Sport Without Injury ProgrammE Floorball (SWIPE)

August 20, 2018 updated by: Martin Hägglund, Linkoeping University
This study evaluates the preventive effect of a neuromuscular training program on injuries in youth floorball players. Half of participants will receive the training program, and half act as control and perform their usual training practices.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The study is a cluster-randomized controlled trial including male and female youth (12-17 years) floorball players. Club is used as cluster unit.

Coaches in the intervention group receive education of the preventive neuromuscular training program Knee Control (Knäkontroll) before the start of the season. Knee Control consists of 6 different exercises, with 4 different variations and 1 pair-exercise, and takes about 10 minutes to complete. In addition, coaches are instructed to perform a 5-minute running warm-up before the Knee Control exercises. Teams are to carry out the intervention at all training sessions, and the 5-minute warm-up also before all matches.

Coaches in the control group carry on their normal training and warm-up routines with their clubs.

Teams are followed for one full season: October 2017 - March 2018. Data registered for the study include exposure to floorball training and matches, and injuries that occur as a result of participation in floorball.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
910

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Linköping, Sweden, 58183
        • Linköping University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Teams with players 12-17 years of age (born 2000-2005)
  • Teams who have not used a structured training program aiming to prevent injuries (the Knee Control or similar program) on a regular basis the last year
  • Teams who have training at least twice per week

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Knee Control training program
The Knee Control program is a neuromuscular training program that consists of 6 different exercises, with 4 levels of progression and one pair-exercise, for each exercise. The Knee Control program takes about 10 minute to complete after familiarization. In addition, a 5-minute running warm-up is instructed to coaches. Coaches are to perform the Knee Control program + the 5 minute warm-up at all training sessions during the season, and the 5 minute warm-up before all matches.
Other: Knee Control training program
10-minute training program to be performed at all team training sessions during the season.
No Intervention: Control group - usual training
The control group teams receive no intervention, and coaches are instructed to carry out their normal training and warm-up practice throughout the season.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
All physical complaints injury
Time Frame: Study start up to end of season (6 months)
Any floorball related injury regardless of need of care or absence from floorball training or matches ("all physical complaints" injury definition)
Study start up to end of season (6 months)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time-loss injury
Time Frame: Study start up to end of season (6 months)
Floorball related injury causing absence from the next training or match with the team ("time-loss injury")
Study start up to end of season (6 months)
Medical attention injury
Time Frame: Study start up to end of season (6 months)
Floorball related injury requiring the player to seek care ("medical attention injury")
Study start up to end of season (6 months)
Adverse events
Time Frame: Study start up to end of season (6 months)
Adverse events of using the program (intervention group only)
Study start up to end of season (6 months)
Intervention compliance and fidelity
Time Frame: Study start up to end of season (6 months)
Coach reported compliance and fidelity with the program protocol (intervention group only)
Study start up to end of season (6 months)
Coach experience of injuries and intervention program
Time Frame: Baseline and 6 months
Coach baseline and follow-up experiences of injuries (control group and intervention group) and of the Knee Control program (intervention group only)
Baseline and 6 months
Player experience of injuries and intervention program
Time Frame: Baseline and 6 months
Player baseline and follow-up experiences of injuries (control group and intervention group) and of the Knee Control program (intervention group only)
Baseline and 6 months
Exercise fidelity
Time Frame: At approximately 2 months and 5 months
Exercise fidelity (observation of the technique when using the intervention in select intervention group teams)
At approximately 2 months and 5 months
Health care need
Time Frame: After study end at 6 months
Number of health care visits due to floorball related injuries during the season, type of diagnostic examinations and treatments
After study end at 6 months
Costs
Time Frame: After study end at 6 months
Estimated costs of floorball related injuries and costs of the intervention
After study end at 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Linkoeping University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Martin Hägglund, PhD, Linkoeping University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 15, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 10, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 16, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 20, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MHägglund SWIPE Floorball

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Undecided, possibly share deidentified exposure and injury outcome data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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