NCT02988596

Role of Rehabilitation in Concussion Management: A Randomized Controlled Trial

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: University of North Carolina, Chapel Hill · Academic / Other
• Sex: All
• Age: 13 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Concussion, Brain

Interventions

Type	Name	Description
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.
OTHER	Enhanced Graded Exertion	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.

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-08-01
• Completion: 2019-08-01
• First posted: 2016-12-09
• Last updated: 2021-07-30

Locations

11 sites across 3 countries: United States, Canada, New Zealand