Looking in the rear view mirror when conversing with back seat drivers: the EXCITE trial revisited.

ABSTRACT

The initial point of view Directions for Research (Neurorehabilitation and Neural Repair, 2007;213-13) identified confounders that might limit the impact that rehabilitation multicenter clinical trials may have upon altering practice patterns. Part of that viewpoint addressed the Extremity Constraint Induced Therapy Evaluation (EXCITE) Trial and highlighted some of its perceived strengths and limitations. The present Point of View expands upon factors worthy of consideration in planning and executing clinical trials in neurorehabilitation based upon experiences encountered by the EXCITE team. Cost factors and patient attributes, both of which profoundly influence the ability of clinical researchers to execute the ideal study, are among these factors. In particular, the costs associated with large trials necessitate compromise in study design or implementation, resulting in a dichotomy between what should be undertaken and what can be accomplished.