Symptom Exacerbation and Adverse Events During a Randomized Trial of Early-Stage Rehabilitation After Sport-Related Concussion: Safety Outcomes From the Active Rehab Study

• Published in: Journal of athletic training 2024-12, Vol.59 (12), p.1163-1170
• Main Authors: Register-Mihalik, Johna K, Guskiewicz, Kevin M, Marshall, Stephen W, McCulloch, Karen L, Mihalik, Jason P, Mrazik, Martin, Murphy, Ian, Naidu, Dhiren, Ranapurwala, Shabbar I, Schneider, Kathryn J, Gildner, Paula, Salmon, Danielle M, Auton, Brandon, Bowman, Thomas G, Hall, Eric E, Hynes, Loriann M, Jewell, Elizabeth, Ketcham, Caroline J, Siler, Caroline Wesley, Sullivan, S John, Kostogiannes, Vasiliki, McCrea, Michael A
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Anxiety Disorders; Athletes; Athletic Injuries - rehabilitation; Brain Concussion - rehabilitation; Canada; Concussion; Exercise Therapy - methods; Female; Football - injuries; Humans; Male; New Zealand; Post-Concussion Syndrome - rehabilitation; Rehabilitation; Return to Sport; Young Adult
• ISSN: 1062-6050; 1938-162X; 1938-162X
• DOI: 10.4085/1062-6050-0696.23

Authors of few studies have used randomized controlled trials (RCTs) to quantify clinical intervention safety of rehabilitation after sport-related concussion across sport levels. Describe symptom exacerbation and adverse events (AEs) associated with two concussion rehabilitation interventions. Cluster RCT (NCT02988596). Sports medicine clinic and field settings. The RCT enrolled 251 concussed athletes (median age = 20 years; female, n = 48) across 28 sites from New Zealand professional rugby (n = 31), Canadian professional football (n = 52), US/Canadian colleges (n = 128) and US high schools (n = 40). Two medically supervised interventions: (1) enhanced graded exertion (EGE): international return-to-sport strategy and sport-specific activities only (EGE only, n = 119); and (2) multidimensional rehabilitation (MDR) followed by EGE: early symptom-directed exercises once symptoms were stable, followed by EGE after symptoms resolved (MDR + EGE, n = 132). Primary outcomes were intrasession total symptom severity score exacerbation and significant intersession (increase 10+ severity points) sustained total symptom severity exacerbation, each measured with the Postconcussion Symptom Scale (132 total severity points on scale). Reported AEs were also described. Activity-based rehabilitation sessions (n = 1437) were the primary analysis unit. Frequencies, proportions, medians, and interquartile ranges were calculated for outcomes by treatment group. The 251 postinjury participants completed 1437 (MDR + EGE = 819, EGE only = 618) activity-based intervention sessions. A total of 110 and 105 participants contributed data (those missing had no documented session data) to at least 1 activity-based session in the MDR + EGE and EGE-only arms, respectively. Intrasession symptom exacerbations were equivalently low in MDR + EGE and EGE-only arms (MDR + EGE: 16.7%, 95% CI = 14.1%, 19.1%; EGE only: 15.7%, 95% CI = 12.8%, 18.6%). In total, 9/819 MDR + EGE sessions (0.9%) and 1/618 EGE-only sessions (0.2%) resulted in a presession to postsession symptom exacerbation beyond a 10+ severity point increase; 8/9 resolved to