Methodology and Implementation of a Randomized Controlled Trial (RCT) for Early Post-concussion Rehabilitation: The...

Background: Sports-related concussion (SRC) is a complex injury with heterogeneous presentation and management. There are few studies that provide guidance on the most effective and feasible strategies for recovery and return to sports participation. Furthermore, there have been no randomized studies of the feasibility, safety, and efficacy of early rehabilitation strategies across multiple sports and age groups. This international cluster-randomized pragmatic trial evaluates the effectiveness of early multi-dimensional rehabilitation integrated with the current return to sport strategy vs. the current return to sport strategy alone. Methods: The study is a cluster-randomized pragmatic trial enrolling male and female athletes from 28 sites. The sites span three countries, and include multiple sports, levels of play (high school, college, and professional), and levels of contact. The two study arms are Enhanced Graded Exertion (EGE) and Multidimensional Rehabilitation (MDR). The EGE arm follows the current return to sport strategy and the MDR arm integrates early, MDR strategies in the context of the current return to sport strategy. Each arm employs a post-injury protocol that applies to all athletes from that site in the event they sustain a concussion during their study enrollment. Participants are enrolled at pre-season baseline. Assessment timepoints include pre-season baseline, time of injury (concussion), 24-48 h post-injury, asymptomatic, and 1-month post-injury. Symptoms and activity levels are tracked post injury through the return to play process and beyond. Injury and recovery characteristics are obtained for all participants. Primary endpoints include time to medical clearance for full return to sport and time to become asymptomatic. Secondary endpoints include symptom, neurocognitive, mental status, balance, convergence insufficiency, psychological distress, and quality of life trajectories post-injury. Discussion: Outputs from the trial are expected to inform both research and clinical practice in post-concussion rehabilitation across all levels of sport and extend beyond civilian medicine to care for military personnel. Ethics and Dissemination: The study is approved by the data coordinating center Institutional Review Board and registered at clinicaltrials.gov. Dissemination will include peer-reviewed publications, presentation to patients and public groups, as well as dissemination in other healthcare and public venues of interest. Clinical Trial Registration: www.ClinicalTrials.gov, identifier: NCT02988596 Trial Funding: National Football League.