Evidence map›Paper›PMID 36758111›Full record

Observational studyPloS one2023

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

Anabel Granja Domínguez, Raúl Romero Sevilla, Aurora Alemán, Carmen Durán, Anja Hochsprung, Guillermo Navarro, Cristina Páramo, Ana Venegas, Ana Lladonosa, Guillermo Izquierdo Ayuso

Abstract readObservational Study
In one paragraph

Observational study in PloS one, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed.

  1. Article
  2. Article
  3. Sensors in Multiple Sclerosis.Current neurology and neuroscience reports · 2025
    Review
  4. Review
  5. Article
  6. Review
  7. The FeetMeSensors (Basel, Switzerland) · 2024
    Article
  8. Article
  9. Review
  10. Review
  11. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Anabel Granja DomínguezDepartamento de Neurología, Fundación para el Desarrollo de la Investigación y Asistencia de Enfermedades Neurológicas y Afines Crónicas (DINAC), Castilleja de la Cuesta, Sevilla, Spain.
Raúl Romero SevillaNeurociencias, Novartis Farmacéutica, S.A., Barcelona, Spain.
Aurora AlemánDepartamento de Neurología, Fundación para el Desarrollo de la Investigación y Asistencia de Enfermedades Neurológicas y Afines Crónicas (DINAC), Castilleja de la Cuesta, Sevilla, Spain.ORCID 0000-0003-4305-4714
Carmen DuránDepartamento de Neurología, Fundación para el Desarrollo de la Investigación y Asistencia de Enfermedades Neurológicas y Afines Crónicas (DINAC), Castilleja de la Cuesta, Sevilla, Spain.ORCID 0000-0002-1192-4976
Anja HochsprungDepartamento de Neurología, Fundación para el Desarrollo de la Investigación y Asistencia de Enfermedades Neurológicas y Afines Crónicas (DINAC), Castilleja de la Cuesta, Sevilla, Spain.
Guillermo NavarroDepartamento de Neurología, Fundación para el Desarrollo de la Investigación y Asistencia de Enfermedades Neurológicas y Afines Crónicas (DINAC), Castilleja de la Cuesta, Sevilla, Spain.
Cristina PáramoDepartamento de Neurología, Fundación para el Desarrollo de la Investigación y Asistencia de Enfermedades Neurológicas y Afines Crónicas (DINAC), Castilleja de la Cuesta, Sevilla, Spain.
Ana VenegasDepartamento de Neurología, Fundación para el Desarrollo de la Investigación y Asistencia de Enfermedades Neurológicas y Afines Crónicas (DINAC), Castilleja de la Cuesta, Sevilla, Spain.
Ana LladonosaNeurociencias, Novartis Farmacéutica, S.A., Barcelona, Spain.
Guillermo Izquierdo AyusoDepartamento de Neurología, Fundación para el Desarrollo de la Investigación y Asistencia de Enfermedades Neurológicas y Afines Crónicas (DINAC), Castilleja de la Cuesta, Sevilla, Spain.ORCID 0000-0002-6340-5609

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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).

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.

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®.

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.

Indexed as

Multiple SclerosisCross-Sectional StudiesFemaleGaitHumansMaleProspective StudiesWalking

Identifiers

PMID36758111
PMCPMC9910712

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.