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NCT Number: NCT07321340

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.

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Key information

Conditions

Rhumatoid Arthisis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu de Saint-Etienne

Saint-Etienne, 42055, France

Location status: Recruiting

Location contact

Adamah AMOUZOUGAN, MD

SUB_INVESTIGATOR

Hubert MAROTTE, MD PhD

CONTACT

[email protected]

(0)4 77 12 76 49 ext. +33

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

gait analysis from 3D imaging (ENSENSO)

Other

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

Primary outcomes

  1. Construction of a patient-specific 3D model reproducing a gait cycle with or without an orthosis.

    Time frame: Week 1

    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

Secondary outcomes

  1. Correlation of model parameters with pain

    Time frame: Day 1

    • Visual analogue scale (VAS) for pain in the right and left foot (0 = no pain; 10 = worst imaginable pain).

  2. Correlation of model parameters with insole-wearing comfort.

    Time frame: Day 1

    Visual analogue scale (VAS) for comfort in the right and left foot (0 = most comfortable; 10 = most uncomfortable).

Study contacts

Contact information is provided by the study sponsor or research team.

Florence RANCON, CDP

CONTACT

[email protected]

(0)477829458 ext. +33

Hubert MAROTTE, MD PhD

CONTACT

[email protected]

(0)4 77 12 76 49 ext. +33

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Collaborators

  • SAINBIOSE

Registry information

Official study title

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

Acronym: INORA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 7, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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