We propose a randomized clinical trial to yield preliminary data on the added benefits of active rehabilitation during recovery after sport-related concussion in professional and amateur athletes. This trial marks an international collaborative effort involving the NFL, CFL, New Zealand Rugby, American Hockey League, and academic researchers in the United States.
The specific technical and scientific aims of this study are to:
1. Compare the effects of a multidimensional rehabilitation protocol versus enhanced graded exertion on clinical recovery, return to play, and patient outcomes after SRC.
2. Demonstrate the safety and feasibility of active intervention protocols when introduced during the sub-acute recovery period after SRC, as part of an multidimensional rehabilitation protocol.
We have chosen to intervene at the sub-acute phase based on the hypothesis that controlled and supervised activity will facilitate recovery and will result in accelerated recovery and more prepared return to participation in sport.
The proposed study design will be a cluster (sport participation group: CFL, NZ Rugby, AHL, College, High School), randomized control trial . The study will be conducted over a 36-month period with a 28-month data collection period to capture two full football seasons of data. Concussion will be defined as a change in brain function following a force to the head, which may be accompanied by temporary loss of consciousness, but is identified in awake individuals with measures of neurologic and cognitive dysfunction (Dept. of Defense Evidence Based Guidelines). Diagnosis of concussion will be made through a clinical exam and supported by objective measures. Historical standard of care data will be incorporated through two-years of retrospective datasets available for all cohorts included in the study.
Investigators and Key Personnel
Johna Register-Mihalik, PI, Kevin Guskiewicz, Steve Marshall, Jason Mihalik, Mike McCrea Karen McCulloch, Julianna Prim
Primary Funding Source
Injury Prevention Research Center as a collaborating institute Also add National Football League