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

Primary Purpose

Ankylosing Spondylitis

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
XSENS-Awinda
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Ankylosing Spondylitis focused on measuring rheumatology, Rehabilitation, Bioinformatics, Spondylitis, Motion sensor, XSENS-Awinda

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Centre Hospitalier Universitaire de MontpellierRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

AS patients

healthy volunteers

Arm Description

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.)

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.)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
percentage of correlation between clinical and kinematic parameters
establishing the correlation between clinical parameters and kinematic parameters

Full Information

First Posted
September 29, 2022
Last Updated
December 19, 2022
Sponsor
University Hospital, Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT05570656
Brief Title
Modeling Spinal Mobility in Ankylosing Spondylitis: Towards New Telekinetic Biomarkers
Acronym
TELESPA
Official Title
Modeling Spinal Mobility in Ankylosing Spondylitis (AS) : Towards New Telekinetic Biomarkers
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 13, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ankylosing Spondylitis
Keywords
rheumatology, Rehabilitation, Bioinformatics, Spondylitis, Motion sensor, XSENS-Awinda

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AS patients
Arm Type
Active Comparator
Arm Description
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.)
Arm Title
healthy volunteers
Arm Type
Active Comparator
Arm Description
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.)
Intervention Type
Device
Intervention Name(s)
XSENS-Awinda
Intervention Description
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.
Primary Outcome Measure Information:
Title
Variation in spinal angle measurement between APS patients and healthy volunteers
Description
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
Secondary Outcome Measure Information:
Title
Percentage of AS activity by BASDAI score
Description
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
Title
Percentage of functional impact of the AS by BASFI score
Description
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
Title
Percentage of functional impact of the AS by BASMI score
Description
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.
Time Frame
1 day
Title
Variation of kinematic parameters of movement between BASFI and sensors
Description
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.
Time Frame
1 day
Title
percentage of diagnosis concordant between the kinematic parameters of the spine and the diagnosis of AS
Description
Evaluate the diagnostic performance of other kinematic parameters of the spine in the diagnosis of AS.
Time Frame
1 day
Title
percentage of diagnosis concordant between the kinematic parameters of the lower limb joints and the diagnosis of AS
Description
Evaluate the diagnostic performance of other kinematic parameters of lower limb joints in the diagnosis of AS.
Time Frame
1 day
Title
percentage of correlation between clinical and kinematic parameters
Description
establishing the correlation between clinical parameters and kinematic parameters
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian JORGENSEN, PU-PH
Phone
04 67 33 77 98
Ext
+33
Email
c-jorgensen@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christian JORGENSEN, PU-PH
Organizational Affiliation
UF of Montpellier
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian JORGENSEN, PU-PH
Phone
04 67 33 77 98
Ext
+33
Email
c-jorgensen@chu-montpellier.fr

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Citation
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Modeling Spinal Mobility in Ankylosing Spondylitis: Towards New Telekinetic Biomarkers

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