Implementation of Active Injury Management (AIM) in Youth with Acute Concussion: A Randomized Controlled Trial

Abstract

Background: Nearly 2 million youth seek acute medical care following concussion in the U.S. each year. Current standard of care recommends rest for the first 48 hours after a concussion. However, research suggests that prolonged rest may lengthen recovery time especially for patients with certain risk profiles. Research indicates that physical activity and behavioral management interventions (sleep, stress management) may enhance recovery. To date, there is limited empirical evidence to inform acute (<72 hours) concussion recommendations for physical activity and behavioral management in adolescents.

Objective: To determine the effectiveness of physical activity and behavioral management for acute concussion in adolescents and young adults, and to evaluate the role of patient characteristics on treatment response.

Methods: This multicenter prospective randomized controlled trial will determine which combination of physical activity and behavioral management is most effective for patients 11-24 years old who present to the emergency department or concussion clinic within 72 hours of injury. Participants are randomized into: 1) rest, 2) physical activity, 3) mobile health application (mHealth) behavioral management, or 4) physical activity and mHealth app conditions. Assessments at enrollment, 3-5 days, 14 days, 1 month, and 2 months include: concussion symptoms, balance, vestibular-ocular and cognitive assessments, quality of life, and recovery time. Somatic symptoms and other risk factors are evaluated at enrollment. Compliance with treatment and symptoms are assessed daily using actigraph and daily self-report. The primary study outcome is symptoms at 14 days.

Conclusion: Prescribed physical activity and behavioral management may improve outcomes in youth following acute concussion.

Note:
Clinical Trial Registration Details: This trial is recorded on clinicaltrials.gov, NCT03869970 https://clinicaltrials.gov/ct2/show/NCT03869970.

Funding Information: This study is supported by the Centers for Disease Control & Prevention (CDC), grant number 5U01CE002939-03, titled Research on Improving Pediatric mTBI Outcomes Through Clinician Training, Decision Support, and Discharge Instructions.

Declaration of Interests: None to declare.

Ethics Approval Statement: This trial is monitored by the Medical College of Wisconsin internal review board (IRB), Approval number PRO00033221.

Keywords: Concussionmild traumatic brain injurypediatricrandomized controlled trialphysical activity