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Insole Optimization for Rheumatoid Arthritis Patients

ConditionRhumatoid Arthisis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire de Saint Etienne

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

Patients with a contraindication to a bone scan

Patients with neurological gait disorders that interfere with gait analysis

Pregnant women, parturients, nursing mothers;

Persons deprived of liberty, hospitalized without consent, hospitalized for purposes other than research;

Trial design

Design model

Single group

Treatments tested in this trial

  • gait analysis from 3D imaging (ENSENSO)

    Other intervention

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

Treatment groups

10 Participants
are divided into 1 treatment group
Group A: 3D imaging (foot CT scan)Other 1 intervention

Trial outcomes

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

Time frame
Week 1

Secondary outcomes

1

Correlation of model parameters with pain

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

Time frame
Day 1
2

Correlation of model parameters with insole-wearing comfort.

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

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire de Saint Etienne

Lead sponsor

SAINBIOSE

Collaborator

Source ClinicalTrials.gov
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