Effect of Specific ACL Injury Prevention Training in Female Handball Players

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:

1. Medial hamstring muscles activation during sidecutting;
2. Well-known biomechanical ACL injury-risk factors during high risk movements, such as cutting and landing tasks;
3. Cortical and muscular activity and functional connectivity patterns during controlled knee movements;
4. Visuomotor skill learning during a simple task involving the hamstring muscles.

Study Overview

• Status: Active, not recruiting
• Conditions: ACL Injury Prevention
• Intervention / Treatment: Other: ACL Injury Prevention Training; Other: Control - Shoulder Injury Prevention Training

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2200
    • Department of Midwifery, Physiotherapy, Occupational Therapy and Psychomotor Therapy, Faculty of Health, University College Copenhagen
  • Copenhagen, Denmark, 2200
    • Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark
  • Hvidovre, Denmark, 2650
    • Human Movement Analysis Laboratory, Department of Orthopaedic Surgery, Copenhagen University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Pre-adolescent Intervention; 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; Supervised ACL injury prevention training twice a week (2 x 15 minutes) over an 8-week period.
Other: Pre-adolescent Control; 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; Supervised shoulder injury prevention training twice a week (2 x 15 minutes) over an 8-week period.
Experimental: Adult Intervention; 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; Supervised ACL injury prevention training twice a week (2 x 15 minutes) over an 8-week period.
Other: Adult Control; 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; Supervised shoulder injury prevention training twice a week (2 x 15 minutes) over an 8-week period.

What is the study measuring?

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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Injury monitoring	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.	Weekly for 16 weeks (from the start of the intervention to the end of the 8-week retention period)
Training and match exposure	Number of training and match hours will be collected on a weekly basis using an electronical study-specific questionary	Weekly for 16 weeks (from the start of the intervention to the end of the 8-week retention period)

Collaborators and Investigators

• Sponsor: Copenhagen University Hospital, Hvidovre
• Collaborators: University of Copenhagen; University College Copenhagen; Team Denmark

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): February 28, 2023
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: April 21, 2023
• First Submitted That Met QC Criteria: July 13, 2023
• First Posted (Actual): July 21, 2023

Study Record Updates

• Last Update Posted (Actual): July 21, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Neuromuscular; Age-related; ACL Injuries; Motor-Learning
• Additional Relevant MeSH Terms: Leg Injuries; Knee Injuries; Wounds and Injuries; Anterior Cruciate Ligament Injuries
• Other Study ID Numbers: H-21030337

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No