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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02988596




Registration number
NCT02988596
Ethics application status
Date submitted
2/12/2016
Date registered
9/12/2016
Date last updated
30/07/2021

Titles & IDs
Public title
Role of Rehabilitation in Concussion Management: A Randomized Controlled Trial
Scientific title
Management and Treatment of Sport-related Concussion: Early Multidimensional Rehabilitation Versus Enhanced Graded Exercise
Secondary ID [1] 0 0
16-1228
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Concussion, Brain 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Injuries and Accidents 0 0 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Multidimensional Active Rehabilitation
Other interventions - Enhanced Graded Exertion

Active comparator: Enhanced Graded Exertion - At the time of the injury, participants will be given guided activity instructions regarding what activities to consider and how to observe for increases in symptoms. The focus will be on guided activity and not on restriction. Symptoms will be assessed at the end of each day. Once the patient has been asymptomatic for 24 hours or within 85% of their baseline symptom score (BSS) they will begin the enhanced graded exertion progression (Zurich/Berlin protocol). This protocol will follow the Zurich/Berlin guidelines, but will be enhanced to include sports and skill specific activities. Each step will be completed on a separate day. A medical professional will determine the symptom status of the athlete and when the graded exertion will begin.

Experimental: Multidimensional Active Rehabilitation - At injury, participants are given instructions regarding guided activities to consider and how to observe for symptom increase. Focus is on guided activity, not restriction. The intervention consists of 5 phases designed to facilitate an active approach to concussion rehabilitation. Phases are symptom stabilization, impairment reduction, activity integration, recovery acceleration, and sport specific application. Participants complete phase specific activities under direction of a clinical professional, and progress upon meeting specific requirements. Participants are required to spend at least 2 days in Phase 1; subsequent phases are completed on separate days. Once asymptomatic for 24 hours or within 85% of their BSS they begin the enhanced graded exertion progression (Zurich/Berlin protocol).


Other interventions: 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.

Other interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Average Days to Recovery
Timepoint [1] 0 0
1 to approximately 240 days
Secondary outcome [1] 0 0
Change in Fatigue from Baseline to 1 Month Post Return to Play
Timepoint [1] 0 0
Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
Secondary outcome [2] 0 0
Change in Quality of Life Perception (PROMIS) from Baseline to 1 Month Post Return to Play
Timepoint [2] 0 0
Baseline, asymptomatic (1 to approximately 240 days), 1 month post return to play
Secondary outcome [3] 0 0
Change in Concussive Symptoms using the Sport Concussion Assessment Tool (SCAT 3) from Baseline to 1 Month Post Return to Play
Timepoint [3] 0 0
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 outcome [4] 0 0
Change in Psychological Distress using the Brief Symptom Inventory-18 (BSI-18) from Baseline to 1 Month Post Return to Play
Timepoint [4] 0 0
Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
Secondary outcome [5] 0 0
Change in Cognitive Status using the Standard Assessment of Concussion (SAC) from Baseline to 1 Month Post Return to Play
Timepoint [5] 0 0
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 outcome [6] 0 0
Change in Balance using the Balance Error Scoring System (BESS) from Baseline to 1 Month Post Return to Play
Timepoint [6] 0 0
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 outcome [7] 0 0
Change in Cognition from Baseline to 1 Month Post Return to play
Timepoint [7] 0 0
Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
Secondary outcome [8] 0 0
Change in Near-Point Convergence from Baseline to 1 Month Post Return to Play
Timepoint [8] 0 0
Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
Secondary outcome [9] 0 0
Change in Dual-Task Ability using a Gait + Digit Span Dual-Task from Baseline to 1 Month Post Return to Play
Timepoint [9] 0 0
24-48 hrs post injury, asymptomatic, (1 to approximately 240 days) 1 month post return to play
Secondary outcome [10] 0 0
Change in Daily Concussion Symptoms
Timepoint [10] 0 0
Daily post injury - 1 to approximately 240 days
Secondary outcome [11] 0 0
Change in Daily Activity
Timepoint [11] 0 0
Daily post injury - 1 to approximately 240 days

Eligibility
Key inclusion 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).
Minimum age
13 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2019
Sample size
Target
Accrual to date
Final
251
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Carolina
Country [2] 0 0
United States of America
State/province [2] 0 0
Virginia
Country [3] 0 0
United States of America
State/province [3] 0 0
Wisconsin
Country [4] 0 0
Canada
State/province [4] 0 0
Alberta
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
New Zealand
State/province [6] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Other
Name
University of North Carolina, Chapel Hill
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Medical College of Wisconsin
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
National Football League Foundation
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/study/NCT02988596
Trial related presentations / publications
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.
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.
Public notes

Contacts
Principal investigator
Name 0 0
Johna K Mihalik, PhD
Address 0 0
University of North Carolina, Chapel Hill
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT02988596