Role of Rehabilitation in Concussion Management: A Randomized Controlled Trial
Role of Rehabilitation in Concussion Management: A Randomized Controlled Trial
Approximately 420 professional and amateur athletes will participate in rehabilitation during
 recovery after sports-related concussion. Participants will be cluster randomized, by study
 site, to a specific study arm. Participants will complete post-injury assessments and the
 intervention of their randomized group aimed at understanding the effects of a
 multidimensional rehabilitation protocol versus enhanced graded exertion on clinical
 recovery, return to play, and patient outcomes after sport related concussion
Approximately 6,600 athletes will complete baseline assessments and 420 of these individuals
 who suffer a concussion during the course of study will be directed through the post-injury
 protocol. Following injury, participants will complete post-injury assessments and follow the
 specific intervention of their randomized group. Post-injury assessments will focus on the
 following: postural stability, neuro-cognitive function, symptom presence and severity,
 fatigue, vision, dual-task ability, and mental status. Participants will complete outcome
 assessments at the following time points: time of injury, 24-48 hours post-injury,
 asymptomatic, and one month post return to play. Symptoms and physical and cognitive activity
 will be assessed daily from the first assessment point to 7 days post return to play. Session
 logs will be kept by the supervising clinician at each study site regardless of study arm.
 Baseline and outcome assessments will be entered into a secure online platform, each study
 site will have the option for paper records of outcomes and session logs to be double entered
 into the electronic system at a later date.
Subjects will be recruited from 3 cohorts of athletes: 1) high school; 2)
 college/university and 3) professional.

 HIGH SCHOOL COLLEGE/UNIVERSITY COHORTS:

 Inclusion criteria:

 -  Individuals who are at least 13 years of age and a rostered student-athlete on the
 participating teams at the enrolled schools (football, wrestling, men's/women's
 soccer, men's/women's lacrosse, and men's/women's ice hockey, men's/women's rugby, and
 men's/women's basketball or other sports designated at the site).

 Exclusion criteria:

 -  Individuals who are at least 13 years of age and those not rostered in a sport at
 his/her school.

 PROFESSIONAL COHORT:

 Inclusion criteria:

 -  Individuals who are 18 years of age or older and rostered on one of the participating
 professional teams.

 Exclusion criteria:

 -  Individuals under 18 years of age and those not rostered on one of the participating
 professional teams.

 ELIGIBILITY FOR THE STUDY INTERVENTION: ALL COHORTS

 Inclusion criteria:

 -  Only those athletes with a concussion, guided by the following definition will engage
 in their respective intervention arms following concussion. The study definition is
 one from the Department of Defense (DOD). This definition was chosen, as it is s a
 guiding definition in the NCAA-DOD grand alliance Concussion Assessment, Research and
 Education (CARE) consortium, the largest concussion study to date
 (http://www.careconsortium.net/about/).

 -  Concussion will be defined as a change in brain function following a force to the
 head, which may (or may not) be accompanied by temporary loss of consciousness (LOC)
 (if LOC, temporary is study defined as < 30 minutes based on the Mayo traumatic brain
 injury (TBI) severity guidelines), but is identified in awake individuals with
 measures of neurologic and cognitive dysfunction, as indicated by 1 or more the
 symptoms listed below.

 Symptoms: headache, 'pressure in the head', neck pain, nausea/vomiting, dizziness, blurred
 vision, balance problems, sensitivity to light, sensitivity to noise, feeling slowed down,
 felling like 'in a fog', 'don't feel right, difficulty concentrating, difficulty
 remembering, fatigue/low energy, confusion, drowsiness, trouble falling asleep, more
 emotional, irritability, sadness, nervous/anxious.

 -  These symptoms are from the international consensus document on concussion in sport
 and represent the most common 22 symptoms of concussion (McCroy & Concussion in Sport
 Group, 2013). All concussions are, by general definition, mild TBIs with Glasgow Coma
 Score (GCS) scores of 13-15 (with the majority being 14-15). No athlete with a GCS <13
 will be started in the intervention progression of either arm.

 Exclusion criteria:

 -  Individuals with any positive/abnormal clinical neuroimaging finding(s) following
 injury WILL NOT enter the intervention or will discontinue the intervention should
 these findings be observed after intervention has begun.

 -  In addition, any individual presenting with any of the moderate-severe TBI
 presentation as defined in the Mayo definitions (Malec, 2007) will not enter the
 intervention or will be withdrawn if observed at a later time. Although these
 individuals will be discontinued from the intervention, the investigators will
 continue to collect assessment time point data on these individuals and documentation
 for their overall care.