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.
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.
Study Type
OBSERVATIONAL
Enrollment
90
CHU Grenoble Alpes - hôpital sud
Échirolles, France
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 18 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: From day 0 to 18-month