CTRI registration and protocol designing for clinical trial of medical devices: A case of FES device for foot drop

This paper describes our experience in designing a clinical trial protocol and its registration in Clinical Trials Registry- India (CTRI). The aim of our trial is to assess efficacy of a newly developed indigenous, low cost functional electrical stimulator (FES) device for correcting foot drop in stroke survivors. We started with shortlisting the existing trials from the search result of different trial databases and published literatures. We picked those trials which are related to our research question and useful for designing our protocol. We compared our trial with shortlisted trials and explained the significance of various trial characteristics in designing a medical device trial. With this model study we intend to explain the processes involved in designing a clinical trial for devices from initiation of idea to registration in clinical trials registry.