Statistical interim analysis and stopping guidance
IPS
RECRUITMENT
To check the congruity of nuisance parameters used in sample size calculation, an internal pilot study (IPS) for sample-size recalculation was planned on data of primary outcome in the first 20 participants. Specifically, estimates of standard deviations of the effectiveness of the FMA score at the end of intervention training (T1) in the intervention group will be obtained from masked IPS data and used in the sample size procedure specified in the “No interim efficacy analysis is planned. Pockock method for control of family-wise type I might be implemented by using the software RPACK (Confirmatory Adaptive Clinical Trial Design and Analysis, R package), if an interim analysis is required due to changes in the recruitment conditions.