NCT05570656

Modeling Spinal Mobility in Ankylosing Spondylitis: Towards New Telekinetic Biomarkers

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University Hospital, Montpellier · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Detailed description

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. Today, these patients benefit from treatments by biotherapy but the functional monitoring of the therapeutic response is based on the clinical examination, questionnaires, and the measurement of CRP (C reactive Protein). 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 prevention and/or the restoration of these movement limitations, responsible for gait/attitude/balance disorders, are also among the therapeutic objectives of AS. In the AS, the synergy between the trunk and the lower limbs is altered with a restriction of the movements of the trunk in the three planes of space. The study of the kinematic variability seems to show a loss of complexity. In addition, MRI morphological examinations are insufficient to assess stiffness and functional disability related to AS. The investigators 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.

Conditions

• Ankylosing Spondylitis

Interventions

Type	Name	Description
DEVICE	XSENS-Awinda	The participant wears inertial sensors X-Sens that measure the kinematic data and the amplitude of joint movements during different movements (flexion and extension of the spine, walking, picking up an object on the ground, tying their shoelaces, getting up from a chair... ) Each movement will be repeated 3 times. Participants will also have self-questionnaires to complete (BASDAI and BASFI). The exams are carried out on one day.

Timeline

• Start date: 2022-12-13
• Primary completion: 2023-09-14
• Completion: 2023-09-14
• First posted: 2022-10-06
• Last updated: 2024-04-17

Locations

1 site across 1 country: France