NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Insole Optimization for Rheumatoid Arthritis Patients
Insole Optimization for Rheumatoid Arthritis Patients

NCT07321340

RecruitingNA

Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Conditions: Rhumatoid Arthisis

Interventions: gait analysis from 3D imaging (ENSENSO)

Countries: France

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.

Eligibility overview

Sex: ALL

Age: 18 Years to

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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;
Locations (1)
  • Saint-Etienne, France