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Concussion, BrainNCT02988596

Role of Rehabilitation in Concussion Management: A Randomized Controlled Trial

A study testing Multidimensional Active Rehabilitation and Enhanced Graded Exertion in people with Concussion, Brain, run by University of North Carolina, Chapel Hill at 11 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 13 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Concussion, Brain
What is being tested?
Multidimensional Active Rehabilitation and Enhanced Graded Exertion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
251 participants
Where
11 sitesin 3 countries
Study dates
Jan 2017to Aug 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • Individuals who are at least 13 years of age and those not rostered in a sport at his/her school.
  • PROFESSIONAL COHORT:
  • Individuals under 18 years of age and those not rostered on one of the participating professional teams.
  • ELIGIBILITY FOR THE STUDY INTERVENTION: ALL COHORTS
  • 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.

Trial locations and contacts

11 sites in 3 countries.

11 sites in 3 countries

United States7 sites

  • North Carolina Central University

    Durham, North Carolina, 27707

  • Elon University

    Elon, North Carolina, 27244

  • Orange County High School

    Hillsborough, North Carolina, 27278

  • Lynchburg College

    Lynchburg, Virginia, 24501

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Northwood High School

    Pittsboro, North Carolina, 27312

  • Catawba College

    Salisbury, North Carolina, 28144

Other trials in United States

Canada3 sites

  • University of Alberta

    Edmonton, Alberta, T6G2R3

  • York University

    Toronto, Ontario, M3J1P3

  • Canadian Football League

    Toronto, Ontario, M5E 1C8

Other trials in Canada

New Zealand1 site

  • New Zealand Rugby

    Wellington, 6149

Other trials in New Zealand

About this study

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

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

Read the 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.

Being tested
Multidimensional Active Rehabilitation, Enhanced Graded Exertion
Keywords
Concussion, Rehabilitation
Medical subject headings
Brain Concussion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multidimensional Active RehabilitationOther

    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 ExertionOther

    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.

Study groups in NCT02988596
Study groupRoleWhat they receive
Enhanced Graded ExertionActive comparatorAt 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.
Receives: Other: Enhanced Graded Exertion
Multidimensional Active RehabilitationExperimentalAt 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).
Receives: Other: Multidimensional Active Rehabilitation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 1 to approximately 240 days

Secondary outcomes (11)

  1. 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).

    Measured: Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play

  2. 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.

    Measured: Baseline, asymptomatic (1 to approximately 240 days), 1 month post return to play

  3. 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.

    Measured: Baseline, time of injury (within 6 hrs), 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play

  4. 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.

    Measured: Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play

  5. 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.

    Measured: Baseline, time of injury (within 6 hrs), 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play

  6. 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.

    Measured: Baseline, time of injury (within 6 hrs), 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play

  7. 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).

    Measured: Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play

  8. 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.

    Measured: Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play

  9. 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.

    Measured: 24-48 hrs post injury, asymptomatic, (1 to approximately 240 days) 1 month post return to play

  10. Change in Daily Concussion Symptoms

    Participants are asked to complete a modified version of the SCAT 3 to assess symptom burden.

    Measured: Daily post injury - 1 to approximately 240 days

  11. Change in Daily Activity

    Participants are asked to complete a cognitive and physical daily activity log to assess cognitive and physical activity burden.

    Measured: Daily post injury - 1 to approximately 240 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2016 (estimated)
  2. Study startJan 2017
  3. Primary completionAug 2019
  4. Study completionAug 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
251 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02988596
Sponsor's protocol ID
16-1228
Status last verified
Jul 2021
First submitted
2 Dec 2016
Last updated
30 Jul 2021
Results posted
No
Data monitoring committee
No
Individual data sharing
No

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.

    PubMed 17892404

  • Register-Mihalik JK, Guskiewicz KM, Marshall SW, McCulloch KL, Mihalik JP, Mrazik M, Murphy I, Naidu D, Ranapurwala SI, Schneider KJ, Gildner P, Salmon DM, Auton B, Bowman TG, Hall EE, Hynes LM, Jewell E, Ketcham CJ, Siler CW, Sullivan SJ, Kostogiannes V, McCrea MA; Active Rehab Study Consortium. Symptom Exacerbation and Adverse Events During a Randomized Trial of Early-Stage Rehabilitation After Sport-Related Concussion: Safety Outcomes From the Active Rehab Study. J Athl Train. 2024 Dec 1;59(12):1163-1170. doi: 10.4085/1062-6050-0696.23.

    PubMed 38775119

  • 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.

    PubMed 31781021

Questions about this trial

What is this clinical trial studying?

A study testing Multidimensional Active Rehabilitation and Enhanced Graded Exertion in people with Concussion, Brain, run by University of North Carolina, Chapel Hill at 11 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States, Canada, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Days to Recovery (time frame: 1 to approximately 240 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02988596, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2021.

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