Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Insole Optimization for Rheumatoid Arthritis Patients

Official title: Insole Optimization for Rheumatoid Arthritis Patients - INORA - (Insole Optimization for Rheumatoid Arthritis Patients)

Run by Centre Hospitalier Universitaire de Saint Etienne · NCT07321340 · Data updated 2026-11-12

We’re testing a digital model to design better orthopedic insoles to help people with rheumatoid arthritis who have foot pain and forefoot involvement.

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment10 (estimated)
SponsorCentre Hospitalier Universitaire de Saint Etienne
Academic / other
Locations1 site (Saint-Etienne)
StatusRecruiting
StartedJune 2, 2026
Main results expectedNovember 2026
Study endsDecember 2026
Registry record updatedJune 5, 2026
Trial IDNCT07321340 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with rheumatoid arthritis (2010 ACR/EULAR criteria), low disease activity (DAS28 ≤ 3.2), and mechanical forefoot involvement that responds to foot orthoses.

Probably not a fit

Patients without forefoot mechanical involvement or with conditions that affect gait may not benefit from the optimized insoles.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study uses 3D gait analysis and CT-based plantar pressure modeling to create optimized insoles for rheumatoid arthritis patients with forefoot pain. It compares gait and pressure patterns with and without standard insoles to identify mechanical factors linked to pain. The goal is to validate the new insole designs through gait analysis and demonstrate potential improvements in comfort and function. Recruitment focuses on adults diagnosed with RA, low disease activity, and mechanical forefoot involvement, excluding those with certain conflicts or gait disorders.

Why it matters

Potential benefit: If successful, patients may experience reduced foot pain and improved walking comfort from more effective insoles.

How similar studies have gone: Previous work on personalized insoles and gait analysis has shown promise, though this exact digital modeling approach is being tested in this context.

Who can join: the full rules

Show full inclusion / exclusion 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;

Where it's running

  • Chu de Saint-Etienne
    Saint-Etienne, France
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.