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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT02988596
Ethics application status
Date submitted
2/12/2016
Date registered
9/12/2016
Date last updated
20/06/2019

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 - Average number of days from injury to recovery (recovery is defined as full clearance by physician for full return to sport participation)
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 - Participants are asked to rate their level of fatigue on a scale from 0 (completely exhausted) to 100 (completely alert).
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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.
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 - 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).
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 - 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.
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 - 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.
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 - Participants are asked to complete a modified version of the SCAT 3 to assess symptom burden.
Timepoint [10] 0 0
Daily post injury - 1 to approximately 240 days
Secondary outcome [11] 0 0
Change in Daily Activity - Participants are asked to complete a cognitive and physical daily activity log to assess cognitive and physical activity burden.
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
Gender
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
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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/show/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.
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
Other publications