Safe Return to Play After Concussion

April 27, 2021 updated by: Signe Refsgaard Bech, University College of Northern Denmark

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 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.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
How pain catastrophizing influence recovery after a concussion
Time Frame: at least 4 years
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University College of Northern Denmark

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Signe R Bech, Phd, University College of Northern Denamrk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 10, 2020

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 26, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 28, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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