Concussion, BrainNCT04107844
Safe Return to Play After Concussion
An observational study of Concussion, Brain and Sports Injury, run by University College of Northern Denmark at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 15 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Concussion, Brain, Sports Injury
- What is being tested?
- Novel facilitating agility dual-task test combined with already known tests
- How many people
- 1,200 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Feb 2020to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 to 40 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Athletes participating in risk sports in terms of concussion.
Who may be able to join
- Athletes participating in sports at least 1xweek
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Signe Refsgaard Bech
Aalborg, 9000
Signe R Bech, Phd, 4526220309 ext. 4526220309, sgb@ucn.dk
Steffan w Christensen, Phd, 4526220309 ext. 4526220309, sgb@ucn.dk
About this study
Official title: 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.
Read the 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.
- Conditions
- Concussion, Brain, Sports Injury
- Being tested
- Novel facilitating agility dual-task test combined with already known tests
- Keywords
- return to play, pain catastrophizing, athletes
- Medical subject headings
- Brain Concussion, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel facilitating agility dual-task test combined with already known testsDiagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Athletes without concussion | We follow the athletes in terms of injuries and make a baseline test each season. Receives: Diagnostic Test: Novel facilitating agility dual-task test combined with already known tests | |
| 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. Receives: Diagnostic Test: Novel facilitating agility dual-task test combined with already known tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (1)
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.
Measured: at least 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start10 Feb 2020
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College of Northern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Signe Refsgaard Bech, University College of Northern Denmark
- Investigators
- Signe R Bech, Phd, Principal investigator, University College of Northern Denamrk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107844
- Sponsor's protocol ID
- Concussiondualtask
- Status last verified
- Apr 2021
- First submitted
- 26 Sep 2019
- Last updated
- 28 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Maybe we will share data on the concussed athletes.
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe Return to Play After Concussion, Increased Knowledge of a Potential Physiological Deficit After Cessation of Symptoms
- ClinicalTrials.gov ID
- NCT04107844
- Acronym / sponsor ID
- Concussiondualtask
- Conditions
- Concussion, Brain, Sports Injury
- Keywords
- return to play, pain catastrophizing, athletes
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- University College of Northern DenmarkUniversity, hospital or other
- Study start
- 10 Feb 2020 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Athletes without concussion | – | Diagnostic Test: Novel facilitating agility dual-task test combined with already known testsWe follow the athletes in terms of injuries and make a baseline test each season. |
| Athletes suffering a concussion | – | Diagnostic Test: Novel facilitating agility dual-task test combined with already known testsWe 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. |
Who may qualify
- Ages
- 15 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Athletes participating in risk sports in terms of concussion.
Key inclusion criteria (1 listed)
- Athletes participating in sports at least 1xweek
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel facilitating agility dual-task test combined with already known testsWe 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. | Diagnostic test | Athletes suffering a concussion, Athletes without concussion |
Primary outcome
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.
1 secondary outcome
How pain catastrophizing influence recovery after a concussion
Time frame: at least 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2021.
- Individual participant dataSharing planned: Undecided. Maybe we will share data on the concussed athletes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Signe R Bech, Phd principal investigator
University College of Northern Denamrk
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concussion, Brain and Sports Injury, run by University College of Northern Denmark at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Signe R Bech, Ph.D. (26220309, sgb@ucn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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. (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2021.