Safe Return to Play After Concussion

NCT04107844 | Unknown DMC

• 1 other identifier: Concussiondualtask
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Concussion, Brain; Sports Injury

Keywords

return to play; pain catastrophizing; athletes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• How pain catastrophizing influence recovery after a concussion

  at least 4 years

Study Arms (2)

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

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

Interventions

Novel facilitating agility dual-task test combined with already known tests DIAGNOSTIC_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.

Athletes suffering a concussion; Athletes without concussion

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Athletes participating in risk sports in terms of concussion.

You may qualify if:

• Athletes participating in sports at least 1xweek

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College of Northern Denmark: lead

Study Sites (1)

Signe Refsgaard Bech

Aalborg, 9000, Denmark

RECRUITING

MeSH Terms

Conditions

Brain Concussion; Athletic Injuries

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Signe R Bech, Phd

  University College of Northern Denamrk

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Signe R Bech, Ph.D.

CONTACT

26220309; sgb@ucn.dk

Vibeke B Løite, M.Sc.

CONTACT

+4572690964; vbk@ucn.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Ph.d.

Study Record Dates

• First Submitted: September 26, 2019
• First Posted: September 27, 2019
• Study Start: February 10, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2024
• Last Updated: April 28, 2021

Record last verified: 2021-04

Locations

DK (1)