Sergi, FabrizioPehlivan, Ali UtkuFitle, KyleNedley, KathrynYozbatiran, NurayFrancisco, Gerard E.O’Malley, Marcia K.2016-01-202016-01-202015Sergi, Fabrizio, Pehlivan, Ali Utku, Fitle, Kyle, et al.. "Design of a parallel-group balanced controlled trial to test the effects of assist-as-needed robotic therapy." <i>2015 IEEE International Conference on Rehabilitation Robotics (ICORR),</i> (2015) IEEE: 840-845. http://dx.doi.org/10.1109/ICORR.2015.7281307.https://hdl.handle.net/1911/87886In this methods paper, we report on the design of a clinical study testing the efficacy of a newly developed control scheme for robot-aided rehabilitation. To measure the value added by a new control scheme, we pursued a parallel-group controlled clinical study design. This approach enables comparing the effects of the novel scheme, based on the Assist-As-Needed (AAN) paradigm, with those of a less sophisticated, fixed gain, Subject-Triggered (ST) controller. We describe the steps followed in the design of this clinical study, including details on the implementation of the two control modes, and a power analysis to determine the required number of subjects to test a clinically significant difference hypothesis. Finally, we present a method for sequential group assignment with co-variates minimization, capable of guaranteeing a desired level of balance of prognostic factors in the two study groups, a crucial requisite for small-scale clinical studies in rehabilitation. To the best of our knowledge, the study presented is the first one testing, in a controlled fashion, the differential effects of a specific control mode in upper extremity rehabilitation after incomplete spinal cord injury.engThis is an author's peer-reviewed final manuscript, as accepted by the publisher. The published article is copyrighted by IEEE.Journal articlehttp://dx.doi.org/10.1109/ICORR.2015.7281307