Ankylosing SpondylitisTELESPANCT05570656
Modeling Spinal Mobility in Ankylosing Spondylitis: Towards New Telekinetic Biomarkers
A study testing XSENS-Awinda in people with Ankylosing Spondylitis, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- XSENS-Awinda
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 13 Dec 2022to 14 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
Centre Hospitalier Universitaire de Montpellier
Montpellier, France, 34295
About this study
Official title: Modeling Spinal Mobility in Ankylosing Spondylitis (AS) : Towards New Telekinetic Biomarkers
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.
Read the 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
- Being tested
- XSENS-Awinda
- Keywords
- rheumatology, Rehabilitation, Bioinformatics, Spondylitis, Motion sensor, XSENS-Awinda
- Medical subject headings
- Spondylitis, Ankylosing, Spondylitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XSENS-AwindaDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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.) Receives: 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.) Receives: Device: XSENS-Awinda |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Secondary outcomes (7)
Percentage of AS activity by BASDAI score
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.
Measured: 1 day
Percentage of functional impact of the AS by BASFI score
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.
Measured: 1 day
Percentage of functional impact of the AS by BASMI score
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.
Measured: 1 day
Variation of kinematic parameters of movement between BASFI and sensors
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.
Measured: 1 day
percentage of diagnosis concordant between the kinematic parameters of the spine and the diagnosis of AS
Evaluate the diagnostic performance of other kinematic parameters of the spine in the diagnosis of AS.
Measured: 1 day
percentage of diagnosis concordant between the kinematic parameters of the lower limb joints and the diagnosis of AS
Evaluate the diagnostic performance of other kinematic parameters of lower limb joints in the diagnosis of AS.
Measured: 1 day
percentage of correlation between clinical and kinematic parameters
establishing the correlation between clinical parameters and kinematic parameters
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2022
- Study start13 Dec 2022
- Primary completion14 Sep 2023
- Study completion14 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian JORGENSEN, PU-PH, Principal investigator, UF of Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05570656
- Sponsor's protocol ID
- RECHMPL21_0601
- Acronym
- TELESPA
- Status last verified
- Dec 2022
- First submitted
- 29 Sep 2022
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 24534717Dougados 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.
PubMed 28684556Wang R, Ward MM. Epidemiology of axial spondyloarthritis: an update. Curr Opin Rheumatol. 2018 Mar;30(2):137-143. doi: 10.1097/BOR.0000000000000475.
PubMed 29227352Costantino 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.
PubMed 24351517van 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.
PubMed 28087505Dagfinrud 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.
PubMed 18254008Zochling 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.
PubMed 22588768Soulard 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.
PubMed 33025884Sawacha 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.
PubMed 22931459Del 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.
PubMed 21229328Robert-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.
PubMed 28279850Iosa 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.
PubMed 27309490Desmyttere G, Ralandison S, Dusfour G, Moulis L, Amico M, Julia M, Pers YM, Jorgensen C. A combined analysis of spinal mobility and gait spatiotemporal parameters in axial spondyloarthritis using wearable sensors. Clin Biomech (Bristol). 2025 Jun;126:106555. doi: 10.1016/j.clinbiomech.2025.106555. Epub 2025 May 7.
PubMed 40359639
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modeling Spinal Mobility in Ankylosing Spondylitis (AS) : Towards New Telekinetic Biomarkers
- ClinicalTrials.gov ID
- NCT05570656
- Acronym / sponsor ID
- TELESPA / RECHMPL21_0601
- Conditions
- Ankylosing Spondylitis
- Keywords
- rheumatology, Rehabilitation, Bioinformatics, Spondylitis, Motion sensor, XSENS-Awinda
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 13 Dec 2022 (actual)
- Primary completion
- 14 Sep 2023 (actual)
- Study completion
- 14 Sep 2023 (actual)
- First posted
- 6 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AS patients | Active comparator | Device: XSENS-AwindaEvaluation 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.) |
| healthy volunteers | Active comparator | Device: XSENS-AwindaEvaluation 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.) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XSENS-AwindaThe 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. | Device | AS patients, healthy volunteers |
Primary outcome
Variation in spinal angle measurement between APS patients and healthy volunteers
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.
7 secondary outcomes
Percentage of AS activity by BASDAI score
Time frame: 1 day
Percentage of functional impact of the AS by BASFI score
Time frame: 1 day
Percentage of functional impact of the AS by BASMI score
Time frame: 1 day
Variation of kinematic parameters of movement between BASFI and sensors
Time frame: 1 day
percentage of diagnosis concordant between the kinematic parameters of the spine and the diagnosis of AS
Time frame: 1 day
percentage of diagnosis concordant between the kinematic parameters of the lower limb joints and the diagnosis of AS
Time frame: 1 day
percentage of correlation between clinical and kinematic parameters
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Background: PubMed 24534717Raychaudhuri 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.
- Background: PubMed 28684556Dougados 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.
- Background: PubMed 29227352Wang R, Ward MM. Epidemiology of axial spondyloarthritis: an update. Curr Opin Rheumatol. 2018 Mar;30(2):137-143. doi: 10.1097/BOR.0000000000000475.
- Background: PubMed 24351517Costantino 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.
- Background: PubMed 28087505van 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.
- Background: PubMed 18254008Dagfinrud 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.
- Background: PubMed 22588768Zochling 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.
- Background: PubMed 33025884Soulard 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.
- Background: PubMed 22931459Sawacha 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.
- Background: PubMed 21229328Del 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.
- Background: PubMed 28279850Robert-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.
- Background: PubMed 27309490Iosa 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christian JORGENSEN, PU-PH principal investigator
UF of Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XSENS-Awinda in people with Ankylosing Spondylitis, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variation in spinal angle measurement between APS patients and healthy volunteers (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05570656, which also lists 13 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.