Clinical trial NCT03761212: Function, Locomotion, Measurement and Inflammation
Official title: Gait Parameters as Predictors of Functional and Activity Scores in Ankylosing Spondylitis : the FoLoMI Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ankylosing Spondylitis
Keywords: Ankylosing spondylitis
Gait
BASFI
BASDAI
6MWT
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient with Ankylosing Spondylitis or Axial Spondyloarthritis at any stage of disease evolution followed at the Rhumatology unit of Grenoble Hospital

Brief summary: FoLoMI is a pilot study in which the investigators will seek to determine if gait spatio-temporal and kinematic parameters can explain the evolution of a functional score, the Bath Ankylosing Spondylitis Functional Index (BASFI), at 18 months.

The secondary objectives are: (1) to study the relationship between gait parameters measured at T0 and the BASFI at T0, (2) to study the relationship between gait parameters at T0 and the BASDAI at T0, (3) to assess general state of health of the patients and its evolution by appreciating: level of physical activity, state of fatigue, diurnal sleepiness and quality of life, and (4) to compare spatio-temporal gait parameters between patients and healthy controls.

Detailed description: This longitudinal cohort study is aiming to follow 60 persons with ankylosing spondylitis during 18 months. Assessments will be conducted at baseline and every 6 months.

An healthy control group of 30 persons will be included and age and sex matched to the first 30 patients.

Eligibility criteria: Inclusion Criteria:

* Ankylosing spondylitis or Axial Spondyloarthritis patient
* Patient able to walk at least 180 meters without technical help
* Stable treatment for 3 months
* Affiliated to a social security system

Exclusion Criteria:

* Concomitant musculo-skeletal disease
* Cardio-respiratory disease with an impact on locomotion
* Hips, ankle or knee arthroplasty (scheduled or done within 18 months)
* No french understanding
* Central or peripheric neurologic disease
* Other disease with impact on posture, locomotion or prehension
* Quickly evolutive disease (less than 12 month life expectancy)
* Chemotherapy or radiotherapy ongoing
* Patient who live more than 50 km away from Grenoble Hospital
* Willing of pregnancy within 18 months
* People protected by law (Article L1121.5 of Public Health Code)

Primary outcomes:
measure: Gait speed
timeFrame: Baseline : Day 0
measure: Stride time
timeFrame: Baseline : Day 0
measure: Stride length
timeFrame: Baseline : Day 0
measure: Double support time
timeFrame: Baseline : Day 0
measure: Stance time
timeFrame: Baseline : Day 0
measure: The Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: 18 months
Secondary outcomes:
measure: Evolution of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
timeFrame: From day 0 to 18-months
measure: Evolution of the Bath Ankylosing Spondylitis Functional Index (BASFI)
timeFrame: From day 0 to 18-months
measure: Evolution of gait pattern
timeFrame: From day 0 to 18-months
measure: Evolution of physical activity
timeFrame: From day 0 to 18-months
measure: Evolution of quality of life
timeFrame: From day 0 to 18-months
measure: Evolution of daytime sleepiness
timeFrame: From day 0 to 18-months
measure: Evolution of tiredness
timeFrame: From day 0 to 18-months
measure: Evolution of lower limbs range of motion assessments
timeFrame: From day 0 to 18-months
measure: Evolution of foot function
timeFrame: From day 0 to 18-months
measure: Evolution of six minute walk distance
timeFrame: From day 0 to 18-months
measure: Evolution of time to realize instrumented Timed Up and Go (iTUG)
timeFrame: From day 0 to 18-month
measure: Evolution of work impairment
timeFrame: From day 0 to 18-month
measure: Evolution of smoking status
timeFrame: From day 0 to 18-month
measure: Evolution of nicotine dependence
timeFrame: From day 0 to 18-month
measure: Evolution of social support
timeFrame: From day 0 to 18-month
Other outcomes:
Locations:
city: Échirolles
country: France
facility: CHU Grenoble Alpes - hôpital sud
Study officials:
References:
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citation: Zebouni L, Helliwell PS, Howe A, Wright V. Gait analysis in ankylosing spondylitis. Ann Rheum Dis. 1992 Jul;51(7):898-9. doi: 10.1136/ard.51.7.898.
citation: Mangone M, Scettri P, Paoloni M, Procaccianti R, Spadaro A, Santilli V. Pelvis-shoulder coordination during level walking in patients with ankylosing spondylitis. Gait Posture. 2011 May;34(1):1-5. doi: 10.1016/j.gaitpost.2011.02.002. Epub 2011 Mar 4.
citation: Soulard J, Vaillant J, Baillet A, Gaudin P, Vuillerme N. The effects of a secondary task on gait in axial spondyloarthritis. Sci Rep. 2021 Oct 1;11(1):19537. doi: 10.1038/s41598-021-98732-z.
citation: Soulard J, Vaillant J, Baillet A, Gaudin P, Vuillerme N. Gait and Axial Spondyloarthritis: Comparative Gait Analysis Study Using Foot-Worn Inertial Sensors. JMIR Mhealth Uhealth. 2021 Nov 9;9(11):e27087. doi: 10.2196/27087.
citation: Soulard J, Vaillant J, Balaguier R, Vuillerme N. Spatio-temporal gait parameters obtained from foot-worn inertial sensors are reliable in healthy adults in single- and dual-task conditions. Sci Rep. 2021 May 13;11(1):10229. doi: 10.1038/s41598-021-88794-4.
citation: Soulard J, Vaillant J, Balaguier R, Baillet A, Gaudin P, Vuillerme N. Foot-Worn Inertial Sensors Are Reliable to Assess Spatiotemporal Gait Parameters in Axial Spondyloarthritis under Single and Dual Task Walking in Axial Spondyloarthritis. Sensors (Basel). 2020 Nov 12;20(22):6453. doi: 10.3390/s20226453.
citation: Soulard J, Vuillerme N, Gaudin P, Grange L, Baillet A, Cracowski JL, Juvin R, Vaillant J. Gait as predictor of physical function in axial spondyloarthritis: the prospective longitudinal FOLOMI (Function, Locomotion, Measurement, Inflammation) study protocol. Rheumatol Int. 2019 Oct;39(10):1681-1688. doi: 10.1007/s00296-019-04396-4. Epub 2019 Aug 7.