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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05752695
Other study ID # 2022-06554-01
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date March 1, 2023
Est. completion date December 31, 2028

Study information

Verified date March 2023
Source Linnaeus University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

This study aims to investigate if a detailed and comprehensive survey can identify, explain and prevent the risk factors for ACL injury. A a new questionnaire has been developed with questions to young athletes who have suffered an anterior cruciate ligament injury. The questionnaire is more detailed and provide more information about how the anterior cruciate ligament injury occurred compared with the questionnaires currently available in the literature. This careful documentation will provide new knowledge and might be used to identify, explain and prevent risk factors that cause young athletes to suffer an anterior cruciate ligament injury.


Description:

Participants will be prospectively recruited at their first physiotherapist clinical session. On this occasion, participants will be asked to fill in a questionnaire regarding injury situation, game or training, sex, age, sport affiliation, level of sport, other aspects of sport such as participation in several teams and junior versus senior games/training. In addition, questions regarding previous injury will also be documented.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date December 31, 2028
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 12 Years to 55 Years
Eligibility Inclusion Criteria: - Athlete - Defined ACL injury Exclusion Criteria: - Non athletes - Younger than 12 years

Study Design


Related Conditions & MeSH terms

  • Anterior Cruciate Ligament Injuries

Locations

Country Name City State
Sweden Sofia Ryman Augustsson Kalmar

Sponsors (2)

Lead Sponsor Collaborator
Linnaeus University Kalmar County Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total work load Total hours, per week, of practice and games. Day 1
Secondary Number of teams In team athletes, the number of teams in which the athlete participates. Day 1
Secondary Injury situation 1 Question regarding when the injury occurred; training vs game. Day 1
Secondary Injury situation 2 Question regarding at what situation the injury occurred (e.g. jump, landing, header duel, defense, attack...) Day 1
Secondary Injury situation 3 Question regarding at what time, during a game, the injury occurred; approximate match minute Day 1
Secondary Physical well-being Physical well-being is assessed with a likert scale ranging from 1-5 where '1' represents 'out of shape' while '5' represents that you felt 'in top shape'. Day 1
Secondary Mental wellbeing Mental well-being is assessed with a likert scale ranging from 1-5 where '1' represents 'out of shape' while '5' represents that you felt 'in top shape'. Day 1
Secondary Previous injury Description of previous injury prior to the ACL injury, such as other injuries to lower extremity or concussion. Day 1
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