Role of Rehabilitation in Concussion Management: A Randomized Controlled Trial
Completed · Not applicable
Conditions studied: Concussion, Brain
In brief
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
Key facts
- Study ID
- NCT02988596
- Run by
- University of North Carolina, Chapel Hill
- People needed
- 251
- Starts
- 2017-01-01
- Expected to finish
- 2019-08-01
- Last updated by the study team
- 2021-07-30
Who can join
Age: 13 and older, up to 99. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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).
You may not qualify if…
- 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.
Where it is running
- North Carolina Central University — Durham, North Carolina, United States
- Elon University — Elon, North Carolina, United States
- Orange County High School — Hillsborough, North Carolina, United States
- Northwood High School — Pittsboro, North Carolina, United States
- Catawba College — Salisbury, North Carolina, United States
- Lynchburg College — Lynchburg, Virginia, United States
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
- University of Alberta — Edmonton, Alberta, Canada
- York University — Toronto, Ontario, Canada
- Canadian Football League — Toronto, Ontario, Canada
- New Zealand Rugby — Wellington, New Zealand
Full record on ClinicalTrials.gov
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