Safe Return to Play After Concussion

Recruiting

• Conditions: Concussion, Brain; Sports Injury
• Interventions: Diagnostic Test: Novel facilitating agility dual-task test combined with already known tests

• Registration Number: NCT04107844
• Lead Sponsor: University College of Northern Denmark

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.

Study Timeline

• Study First Submitted: 2019-09-26
• Study First Submitted QC: 2019-09-26
• Study First Posted: 2019-09-27
• Study Start: 2020-02-10
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-27
• Last Update Posted: 2021-04-28
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1200

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Athletes suffering a concussion	Novel facilitating agility dual-task test combined with already known tests	We follow the athletes in terms of injuries and make a baseline test each season and when they suffer a concussion, then we follow them with the same test as at baseline every 14th day for 3 months, after that they will get enrolled in another study.
Athletes without concussion	Novel facilitating agility dual-task test combined with already known tests	We follow the athletes in terms of injuries and make a baseline test each season.

Primary Outcome Measures

Name	Time	Method
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.	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.	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.

Secondary Outcome Measures

Name	Time	Method
How pain catastrophizing influence recovery after a concussion	at least 4 years	Be measuring pain catastrophizing at baseline and after concussion, we will evaluate if pain catastrophizing correlates with recovery time.

Trial Locations

Locations (1)

Signe Refsgaard Bech; 🇩🇰 Aalborg, Denmark