Role of Rehabilitation in Concussion Management: A Randomized Controlled Trial
Condition: Concussion, Brain
MeSH terms: Brain Concussion
Study type: Interventional

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.
    

Intervention name(s): Multidimensional Active Rehabilitation; Enhanced Graded Exertion
Intervention type(s): Other; Other
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Concussion; Rehabilitation