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Insole Optimization for Rheumatoid Arthritis Patients

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07321340
Acronym
INORA
Enrollment
10
Registered
2026-01-07
Start date
2026-06-02
Completion date
2026-12-01
Last updated
2026-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhumatoid Arthisis

Keywords

Insole, Rheumatoid arthritis, Feet

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.

Interventions

OTHERgait analysis from 3D imaging (ENSENSO)

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

Sponsors

Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER
SAINBIOSE
CollaboratorUNKNOWN

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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;

Design outcomes

Primary

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

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

Countries

France

Contacts

CONTACTHubert MAROTTE, MD PhD
hubert.marotte@chu-st-etienne.fr(0)4 77 12 76 49
CONTACTFlorence RANCON, CDP
florence.rancon@chu-st-etienne.fr(0)477829458

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 6, 2026