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Insole Optimization for Rheumatoid Arthritis Patients

RecruitingNAAges 18 Years - anyAllCentre Hospitalier Universitaire de Saint Etienne
NCT07321340 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Rheumatoid arthritis affects 0.5% of the population, often leading to foot deformities and pain that are difficult to treat. Management is based on controlling inflammation, adapting footwear and using custom-made insoles, all of which have proven effective. The aim of this research is to build a digital model of plantar pressures based on CT scans, in order to optimize orthopedic insoles. The study will analyze the gait of patients with and without standard insoles to identify mechanical criteria correlated with pain. The ultimate aim is to design optimized insoles, validated by a new gait analysis.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients with rheumatoid arthritis according to 2010 ACR/EULAR criteria * RA at low activity level according to DAS28≤3.2 * Patient with mechanical forefoot involvement on walking and improved by foot orthoses. Exclusion Criteria: * Patients with a contraindication to a bone scan * Patients with neurological gait disorders that interfere with gait analysis * Exclude particularly protected persons: * Pregnant women, parturients, nursing mothers; * Persons deprived of liberty, hospitalized without consent, hospitalized for purposes other than research; * Minors;
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What it tests

  • gait analysis from 3D imaging (ENSENSO)
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Where

1 site
Chu de Saint-Etienne
Saint-Etienne, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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