Centre Hospitalier Universitaire de Montpellier
Montpellier, France, 34295
NCT Number: NCT05570656
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.
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Notify Me18 year–65 year
All sexes
Interventional
Not applicable
Montpellier, France, 34295
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
specific to the AS group:
Exclusion criteria
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.
Time frame: 1 day
Assess the diagnostic performance of angular measurement in the sagittal plane during flexion and extension of the spine in the diagnosis of AS. spinal angle measurement (in degrees) for both APS patients and healthy volunteers will be compared using a Student's test or Wilcoxon Mann Whitney test depending on the distribution. The diagnostic performances of the different kinematic parameters will be estimated in percentage (%) with their 95% confidence interval.
Time frame: 1 day
The BASDAI (Bath Ankylosing Spondylitis Disease Activity Index) is a questionnaire to calculate the activity index of ankylosing spondylitis.
Rate the intensity of 5 symptoms during the past week, giving a score from 0 to 10, knowing that 0 means the absence of the symptom and 10 its presence at the highest degree.
This score is an aid in monitoring ankylosing spondylitis.
Time frame: 1 day
The BASFI (Bath ankylosing spondylitis functional index) reflects functional impact, that is to say the inability to perform actions of daily living. It contains 10 questions on activities of daily living, which are scored with a rating scale from 0 (no functional impairments) to 10 (maximal impairment) [38] (Box 5.2). The sum score ranges from 0 to 10, with higher values indicating worse functioning.
Time frame: 1 day
The BASMI (Bath Ankylosing Spondylitis Metrology Index) was established to assess the mobility of the spine and hips.
It measures :
A conversion table allows investigators to give a rating from 0 to 10 for each measurement. The average of the 5 ratings gives the BASMI. It varies from 0 to 10 and the higher the rating, the more limited the movements.
Time frame: 1 day
Describe the kinematic parameters of the movements evaluated in the BASFI score through the X Sens sensors.
Clinical parameters are :
10 questions on activities of daily living, which are scored with a rating scale from 0 (no functional impairments) to 10 (maximal impairment)
Kinematic parameters measured with the X sens sensors are :
To establish the correlation between the clinical parameters and the kinematic parameters the investigators will use Spearman or Pearson correlation tests.
Time frame: 1 day
Evaluate the diagnostic performance of other kinematic parameters of the spine in the diagnosis of AS.
Time frame: 1 day
Evaluate the diagnostic performance of other kinematic parameters of lower limb joints in the diagnosis of AS.
Time frame: 1 day
establishing the correlation between clinical parameters and kinematic parameters
University Hospital, Montpellier
Other
Modeling Spinal Mobility in Ankylosing Spondylitis (AS) : Towards New Telekinetic Biomarkers
Acronym: TELESPA
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