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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 10 (estimated) |
| Sponsor | Centre Hospitalier Universitaire de Saint Etienne Academic / other |
| Locations | 1 site (Saint-Etienne) |
| Status | Recruiting |
| Started | June 2, 2026 |
| Main results expected | November 2026 |
| Study ends | December 2026 |
| Registry record updated | June 5, 2026 |
| Trial ID | NCT07321340 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
- Study coordinator: Hubert MAROTTE, MD PhD
- Email: hubert.marotte@chu-st-etienne.fr
- Phone: (0)4 77 12 76 49
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Nicorandil for reducing inflammation in rheumatoid arthritis
This trial will test whether taking a 10 mg nicorandil tablet can reduce inflammation and improve symptoms in adults with active rheumatoid arthritis who are already on conventional DMARDs.
-
Aerobic exercise to reduce heart risk in people with rheumatoid arthritis or chronic kidney disease
This program will test whether a six-week individualized aerobic exercise plan can lower heart-related risk in people with rheumatoid arthritis or stage III–IV chronic kidney disease.
-
Self-management app to help people with inflammatory arthritis stay safe
A smartphone app from the French Rheumatology Society is being tested to help adults with rheumatoid arthritis or spondyloarthritis manage their treatments and safety while starting a new DMARD.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.