Are explanatory randomized controlled trials feasible in rehabilitation?

Randomized controlled trials (RCTs) investigate causal relationships and are considered to provide the best evidence of intervention efficacy in health care (Roland and Torgerson, 1998). To ensure valid and reliable results, a RCT should include specific criteria such as a clearly defined participant group and intervention, adequate sample size, randomization, allocation concealment, baseline reporting, prescriber/assessor and participant blinding, appropriate outcome measures, and consideration of the intention-to-treat principle (Morrow, 2008). While RCTs may be considered an appropriate methodology to answer some clinical questions in the field of rehabilitation, it is not typically possible to satisfy all RCT criteria in most rehabilitation settings. In particular, blinding, and defining both the intervention and the participant group are difficult criteria to implement in this field (Halm et al, 2002; Boutron et al, 2007).