Modeling Spinal Mobility in Ankylosing Spondylitis (AS) : Towards New Telekinetic Biomarkers

Status: Completed
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

• 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

• 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

Locations
Other Locations
France
Centre Hospitalier Universitaire de Montpellier
Montpellier
Time Frame
Start Date: 2022-12-13
Completion Date: 2023-09-14
Participants
Target number of participants: 40
Treatments
Active_comparator: AS patients
Evaluation of kinematic parameters by wearing X-Sens sensors in different movements (flexion and extension of the spine, tying shoelaces, picking up an object on the ground, walking, etc.)
Active_comparator: healthy volunteers
Evaluation of kinematic parameters by wearing X-Sens sensors in different movements (flexion and extension of the spine, tying shoelaces, picking up an object on the ground, walking, etc.)
Sponsors
Leads: University Hospital, Montpellier

This content was sourced from clinicaltrials.gov