Soulard, Julie http://orcid.org/0000-0001-8138-1447
Vuillerme, Nicolas http://orcid.org/0000-0003-3773-393X
Gaudin, Philippe http://orcid.org/0000-0002-7864-280X
Grange, Laurent http://orcid.org/0000-0002-3288-2015
Baillet, Athan http://orcid.org/0000-0001-6006-2519
Cracowski, Jean-Luc http://orcid.org/0000-0003-0787-1469
Juvin, Robert http://orcid.org/0000-0001-8286-6411
Vaillant, Jacques http://orcid.org/0000-0001-5288-7086
Clinical trials referenced in this document:
Documents that mention this clinical trial
Gait as predictor of physical function in axial spondyloarthritis: the prospective longitudinal FOLOMI (Function, Locomotion, Measurement, Inflammation) study protocol
https://doi.org/10.1007/s00296-019-04396-4
Funding for this research was provided by:
French Ministry of Health and Solidarity (PHRIP-16-0528)
Agence Nationale de la Recherche (ANR-10-AIRT-05, ANR-15-IDEX-02)
Article History
Received: 2 July 2019
Accepted: 26 July 2019
First Online: 7 August 2019
Compliance with ethical standards
:
: The authors declare that they have no proprietary, financial, professional, or other competing interests regarding this study and the publication of this paper.
: The study was approved by local ethic committee (CPP IDF1, RCB: 2017-A03468-45, date of agreement: July 17th, last version: V4.0, 2018, March 5th, 2019). This study protocol is registered on ClinicalTrials.gov, with the following ID: NCT03761212 and follow the SPIRIT checklist. Written informed consent will be obtained from all participants by the physiotherapist or a medical doctor. Any modification to the initial protocol will be presented to the local ethics committee and has to be accepted before application and will be registered on ClinicalTrials.gov.
: Data of the participants are anonymized with a participant number. A clinical research associate, mandated by the Grenoble Alpes University Hospital, will monitor the study depending on inclusion rhythm and following a pre-prepared plan. Each monitoring will be associated with a written record. Besides, an audit or an inspection by health authorities can be conducted, independently of the sponsor and promotor, at any time to ensure research quality, result validity, and law respect.
: The data collection started in August 2018 and will be completed with the inclusion and follow-up of all the participants (60 patients with axSpA and 30 healthy controls). We plan the results of this study to be presented at international oriented scientific and clinical conferences and to be published in peer-reviewed scientific journals.