NCT04109677

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2019

Completed
12 days until next milestone

Study Start

First participant enrolled

September 25, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 30, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

1.8 years

First QC Date

September 13, 2019

Last Update Submit

January 24, 2021

Conditions

Keywords

Handball, sport injuries, concussion, acute overload injury

Outcome Measures

Primary Outcomes (2)

  • 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.)

    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.

    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

    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

    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

    The handball season 2019 to 2020 - performed consequently in teams with a player reported head injury.

Study Arms (2)

SHE player

Female player in the top Swedish handball league

Handbollsligan player

Male player in the top Swedish handball league

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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. .

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linköping University

Linköping, S- 581 83, Sweden

Location

MeSH Terms

Conditions

Athletic InjuriesBrain Concussion

Condition Hierarchy (Ancestors)

Wounds and InjuriesBrain Injuries, TraumaticBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemHead Injuries, ClosedWounds, Nonpenetrating

Study Officials

  • Kajsa Johansson, Ass.Prof.

    Linköping University, div. of Physiotherapy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor, senior lecturer

Study Record Dates

First Submitted

September 13, 2019

First Posted

September 30, 2019

Study Start

September 25, 2019

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

January 26, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations