Ankylosing SpondylitisFoLoMINCT03761212
Function, Locomotion, Measurement and Inflammation
An observational study of Ankylosing Spondylitis, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankylosing Spondylitis
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 13 Aug 2018to 10 Feb 2022
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patient with Ankylosing Spondylitis or Axial Spondyloarthritis at any stage of disease evolution followed at the Rhumatology unit of Grenoble Hospital
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Gait Parameters as Predictors of Functional and Activity Scores in Ankylosing Spondylitis : the FoLoMI Study
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.
Read the 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.
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing spondylitis, Gait, BASFI, BASDAI, 6MWT
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient with ankylosing spondylitis or axial spondyloarthritis | No intervention - observational study | |
| Healthy controls | Age and sex matched healthy controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 18 months
Secondary outcomes (15)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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.
Measured: From day 0 to 18-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start13 Aug 2018
- Primary completion10 Feb 2022
- Study completion10 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03761212
- Sponsor's protocol ID
- 38RC17.158.
- Acronym
- FoLoMI
- Status last verified
- Nov 2022
- First submitted
- 19 Jul 2018
- Last updated
- 23 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zochling 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 22588768Auvinet B, Chaleil D, Cabane J, Dumolard A, Hatron P, Juvin R, Lanteri-Minet M, Mainguy Y, Negre-Pages L, Pillard F, Riviere D, Maugars YM. The interest of gait markers in the identification of subgroups among fibromyalgia patients. BMC Musculoskelet Disord. 2011 Nov 11;12:258. doi: 10.1186/1471-2474-12-258.
PubMed 22078002Viccaro LJ, Perera S, Studenski SA. Is timed up and go better than gait speed in predicting health, function, and falls in older adults? J Am Geriatr Soc. 2011 May;59(5):887-92. doi: 10.1111/j.1532-5415.2011.03336.x. Epub 2011 Mar 15.
PubMed 21410448Del 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 21229328Verweij NM, Schiphorst AH, Pronk A, van den Bos F, Hamaker ME. Physical performance measures for predicting outcome in cancer patients: a systematic review. Acta Oncol. 2016 Dec;55(12):1386-1391. doi: 10.1080/0284186X.2016.1219047. Epub 2016 Oct 8.
PubMed 27718777Zebouni 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.
PubMed 1632666Mangone 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.
PubMed 21377366Soulard 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.
PubMed 34599222Soulard 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.
PubMed 34751663Soulard 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.
PubMed 33986307Soulard 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.
PubMed 33198119Soulard 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.
PubMed 31392500
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gait Parameters as Predictors of Functional and Activity Scores in Ankylosing Spondylitis : the FoLoMI Study
- ClinicalTrials.gov ID
- NCT03761212
- Acronym / sponsor ID
- FoLoMI / 38RC17.158.
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing spondylitis, Gait, BASFI, BASDAI, 6MWT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 10 Feb 2022 (actual)
- Study completion
- 10 Feb 2022 (actual)
- First posted
- 3 Dec 2018 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with ankylosing spondylitis or axial spondyloarthritis | – | –No intervention - observational study |
| Healthy controls | – | –Age and sex matched healthy controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with Ankylosing Spondylitis or Axial Spondyloarthritis at any stage of disease evolution followed at the Rhumatology unit of Grenoble Hospital
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gait speed
Time frame: Baseline : Day 0
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.
Stride time
Time frame: Baseline : Day 0
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.
Stride length
Time frame: Baseline : Day 0
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.
Double support time
Time frame: Baseline : Day 0
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.
Stance time
Time frame: Baseline : Day 0
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.
The Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: 18 months
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.
15 secondary outcomes
Evolution of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: From day 0 to 18-months
Evolution of the Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: From day 0 to 18-months
Evolution of gait pattern
Time frame: From day 0 to 18-months
Evolution of physical activity
Time frame: From day 0 to 18-months
Evolution of quality of life
Time frame: From day 0 to 18-months
Evolution of daytime sleepiness
Time frame: From day 0 to 18-months
Evolution of tiredness
Time frame: From day 0 to 18-months
Evolution of lower limbs range of motion assessments
Time frame: From day 0 to 18-months
Evolution of foot function
Time frame: From day 0 to 18-months
Evolution of six minute walk distance
Time frame: From day 0 to 18-months
Evolution of time to realize instrumented Timed Up and Go (iTUG)
Time frame: From day 0 to 18-month
Evolution of work impairment
Time frame: From day 0 to 18-month
Evolution of smoking status
Time frame: From day 0 to 18-month
Evolution of nicotine dependence
Time frame: From day 0 to 18-month
Evolution of social support
Time frame: From day 0 to 18-month
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 23 Nov 2022.
- 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 22078002Auvinet B, Chaleil D, Cabane J, Dumolard A, Hatron P, Juvin R, Lanteri-Minet M, Mainguy Y, Negre-Pages L, Pillard F, Riviere D, Maugars YM. The interest of gait markers in the identification of subgroups among fibromyalgia patients. BMC Musculoskelet Disord. 2011 Nov 11;12:258. doi: 10.1186/1471-2474-12-258.
- Background: PubMed 21410448Viccaro LJ, Perera S, Studenski SA. Is timed up and go better than gait speed in predicting health, function, and falls in older adults? J Am Geriatr Soc. 2011 May;59(5):887-92. doi: 10.1111/j.1532-5415.2011.03336.x. Epub 2011 Mar 15.
- 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 27718777Verweij NM, Schiphorst AH, Pronk A, van den Bos F, Hamaker ME. Physical performance measures for predicting outcome in cancer patients: a systematic review. Acta Oncol. 2016 Dec;55(12):1386-1391. doi: 10.1080/0284186X.2016.1219047. Epub 2016 Oct 8.
- Background: PubMed 1632666Zebouni 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.
- Background: PubMed 21377366Mangone 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.
- Results publication: PubMed 34599222Soulard 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.
- Results publication: PubMed 34751663Soulard 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.
- Results publication: PubMed 33986307Soulard 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.
- Results publication: PubMed 33198119Soulard 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.
- Results publication: PubMed 31392500Soulard 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ankylosing Spondylitis, run by University Hospital, Grenoble 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 4 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 23 Nov 2022. 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?
Gait speed (time frame: Baseline : Day 0). The study lists 6 primary outcomes in all. 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 NCT03761212, which also lists 12 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 23 Nov 2022.