Citation

Thomas D, Erpenbach H, Hickey RW, Waltzman D, Haarbauer-Krupa J, Nelson LD, Patterson CG, McCrea M, Collins M, Kontos AP. Contemp. Clin. Trials 2022; ePub(ePub): ePub.

Copyright

(Copyright © 2022, Elsevier Publishing)

DOI

10.1016/j.cct.2022.106965

PMID

36252936

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 h 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 h) 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 h 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.

Language: en

Keywords

Pediatrics; Concussion; Clinical trial