Role of Rehabilitation in Concussion Management: A Randomized Controlled Trial

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.