Analysis methods for primary and secondary outcomes
SECONDARY
The primary analysis will be carried out on the primary outcome in the ITT population—namely effectiveness of the UE-FMA at T1. In the secondary analysis, the analysis of the primary outcome will be carried out in the PP population. The secondary outcomes will be compared between groups both in the ITT and PP populations.For continuous variables (effectiveness of UE-FMA score, of ARAT score, of NIHSS score, of MMT score, NRS, QCM, Workload NASA-TLX, SUS, QUEST, VAS Mood, VAS Satisfaction) descriptive statistics (mean and standard deviation, median and interquartile range) will be reported by intervention group for each evaluation time/training session. To determine whether and to what extent the long-term efficacy of the BCI intervention on the UE-FMA score can be maintained after the end of the intervention, we will use a repeated measures analysis of variance (ANOVA). ANOVA will treat the group as a between-subject factor and time as a within-subject factor, assessing the effectiveness of the UE-FMA scores at T1, T2, T3, and T4.All categorical variables will be summarized (by number and frequency) in each intervention group and compared between groups by Fisher’s test, at each evaluation time (T2, T3, T4).To identify clinical and/or neurophysiological determinants of MCID (Table Statistical analysis of the MAS score will be detailed for shoulder, elbow, and wrist. Descriptive statistics on frequency distributions will be reported for each time point (T1, T2, T3 and T4) and compared between intervention groups by chi-square test. Moreover, a change in the score between T0 and T1, and changes along the follow-up (e.g. T2 vs T0; T3 vs T0, T3 vs T0, and T4 vs T0) will be computed and defined as improved/stable/deteriorated. Such changes will be compared in the intervention groups using a chi-square test or Fisher’s exact test.Scores obtained in user experience assessments for QCM (separately for Mastery confidence, Incompetence/Fear-to Fall, Challenge and Interest), Workload NASA-TLX, SUS, QUEST, VAS Mood, and VAS Satisfaction, will be described for each experimental group and comparisons will be carried out using the methodologies adopted for other continuous variables. Analyses will be carried out by training sessions.