Modeling Spinal Mobility in Ankylosing Spondylitis: Towards New Telekinetic Biomarkers
NCT ID: NCT05570656
Last Updated: 2024-04-17
Study Results
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Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2022-12-13
2023-09-14
Brief Summary
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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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Detailed Description
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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
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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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.)
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.
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.)
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
65 Years
ALL
Yes
Sponsors
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University Hospital, Montpellier
OTHER
Responsible Party
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Principal Investigators
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Christian JORGENSEN, PU-PH
Role: PRINCIPAL_INVESTIGATOR
UF of Montpellier
Locations
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Centre Hospitalier Universitaire de Montpellier
Montpellier, , France
Countries
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References
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Raychaudhuri SP, Deodhar A. The classification and diagnostic criteria of ankylosing spondylitis. J Autoimmun. 2014 Feb-Mar;48-49:128-33. doi: 10.1016/j.jaut.2014.01.015. Epub 2014 Feb 16.
Dougados M, Sepriano A, Molto A, van Lunteren M, Ramiro S, de Hooge M, van den Berg R, Navarro Compan V, Demattei C, Landewe R, van der Heijde D. Sacroiliac radiographic progression in recent onset axial spondyloarthritis: the 5-year data of the DESIR cohort. Ann Rheum Dis. 2017 Nov;76(11):1823-1828. doi: 10.1136/annrheumdis-2017-211596. Epub 2017 Jul 6.
Wang R, Ward MM. Epidemiology of axial spondyloarthritis: an update. Curr Opin Rheumatol. 2018 Mar;30(2):137-143. doi: 10.1097/BOR.0000000000000475.
Costantino F, Talpin A, Said-Nahal R, Goldberg M, Henny J, Chiocchia G, Garchon HJ, Zins M, Breban M. Prevalence of spondyloarthritis in reference to HLA-B27 in the French population: results of the GAZEL cohort. Ann Rheum Dis. 2015 Apr;74(4):689-93. doi: 10.1136/annrheumdis-2013-204436. Epub 2013 Dec 18.
van der Heijde D, Ramiro S, Landewe R, Baraliakos X, Van den Bosch F, Sepriano A, Regel A, Ciurea A, Dagfinrud H, Dougados M, van Gaalen F, Geher P, van der Horst-Bruinsma I, Inman RD, Jongkees M, Kiltz U, Kvien TK, Machado PM, Marzo-Ortega H, Molto A, Navarro-Compan V, Ozgocmen S, Pimentel-Santos FM, Reveille J, Rudwaleit M, Sieper J, Sampaio-Barros P, Wiek D, Braun J. 2016 update of the ASAS-EULAR management recommendations for axial spondyloarthritis. Ann Rheum Dis. 2017 Jun;76(6):978-991. doi: 10.1136/annrheumdis-2016-210770. Epub 2017 Jan 13.
Dagfinrud H, Kvien TK, Hagen KB. Physiotherapy interventions for ankylosing spondylitis. Cochrane Database Syst Rev. 2008 Jan 23;2008(1):CD002822. doi: 10.1002/14651858.CD002822.pub3.
Zochling J. Measures of symptoms and disease status in ankylosing spondylitis: Ankylosing Spondylitis Disease Activity Score (ASDAS), Ankylosing Spondylitis Quality of Life Scale (ASQoL), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Global Score (BAS-G), Bath Ankylosing Spondylitis Metrology Index (BASMI), Dougados Functional Index (DFI), and Health Assessment Questionnaire for the Spondylarthropathies (HAQ-S). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S47-58. doi: 10.1002/acr.20575. No abstract available.
Soulard J, Vaillant J, Agier CT, Vuillerme N. Gait characteristics in patients with ankylosing spondylitis: a systematic review. Clin Exp Rheumatol. 2021 Jan-Feb;39(1):173-186. doi: 10.55563/clinexprheumatol/le3bmj. Epub 2020 Oct 5.
Sawacha Z, Carraro E, Del Din S, Guiotto A, Bonaldo L, Punzi L, Cobelli C, Masiero S. Biomechanical assessment of balance and posture in subjects with ankylosing spondylitis. J Neuroeng Rehabil. 2012 Aug 29;9:63. doi: 10.1186/1743-0003-9-63.
Del Din S, Carraro E, Sawacha Z, Guiotto A, Bonaldo L, Masiero S, Cobelli C. Impaired gait in ankylosing spondylitis. Med Biol Eng Comput. 2011 Jul;49(7):801-9. doi: 10.1007/s11517-010-0731-x. Epub 2011 Jan 13.
Robert-Lachaine X, Mecheri H, Larue C, Plamondon A. Accuracy and repeatability of single-pose calibration of inertial measurement units for whole-body motion analysis. Gait Posture. 2017 May;54:80-86. doi: 10.1016/j.gaitpost.2017.02.029. Epub 2017 Mar 1.
Iosa M, Picerno P, Paolucci S, Morone G. Wearable inertial sensors for human movement analysis. Expert Rev Med Devices. 2016 Jul;13(7):641-59. doi: 10.1080/17434440.2016.1198694. Epub 2016 Jun 17.
Other Identifiers
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RECHMPL21_0601
Identifier Type: -
Identifier Source: org_study_id
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