Clinical Trial: Assessing the Effects of a Clinical Exercise Protocol on Children With Post-concussion Syndrome

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Assessing the Effects of a Clinical Exercise Protocol on Children With Post-concussion Syndrome

Brief Summary: The general consensus in sports medicine demonstrates a graduated return to activity protocol for individuals with post-concussion syndrome. This is commonly practiced but there is insufficient literature to indicate evidence-based practice. This study will provide evidence of the effectiveness of the clinical gradual return to exercise protocols beginning after diagnosis of post-concussion syndrome through standardization and measurement of outcomes.

Detailed Summary:

Concussion is referred to as a mild form of traumatic brain injury (mTBI) that can result in temporary loss of consciousness, memory, or awareness. mTBI can also cause physiologic symptoms such as nausea or vomiting, headaches, vestibulo-ocular dysfunction, and balance errors. The majority of individuals with mTBI will fully recover within a 7-10 day period, although adolescents may require more time to recover than adults. The American Medical Society for Sports Medicine (AMSSM) position statement on concussion management indicates that there are no standardized guidelines for return to school and return to play recommendations involve a graduated activity program once all symptoms have resolved.[1] Treatment varies amongst physicians, but it is widely held that a minimum of 5 days strict rest at home (specifically, no school, work, or physical activity) followed by a stepwise return to activity. Recent articles, however have questioned the validity of strict rest for that many days as for other similar injuries (whiplash) recommendations involve attempts to gradually resume normal activities of daily living.[2]

Individuals whose concussion symptoms do not resolve within 7-10 days are considered to have post concussion syndrome (PCS) which is ill-defined and poorly understood, however the AMSSM describes the benefit of supervised progressive exercise programs that increase tolerance as symptoms permit. The protocols in the literature for adults involve assessing the maximum threshold at which symptoms are exacerbated then have individuals perform supervised exercise at 80% of that rate,[3, 4] however this has not been done in the pediatric population and most pediatric physicians instead perform graduated activity protocols starting at a lower thresholds and increasing unless an exacerbation occurs (SORT Level of Evidence C).[5, 6] It is proposed that the fundamental cau
Sponsor: University of Arizona

Current Primary Outcome: Reduction in symptoms [ Time Frame: 12 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Improvement in Neuropsychological testing performance [ Time Frame: 12 Weeks ]

Original Secondary Outcome: Same as current

Information By: University of Arizona

Dates:
Date Received: May 19, 2015
Date Started: June 2015
Date Completion: May 2017
Last Updated: January 25, 2016
Last Verified: January 2016