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Recruiting NCT07321340

Insole Optimization for Rheumatoid Arthritis Patients

No phase Interventional Rhumatoid Arthisis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: gait analysis from 3D imaging (ENSENSO).
Who it may be relevant to
Registry conditions: Rhumatoid Arthisis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Insole Optimization for Rheumatoid Arthritis Patients - INORA - (Insole Optimization for Rheumatoid Arthritis Patients)

Overview

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.

Interventions

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

Primary outcome measures

  • Construction of a patient-specific 3D model reproducing a gait cycle with or without an orthosis. [Time frame: Week 1]
Secondary outcome measures (2)
  • Correlation of model parameters with pain [Time frame: Day 1]
  • Correlation of model parameters with insole-wearing comfort. [Time frame: Day 1]

Eligibility criteria

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;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Basic science

Study locations

France · 1 center
  • Chu de Saint-Etienne — Saint-Etienne

Identifiers

NCT: NCT07321340 · 25CH256 · ANSM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗