Role of Rehabilitation in Concussion Management: A Randomized Controlled Trial

Concussion, Brain Clinical Trial

Official title:

Management and Treatment of Sport-related Concussion: Early Multidimensional Rehabilitation Versus Enhanced Graded Exercise

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02988596
• Other study ID #: 16-1228
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: August 2019

Study information

• Verified date: July 2021
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: August 2019
• Est. primary completion date: August 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Brain Concussion
• Concussion, Brain

Intervention

Other:
• Multidimensional Active Rehabilitation
Participants will be asked to complete activities aimed at: stabilization of symptoms, impairment reduction, activity integration, recovery acceleration and sport specific application during a 20 minute session at least 4 times a week. Activities will be selected by the supervising clinician with respect to the specific impairment presentation of each participant. Session logs will be completed by each clinician and will include the following information: initial symptom checklist, activity parameters, percentage of rest during the session, participants rating of perceived exertion, and final symptom checklist, session satisfaction rating, and session feedback.
• Enhanced Graded Exertion
Participants will be asked to use their symptoms to guide their activity from the time of their injury until they are asymptomatic. Once they are asymptomatic they will begin the graded exertion (Zurich/Berlin Protocol). During this time clinicians will complete session logs that include the following information: initial symptom checklist, phase of graded return to play progression, activity parameters, percentage of rest during the session, participants rating of perceived exertion, and final symptom checklist, session satisfaction rating, and session feedback.

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta
Canada	Canadian Football League	Toronto	Ontario
Canada	York University	Toronto	Ontario
New Zealand	New Zealand Rugby	Wellington
United States	North Carolina Central University	Durham	North Carolina
United States	Elon University	Elon	North Carolina
United States	Orange County High School	Hillsborough	North Carolina
United States	Lynchburg College	Lynchburg	Virginia
United States	Medical College of Wisconsin	Milwaukee	Wisconsin
United States	Northwood High School	Pittsboro	North Carolina
United States	Catawba College	Salisbury	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	Medical College of Wisconsin, National Football League Foundation

Countries where clinical trial is conducted

United States,  Canada,  New Zealand, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average Days to Recovery	Average number of days from injury to recovery (recovery is defined as full clearance by physician for full return to sport participation)	1 to approximately 240 days
Secondary	Change in Fatigue from Baseline to 1 Month Post Return to Play	Participants are asked to rate their level of fatigue on a scale from 0 (completely exhausted) to 100 (completely alert).	Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
Secondary	Change in Quality of Life Perception (PROMIS) from Baseline to 1 Month Post Return to Play	The investigators will utilize the short version of the PROMIS general scale and the PROMIS cognitive and fatigue modules. For the PROMIS general scale and modules, participants are asked to rate items on scale from 1-5, each item rating in a given scale is summed and a scale score is computed using PROMIS guidelines.	Baseline, asymptomatic (1 to approximately 240 days), 1 month post return to play
Secondary	Change in Concussive Symptoms using the Sport Concussion Assessment Tool (SCAT 3) from Baseline to 1 Month Post Return to Play	The SCAT 3 concussion symptom checklist is a commonly used symptom assessment following concussion. Participants are asked to rate the severity of 22 symptoms on a scale from 0 (none) to 6 (severe). Each symptom item is added together to compute overall symptom burden.	Baseline, time of injury (within 6 hrs), 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
Secondary	Change in Psychological Distress using the Brief Symptom Inventory-18 (BSI-18) from Baseline to 1 Month Post Return to Play	The BSI-18 asks the participant to rate their level of distress associated with 18 symptom items on a scale from 0 (not at all) to 4 (extremely), ratings from each item are added together to compute overall symptom distress.	Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
Secondary	Change in Cognitive Status using the Standard Assessment of Concussion (SAC) from Baseline to 1 Month Post Return to Play	The SAC will be used to assess cognitive status after acute injury. The SAC has demonstrated validity, reliability, and sensitivity to concussion. The SAC contains sections on orientation, immediate memory, concentration, and delayed memory sections. The sum scores for each of these sections are used to calculate a SAC total score.	Baseline, time of injury (within 6 hrs), 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
Secondary	Change in Balance using the Balance Error Scoring System (BESS) from Baseline to 1 Month Post Return to Play	The Balance Error Scoring System (BESS) is a commonly used measure of static balance and postural stability. A combination of three stances (narrow double leg stance, single leg stance, and tandem stance) and two footing surfaces (firm surface/floor or medium density foam) are used for the test. Each stance is held, with hands on hips and eyes closed, for 20 seconds. Points are given for specific behaviors ("errors"), including opening eyes, lifting hands off hips, or stepping, stumbling, or falling. It will be conducted by a trained study team member. Safety issue: Fall related injuries.	Baseline, time of injury (within 6 hrs), 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
Secondary	Change in Cognition from Baseline to 1 Month Post Return to play	Computerized neuropsychological testing to determine cognitive functioning will be utilized. Percentiles of participant's overall achievement on the computerized neurocognitive test is reported. Measures will include Immediate Postconcussion and Cognitive Test (ImPact) and Concussion Vital Signs (CVS) and CogState (Axon Sports).	Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
Secondary	Change in Near-Point Convergence from Baseline to 1 Month Post Return to Play	Near-point convergence is a commonly used oculomotor exam that defines the amplitude of convergence or the closest point in space where the patient can hold fusion, and therefore, see one target. Participants complete 3 trials assessing near-point convergence: the average of the three trials is recorded.	Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
Secondary	Change in Dual-Task Ability using a Gait + Digit Span Dual-Task from Baseline to 1 Month Post Return to Play	The Gait + Digit Span Dual-Task begins with a walking task of 7 meters (timed). The participant then completes a memory recall task and is assessed for accuracy. Finally, the participant is asked to complete these two tasks simultaneously while the clinician records the same measures. Safety issue: Fall related injury. All Dual-Task testing will be supervised by a clinical professional or physician.	24-48 hrs post injury, asymptomatic, (1 to approximately 240 days) 1 month post return to play
Secondary	Change in Daily Concussion Symptoms	Participants are asked to complete a modified version of the SCAT 3 to assess symptom burden.	Daily post injury - 1 to approximately 240 days
Secondary	Change in Daily Activity	Participants are asked to complete a cognitive and physical daily activity log to assess cognitive and physical activity burden.	Daily post injury - 1 to approximately 240 days