Function, Locomotion, Measurement and Inflammation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Gait Parameters as Predictors of Functional and Activity Scores in Ankylosing Spondylitis : the FoLoMI Study

Conditions
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Ankylosing Spondylitis

Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with ankylosing spondylitis or axial spondyloarthritis<br>No intervention - observational study | |
| Healthy controls<br>Age and sex matched healthy controls | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gait speed | Mean gait speed (m/s) will be assessed during a 10-m walk test at comfortable speed, under single and dual task, and its coefficient of variation calculate. | Baseline : Day 0 | 
| Stride time | Mean stride time (s) will be assessed during a 10-m walk test at comfortable speed, under single and dual task, and its coefficient of variation calculate. | Baseline : Day 0 | 
| Stride length | Mean stride length (m) will be assessed during a 10-m walk test at comfortable speed, under single and dual task, and its coefficient of variation calculate. | Baseline : Day 0 | 
| Double support time | Double support time (%) will be assessed during a 10-m walk test at comfortable speed, under single and dual task, and its coefficient of variation calculate. | Baseline : Day 0 | 
| Stance time | Stance time (%) will be assessed during a 10-m walk test at comfortable speed, under single and dual task, and its coefficient of variation calculate. | Baseline : Day 0 | 
| The Bath Ankylosing Spondylitis Functional Index (BASFI) | The self-administered Bath Ankylosing Functional Index (BASFI) measures functional consequences of ankylosing spondylitis (AS). The patient indicates its level of ability in ten domains of daily life: put the socks, bend to pick a pen from the floor, reach up to a high shelf, get up from a chair and from the floor, stand unsupported for 10 minutes, climb steps, look over the shoulder, do physically demanding activities and do a full days activities. Each question is answered on a 10 cm horizontal visual analog scale, the mean of which gives the BASFI score (0-10). Higher is the score, higher are the functional consequences of AS. | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) | The self-administered Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) measures disease activity. Six 10 cm horizontal visual analog scales are used to measure severity of fatigue, spinal and peripheral joint pain, localized tenderness and morning stiffness (qualitative and quantitative). The final BASDAI score has a range from 0 to 10, with higher scores meaning higher activity of the disease. | From day 0 to 18-months | 
| Evolution of the Bath Ankylosing Spondylitis Functional Index (BASFI) | The self-administered Bath Ankylosing Functional Index (BASFI) measures functional consequences of ankylosing spondylitis (AS). The patient indicates its level of ability in ten domains of daily life: put the socks, bend to pick a pen from the floor, reach up to a high shelf, get up from a chair and from the floor, stand unsupported for 10 minutes, climb steps, look over the shoulder, do physically demanding activities and do a full days activities. Each question is answered on a 10 cm horizontal visual analog scale, the mean of which gives the BASFI score (0-10). Higher is the score, higher are the functional consequences of AS. | From day 0 to 18-months | 
| Evolution of gait pattern | Gait pattern will be captured by Physilog sensors (Gait Up ®) and Opal sensors (APDM®) during a 10-m walk test in single and dual task, the iTUG and the i6MWT. | From day 0 to 18-months | 
| Evolution of physical activity | Patients will fill in the self-assessment questionnaire: International Physical Activity Questionnaires (IPAQ) to measure health-related physical activity. Data will be summarized according to each physical activity domain (walking, moderate and vigorous activities) and estimated time spend sitting per week. Then data will be used to estimate Metabolic Equivalent of Task (MET) energy expenditure assigned to each category. | From day 0 to 18-months | 
| Evolution of quality of life | Patients will fill in the self-assessment questionnaire: Short Form-36 (SF-36) to measure quality of life. Eight domains will be assessed : physical activity, daily life limitations, physical pain, health, social life, psychological health, psychological limitations, health evolution. | From day 0 to 18-months | 
| Evolution of daytime sleepiness | Patients will fill in the self-assessment questionnaire: Epworth score for evaluation of daytime sleepiness. Patients wil rate the chances that they would doze off or fall asleep while in eight different situations, from no chance to doze or sleep (0) to strong chance to sleep (3). | From day 0 to 18-months | 
| Evolution of tiredness | Patients will fill in the self-assessment questionnaire: Pichot score for evaluation of daytime tiredness. This scale assess the importance of tiredness to carry out daily activities.Patients rate how the eight proposals correspond to their feeling, from not at all (0) to extremely (4). | From day 0 to 18-months | 
| Evolution of lower limbs range of motion assessments | Lower limb range of motion will be assessed using a goniometer in each joint. | From day 0 to 18-months | 
| Evolution of foot function | Foot function will be assessed with the validated and commonly used Foot Function Index. Participants will rate 0 to 10 on a numeric scale, in 3 domains concerning feet, i.e. pain, disability and activity restriction. The score is out of 230 and translated out of 100. Higher scores are related to worse outcome. | From day 0 to 18-months | 
| Evolution of six minute walk distance | The instrumented six minute walk test (i6MWT) will be performed in a 30-m corridor. | From day 0 to 18-months | 
| Evolution of time to realize instrumented Timed Up and Go (iTUG) | Patients will performed the iTUG : they have to stand up from a chair, walk 7 meters, turn and go back to the chair, as fast as possible | From day 0 to 18-month | 
| Evolution of work impairment | The validated Work Productivity and Activity Impairment scale (WPAI) will be assessed to evaluate absenteeism, presenteeism, overall work productivity loss and activity impairment. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity, i.e., worse outcomes. | From day 0 to 18-month | 
| Evolution of smoking status | Smoking status will be assessed with the calculation of number of pack-year smoked. It is calculated by multiplying the number of packs of cigarettes smoked per day by the number of years the person has smoked. | From day 0 to 18-month | 
| Evolution of nicotine dependence | Smoking status will be assessed with the validated and commonly used Fagerström index, giving a score from 0 to 10, with high scores related to high dependence | From day 0 to 18-month | 
| Evolution of social support | Social support will be assessed with the validated and commonly used Medical Outcome Study (MOS) Social Support Survey in French. The survey consists of four separate social support subscales and an overall functional social support index. A higher score for an individual scale or for the overall support index indicates more support. | From day 0 to 18-month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ankylosing spondylitis, Gait, BASFI, BASDAI, 6MWT