Statistical Analysis Plan (SAP) for AyuRvedic TrEatment in the Rehabilitation of Ischemic STrOke Patients in India: A Randomized Controlled Trial (RESTORE)

Abstract

Background Stroke often results in a loss of functional ability. The evaluation of recovery after a stroke is crucial for both treatment and research. The AyuRvedic TrEatment in the Rehabilitation of Ischemic STrOke Patients in India: A randomized controlled trial (RESTORE) aims to generate evidence-based data for creating a uniform rehabilitation protocol and initiating a cross-referral practice to support an integrative treatment approach. The objective is to develop a detailed statistical analysis plan for the RESTORE trial prior to data analysis. Methods The statistical analysis plan was developed by the trial statistician with the assistance of the RESTORE trial principal investigator and the trial management team. The statistical analysis plan was built using the specified primary and secondary outcome measures, as well as knowledge of important baseline data. All data collected will be thoroughly examined. Results The final statistical analysis plan corresponds to established criteria and will allow for transparent and efficient reporting. Conclusions The RESTORE trial statistical analysis plan is created to reduce analysis bias caused by prior knowledge of results and to explicitly outline prespecified analysis.