Clinical trial NCT04109677: AIM CONTROL and SWECON - Handball The SWEdish CONcussion Study in Elite Handball
Official title: AIM CONTROL and the SWEdish CONcussion Study in Elite Handball (SWECON - Handball)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sports Injuries
Concussion, Brain
Exposure
Psychological
Sports Physical Therapy
Keywords: Handball, sport injuries, concussion, acute overload injury
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Swedish Handball Federation
First posted: 2019-09-30
Enrollment: 126
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Players in the top League in Swedish handball fort both men (called Handbollsligan) and women (called SHE) together with contact persons for the Medical team.

There are 14 possible teams within Handbollsligan and 12 possible teams in SHE. The assessed possible number of players to register as a user of AIM Control is thought to be between 15-25 players per team. The total number of participants completing the study and possible for inclusion in the analysis is approximated to around 150 players.

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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.

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)

Primary outcomes:
measure: Handball related injuries - prevalence/incidence
timeFrame: Weekly assessment during the handball season 2019 to 2020, retrospective related to the past week. Analyzed due to whole and part of the season.
measure: Focus: number of concussions (prevalence/incidence), severity of symptoms and duration, proportion due to other handball injuries,
timeFrame: Weekly assessment during the handball season 2019 to 2020, retrospective related to the past week. Analyzed due to whole and part of the season.
Secondary outcomes:
measure: 12-item PANAS recording Positive and negative affects - relationship to injury or not
timeFrame: Weekly assessment during the handball season 2019 to 2020, retrospective related to the past week.
measure: Exposure exercises/sports specific load due to practice sessions and matches and self assessed recovery - relationship to injury or not
timeFrame: Weekly assessment during the handball season 2019 to 2020, retrospective related to the past week
measure: Injury analysis of a head trauma/concussion and related management within the handball teams medical support
timeFrame: The handball season 2019 to 2020 - performed consequently in teams with a player reported head injury.
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping University
Study officials:
affiliation: Linköping University, div. of Physiotherapy
name: Kajsa Johansson, Ass.Prof.
role: PRINCIPAL_INVESTIGATOR
References: