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Recruiting Not applicable

Insole Optimization for Rheumatoid Arthritis Patients

NCT07321340 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2026-06-02
Last updated
2026-06-05

Condition(s) studied

Rhumatoid Arthisis

Investigational drug(s) / intervention(s)

gait analysis from 3D imaging (ENSENSO)

gait analysis from 3D imaging (ENSENSO): gait analysis from 3D imaging (ENSENSO) on patients with bone geomtry 3D imaging

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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;

Primary outcome measure(s)

  • Construction of a patient-specific 3D model reproducing a gait cycle with or without an orthosis. — Week 1
    Bone geometry from 3D imaging (foot CT) combined with gait analysis (speed, step length, angular variation at the knee and ankle) from 3D imaging (ENSENSO) and accelerometers

Trial sites (1)

FacilityCityRegionStatus
Chu de Saint-Etienne Saint-Etienne France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07321340 on ClinicalTrials.gov ↗ ← All trials in France