Scientific research with individuals post stroke: difficulties in recruitment, allocation and adherence on two different protocols of physiotherapy intervention

Abstract

This study analyze the difficulties in recruitment, allocation and adherence of individuals with hemiparesis after stroke in the development of two randomized clinical trials (RCTs). For this, data were extracted from two RCTs that investigated patients with hemiparesis due to stroke, living in Florianópolis, aged over 40 years. RCTs interventions were based to task-oriented training and were performed evaluations at three different times (pre, post, follow-up). The sample calculations determined the need of 54 participants for Study I and 36 for Study II. The quantitative data were analyzed using descriptive statistics and qualitative information through the content analysis. It was found that of 127 potential participants, it was not possible to contact 18.1%, and 5.5% came to death. In preselection 6.3% were hospitalized/bedridden, 7% had no interest and 4.7% were unable to transport. During allocation 33% were excluded for not meeting the eligibility criteria. Among 32 patients who remained in the study, 16% missed the Study I and 2.5% the Study II. Wrong contact data, lack of resources for transportation, eligibility criteria and lack of interest were the factors that hindered the recruitment of subjects. Therefore, we suggested that the relations improvement between research centers and institutions, the proper recording of contacts, access to clinical records, the availability of financial resources to support the recruitment and transportation and increased funding for RCTs can improve the viability of this type of study in Brazil.