Clinical trial NCT05955599: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: ACL Injury Prevention
Keywords: ACL Injuries
Age-related
Neuromuscular
Motor-Learning
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
Collaborators: name: University College Copenhagen
name: University of Copenhagen
name: Team Denmark
First posted: 2023-07-21
Enrollment: 80
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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:

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.


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

Primary outcomes:
measure: Neuromuscular adaptations during sidecutting
timeFrame: Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.
Secondary outcomes:
measure: Changes in isometric strength
timeFrame: Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.
measure: Changes in 3D hip and knee joint angles
timeFrame: Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.
measure: Changes in 3D hip and knee joint moments
timeFrame: Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.
measure: Changes in hamstring and quadriceps pre-activation
timeFrame: Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.
measure: Visuomotor Skill Learning
timeFrame: 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.
measure: Changes in shoulder sensorimoter stability
timeFrame: Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.
measure: Changes in Shoulder Rotator Cuff Strength
timeFrame: Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.
Other outcomes:
measure: Injury monitoring
timeFrame: Weekly for 16 weeks (from the start of the intervention to the end of the 8-week retention period)
measure: Training and match exposure
timeFrame: Weekly for 16 weeks (from the start of the intervention to the end of the 8-week retention period)
Locations:
city: Copenhagen
country: Denmark
facility: Department of Midwifery, Physiotherapy, Occupational Therapy and Psychomotor Therapy, Faculty of Health, University College Copenhagen
city: Copenhagen
country: Denmark
facility: Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark
city: Hvidovre
country: Denmark
facility: Human Movement Analysis Laboratory, Department of Orthopaedic Surgery, Copenhagen University Hospital
Study officials:
References: