Back to resultsEffect of Specific ACL Injury Prevention Training in Female Handball Players
Primary Purpose
ACL Injury Prevention
Status
Active
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
ACL Injury Prevention Training
Control - Shoulder Injury Prevention Training
Sponsored by
About this trial
This is an interventional prevention trial for ACL Injury Prevention focused on measuring ACL Injuries, Age-related, Neuromuscular, Motor-Learning
Eligibility Criteria
Inclusion Criteria: Female handball players playing in youth teams from the age group under 13 (11-13 years old) and adult (≥18 - 40 years old) females playing for elite u19 or senior teams in Denmark Have minimum 1 year of experience from playing handball Mental and physical skills to complete the electrophysiological and biomechanical tests Exclusion Criteria: Girls/women outside the age groups listed above Prior surgeries to the lower limbs (e.g. ACL-reconstructions, meniscus lesions) Current intake of medications that include antidepressants, anxiolytics, anticonvulsants, antipsychotics, antiparkinson, hypnotics, stimulants, and/or antihistamines Neurological and/or psychiatric diagnoses Pregnant
Sites / Locations
- Department of Midwifery, Physiotherapy, Occupational Therapy and Psychomotor Therapy, Faculty of Health, University College Copenhagen
- Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark
- Human Movement Analysis Laboratory, Department of Orthopaedic Surgery, Copenhagen University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Other
Experimental
Other
Arm Label
Pre-adolescent Intervention
Pre-adolescent Control
Adult Intervention
Adult Control
Arm Description
11-13 year old female handball players complete a supervised ACL injury prevention program twice a week (2 x 15 minutes) for a duration of 8 weeks. The ACL injury prevention training consists of three tracks focusing on 1) hamstring and hip external rotation strength; 2) medial hamstring activation; 3) single leg landing technique training with a special focus on knee control. The training is integrated in the players/team's normal handball practice.
11-13 year old female handball players complete a supervised shoulder injury prevention program twice a week (2 x 15 minutes) for a duration of 8 weeks. The shoulder injury prevention training consists of three tracks focusing on 1) external rotator cuff strength; 2) scapula stability; 3) core strength and trunk rotation. The training is integrated in the players/team's normal handball practice.
Adult (≥18 year old) female handball players complete a supervised ACL injury prevention program twice a week (2 x 15 minutes) for a duration of 8 weeks. The ACL injury prevention training consists of three tracks focusing on 1) hamstring and hip external rotation strength; 2) medial hamstring activation; 3) single leg landing technique training with a special focus on knee control. The training is integrated in the players/team's normal handball practice.
Adult (≥18 year old) female handball players completed a supervised shoulder injury prevention program twice a week (2 x 15 minutes) for a duration of 8 weeks. The shoulder injury prevention training consists of three tracks focusing on 1) external rotator cuff strength; 2) scapula stability; 3) core strength and trunk rotation. The training is integrated in the players/team's normal handball practice.
Outcomes
Primary Outcome Measures
Neuromuscular adaptations during sidecutting
Semitendinosus muscle pre-activity (sEMG) duirng handball specific sidecutting. Outcome measure is expressed in %MVC.during sidecutting.
Secondary Outcome Measures
Changes in isometric strength
Peak isometric hamstring and hip external rotation strength, respectively. Outcome measure is expressed in force (Newtons).
Changes in 3D hip and knee joint angles
Hip and knee joint kinematic for sidecutting and single-leg landings. This include joint kinetics at initial contact and local maximum and minimums. Outcome is expressed in three-dimensional joint angles (degrees)
Changes in 3D hip and knee joint moments
Hip and knee joint kinetics for sidecutting and single-leg landings. Outcome is expressed in three-dimensional joint moments (M)
Changes in hamstring and quadriceps pre-activation
Hamstring (biceps femoris) and quadriceps (vastus lateralis and medialis) pre-activation (sEMG) during sidecutting and single-leg landings. Outcome measure is expressed in %MVC.
Visuomotor Skill Learning
Age-related differences in motor performance, skill acquisition and retention during and following visuomotor skill practice. Specific outcomes measure will be time on target (seconds per target).
Changes in shoulder sensorimoter stability
Shoulder sensorimoter stability measured as CoP length (mm) from force platform data.
Changes in Shoulder Rotator Cuff Strength
Peak isometric internal and external rotator cuff strength. Outcome measure is expressed in force (Newtons).
Full Information
NCT ID
NCT05955599
First Posted
April 21, 2023
Last Updated
July 13, 2023
Sponsor
Copenhagen University Hospital, Hvidovre
Collaborators
University College Copenhagen, University of Copenhagen, Team Denmark
1. Study Identification
Unique Protocol Identification Number
NCT05955599
Brief Title
Effect of Specific ACL Injury Prevention Training in Female Handball Players
Official Title
Effect of Specific ACL Injury Prevention Training in Female Handball Players
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
February 28, 2023 (Actual)
Study Completion Date
December 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Copenhagen University Hospital, Hvidovre
Collaborators
University College Copenhagen, University of Copenhagen, Team Denmark
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The anterior Cruciate Ligament (ACL) injuries rates in female handball are high, particularly among adolescents. Therefore, the primary purpose of this randomized control trial is to explore the effects of an 8-week ACL injury prevention program on muscle activation of the medial hamstring muscles during sidecutting in female handball players.
Secondary aims are to evaluate if training effects are age-related (pre-adolescent: 11-13 year old vs. adults: ≥18 years old). The age-related comparisons Include:
Medial hamstring muscles activation during sidecutting;
Well-known biomechanical ACL injury-risk factors during high risk movements, such as cutting and landing tasks;
Cortical and muscular activity and functional connectivity patterns during controlled knee movements;
Visuomotor skill learning during a simple task involving the hamstring muscles.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ACL Injury Prevention
Keywords
ACL Injuries, Age-related, Neuromuscular, Motor-Learning
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Pre-adolescent Intervention
Arm Type
Experimental
Arm Description
11-13 year old female handball players complete a supervised ACL injury prevention program twice a week (2 x 15 minutes) for a duration of 8 weeks. The ACL injury prevention training consists of three tracks focusing on 1) hamstring and hip external rotation strength; 2) medial hamstring activation; 3) single leg landing technique training with a special focus on knee control. The training is integrated in the players/team's normal handball practice.
Arm Title
Pre-adolescent Control
Arm Type
Other
Arm Description
11-13 year old female handball players complete a supervised shoulder injury prevention program twice a week (2 x 15 minutes) for a duration of 8 weeks. The shoulder injury prevention training consists of three tracks focusing on 1) external rotator cuff strength; 2) scapula stability; 3) core strength and trunk rotation. The training is integrated in the players/team's normal handball practice.
Arm Title
Adult Intervention
Arm Type
Experimental
Arm Description
Adult (≥18 year old) female handball players complete a supervised ACL injury prevention program twice a week (2 x 15 minutes) for a duration of 8 weeks. The ACL injury prevention training consists of three tracks focusing on 1) hamstring and hip external rotation strength; 2) medial hamstring activation; 3) single leg landing technique training with a special focus on knee control. The training is integrated in the players/team's normal handball practice.
Arm Title
Adult Control
Arm Type
Other
Arm Description
Adult (≥18 year old) female handball players completed a supervised shoulder injury prevention program twice a week (2 x 15 minutes) for a duration of 8 weeks. The shoulder injury prevention training consists of three tracks focusing on 1) external rotator cuff strength; 2) scapula stability; 3) core strength and trunk rotation. The training is integrated in the players/team's normal handball practice.
Intervention Type
Other
Intervention Name(s)
ACL Injury Prevention Training
Intervention Description
Supervised ACL injury prevention training twice a week (2 x 15 minutes) over an 8-week period.
Intervention Type
Other
Intervention Name(s)
Control - Shoulder Injury Prevention Training
Intervention Description
Supervised shoulder injury prevention training twice a week (2 x 15 minutes) over an 8-week period.
Primary Outcome Measure Information:
Title
Neuromuscular adaptations during sidecutting
Description
Semitendinosus muscle pre-activity (sEMG) duirng handball specific sidecutting. Outcome measure is expressed in %MVC.during sidecutting.
Time Frame
Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.
Secondary Outcome Measure Information:
Title
Changes in isometric strength
Description
Peak isometric hamstring and hip external rotation strength, respectively. Outcome measure is expressed in force (Newtons).
Time Frame
Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.
Title
Changes in 3D hip and knee joint angles
Description
Hip and knee joint kinematic for sidecutting and single-leg landings. This include joint kinetics at initial contact and local maximum and minimums. Outcome is expressed in three-dimensional joint angles (degrees)
Time Frame
Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.
Title
Changes in 3D hip and knee joint moments
Description
Hip and knee joint kinetics for sidecutting and single-leg landings. Outcome is expressed in three-dimensional joint moments (M)
Time Frame
Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.
Title
Changes in hamstring and quadriceps pre-activation
Description
Hamstring (biceps femoris) and quadriceps (vastus lateralis and medialis) pre-activation (sEMG) during sidecutting and single-leg landings. Outcome measure is expressed in %MVC.
Time Frame
Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.
Title
Visuomotor Skill Learning
Description
Age-related differences in motor performance, skill acquisition and retention during and following visuomotor skill practice. Specific outcomes measure will be time on target (seconds per target).
Time Frame
Change from Baseline to Baseline +1 Day, Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.
Title
Changes in shoulder sensorimoter stability
Description
Shoulder sensorimoter stability measured as CoP length (mm) from force platform data.
Time Frame
Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.
Title
Changes in Shoulder Rotator Cuff Strength
Description
Peak isometric internal and external rotator cuff strength. Outcome measure is expressed in force (Newtons).
Time Frame
Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.
Other Pre-specified Outcome Measures:
Title
Injury monitoring
Description
Type and number of injuries will be collected on a weekly basis using an electronical study-specific questionary. If injured, player's will be asked to complete a detailed questionary about the injury.
Time Frame
Weekly for 16 weeks (from the start of the intervention to the end of the 8-week retention period)
Title
Training and match exposure
Description
Number of training and match hours will be collected on a weekly basis using an electronical study-specific questionary
Time Frame
Weekly for 16 weeks (from the start of the intervention to the end of the 8-week retention period)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Female handball players playing in youth teams from the age group under 13 (11-13 years old) and adult (≥18 - 40 years old) females playing for elite u19 or senior teams in Denmark
Have minimum 1 year of experience from playing handball
Mental and physical skills to complete the electrophysiological and biomechanical tests
Exclusion Criteria:
Girls/women outside the age groups listed above
Prior surgeries to the lower limbs (e.g. ACL-reconstructions, meniscus lesions)
Current intake of medications that include antidepressants, anxiolytics, anticonvulsants, antipsychotics, antiparkinson, hypnotics, stimulants, and/or antihistamines
Neurological and/or psychiatric diagnoses
Pregnant
Facility Information:
Facility Name
Department of Midwifery, Physiotherapy, Occupational Therapy and Psychomotor Therapy, Faculty of Health, University College Copenhagen
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark
Facility Name
Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark
City
Copenhagen
ZIP/Postal Code
2200
Country
Denmark
Facility Name
Human Movement Analysis Laboratory, Department of Orthopaedic Surgery, Copenhagen University Hospital
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Specific ACL Injury Prevention Training in Female Handball Players
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