Clinical trial NCT02988596: Role of Rehabilitation in Concussion Management: A Randomized Controlled Trial
Official title: Management and Treatment of Sport-related Concussion: Early Multidimensional Rehabilitation Versus Enhanced Graded Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion, Brain
Keywords: Concussion
Rehabilitation
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Medical College of Wisconsin
name: National Football League Foundation
First posted: 2016-12-09
Enrollment: 251
Sex: ALL
Minimum age (years): 13
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Approximately 420 professional and amateur athletes will participate in rehabilitation during recovery after sports-related concussion. Participants will be cluster randomized, by study site, to a specific study arm. Participants will complete post-injury assessments and the intervention of their randomized group aimed at understanding the effects of a multidimensional rehabilitation protocol versus enhanced graded exertion on clinical recovery, return to play, and patient outcomes after sport related concussion

Detailed description: Approximately 6,600 athletes will complete baseline assessments and 420 of these individuals who suffer a concussion during the course of study will be directed through the post-injury protocol. Following injury, participants will complete post-injury assessments and follow the specific intervention of their randomized group. Post-injury assessments will focus on the following: postural stability, neuro-cognitive function, symptom presence and severity, fatigue, vision, dual-task ability, and mental status. Participants will complete outcome assessments at the following time points: time of injury, 24-48 hours post-injury, asymptomatic, and one month post return to play. Symptoms and physical and cognitive activity will be assessed daily from the first assessment point to 7 days post return to play. Session logs will be kept by the supervising clinician at each study site regardless of study arm. Baseline and outcome assessments will be entered into a secure online platform, each study site will have the option for paper records of outcomes and session logs to be double entered into the electronic system at a later date.

Eligibility criteria: Subjects will be recruited from 3 cohorts of athletes: 1) high school; 2) college/university and 3) professional.

HIGH SCHOOL COLLEGE/UNIVERSITY COHORTS:

Inclusion criteria:

* Individuals who are at least 13 years of age and a rostered student-athlete on the participating teams at the enrolled schools (football, wrestling, men's/women's soccer, men's/women's lacrosse, and men's/women's ice hockey, men's/women's rugby, and men's/women's basketball or other sports designated at the site).

Exclusion criteria:

* Individuals who are at least 13 years of age and those not rostered in a sport at his/her school.

PROFESSIONAL COHORT:

Inclusion criteria:

* Individuals who are 18 years of age or older and rostered on one of the participating professional teams.

Exclusion criteria:

* Individuals under 18 years of age and those not rostered on one of the participating professional teams.

ELIGIBILITY FOR THE STUDY INTERVENTION: ALL COHORTS

Inclusion criteria:

* Only those athletes with a concussion, guided by the following definition will engage in their respective intervention arms following concussion. The study definition is one from the Department of Defense (DOD). This definition was chosen, as it is s a guiding definition in the NCAA-DOD grand alliance Concussion Assessment, Research and Education (CARE) consortium, the largest concussion study to date (http://www.careconsortium.net/about/).
* Concussion will be defined as a change in brain function following a force to the head, which may (or may not) be accompanied by temporary loss of consciousness (LOC) (if LOC, temporary is study defined as \< 30 minutes based on the Mayo traumatic brain injury (TBI) severity guidelines), but is identified in awake individuals with measures of neurologic and cognitive dysfunction, as indicated by 1 or more the symptoms listed below.

Symptoms: headache, 'pressure in the head', neck pain, nausea/vomiting, dizziness, blurred vision, balance problems, sensitivity to light, sensitivity to noise, feeling slowed down, felling like 'in a fog', 'don't feel right, difficulty concentrating, difficulty remembering, fatigue/low energy, confusion, drowsiness, trouble falling asleep, more emotional, irritability, sadness, nervous/anxious.

* These symptoms are from the international consensus document on concussion in sport and represent the most common 22 symptoms of concussion (McCroy \& Concussion in Sport Group, 2013). All concussions are, by general definition, mild TBIs with Glasgow Coma Score (GCS) scores of 13-15 (with the majority being 14-15). No athlete with a GCS \<13 will be started in the intervention progression of either arm.

Exclusion criteria:

* Individuals with any positive/abnormal clinical neuroimaging finding(s) following injury WILL NOT enter the intervention or will discontinue the intervention should these findings be observed after intervention has begun.
* In addition, any individual presenting with any of the moderate-severe TBI presentation as defined in the Mayo definitions (Malec, 2007) will not enter the intervention or will be withdrawn if observed at a later time. Although these individuals will be discontinued from the intervention, the investigators will continue to collect assessment time point data on these individuals and documentation for their overall care.

Primary outcomes:
measure: Average Days to Recovery
timeFrame: 1 to approximately 240 days
Secondary outcomes:
measure: Change in Fatigue from Baseline to 1 Month Post Return to Play
timeFrame: Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
measure: Change in Quality of Life Perception (PROMIS) from Baseline to 1 Month Post Return to Play
timeFrame: Baseline, asymptomatic (1 to approximately 240 days), 1 month post return to play
measure: Change in Concussive Symptoms using the Sport Concussion Assessment Tool (SCAT 3) from Baseline to 1 Month Post Return to Play
timeFrame: Baseline, time of injury (within 6 hrs), 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
measure: Change in Psychological Distress using the Brief Symptom Inventory-18 (BSI-18) from Baseline to 1 Month Post Return to Play
timeFrame: Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
measure: Change in Cognitive Status using the Standard Assessment of Concussion (SAC) from Baseline to 1 Month Post Return to Play
timeFrame: Baseline, time of injury (within 6 hrs), 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
measure: Change in Balance using the Balance Error Scoring System (BESS) from Baseline to 1 Month Post Return to Play
timeFrame: Baseline, time of injury (within 6 hrs), 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
measure: Change in Cognition from Baseline to 1 Month Post Return to play
timeFrame: Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
measure: Change in Near-Point Convergence from Baseline to 1 Month Post Return to Play
timeFrame: Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
measure: Change in Dual-Task Ability using a Gait + Digit Span Dual-Task from Baseline to 1 Month Post Return to Play
timeFrame: 24-48 hrs post injury, asymptomatic, (1 to approximately 240 days) 1 month post return to play
measure: Change in Daily Concussion Symptoms
timeFrame: Daily post injury - 1 to approximately 240 days
measure: Change in Daily Activity
timeFrame: Daily post injury - 1 to approximately 240 days
Other outcomes:
Locations:
city: Durham
country: United States
facility: North Carolina Central University
state: North Carolina
city: Elon
country: United States
facility: Elon University
state: North Carolina
city: Hillsborough
country: United States
facility: Orange County High School
state: North Carolina
city: Pittsboro
country: United States
facility: Northwood High School
state: North Carolina
city: Salisbury
country: United States
facility: Catawba College
state: North Carolina
city: Lynchburg
country: United States
facility: Lynchburg College
state: Virginia
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Toronto
country: Canada
facility: York University
state: Ontario
city: Toronto
country: Canada
facility: Canadian Football League
state: Ontario
city: Wellington
country: New Zealand
facility: New Zealand Rugby
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Johna K Mihalik, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Malec JF, Brown AW, Leibson CL, Flaada JT, Mandrekar JN, Diehl NN, Perkins PK. The mayo classification system for traumatic brain injury severity. J Neurotrauma. 2007 Sep;24(9):1417-24. doi: 10.1089/neu.2006.0245.
citation: Register-Mihalik JK, Guskiewicz KM, Marshall SW, McCulloch KL, Mihalik JP, Mrazik M, Murphy I, Naidu D, Ranapurwala SI, Schneider K, Gildner P, McCrea M; Active Rehab Study Consortium Investigators. Methodology and Implementation of a Randomized Controlled Trial (RCT) for Early Post-concussion Rehabilitation: The Active Rehab Study. Front Neurol. 2019 Nov 8;10:1176. doi: 10.3389/fneur.2019.01176. eCollection 2019.