Recruitment challenges in stroke neurorecovery clinical trials

Abstract

There are multiple available treatments to enhance stroke rehabilitation, although few interventions have confirmed significant clinical improvements on motor function in pivotal Randomized Clinical Trials. Development of large Randomized Clinical Trials is limited by several barriers and low enrollment rate is considered an important factor. Consequently, most of the evidence comes from small sample size studies, often leading to limited conclusions. According to the National Institute of Health (NIH), about 80% of clinical trials in the United States do not achieve their timelines, increasing research costs and postponing regulatory approval of new therapies. Given that the success of a Randomized Clinical Trial is dependent on enrolling an adequate number of subjects, effective strategies to enhance recruitment rates are highly desirable. In addition, given the resources and time limitations, it is important to understand which strategies are most cost-effective. In this manuscript, we summarize and discuss nine recruitment strategies used in an NIH R21 sponsored clinical trial, including medical records review and online advertising, among others. In addition, we developed an index to compare the time spent benefit of each approach and guide the allocation of the recruitment efforts. For this trial, online advertising and referral from health care professionals other than physicians were the strategies with greater time-benefit, leading to the largest number of stroke subjects enrolled.

Deficit of Inhibition as a Marker of Neuroplasticity (DEFINE Study) in Rehabilitation: A Longitudinal Cohort Study Protocol

“…The development of (i) substitute results for functional recovery and the understanding of the factors that influence the rehabilitation process will be possible to develop consistent and feasible studies. Currently, the majority of the studies in this field have low statistical power, without control of confounding variables, and reproducibility problems ( 64 ). In addition, the lack of substitute markers has allowed the approval of therapies without the background of consistent methodological studies.…”

Feasibility of the Lee Silverman Voice Treatment-BIG Intervention in Stroke

“…It is feasible to deliver the LSVT BIG intervention with individuals post-stroke. The recruitment rate was low but on par with current stroke rehabilitation clinical trial research (Ferreira et al, 2019). Retention and adherence rates were also high and above other recent larger studies of task-oriented approaches (Winstein et al, 2016).…”

General Practice and Digital Methods to Recruit Stroke Survivors to a Clinical Mobility Study: Comparative Analysis

“…Participant recruitment remains one of the main challenges in conducting clinical research, with many trials failing due to recruiting an inadequate number of study participants [ 1 , 2 ]. This is also true with regard to recruiting people poststroke to clinical research studies [ 3 ]. The disabling nature of a stroke, which often includes functional and cognitive impairments, makes recruiting patients particularly complex and challenging [ 3 , 4 ].…”