Insole Optimization for Rheumatoid Arthritis Patients - INORA - (Insole Optimization for Rheumatoid Arthritis Patients)
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Construction of a patient-specific 3D model reproducing a gait cycle with or without an orthosis.
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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;
Arms & Interventions
3D imaging (foot CT scan)
foot CT scan
Intervention: gait analysis from 3D imaging (ENSENSO) (Other)
Outcomes
Primary Outcomes
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
- Correlation of model parameters with insole-wearing comfort.(Day 1)
- Correlation of model parameters with pain(Day 1)