ACL Injury PreventionNCT05955599
Effect of Specific ACL Injury Prevention Training in Female Handball Players
A study testing ACL Injury Prevention Training in people with ACL Injury Prevention, run by Copenhagen University Hospital, Hvidovre at 3 sites in Denmark.
Trial 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… Read more about this study
- Who is it for?
- Ages 11 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- ACL Injury Prevention
- What is being tested?
- ACL Injury Prevention Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesDenmark
- Study dates
- 1 Jan 2022to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Department of Midwifery, Physiotherapy, Occupational Therapy and Psychomotor Therapy, Faculty of Health, University College Copenhagen
Copenhagen, 2200
Department of Nutrition, Exercise and Sports, University of Copenhagen, Copenhagen, Denmark
Copenhagen, 2200
Human Movement Analysis Laboratory, Department of Orthopaedic Surgery, Copenhagen University Hospital
Hvidovre, 2650
About this study
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.
- Conditions
- ACL Injury Prevention
- Being tested
- ACL Injury Prevention Training, Control - Shoulder Injury Prevention Training
- Keywords
- ACL Injuries, Age-related, Neuromuscular, Motor-Learning
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL Injury Prevention TrainingOther
Supervised ACL injury prevention training twice a week (2 x 15 minutes) over an 8-week period.
Control - Shoulder Injury Prevention TrainingOther
Supervised shoulder injury prevention training twice a week (2 x 15 minutes) over an 8-week period.
| Study group | Role | What they receive |
|---|---|---|
| Pre-adolescent Intervention | Experimental | 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. Receives: Other: ACL Injury Prevention Training |
| Pre-adolescent Control | Other | 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. Receives: Other: Control - Shoulder Injury Prevention Training |
| Adult Intervention | Experimental | 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. Receives: Other: ACL Injury Prevention Training |
| Adult Control | Other | 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. Receives: Other: Control - Shoulder Injury Prevention Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neuromuscular adaptations during sidecutting
Semitendinosus muscle pre-activity (sEMG) duirng handball specific sidecutting. Outcome measure is expressed in %MVC.during sidecutting.
Measured: Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.
Secondary outcomes (7)
Changes in isometric strength
Peak isometric hamstring and hip external rotation strength, respectively. Outcome measure is expressed in force (Newtons).
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2023
- Study start1 Jan 2022
- Primary completion28 Feb 2023
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ACL Injury PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Hvidovre
- Sponsor type
- University, hospital or other
- Collaborators
- University College Copenhagen, University of Copenhagen, Team Denmark
- Responsible party
- Principal investigator, Niels Jensby Nedergaard, Copenhagen University Hospital, Hvidovre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05955599
- Sponsor's protocol ID
- H-21030337
- Status last verified
- Jul 2023
- First submitted
- 21 Apr 2023
- Last updated
- 21 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nedergaard NJ, Bencke J, Egholm J, Nielsen AL, Karabanov AN, Lundbye-Jensen J, Zebis MK. No Alterations in ACL Injury Risk Factors in Preadolescent Elite Female Handball Players Following an Eight-Week Targeted Training Intervention: A Randomised Controlled Trial. Transl Sports Med. 2026 Jan 2;2026:2570210. doi: 10.1155/tsm2/2570210. eCollection 2026.
PubMed 41522287
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Specific ACL Injury Prevention Training in Female Handball Players
- ClinicalTrials.gov ID
- NCT05955599
- Acronym / sponsor ID
- H-21030337
- Conditions
- ACL Injury Prevention
- Keywords
- ACL Injuries, Age-related, Neuromuscular, Motor-Learning
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, HvidovreUniversity, hospital or other
- Collaborators
- University College Copenhagen, University of Copenhagen, Team Denmark
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 21 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Pre-adolescent Intervention | Experimental | Other: ACL Injury Prevention Training11-13 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. |
| Pre-adolescent Control | Other | Other: Control - Shoulder Injury Prevention Training11-13 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 Intervention | Experimental | Other: ACL Injury Prevention TrainingAdult (≥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 Control | Other | Other: Control - Shoulder Injury Prevention TrainingAdult (≥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. |
Who may qualify
- Ages
- 11 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACL Injury Prevention TrainingSupervised ACL injury prevention training twice a week (2 x 15 minutes) over an 8-week period. | Other | Adult Intervention, Pre-adolescent Intervention |
| Control - Shoulder Injury Prevention TrainingSupervised shoulder injury prevention training twice a week (2 x 15 minutes) over an 8-week period. | Other | Adult Control, Pre-adolescent Control |
Primary outcome
Neuromuscular adaptations during sidecutting
Time frame: Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.
Semitendinosus muscle pre-activity (sEMG) duirng handball specific sidecutting. Outcome measure is expressed in %MVC.during sidecutting.
7 secondary outcomes
Changes in isometric strength
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.
Visuomotor Skill Learning
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.
Changes in shoulder sensorimoter stability
Time frame: 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
Time frame: Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2023.
- Derived from this study: PubMed 41522287Nedergaard NJ, Bencke J, Egholm J, Nielsen AL, Karabanov AN, Lundbye-Jensen J, Zebis MK. No Alterations in ACL Injury Risk Factors in Preadolescent Elite Female Handball Players Following an Eight-Week Targeted Training Intervention: A Randomised Controlled Trial. Transl Sports Med. 2026 Jan 2;2026:2570210. doi: 10.1155/tsm2/2570210. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACL Injury Prevention Training in people with ACL Injury Prevention, run by Copenhagen University Hospital, Hvidovre at 3 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neuromuscular adaptations during sidecutting (time frame: Change from Baseline to Training Completion at 8 weeks. And retention 8-weeks after the prevention program was completed.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05955599, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2023.