AIM CONTROL and SWECON - Handball The SWEdish CONcussion Study in Elite Handball

NCT ID: NCT04109677

Last Updated: 2021-01-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 126 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-09-25
• Study Completion Date: 2021-07-31

Brief Summary

Handball is reported to be top 5 in Europe when it comes to sports injuries. There are few studies based on player reported data, and earlier Swedish data is mainly based on data from Insurance ´companies and mostly acute injuries. Earlier data lack the overuse injuries and number of injuries are taught to be underreported.

This epidemiological study has the objective to create research based knowledge about the injury panorama within Swedish handball with special interest in head-injuries in the elite level.

By using a mobile application "AIM Control", a retrospective weekly registration of handball related injuries was recorded together with self-assessed injury impact. Also data about sports/exercise exposure, other causes that could affect the players ability to practice/play matches, self-rated recovery before next practice/match as well as positive and negative affects will be analyzed.

Special emphasis is given to self-reported head injuries and the symptoms that the player might experience during the handball season 2019/2020. Data about symptom severity will be collected and analyzed together with AIM Controls other variables i.e. duration of symptoms and time to return-to-play. In case of a head-injury the Medical support team is contacted in order to describe the event, and interviewed with standardized questions about their thinking and action about how head injuries should be managed and prognosis of time to recovery and how to decide when a player is ready to play again? This is part of the AIM Control study called SWECON - handball.

Detailed Description

In co-operation with the Swedish Handball Federation, Swedish elite players are invited to participate during September 2019 and start to use the mobile application weekly during the current season (2019 to 2020.

By an electronic signed agreement, they receive unique user-name and log in. Download the free app from AppStore or Google Play, and then they are ready to start registration with questions in order to get retrospective data from the last week.

It takes 2-8 minutes to complete a registration, depending on if they have had a injury to report or not.

The data are stored according to data-regulations and GDPR on a secure server at Linköping University.

Players in the top League in Swedish handball, for the men called Handbollsligan and for females called SHE, together with contact persons for their Medical team will take part in the study. The later only when it comes to analysis of management of a head injury/concussion in case of such an injury in their team.

There is 14 possible male-teams within Handbollsligan and 12 possible female-team in SHE. Assessed possible number of players to register as a user of AIM Control is thought to be between 15-25 players peer team. Considering that some of them will not agree to participate or complete the study, a probable total number of participants might be 150 players in analysis.

This epidemiological study has the objective to create research based knowledge about the injury panorama within Swedish handball with special interest in head-injuries in the elite level.

A retrospective weekly registration by the handball player to record handball related injuries together with self-assessed injury impact. The application will push notice when it is time to do the weekly registration as well as a reminder.

Also data about sports/exercise exposure, other causes that could affect the players ability to practice/play matches, self-rated recovery before next practice/match as well as positive and negative affects will be analyzed.

If power, association between variables before injury occurs as well as afterwards is taught to be analyzed.

If a head injury is reported, possible symptoms afterwards will be self-reported in the app (part 2 in SCAT 5), and duration and when they return to team practice will be analyzed. Several questions regarding standard management and decisions for return to play is monitored by interviewing members of the Medical team and a follow-up interview with players with a handball related head-injury is planned to map retrospective experiences.

Conditions

Sports Injuries; Concussion, Brain; Exposure; Psychological; Sports Physical Therapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

SHE player

Female player in the top Swedish handball league

No interventions assigned to this group

Handbollsligan player

Male player in the top Swedish handball league

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

Player in the top league in Swedish handball (both men and women).

Exclusion Criteria

• don´t read Swedish (the app:s language is Swedish)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Swedish Handball Federation

UNKNOWN

Sponsor Role: collaborator

Linkoeping University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Kajsa Johansson

Associate professor, senior lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kajsa Johansson, Ass.Prof.

Role: PRINCIPAL_INVESTIGATOR

Linköping University, div. of Physiotherapy

Locations

Linköping University

Linköping, , Sweden

Countries

Sweden

Other Identifiers

88008-KJ-AIMCONTROL-SWECON

Identifier Type: -

Identifier Source: org_study_id