Primary endpoint was gait velocity. Secondary endpoints were ambulation time, cadence, and stride length assessment, while the correlation between gait variables and the clinical parameters of MS subjects was assessed as an exploratory endpoint. A total of 207 MS subjects were enrolled, of whom, 205 were considered in primary analysis. Most subjects were women (66.8%) and had relapsing-remitting MS (RRMS) (82.9%), with overall mean (standard deviation [SD]) age of 41.5 (8.0) year and EDSS 3.1 (2.0). There was a statistically significant (p<0.0001) and strong agreement (intra-class correlation coefficient (ICC) >0.830) in gait velocity, ambulation time and cadence assessment between FeetMe® and GAITRite®. Agreement between devices was strong (ICC≥0.800). FeetMe® is the first validated wearable medical device that allows gait monitoring in MS subjects, being potentially able to assess disease activity, progression, and treatment response.
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Competing Interests: I have read the journal’s policy and the authors of this manuscript have the following competing interests: Carmen Durán has received speaking and/or advisory board honoraria from Sanofi, Novartis, AbbVie, and Bial. Guillermo Navarro has received speaking and/or advisory board honoraria from Biogen, Novartis, Merck, Teva, Sanofi, and Roche. Guillermo Izquierdo Ayuso has received speaking and/or advisory board honoraria from Bayer, Biogen-Idec, Novartis, Sanofi, Merck-Serono, Almirall, and Roche. Anabel Granja Domínguez, Aurora Alemán, Anja Hochsprung, Cristina Páramo, and Ana Venegas have nothing to disclose. Raúl Romero Sevilla and Ana Lladonosa are employees of Novartis, Spain.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0272596