Clinical trial NCT04107844: Safe Return to Play After Concussion
Official title: Safe Return to Play After Concussion, Increased Knowledge of a Potential Physiological Deficit After Cessation of Symptoms
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Concussion, Brain
Sports Injury
Keywords: return to play
pain catastrophizing
athletes
Lead sponsor: University College of Northern Denmark
Sponsor class: OTHER
First posted: 2019-09-27
Enrollment: 1200
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Athletes participating in risk sports in terms of concussion.

Brief summary: This study will evaluate a combination of a novel Dual-task regime together with other already known tests in terms of defining when an athlete is ready to return to play after a concussion.

Detailed description: In this prospective study, we will evaluate a combination of a novel facilitating agility Dual-task regime together with sport concussion assessment tool -5 (SCAT5), Vestibular/Ocular-Motor Screening for Concussion, Agility T-test, Joint repositions error test and Pain Catastrophizing Scale (PCS) in terms of defining when an athlete is ready to return to play after a concussion. We will investigate if a novel facilitating agility Dual-task test together with already widely used tests, can identify more athletes that after a concussion still isn't ready to return to play, due to a physiological deficit. We will test as many athletes as possible each season and when an athlete suffer a concussion, we will follow them to see when they reach their baseline level. As previous studies show a over representation of new injuries in athletes returning to play after a concussion, we will also register injuries from all included subjects in terms of injuries each year, to evaluate if athletes following our recommendations have a lower injury rate after returning to play after a concussion. We also hope to be able to get more knowledge about how pain catastrophizing is related to duration of concussions symptoms.

Eligibility criteria: Inclusion Criteria:

* Athletes participating in sports at least 1xweek

Exclusion Criteria:

* injury that limits the participants ability to conduct the tests If the participant don't speak and understand Danish or English Other diseases or conditions that could interfere with one or more of the tests.

Primary outcomes:
measure: Duration from concussion to physiological rehabilitated with a combination of new and already known test evaluate when the athlete is ready to return to play.
timeFrame: as it is a prospective study and we don't know when and how many athletes will get a concussion, then the timeframe is unknown, but we expect to collect data in at least 4 years.
Secondary outcomes:
measure: How pain catastrophizing influence recovery after a concussion
timeFrame: at least 4 years
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Signe Refsgaard Bech
Study officials:
affiliation: University College of Northern Denamrk
name: Signe R Bech, Phd
role: PRINCIPAL_INVESTIGATOR
References: