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Role of Rehabilitation in Concussion Management: A Randomized Controlled Trial

Primary Purpose

Concussion, Brain

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Multidimensional Active Rehabilitation
Enhanced Graded Exertion
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Concussion, Brain focused on measuring Concussion, Rehabilitation

Eligibility Criteria

13 Years - 99 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • North Carolina Central University
  • Elon University
  • Orange County High School
  • Northwood High School
  • Catawba College
  • Lynchburg College
  • Medical College of Wisconsin
  • University of Alberta
  • York University
  • Canadian Football League
  • New Zealand Rugby

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Enhanced Graded Exertion

Multidimensional Active Rehabilitation

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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).
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.
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.
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.
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.
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.
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).
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.
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.
Change in Daily Concussion Symptoms
Participants are asked to complete a modified version of the SCAT 3 to assess symptom burden.
Change in Daily Activity
Participants are asked to complete a cognitive and physical daily activity log to assess cognitive and physical activity burden.

Full Information

First Posted
December 2, 2016
Last Updated
July 29, 2021
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Medical College of Wisconsin, National Football League Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02988596
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
August 2019 (Actual)
Study Completion Date
August 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Medical College of Wisconsin, National Football League Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Brain
Keywords
Concussion, Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
251 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enhanced Graded Exertion
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Multidimensional Active Rehabilitation
Arm Type
Experimental
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Multidimensional Active Rehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Enhanced Graded Exertion
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average Days to Recovery
Description
Average number of days from injury to recovery (recovery is defined as full clearance by physician for full return to sport participation)
Time Frame
1 to approximately 240 days
Secondary Outcome Measure Information:
Title
Change in Fatigue from Baseline to 1 Month Post Return to Play
Description
Participants are asked to rate their level of fatigue on a scale from 0 (completely exhausted) to 100 (completely alert).
Time Frame
Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
Title
Change in Quality of Life Perception (PROMIS) from Baseline to 1 Month Post Return to Play
Description
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.
Time Frame
Baseline, asymptomatic (1 to approximately 240 days), 1 month post return to play
Title
Change in Concussive Symptoms using the Sport Concussion Assessment Tool (SCAT 3) from Baseline to 1 Month Post Return to Play
Description
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.
Time Frame
Baseline, time of injury (within 6 hrs), 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
Title
Change in Psychological Distress using the Brief Symptom Inventory-18 (BSI-18) from Baseline to 1 Month Post Return to Play
Description
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.
Time Frame
Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
Title
Change in Cognitive Status using the Standard Assessment of Concussion (SAC) from Baseline to 1 Month Post Return to Play
Description
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.
Time Frame
Baseline, time of injury (within 6 hrs), 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
Title
Change in Balance using the Balance Error Scoring System (BESS) from Baseline to 1 Month Post Return to Play
Description
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.
Time Frame
Baseline, time of injury (within 6 hrs), 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
Title
Change in Cognition from Baseline to 1 Month Post Return to play
Description
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).
Time Frame
Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
Title
Change in Near-Point Convergence from Baseline to 1 Month Post Return to Play
Description
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.
Time Frame
Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
Title
Change in Dual-Task Ability using a Gait + Digit Span Dual-Task from Baseline to 1 Month Post Return to Play
Description
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.
Time Frame
24-48 hrs post injury, asymptomatic, (1 to approximately 240 days) 1 month post return to play
Title
Change in Daily Concussion Symptoms
Description
Participants are asked to complete a modified version of the SCAT 3 to assess symptom burden.
Time Frame
Daily post injury - 1 to approximately 240 days
Title
Change in Daily Activity
Description
Participants are asked to complete a cognitive and physical daily activity log to assess cognitive and physical activity burden.
Time Frame
Daily post injury - 1 to approximately 240 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johna K Mihalik, PhD
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
North Carolina Central University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27707
Country
United States
Facility Name
Elon University
City
Elon
State/Province
North Carolina
ZIP/Postal Code
27244
Country
United States
Facility Name
Orange County High School
City
Hillsborough
State/Province
North Carolina
ZIP/Postal Code
27278
Country
United States
Facility Name
Northwood High School
City
Pittsboro
State/Province
North Carolina
ZIP/Postal Code
27312
Country
United States
Facility Name
Catawba College
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Lynchburg College
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
University of Alberta
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G2R3
Country
Canada
Facility Name
York University
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3J1P3
Country
Canada
Facility Name
Canadian Football League
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5E 1C8
Country
Canada
Facility Name
New Zealand Rugby
City
Wellington
ZIP/Postal Code
6149
Country
New Zealand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17892404
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.
Results Reference
background
PubMed Identifier
31781021
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.
Results Reference
derived

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Role of Rehabilitation in Concussion Management: A Randomized Controlled Trial

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