Rhumatoid ArthisisINORANCT07321340
Insole Optimization for Rheumatoid Arthritis Patients
A study testing gait analysis from 3D imaging (ENSENSO) in people with Rhumatoid Arthisis, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhumatoid Arthisis
- What is being tested?
- gait analysis from 3D imaging (ENSENSO)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 2 Jun 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Chu de Saint-Etienne
Saint-Etienne, 42055
Hubert MAROTTE, MD PhD, (0)4 77 12 76 49 ext. +33, hubert.marotte@chu-st-etienne.fr
Adamah AMOUZOUGAN, MD
About this study
Official title: Insole Optimization for Rheumatoid Arthritis Patients - INORA - (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.
- Conditions
- Rhumatoid Arthisis
- Being tested
- gait analysis from 3D imaging (ENSENSO)
- Keywords
- Insole, Rheumatoid arthritis, Feet
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gait analysis from 3D imaging (ENSENSO)Other
gait analysis from 3D imaging (ENSENSO) on patients with bone geomtry 3D imaging
| Study group | Role | What they receive |
|---|---|---|
| 3D imaging (foot CT scan) | Other | foot CT scan Receives: Other: gait analysis from 3D imaging (ENSENSO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 1
Secondary outcomes (2)
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).
Measured: Day 1
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).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start2 Jun 2026
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rhumatoid ArthisisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Collaborators
- SAINBIOSE
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321340
- Sponsor's protocol ID
- 25CH256
- Other IDs
- ANSM
- Acronym
- INORA
- Status last verified
- Jun 2026
- First submitted
- 22 Dec 2025
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insole Optimization for Rheumatoid Arthritis Patients - INORA - (Insole Optimization for Rheumatoid Arthritis Patients)
- ClinicalTrials.gov ID
- NCT07321340
- Acronym / sponsor ID
- INORA / 25CH256
- Conditions
- Rhumatoid Arthisis
- Keywords
- Insole, Rheumatoid arthritis, Feet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Collaborators
- SAINBIOSE
- Study start
- 2 Jun 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 3D imaging (foot CT scan) | Other | Other: gait analysis from 3D imaging (ENSENSO)foot CT scan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- Patients with a contraindication to a bone scan
- Patients with neurological gait disorders that interfere with gait analysis
- Exclude particularly protected persons:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gait analysis from 3D imaging (ENSENSO)gait analysis from 3D imaging (ENSENSO) on patients with bone geomtry 3D imaging | Other | 3D imaging (foot CT scan) |
Primary outcome
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
2 secondary outcomes
Correlation of model parameters with pain
Time frame: Day 1
Correlation of model parameters with insole-wearing comfort.
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing gait analysis from 3D imaging (ENSENSO) in people with Rhumatoid Arthisis, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hubert MAROTTE, MD PhD ((0)4 77 12 76 49 ext. +33, hubert.marotte@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Construction of a patient-specific 3D model reproducing a gait cycle with or without an orthosis. (time frame: Week 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2026.