Safe Return to Play After Concussion

Concussion, Brain Clinical Trial

Official title:

Safe Return to Play After Concussion, Increased Knowledge of a Potential Physiological Deficit After Cessation of Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04107844
• Other study ID #: Concussiondualtask
• Status: Recruiting
• Start date: February 10, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2021
• Source: University College of Northern Denmark
• Contact: Signe R Bech, Ph.D.
• Phone: 26220309
• Email: sgb[@]ucn.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Athletic Injuries
• Brain Concussion
• Concussion, Brain
• Sports Injury

Intervention

Diagnostic Test:
• Novel facilitating agility dual-task test combined with already known tests
We will investigate if a combination of a novel Dual-task test combined with already known tests can identify more athletes, not ready to return to play, although symptoms of concussion have stopped.

Locations

Country	Name	City	State
Denmark	Signe Refsgaard Bech	Aalborg

Sponsors (1)

Lead Sponsor	Collaborator
University College of Northern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	We will by using a combination of new and known tests follow athletes with concussion and their symptoms, and try to get a knowledge about easy accessable test can give coaches a more objective measure for when an athlete is ready to return to play.	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	How pain catastrophizing influence recovery after a concussion	Be measuring pain catastrophizing at baseline and after concussion, we will evaluate if pain catastrophizing correlates with recovery time.	at least 4 years