CompletedNot Applicable

Modeling Spinal Mobility in Ankylosing Spondylitis: Towards New Telekinetic Biomarkers

France40 participantsStarted 2022-12-13

Plain-language summary

Ankylosing spondylitis (AS) is a chronic inflammatory rheumatic disease that mainly affects the spine and pelvis in its axial form. It is responsible for chronic inflammatory pain and sometimes ankylosis with significant functional retention. Clinicians need markers capable of precisely measuring the restriction of range of motion in these patients, reflections of the activity and/or sequelae of the disease. The Inverstigators validated movement markers in the AS by a device including inertial sensors (XSENS) and computer modeling. The accuracy and repeatability of the XSENS-Awinda system compared to the reference measurement system have been demonstrated. The XSENS-Awinda device offers new real-time evaluation possibilities for quantitative gait analysis. This opens the way to new diagnostic tools, prognostics and therapeutic perspectives for the clinician.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age 18-65 * BMI between 18.5 and 30 * Written informed consent * Same gender and age within +/- 3 years compared to an unmatched AS patient Inclusion criteria specific to the AS group: * Age 18-65 * BMI between 18.5 and 30 * Written informed consent * AS meeting the ASAS (Assessment of Spondylo Arthritis International Society) criteria, i.e. with spinal pain ≥ 3 months old, with an age of diagnosis \< 45 years, with: * Sacroiliitis on imaging AND ≥ 1 sign of spondylarthritis. OR * HLA-B27 (human leukocyte antigen-B27) positive AND ≥ 2 other signs of spondylarthritis Exclusion Criteria: * Traumatic, tumoral or infectious low back pain * History of spinal fracture * History of lumbar, pelvis, hips, ankles, and/or knees surgery * Severe scoliosis defined by a Cobb angle \> 50° * Severe impairment of uncorrected visual acuity * Concomitant pathology responsible for ataxia * Lumbar arthrodesis of two or more stages * Pregnant or breastfeeding women * Patient unable to give consent: patient under guardianship or curators, mentally retarded, dementia, language barrier * Patient not affiliated to a social security plan * Patient under legal protection

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Variation in spinal angle measurement between APS patients and healthy volunteers

Timeframe: 1 day

Trial details

NCT IDNCT05570656

SponsorUniversity Hospital, Montpellier

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-09-14

View on ClinicalTrials.gov More Ankylosing Spondylitis trials