Sports InjuriesNCT04109677
AIM CONTROL and SWECON - Handball The SWEdish CONcussion Study in Elite Handball
An observational study of Sports Injuries and Concussion, Brain, run by Linkoeping University at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Sports Injuries, Concussion, Brain, Exposure
- How many people
- 126 participants
- Where
- 1 siteSweden
- Study dates
- 25 Sep 2019to 31 Jul 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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. .
Who may be able to join
- Player in the top league in Swedish handball (both men and women).
Who cannot join
- don´t read Swedish (the app:s language is Swedish)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AIM CONTROL and the SWEdish CONcussion Study in Elite Handball (SWECON - Handball)
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.
Read more
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.
Read the 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.
- Keywords
- Handball, sport injuries, concussion, acute overload injury
- Medical subject headings
- Athletic Injuries, Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| SHE player | Female player in the top Swedish handball league | |
| Handbollsligan player | Male player in the top Swedish handball league |
What is being measured
The primary outcome is the main question the study is designed to answer.
Handball related injuries - prevalence/incidence
Self-rated injury/injuries in three categories:
acute injury; earlier acute injury - still with symptoms; overload injury and their location.
In relation to this, self-assessed impact in three perspectives (graded, ordinal scale):
- participation in handball or handball related activities,
- performance and
- pain assessment. (Descriptive data, sub-categories.)
Measured: Weekly assessment during the handball season 2019 to 2020, retrospective related to the past week. Analyzed due to whole and part of the season.
Focus: number of concussions (prevalence/incidence), severity of symptoms and duration, proportion due to other handball injuries,
Amount of concussions together with symptoms and duration. Using part of SCAT 5 - the "Symptom evaluation" together with analysis of return to play.
Self-assessed impact of concussion in three perspectives (graded, ordinal scale):
- participation within handball or handball related activities,
- performance and
- pain assessment. Descriptive data, sub-categories. Comparison with other injuries among handball players.
Measured: 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 (3)
12-item PANAS recording Positive and negative affects - relationship to injury or not
Six positive and six negative affects (in each 3 activating and 3 deactivating) assessed weekly (range from a score 0-10). In case of injury analyze relationship before or after injury.
Measured: Weekly assessment during the handball season 2019 to 2020, retrospective related to the past week.
Exposure exercises/sports specific load due to practice sessions and matches and self assessed recovery - relationship to injury or not
Load in time for both handball related practice (in hours summeraized for the past week) and matches ( (in minutes of play summeraized for the past week) together with self-rated recovery before next handball session.
Measured: Weekly assessment during the handball season 2019 to 2020, retrospective related to the past week
Injury analysis of a head trauma/concussion and related management within the handball teams medical support
Answers and statements to a telephone questionnaire with medical team members. Open and closed answers about head injury situation within handball. Results in a case for questions about their reasoning about standard management, actions, both in the acute phase and during rehab. Decision making for return to play after head injury/concussion.
Measured: The handball season 2019 to 2020 - performed consequently in teams with a player reported head injury.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2019
- Study start25 Sep 2019
- Primary completion31 Jul 2021 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sports InjuriesStudies of the same condition, open and under way.
- More trials run by Linkoeping UniversityThe sponsor's other registered studies.
- 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
- Retrospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Swedish Handball Federation
- Responsible party
- Principal investigator, Kajsa Johansson, Linkoeping University
- Investigators
- Kajsa Johansson, Ass.Prof., Principal investigator, Linköping University, div. of Physiotherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04109677
- Sponsor's protocol ID
- 88008-KJ-AIMCONTROL-SWECON
- Status last verified
- Jan 2021
- First submitted
- 13 Sep 2019
- Last updated
- 26 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AIM CONTROL and the SWEdish CONcussion Study in Elite Handball (SWECON - Handball)
- ClinicalTrials.gov ID
- NCT04109677
- Acronym / sponsor ID
- 88008-KJ-AIMCONTROL-SWECON
- Keywords
- Handball, sport injuries, concussion, acute overload injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Swedish Handball Federation
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 31 Jul 2021 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 30 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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SHE player | – | –Female player in the top Swedish handball league |
| Handbollsligan player | – | –Male player in the top Swedish handball league |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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. .
Key inclusion criteria (1 listed)
- Player in the top league in Swedish handball (both men and women).
Key exclusion criteria (1 listed)
- don´t read Swedish (the app:s language is Swedish)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Handball related injuries - prevalence/incidence
Time frame: Weekly assessment during the handball season 2019 to 2020, retrospective related to the past week. Analyzed due to whole and part of the season.
Self-rated injury/injuries in three categories: acute injury; earlier acute injury - still with symptoms; overload injury and their location. In relation to this, self-assessed impact in three perspectives (graded, ordinal scale): * participation in handball or handball related activities, * performance and * pain assessment. (Descriptive data, sub-categories.)
Focus: number of concussions (prevalence/incidence), severity of symptoms and duration, proportion due to other handball injuries,
Time frame: Weekly assessment during the handball season 2019 to 2020, retrospective related to the past week. Analyzed due to whole and part of the season.
Amount of concussions together with symptoms and duration. Using part of SCAT 5 - the "Symptom evaluation" together with analysis of return to play. Self-assessed impact of concussion in three perspectives (graded, ordinal scale): * participation within handball or handball related activities, * performance and * pain assessment. Descriptive data, sub-categories. Comparison with other injuries among handball players.
3 secondary outcomes
12-item PANAS recording Positive and negative affects - relationship to injury or not
Time frame: Weekly assessment during the handball season 2019 to 2020, retrospective related to the past week.
Exposure exercises/sports specific load due to practice sessions and matches and self assessed recovery - relationship to injury or not
Time frame: Weekly assessment during the handball season 2019 to 2020, retrospective related to the past week
Injury analysis of a head trauma/concussion and related management within the handball teams medical support
Time frame: The handball season 2019 to 2020 - performed consequently in teams with a player reported head injury.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Kajsa Johansson, Ass.Prof. principal investigator
Linköping University, div. of Physiotherapy
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 Sports Injuries and Concussion, Brain, run by Linkoeping University at 1 site in Sweden.
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 26 Jan 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 Sweden. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Handball related injuries - prevalence/incidence (time frame: Weekly assessment during the handball season 2019 to 2020, retrospective related to the past week. Analyzed due to whole and part of the season.). The study lists 2 primary outcomes in all. 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 26 Jan 2021.