Modeling Spinal Mobility in Ankylosing Spondylitis: Towards New Telekinetic Biomarkers

NCT05570656 | Completed

• 1 other identifier: RECHMPL21_0601
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ankylosing Spondylitis

Keywords

rheumatology; Rehabilitation; Bioinformatics; Spondylitis; Motion sensor; XSENS-Awinda

Outcome Measures

Primary Outcomes (1)

• Variation in spinal angle measurement between APS patients and healthy volunteers

  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.

  1 day

Secondary Outcomes (7)

• Percentage of AS activity by BASDAI score

  1 day

• Percentage of functional impact of the AS by BASFI score

  1 day

• Percentage of functional impact of the AS by BASMI score

  1 day

• Variation of kinematic parameters of movement between BASFI and sensors

  1 day

• percentage of diagnosis concordant between the kinematic parameters of the spine and the diagnosis of AS

  1 day

Study Arms (2)

AS patients

ACTIVE COMPARATOR

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

healthy volunteers

ACTIVE COMPARATOR

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

Interventions

XSENS-Awinda DEVICE

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.

AS patients; healthy volunteers

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Centre Hospitalier Universitaire de Montpellier

Montpellier, 34295, France

Location

Related Publications (12)

• 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.

  PMID: 24534717 BACKGROUND

• 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.

  PMID: 28684556 BACKGROUND

• Wang R, Ward MM. Epidemiology of axial spondyloarthritis: an update. Curr Opin Rheumatol. 2018 Mar;30(2):137-143. doi: 10.1097/BOR.0000000000000475.

  PMID: 29227352 BACKGROUND

• 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.

  PMID: 24351517 BACKGROUND

• 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.

  PMID: 28087505 BACKGROUND

• 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.

  PMID: 18254008 BACKGROUND

• 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.

  PMID: 22588768 BACKGROUND

• 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.

  PMID: 33025884 BACKGROUND

• 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.

  PMID: 22931459 BACKGROUND

• 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.

  PMID: 21229328 BACKGROUND

• 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.

  PMID: 28279850 BACKGROUND

• 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.

  PMID: 27309490 BACKGROUND

MeSH Terms

Conditions

Spondylitis, Ankylosing; Spondylitis

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis; Bone Diseases, Infectious; Infections

Study Officials

• Christian JORGENSEN, PU-PH

  UF of Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 6, 2022
• Study Start: December 13, 2022
• Primary Completion: September 14, 2023
• Study Completion: September 14, 2023
• Last Updated: April 17, 2024

Record last verified: 2022-12

Locations

FR (1)