Insole Optimization for Rheumatoid Arthritis Patients (INORA)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rhumatoid Arthisis
• Intervention / Treatment: Other: gait analysis from 3D imaging (ENSENSO)

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hubert MAROTTE, MD PhD; Phone Number: +33 (0)4 77 12 76 49; Email: hubert.marotte@chu-st-etienne.fr
• Study Contact Backup: Name: Florence RANCON, CDP; Phone Number: +33 (0)477829458; Email: florence.rancon@chu-st-etienne.fr

Study Locations

• France
  • Saint-Etienne, France, 42055
    • CHU de Saint-Etienne
    • Sub-Investigator: Adamah AMOUZOUGAN, MD
    • Contact: Hubert MAROTTE, MD PhD; Phone Number: +33 (0)4 77 12 76 49; Email: hubert.marotte@chu-st-etienne.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 3D imaging (foot CT scan); foot CT scan	Other: gait analysis from 3D imaging (ENSENSO); gait analysis from 3D imaging (ENSENSO) on patients with bone geomtry 3D imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Construction of a patient-specific 3D model reproducing a gait cycle with or without an orthosis.	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	Week 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of model parameters with pain	- Visual analogue scale (VAS) for pain in the right and left foot (0 = no pain; 10 = worst imaginable pain).	Day 1
Correlation of model parameters with insole-wearing comfort.	Visual analogue scale (VAS) for comfort in the right and left foot (0 = most comfortable; 10 = most uncomfortable).	Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: SAINBIOSE

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 22, 2025
• First Submitted That Met QC Criteria: December 22, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 16, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Rheumatoid arthritis; Insole; Feet
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis, Rheumatoid
• Other Study ID Numbers: 25CH256; ANSM (Other Identifier: 2025-A02921-48)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No