TELESPA: Modeling Spinal Mobility in Ankylosing Spondylitis: Towards New Telekinetic Biomarkers

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Recruiting

CT.gov ID

NCT05570656

Collaborator

(none)

Enrollment

Location

Arms

10.6

Anticipated Duration (Months)

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Ankylosing Spondylitis	Device: XSENS-Awinda	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Dec 13, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.)	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.
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.)	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.

Arm

Intervention/Treatment

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.)

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.

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.)

Device: XSENS-Awinda

Outcome Measures

Primary Outcome Measures

Variation in spinal angle measurement between APS patients and healthy volunteers [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.

Secondary Outcome Measures

Percentage of AS activity by BASDAI score [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.
Percentage of functional impact of the AS by BASFI score [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.
Percentage of functional impact of the AS by BASMI score [1 day]
The BASMI (Bath Ankylosing Spondylitis Metrology Index) was established to assess the mobility of the spine and hips. It measures : the ear/wall distance head rotation flexion of the trunk trunk flexion to the side the distance between the internal malleolus (at the ankles) during the maximum spread of the legs 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.
Variation of kinematic parameters of movement between BASFI and sensors [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 : Maximum bending, flexion and rotation angle (degrees) Time up and Go (TUG) ( seconds) To establish the correlation between the clinical parameters and the kinematic parameters the investigators will use Spearman or Pearson correlation tests.
percentage of diagnosis concordant between the kinematic parameters of the spine and the diagnosis of AS [1 day]
Evaluate the diagnostic performance of other kinematic parameters of the spine in the diagnosis of AS.
percentage of diagnosis concordant between the kinematic parameters of the lower limb joints and the diagnosis of AS [1 day]
Evaluate the diagnostic performance of other kinematic parameters of lower limb joints in the diagnosis of AS.
percentage of correlation between clinical and kinematic parameters [1 day]
establishing the correlation between clinical parameters and kinematic parameters

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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