Study for the validation of the FeetMe® integrated sensor insole system compared to GAITRite® system to assess gait characteristics in patients with multiple sclerosis
<h4>Objective</h4> 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 W...
| Main Authors: | , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Public Library of Science (PLoS)
2023-01-01
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| Series: | PLoS ONE |
| Online Access: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9910712/?tool=EBI |
| _version_ | 1811166106464813056 |
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| author | Anabel Granja Domínguez Raúl Romero Sevilla Aurora Alemán Carmen Durán Anja Hochsprung Guillermo Navarro Cristina Páramo Ana Venegas Ana Lladonosa Guillermo Izquierdo Ayuso |
| author_facet | Anabel Granja Domínguez Raúl Romero Sevilla Aurora Alemán Carmen Durán Anja Hochsprung Guillermo Navarro Cristina Páramo Ana Venegas Ana Lladonosa Guillermo Izquierdo Ayuso |
| author_sort | Anabel Granja Domínguez |
| collection | DOAJ |
| description | <h4>Objective</h4> 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). <h4>Methods</h4> 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. <h4>Results</h4> 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®. <h4>Conclusions</h4> 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. |
| first_indexed | 2024-04-10T15:47:10Z |
| format | Article |
| id | doaj.art-276ed94737f042e8a2323d12a55410a5 |
| institution | Directory Open Access Journal |
| issn | 1932-6203 |
| language | English |
| last_indexed | 2024-04-10T15:47:10Z |
| publishDate | 2023-01-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS ONE |
| spelling | doaj.art-276ed94737f042e8a2323d12a55410a52023-02-12T05:31:12ZengPublic Library of Science (PLoS)PLoS ONE1932-62032023-01-01182Study for the validation of the FeetMe® integrated sensor insole system compared to GAITRite® system to assess gait characteristics in patients with multiple sclerosisAnabel Granja DomínguezRaúl Romero SevillaAurora AlemánCarmen DuránAnja HochsprungGuillermo NavarroCristina PáramoAna VenegasAna LladonosaGuillermo Izquierdo Ayuso<h4>Objective</h4> 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). <h4>Methods</h4> 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. <h4>Results</h4> 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®. <h4>Conclusions</h4> 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.https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9910712/?tool=EBI |
| spellingShingle | Anabel Granja Domínguez Raúl Romero Sevilla Aurora Alemán Carmen Durán Anja Hochsprung Guillermo Navarro Cristina Páramo Ana Venegas Ana Lladonosa Guillermo Izquierdo Ayuso Study for the validation of the FeetMe® integrated sensor insole system compared to GAITRite® system to assess gait characteristics in patients with multiple sclerosis PLoS ONE |
| title | Study for the validation of the FeetMe® integrated sensor insole system compared to GAITRite® system to assess gait characteristics in patients with multiple sclerosis |
| title_full | Study for the validation of the FeetMe® integrated sensor insole system compared to GAITRite® system to assess gait characteristics in patients with multiple sclerosis |
| title_fullStr | Study for the validation of the FeetMe® integrated sensor insole system compared to GAITRite® system to assess gait characteristics in patients with multiple sclerosis |
| title_full_unstemmed | Study for the validation of the FeetMe® integrated sensor insole system compared to GAITRite® system to assess gait characteristics in patients with multiple sclerosis |
| title_short | Study for the validation of the FeetMe® integrated sensor insole system compared to GAITRite® system to assess gait characteristics in patients with multiple sclerosis |
| title_sort | study for the validation of the feetme r integrated sensor insole system compared to gaitrite r system to assess gait characteristics in patients with multiple sclerosis |
| url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9910712/?tool=EBI |
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