Randomized Clinical Trials in Medical Rehabilitation Research1

Abstract

The purpose of this article is to provide researchers and clinicians with a basic understanding of randomized clinical trials and to discuss their potential application to and limitations in the field of physical medicine and rehabilitation. A brief history of the development of randomized clinical trials, definitions of clinical trials, types of trials, and overview of methodological issues related to design are offered. Information is provided about the need to establish clear and concise study objectives and to explicitly define interventions and expected outcomes. Recommendations for developing clinical protocols and determining adequate sample size are presented, and various statistical considerations, including power, are discussed. Issues related to sampling strategies, and recruitment are reviewed. Importance of randomization and blinding is emphasized. Readers are also referred to other resources available on this topic. Finally, the authors describe shortfalls associated with the use of this design in rehabilitation research. These are further explored and discussed in terms of the actual benefits and limitations of randomized clinical trials in physical medicine and rehabilitation research. Recommendations are made regarding the use of this methodology to address relevant needs in clinical practice.

The place and promise of theory in rehabilitation psychology research.

“…True to the rather egalitarian spirit of scholarly, scientific inquiry, the unique contributions of psychological theories often fade into the larger, ongoing rehabilitation enterprise and the origins of the theoretical innovation or application are forgotten. Yet it is disconcerting to read recent papers extolling research in rehabilitation, repeatedly emphasizing techniques, tools or support with no mention of theory development from psychological perspectives, or for programmatic research informed by psychological theories (Frontera et al, 2006; Tate, 2006; Tate, et al, 1999). Granted, these essays were chiefly concerned with the larger multidisciplinary enterprise of rehabilitation, but the lack of attention to the role of theory, generally, and psychological theories, specifically, in the research infrastructure (Frontera et al, 2006) or in the use of randomized clinical trials (RCTs; Tate, 2006) raises many questions about the way theory is viewed by many rehabilitation researchers.…”

Effects of isokinetic strength training on walking in persons with stroke: A double-blind controlled pilot study

“…Then, subjects were randomly assigned such that there were equal numbers of subjects for each level of strata in the experimental and control groups. 26,27 Participants were only aware that they were involved in 1 of the 2 different "leg training" programs (subject blinding). One researcher undertook all randomization and stratification procedures and training sessions, whereas another researcher undertook all assessment evaluations without knowledge of the participants' grouping (researcher blinding).…”

Peer Review

“…As a result, reviewers are likely to see a number of different types of research. 3 What is critical is that each research design be rigorously evaluated with an understanding of the challenges surrounding the conduct of rehabilitation research.…”

“…Types of research articles include, in order of preference, (1) cohort studies, such as randomized controlled trials and longitudinal studies, (2) case-control studies, (3) historical prospective studies, (4) cross-sectional studies, and (5) radiologic diagnostic studies. Single-subject design case studies can also be published.…”