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Insole Optimization for Rheumatoid Arthritis Patients (INORA)

C

Centre Hospitalier Universitaire de Saint Etienne

Status

Not yet enrolling

Conditions

Rhumatoid Arthisis

Treatments

Other: gait analysis from 3D imaging (ENSENSO)

Study type

Interventional

Funder types

Other

Identifiers

NCT07321340
25CH256
ANSM (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

10 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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;

Trial design

Primary purpose

Basic Science

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

3D imaging (foot CT scan)
Other group
Description:
foot CT scan
Treatment:
Other: gait analysis from 3D imaging (ENSENSO)

Trial contacts and locations

1

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Central trial contact

Hubert MAROTTE, MD PhD; Florence RANCON, CDP

Data sourced from clinicaltrials.gov

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