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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Abstract	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.
AbstractList	Objective 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). Methods 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. Results 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®. Conclusions 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. Objective 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). Methods 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. Results 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 ® . Conclusions 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. 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).OBJECTIVETo 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.METHODSThis 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®.RESULTSA 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.CONCLUSIONSAgreement 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. 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.
Author	Lladonosa, Ana Durán, Carmen Ayuso, Guillermo Izquierdo Granja Domínguez, Anabel Hochsprung, Anja Alemán, Aurora Páramo, Cristina Venegas, Ana Navarro, Guillermo Romero Sevilla, Raúl
AuthorAffiliation	3 Neurociencias, Novartis Farmacéutica, S.A., Barcelona, Spain 2 Departamento de Neurología, Hospital Vithas Nisa, Unidad de Investigación y Tratamiento de la Esclerosis Múltiple, Sevilla, Spain 1 Departamento de Neurología, Fundación para el Desarrollo de la Investigación y Asistencia de Enfermedades Neurológicas y Afines Crónicas (DINAC), Castilleja de la Cuesta, Sevilla, Spain Universita degli Studi di Napoli Federico II, ITALY
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BackLink	https://www.ncbi.nlm.nih.gov/pubmed/36758111$$D View this record in MEDLINE/PubMed
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CitedBy_id	crossref_primary_10_1038_s41598_025_96878_8 crossref_primary_10_3389_fneur_2024_1470928 crossref_primary_10_3390_jsan14020023 crossref_primary_10_1088_1361_6579_aceecf crossref_primary_10_3390_s24186043 crossref_primary_10_1371_journal_pdig_0000262 crossref_primary_10_3389_fimmu_2025_1514813 crossref_primary_10_1016_j_jbiomech_2025_112705 crossref_primary_10_1080_09638288_2025_2519497 crossref_primary_10_3390_biomechanics5030054 crossref_primary_10_3390_biomechanics5030065 crossref_primary_10_3390_s24175799
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Notes	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 14 ObjectType-Article-2 ObjectType-Undefined-1 ObjectType-Feature-3 content type line 23 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.
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Snippet	To determine the concordance and statistical precision in gait velocity in people with multiple sclerosis (pwMS), measured with FeetMe® (insoles with pressure... Objective To determine the concordance and statistical precision in gait velocity in people with multiple sclerosis (pwMS), measured with FeetMe® (insoles with... Objective To determine the concordance and statistical precision in gait velocity in people with multiple sclerosis (pwMS), measured with FeetMe ® (insoles...
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SubjectTerms	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
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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
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