Corresponding Author: Peter Jüni MD, Applied Health Research Centre, Li Ka Shing Knowledge Institute, St Michael’s Hospital, 250 Yonge St, Toronto, ON M5B 2L7, Canada (peter.juni@utoronto.ca).
Accepted for Publication: March 3, 2020.
Author Contributions: Drs Reichenbach and Jüni had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Reichenbach, Felson, da Costa, Jones, Jüni.
Acquisition, analysis, or interpretation of data: Reichenbach, Felson, Hincapié, Heldner, Bütikofer, Lenz, da Costa, Bonel, Hawker, Jüni.
Drafting of the manuscript: Reichenbach, Felson, Hincapié, Jüni.
Critical revision of the manuscript for important intellectual content: Reichenbach, Hincapié, Heldner, Bütikofer, Lenz, da Costa, Bonel, Jones, Hawker, Jüni.
Statistical analysis: Bütikofer, Lenz, da Costa, Jüni.
Obtained funding: Jüni.
Administrative, technical, or material support: Felson, Heldner, da Costa, Jones, Jüni.
Supervision: Reichenbach, Felson, Bonel, Jüni.
Conflict of Interest Disclosures: Dr Jüni reported receiving grants from AstraZeneca, Biotronik, Biosensors, St Jude Medical, the Medicines Company, and the Canadian Institutes of Health Research; receiving honoraria from Amgen and Fresenius paid directly to his institution for participation on advisory boards; and serving as an unpaid member on steering committees for cardiovascular trials funded by AstraZeneca, Biotronik, Biosensors, St Jude Medical, and the Medicines Company. No other disclosures were reported.
Funding/Support: The trial was sponsored by Bern University Hospital and coordinated by CTU Bern, the University of Bern’s clinical trials unit. The trial was funded by the Mäxi Foundation. Dr Jüni is a tier 1 Canadian research chair in clinical epidemiology of chronic diseases; this research was completed, in part, with funding from the Canada Research Chairs Programme. Apos Medical Assets provided the biomechanical footwear system and the control footwear, and provided the technicians trained to install and calibrate the external pods on the biomechanical footwear without charge.
Role of the Funder/Sponsor: The funders had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
Data Sharing Statement: See Supplement 4.
Additional Contributions: We thank the participants who participated in this trial. We acknowledge Avi Elbaz, MD, and Amit Mor, MD, for their contributions in the development of the control footwear; both were paid members of the board of AposTherapy Israel. We thank Madeleine Dähler and Zina Heg, MSc, for their contributions to data collection. At the time of data collection, both were paid staff members at CTU Bern and their salaries were funded by the Mäxi Foundation.
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