An interventional study of Multidimensional Active Rehabilitation and Enhanced Graded Exertion in Concussion, Brain, sponsored by University of North Carolina, Chapel Hill. Completed at 11 sites in 3 countries. Open to participants aged 13 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-30.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Treatment
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
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.
530 studies on the registry are indexed under Brain Concussion; 151 are open to participants now.
This study's enrollment of 251 is above the median of 64 across 364 interventional studies indexed under Brain Concussion.
Browse Brain Concussion studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,340 studies on the registry; 133 are open to participants now.
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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:
Exclusion criteria:
PROFESSIONAL COHORT:
Inclusion criteria:
Exclusion criteria:
ELIGIBILITY FOR THE STUDY INTERVENTION: ALL COHORTS
Inclusion criteria:
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.
Exclusion criteria:
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.
Other: Enhanced Graded Exertion
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: 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.
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.
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)
Time frame: 1 to approximately 240 days
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).
Time frame: Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
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.
Time frame: Baseline, asymptomatic (1 to approximately 240 days), 1 month post return to play
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.
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
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.
Time frame: Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
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.
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
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.
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
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).
Time frame: Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
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.
Time frame: Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 1 month post return to play
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.
Time frame: 24-48 hrs post injury, asymptomatic, (1 to approximately 240 days) 1 month post return to play
Change in Daily Concussion Symptoms
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
Change in Daily Activity
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
Plan to share: No
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University of North Carolina, Chapel Hill