Safe Return to Play After Concussion

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sports Injury; Concussion, Brain
• Intervention / Treatment: Diagnostic test: Novel facilitating agility dual-task test combined with already known tests

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 Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

• Study Contact: Name: Signe R Bech, Ph.D.; Phone Number: 26220309; Email: sgb@ucn.dk
• Study Contact Backup: Name: Vibeke B Løite, M.Sc.; Phone Number: +4572690964; Email: vbk@ucn.dk

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Recruiting
    • Signe Refsgaard Bech
    • Contact: Signe R Bech, Phd; Phone Number: 4526220309 4526220309; Email: sgb@ucn.dk
    • Contact: Steffan w Christensen, Phd; Phone Number: 4526220309 4526220309; Email: sgb@ucn.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 40 years (ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Athletes participating in risk sports in terms of concussion.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Athletes without concussion; We follow the athletes in terms of injuries and make a baseline test each season.	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.
Athletes suffering a concussion; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University College of Northern Denmark
• Investigators: Principal Investigator: Signe R Bech, Phd, University College of Northern Denamrk

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 10, 2020
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2024

Study Registration Dates

• First Submitted: September 26, 2019
• First Submitted That Met QC Criteria: September 26, 2019
• First Posted (ACTUAL): September 27, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: athletes; return to play; pain catastrophizing
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Athletic Injuries; Brain Concussion
• Other Study ID Numbers: Concussiondualtask

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Maybe we will share data on the concussed athletes.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No