Concussion impacts nearly 2 million children each year. Up to 30% of these patients will experience symptoms lasting weeks to months after injury. Current practice recommends strict rest for 24-48 hours post-concussion followed by a symptom-guided return to activity. Emerging evidence shows prolonged rest may be harmful by contributing to deconditioning, impeding the brain's nascent ability to heal, and/or setting up psychological barriers to recovery. We recently published results from a randomized controlled trial (RCT) of strict rest following acute concussion and found patients who were prescribed prolonged rest experienced greater symptoms and slower recovery. We also found that this negative effect was more pronounced if patients presented with post- concussive symptoms-only in the absence of more severe signs of injury. Exercise has been reported to aid brain recovery and improve symptoms in patients with prolonged recovery. Evidence also shows that early activity in patients is associated with lower rates of persistent post-concussive symptoms at 30 days. The objective of this proposal is to determine the benefit of prescribed low-intensity physical activity, behavioral management, or both, versus standard rest in acute concussion patients presenting to the Emergency Department (ED). We propose an exploratory phase II clinical trial with four treatment groups to determine the impact of an active injury management strategy and a parallel quality improvement (QI) initiative. This study aims to 1) determine the ideal discharge recommendations related to activity and behavioral management, and 2) develop and implement evidence-based decision support for concussion diagnosis, serial symptom assessment, and return to learn instructions. For the clinical trial, a total of 388 patients age 11-18 y/o presenting to the ED within 48 hours of a concussion will be recruited from two sites over three years to participate in a RCT of concussion management. Consented patients will be randomized to one of four treatment groups: 1) REST- prescribed rest for 24-48 hr with return to school and light physical and cognitive activity as soon as tolerated; 2) ACTIVITY-prescribed activity ?10,000 steps per day by the first week post injury?. 3) mHEALTH APP- use of a free ?resilience? app. 4) ACTIVITY + mHEALTH app. The primary outcomes will be symptoms and recovery at 14 days. The secondary outcomes will include activity levels (via actigraph), daily symptoms (via app), symptoms at 3 days (via phone), neurocognitive, vestibular/ocular motor, and balance impairment at 14 day (at follow-up), and pediatric quality of life measures, time to symptom resolution and return to normal activity at 1 and 2 months (via phone). We will conduct a QI initiative to improve the effectiveness and patient-centeredness of the care of patients in the ED with concussion by: 1) improving the quality of ED assessments; 2) improving the discharge process; 3) ensuring appropriate follow-up; and, 3) providing them with a tool to allow for the self-management of concussion as an outpatient. This proposal has potential to shift the paradigm for patients initially evaluated in the ED from rest to active management and demonstrate the impact clinicians can have in improving concussion outcomes.
Concussion impacts millions of children each year and many experience a prolonged recovery. A systematic approach to the evaluation and management of concussion and evidence-based recommendations for early activity could improve the quality of life for many children. This randomized clinical trial of active rehabilitation and quality improvement initiative will inform and improve the care of pediatric concussion in the emergency department.
