Insole Optimization for Rheumatoid Arthritis Patients

NCT07321340 | Not Yet Recruiting

• 2 other identifiers: 25CH256ANSM
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rhumatoid Arthisis

Keywords

Insole; Rheumatoid arthritis; Feet

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Correlation of model parameters with pain

  Day 1

• Correlation of model parameters with insole-wearing comfort.

  Day 1

Study Arms (1)

3D imaging (foot CT scan)

OTHER

foot CT scan

Other: gait analysis from 3D imaging (ENSENSO)

Interventions

gait analysis from 3D imaging (ENSENSO) OTHER

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

3D imaging (foot CT scan)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• SAINBIOSE: collaborator

Study Sites (1)

Chu de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Hubert MAROTTE, MD PhD

CONTACT

(0)4 77 12 76 49; hubert.marotte@chu-st-etienne.fr

Florence RANCON, CDP

CONTACT

(0)477829458; florence.rancon@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 7, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

FR (1)