Design and implementation of clinical trials in rehabilitation research

Tessa Hart, Emilia Bagiella

Research output: Contribution to journalComment/debate

65 Scopus citations


The growth of evidence-based medicine means that both researchers and clinicians must grasp the complex issues involved in implementing clinical trials, which are especially challenging for the behavioral (experience-based) treatments that predominate in rehabilitation. In this article we discuss selected issues germane to the design, implementation, and analysis of group-level clinical trials in rehabilitation. We review strengths, weaknesses, and best applications of 1-sample, between-subjects, and within-subjects study designs, including newer models such as practical clinical trials and point-of-care trials. We also discuss the selection of appropriate control conditions against which to test rehabilitation treatments, as well as issues related to trial blinding. In a section on treatment definition, we discuss the challenges of specifying the active ingredients in the complex interventions that are widely used in rehabilitation, and present an illustration of 1 approach to defining treatments via the learning mechanisms that underlie them. Issues related to treatment implementation are also discussed, including therapist allocation and training, and assessment of treatment fidelity. Finally we consider 2 statistical topics of particular importance to many rehabilitation trials: the use of multiple or composite outcomes, and factors that must be weighed in estimating sample size for clinical trials.

Original languageEnglish
Pages (from-to)S117-S126
JournalArchives of Physical Medicine and Rehabilitation
Issue number8 SUPPL.
StatePublished - Aug 2012
Externally publishedYes


  • Clinical trials as topic
  • Rehabilitation
  • Research design


Dive into the research topics of 'Design and implementation of clinical trials in rehabilitation research'. Together they form a unique fingerprint.

Cite this