Role of Rehabilitation in Concussion Management: A Randomized Controlled Trial
- Conditions
- Concussion, Brain
- Registration Number
- NCT02988596
- Lead Sponsor
- University of North Carolina, Chapel Hill
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 251
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Average Days to Recovery 1 to approximately 240 days 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
Name Time Method Change in Fatigue from Baseline to 1 Month Post Return to Play Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 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 Baseline, asymptomatic (1 to approximately 240 days), 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 Baseline, time of injury (within 6 hrs), 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 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 Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 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 Baseline, time of injury (within 6 hrs), 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 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 Baseline, time of injury (within 6 hrs), 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 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 Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 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 Baseline, 24-48 hrs post injury, asymptomatic (1 to approximately 240 days), 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 24-48 hrs post injury, asymptomatic, (1 to approximately 240 days) 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 Daily post injury - 1 to approximately 240 days Participants are asked to complete a modified version of the SCAT 3 to assess symptom burden.
Change in Daily Activity Daily post injury - 1 to approximately 240 days Participants are asked to complete a cognitive and physical daily activity log to assess cognitive and physical activity burden.
Trial Locations
- Locations (11)
North Carolina Central University
🇺🇸Durham, North Carolina, United States
Elon University
🇺🇸Elon, North Carolina, United States
Orange County High School
🇺🇸Hillsborough, North Carolina, United States
Northwood High School
🇺🇸Pittsboro, North Carolina, United States
Catawba College
🇺🇸Salisbury, North Carolina, United States
Lynchburg College
🇺🇸Lynchburg, Virginia, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University of Alberta
🇨🇦Edmonton, Alberta, Canada
York University
🇨🇦Toronto, Ontario, Canada
Canadian Football League
🇨🇦Toronto, Ontario, Canada
Scroll for more (1 remaining)North Carolina Central University🇺🇸Durham, North Carolina, United States