Effect of Specific ACL Injury Prevention Training in Female Handball Players

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Specific ACL Injury Prevention Training in Female Handball Players

Conditions
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ACL Injury Prevention

Intervention / Treatment
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* Other: ACL Injury Prevention Training
* Other: Control - Shoulder Injury Prevention Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 11 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pre-adolescent Intervention<br>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. | Other: ACL Injury Prevention Training<br>* Supervised ACL injury prevention training twice a week (2 x 15 minutes) over an 8-week period.<br>|
| Other: Pre-adolescent Control<br>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. | Other: Control - Shoulder Injury Prevention Training<br>* Supervised shoulder injury prevention training twice a week (2 x 15 minutes) over an 8-week period.<br>|
| Experimental: Adult Intervention<br>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. | Other: ACL Injury Prevention Training<br>* Supervised ACL injury prevention training twice a week (2 x 15 minutes) over an 8-week period.<br>|
| Other: Adult Control<br>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. | Other: Control - Shoulder Injury Prevention Training<br>* Supervised shoulder injury prevention training twice a week (2 x 15 minutes) over an 8-week period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuromuscular adaptations during sidecutting | Semitendinosus muscle pre-activity (sEMG) duirng handball specific sidecutting. Outcome measure is expressed in %MVC.during sidecutting. | Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in isometric strength | Peak isometric hamstring and hip external rotation strength, respectively. Outcome measure is expressed in force (Newtons). | Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed. | 
| 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) | Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed. | 
| 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) | Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed. | 
| 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. | Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed. | 
| 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). | 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. | 
| Changes in shoulder sensorimoter stability | Shoulder sensorimoter stability measured as CoP length (mm) from force platform data. | Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed. | 
| Changes in Shoulder Rotator Cuff Strength | Peak isometric internal and external rotator cuff strength. Outcome measure is expressed in force (Newtons). | Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACL Injuries, Age-related, Neuromuscular, Motor-Learning