Introduction
sub-acute stroke, post-stroke, long-term disability, Stroke
SECONDARY, STROKE
Stroke is a leading cause of long-term disability with substantial social costs [Electroencephalography (EEG)-based brain-computer interface (BCI) is an emerging technology that enables the direct translation of brain activity into physical motion [In a pilot study, an EEG-based BCI-assisted MI training (BCI-MI) administered using a BCI system fully compliant with rehabilitation requirements—the Promotoer system—proved to be useful in enhancing post-stroke functional hand motor recovery [The primary objective of the “Promotoer” trial is to determine whether the BCI-MI administered using a BCI system fully compatible with a clinical setting (the Promotoer) is superior to a non-BCI assisted MI training (Control-MI) in improving hand motor function outcomes in sub-acute stroke patients admitted to the hospital for their standard rehabilitation care. The secondary objectives of this study are as follows: (i) to assess the long-term efficacy of the BCI-based intervention on hand motor function outcome (6 months follow-up) and (ii) to determine if the clinical improvement is accompanied by a long-lasting neuroplasticity change. Moreover, the study aims to identify biomarkers and potential predictors of patient responses to the BCI-Promotoer training.The protocol of the study, providing detailed information on background, study design, experimental intervention, and clinical procedures, was published previously [In this article, we report the details of the statistical analysis plan (SAP) of the Promotoer study (SAP Version 1.0 July 13, 2023), based on information contained in the PROMOTOER Clinical Protocol Version 1.0 [