Design of a parallel-group balanced controlled trial to test the effects of assist-as-needed robotic therapy

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dc.citation.firstpage840
dc.citation.journalTitle2015 IEEE International Conference on Rehabilitation Robotics (ICORR)
dc.citation.lastpage845
dc.contributor.authorSergi, Fabrizio
dc.contributor.authorPehlivan, Ali Utku
dc.contributor.authorFitle, Kyle
dc.contributor.authorNedley, Kathryn
dc.contributor.authorYozbatiran, Nuray
dc.contributor.authorFrancisco, Gerard E.
dc.contributor.authorO’Malley, Marcia K.
dc.contributor.orgMechatronics and Haptic Interfaces Laboratory
dc.date.accessioned2016-01-20T19:40:21Z
dc.date.available2016-01-20T19:40:21Z
dc.date.issued2015
dc.description.abstractIn 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.
dc.identifier.citationSergi, 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.
dc.identifier.doihttp://dx.doi.org/10.1109/ICORR.2015.7281307
dc.identifier.urihttps://hdl.handle.net/1911/87886
dc.language.isoeng
dc.publisherIEEE
dc.rightsThis is an author's peer-reviewed final manuscript, as accepted by the publisher. The published article is copyrighted by IEEE.
dc.titleDesign of a parallel-group balanced controlled trial to test the effects of assist-as-needed robotic therapy
dc.typeJournal article
dc.type.dcmiText
dc.type.publicationpost-print
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