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ACL InjuryNCT05643261

Can a Strength and Technique Intervention Reduce Knee Abduction Moment in Young Female Handball Players

A study testing Muscle and technique training in people with ACL Injury, run by Norges idrettshøgskole at 1 site in Norway.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Anterior cruciate ligament (ACL) injury constitutes the largest problem in female elite ball/team sport today, due to its relatively high incidence and serious short- and long-term consequences. Especially in handball, these injuries typically occur in actions that are essential for the game, i.e. Read more about this study

Who is it for?
Ages 15 to 18 years, women onlyHealthy volunteers can take part
Conditions the study is for
ACL Injury
What is being tested?
Muscle and technique training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteNorway
Study dates
15 Aug 2022to 30 Nov 2022
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 15 to 18 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Female handball players between the ages of 15 and 18 who go to a sports school in Oslo
  • Consent by the players, in the case of age below 16 years by their parents
  • Match fitness on test day

Who cannot join

  • History of ACL injury in the last 6 months before baseline testing

Trial locations and contacts

1 site in 1 country.

Norway1 site
  • Norwegian School of Sport Sciences

    Oslo, 0806

Other trials in Norway

About this study

Anterior cruciate ligament (ACL) injury constitutes the largest problem in female elite ball/team sport today, due to its relatively high incidence and serious short- and long-term consequences. Especially in handball, these injuries typically occur in actions that are essential for the game, i.e. landings and cutting maneuvers, imposing a challenge for risk reduction strategies. Although knowledge about risk factors is constantly increasing and ACL injury prevention programs have been successful in reducing injuries in rigorous scientific study settings, the real-world injury incidence remains high, and even continues to increase. The purpose of this explorative intervention study is to assess the effect of an eight-week strength and technique training in female handball players and its influence on ACL-specific risk factors, especially knee abduction moment (KAM). The results are compared with a control group that did not do the specially designed technique/muscle training.

Read the detailed description

BACKGROUND:

ACL injuries are the number one problem in female elite ball/team sports due to its relatively high incidence and serious short- and long-term consequences. Typically injuries occur in actions that are essential for the game, i.e. landings and cutting maneuvers, imposing a challenge for risk reduction strategies.

The consequences of an ACL injury are manifold for the players. They not only reduce quality of life but also lead to a loss of social contacts due to missed training sessions what can be difficult, especially for younger players. Additionally, there are serious long-term consequences with a high likelihood of early osteoarthritis, lasting pain and disability. Also the risk of suffering a second ACL injury after returning to sport is high. In fact, as many as 20-30% of female players returning to play after an ACL injury end up with a new ACL injury in the same or contralateral knee, which makes prevention of a first injury even more important.

Video analyses of ACL injuries strongly suggest that biomechanics is important in injury causation. Novel model-based image-matching techniques have shown that valgus movement occurs shortly after initial contact of the foot with the ground. This implies that knee abduction loading is a likely causative factor. Still, video-based methods have limitations in their accuracy and detail level. To address this knowledge gap, the Oslo Sports Trauma Research Center has carried out the world's largest prospective risk factor study on ACL injuries to date-with multiple data collections between 2007 and 2014.

The most recent analyses indicate that there are clear associations between biomechanics of cutting maneuvers and injury risk. Specifically knee abduction moments seems to be greater in players who later go on to sustain an injury and can be affected by the players' cutting technique variables (width of cut, hip abduction, foot rotation, torso movement/rotation, hip rotation, knee valgus, knee flexion, cutting angle, cutting time, approach speed). These findings may simply reflect that injuries take place in cutting maneuvers and underline the importance of investigating such maneuvers, which closely mimic the real-life setting.

Resulting, there are several different cutting technique strategies, where some strategies may lead to a higher risk for ACL injury while others seem to reduce the risk of injury. Especially landing on the forefoot, rather than on the heel, showed to reduce knee abduction moments by 13% and it was found that a narrow cut, rather than a wide-stance cut, reduced knee abduction moments by 17%.

Based on this knowledge, the investigators want to find out whether it is possible to reduce the players' knee loading, especially reduce KAM, through influencing known risk factors for ACL injuries using a specially designed eight-week muscle and technique training.

AIMS:

The aim of this feasibility study is to assess the effect of an eight-week strength and technique training in female handball players on known risk factors for ACL injuries, especially the knee abduction moment (KAM).

STUDY DESIGN AND METHODS:

To recruit participants, the investigators will contact sports schools in and around Oslo that have a focus on handball. The study is a feasibility study with the aim of finding out whether a targeted, eight-week muscle and technique training based on known ACL-injury risk factors can have a positive influence on their reduction.

At baseline, there will be a 3D motion analysis of all participants (25 in the intervention group, 25 in the control group) performing sidestep cuttings (3 trials per side) in the biomechanical laboratory of the Norwegian School of Sport Sciences (NiH) in Oslo, as well as a strength measurement.

Although a variety of biomechanical data (centre of mass, specific joint positions, cutting width, speed, etc.) is collected as part of the analysis, the focus is on ACL-specific risk factors such as forefoot landing and KAM. The strength test focuses on hip abduction and external rotation, as well as a measurement of the posterior calf muscles.

All players in the intervention group will complete the targeted muscle and technique training integrated into their handball training, while players in the control group only continue their regular handball training. There will be a training of the coaches on site, who assess the training of the intervention group during the entire period and document the participation of the players accordingly.

The strength training consists of three exercises (clam shell, side plank, calf raises) with an progressive overload after two to three weeks to ensure a continuous muscle stimulation. The technique training consists of different cutting variations with a focus on forefoot landings and conscious control of the knee to avoid high knee valgus movement and KAM respectively.

The allocation to intervention or control groups is not random, but separated according to sports schools. This is the only way to ensure that there is no overlapping of training. After a eight-week intervention period, all participants will perform a post-test including the same previous mentioned outcome measures.

Conditions
ACL Injury
Being tested
Muscle and technique training
Keywords
ACL injury prevention, Biomechanics, Sidestep cutting, Strength training
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.

  • Muscle and technique trainingOther

    The strength training consists of three exercises (clam shell, side plank, calf raises) with an progressive overload after two to three weeks to ensure a continuous muscle stimulation. The technique training consists of different cutting variations with a focus on forefoot landings and conscious control of the knee to avoid high knee valgus movement and KAM respectively.

Study groups in NCT05643261
Study groupRoleWhat they receive
Intervention groupExperimentalAll players in the intervention group will complete the targeted muscle and technique training integrated into their handball training. There will be a training of the coaches on site, who assess the training of the intervention group during the entire period and document the participation of the players accordingly.
Receives: Other: Muscle and technique training
Control groupNo interventionPlayers in the control group only continue their regular handball training.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Knee Abduction Moment (KAM)

    Peak Knee Abduction Moment (KAM) within the first 100ms after initial contact (IC) of the foot. A known risk factor for ACL injury.

    Measured: Baseline, second testing 8-10 weeks later

Secondary outcomes (4)
  1. Cutting technique factors. These may affect the main outcome variable, but also performance

    Cutting angle (°), approach speed (m/s), knee valgus (°), foot strike angle (°), foot rotation (°), width of cut (cm), hip abduction angle (°), torso rotation (°)

    Measured: Baseline, follow-up 8-10 weeks later

  2. Strength factors. These may affect the main outcome variable, but also performance

    Isometric hip abduction force (N), isometric hip external rotation force (N), isometric plantar flexion force (N)

    Measured: Baseline, follow-up 8-10 weeks later

  3. Performance in a timed run-and-cut task. Run 5 m forward, turn 180 degrees and run back 5 m.

    Total time Time 2,5-5m Time 5m - back to start

    Measured: Baseline, follow-up 8-10 weeks later

  4. Player/trainer knowledge and motivation, implementation likelihood

    Measured through questionnaires and Interviews

    Measured: 2-3 months after the follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2022
  2. Study start15 Aug 2022
  3. Primary completion30 Nov 2022 (estimated)
  4. Study completion30 Nov 2022 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
All players in the intervention group will complete the targeted muscle and technique training integrated into their handball training, while players in the control group only continue their regular handball training. There will be a training of the coaches on site, who assess the training of the intervention group during the entire period and document the participation of the players accordingly.The strength training consists of three exercises (clam shell, side plank, calf raises) with an progressive overload after two to three weeks to ensure a continuous muscle stimulation. The technique training consists of different cutting variations with a focus on forefoot landings and conscious control of the knee to avoid high knee valgus movement and KAM respectively.
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05643261
Sponsor's protocol ID
Søknad 233 - 160622
Status last verified
Dec 2022
First submitted
21 Nov 2022
Last updated
8 Dec 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Alentorn-Geli E, Mendiguchia J, Samuelsson K, Musahl V, Karlsson J, Cugat R, Myer GD. Prevention of anterior cruciate ligament injuries in sports. Part I: systematic review of risk factors in male athletes. Knee Surg Sports Traumatol Arthrosc. 2014 Jan;22(1):3-15. doi: 10.1007/s00167-013-2725-3. Epub 2013 Oct 25.

    PubMed 24385003
  • Ardern CL, Ekas G, Grindem H, Moksnes H, Anderson A, Chotel F, Cohen M, Forssblad M, Ganley TJ, Feller JA, Karlsson J, Kocher MS, LaPrade RF, McNamee M, Mandelbaum B, Micheli L, Mohtadi N, Reider B, Roe J, Seil R, Siebold R, Silvers-Granelli HJ, Soligard T, Witvrouw E, Engebretsen L. 2018 International Olympic Committee consensus statement on prevention, diagnosis and management of paediatric anterior cruciate ligament (ACL) injuries. Knee Surg Sports Traumatol Arthrosc. 2018 Apr;26(4):989-1010. doi: 10.1007/s00167-018-4865-y. Epub 2018 Feb 17.

    PubMed 29455243
  • Ardern CL, Taylor NF, Feller JA, Webster KE. Fifty-five per cent return to competitive sport following anterior cruciate ligament reconstruction surgery: an updated systematic review and meta-analysis including aspects of physical functioning and contextual factors. Br J Sports Med. 2014 Nov;48(21):1543-52. doi: 10.1136/bjsports-2013-093398. Epub 2014 Aug 25.

    PubMed 25157180
  • Benjaminse A, Welling W, Otten B, Gokeler A. Novel methods of instruction in ACL injury prevention programs, a systematic review. Phys Ther Sport. 2015 May;16(2):176-86. doi: 10.1016/j.ptsp.2014.06.003. Epub 2014 Jun 19.

    PubMed 25042094
  • Dempsey AR, Lloyd DG, Elliott BC, Steele JR, Munro BJ. Changing sidestep cutting technique reduces knee valgus loading. Am J Sports Med. 2009 Nov;37(11):2194-200. doi: 10.1177/0363546509334373. Epub 2009 Jun 9.

    PubMed 19509415
  • Dempsey AR, Lloyd DG, Elliott BC, Steele JR, Munro BJ, Russo KA. The effect of technique change on knee loads during sidestep cutting. Med Sci Sports Exerc. 2007 Oct;39(10):1765-73. doi: 10.1249/mss.0b013e31812f56d1.

    PubMed 17909404
  • Filbay SR, Ackerman IN, Russell TG, Macri EM, Crossley KM. Health-related quality of life after anterior cruciate ligament reconstruction: a systematic review. Am J Sports Med. 2014 May;42(5):1247-55. doi: 10.1177/0363546513512774. Epub 2013 Dec 6.

    PubMed 24318609
  • Fox AS. Change-of-Direction Biomechanics: Is What's Best for Anterior Cruciate Ligament Injury Prevention Also Best for Performance? Sports Med. 2018 Aug;48(8):1799-1807. doi: 10.1007/s40279-018-0931-3.

    PubMed 29721837
  • Grindem H, Snyder-Mackler L, Moksnes H, Engebretsen L, Risberg MA. Simple decision rules can reduce reinjury risk by 84% after ACL reconstruction: the Delaware-Oslo ACL cohort study. Br J Sports Med. 2016 Jul;50(13):804-8. doi: 10.1136/bjsports-2016-096031. Epub 2016 May 9.

    PubMed 27162233
  • Havens KL, Sigward SM. Cutting mechanics: relation to performance and anterior cruciate ligament injury risk. Med Sci Sports Exerc. 2015 Apr;47(4):818-24. doi: 10.1249/MSS.0000000000000470.

    PubMed 25102291
  • Huang YL, Jung J, Mulligan CMS, Oh J, Norcross MF. A Majority of Anterior Cruciate Ligament Injuries Can Be Prevented by Injury Prevention Programs: A Systematic Review of Randomized Controlled Trials and Cluster-Randomized Controlled Trials With Meta-analysis. Am J Sports Med. 2020 May;48(6):1505-1515. doi: 10.1177/0363546519870175. Epub 2019 Aug 30.

    PubMed 31469584
  • Koga H, Nakamae A, Shima Y, Iwasa J, Myklebust G, Engebretsen L, Bahr R, Krosshaug T. Mechanisms for noncontact anterior cruciate ligament injuries: knee joint kinematics in 10 injury situations from female team handball and basketball. Am J Sports Med. 2010 Nov;38(11):2218-25. doi: 10.1177/0363546510373570. Epub 2010 Jul 1.

    PubMed 20595545
  • Kristianslund E, Bahr R, Krosshaug T. Kinematics and kinetics of an accidental lateral ankle sprain. J Biomech. 2011 Sep 23;44(14):2576-8. doi: 10.1016/j.jbiomech.2011.07.014. Epub 2011 Aug 6.

    PubMed 21824618
  • Kristianslund E, Faul O, Bahr R, Myklebust G, Krosshaug T. Sidestep cutting technique and knee abduction loading: implications for ACL prevention exercises. Br J Sports Med. 2014 May;48(9):779-83. doi: 10.1136/bjsports-2012-091370. Epub 2012 Dec 20.

    PubMed 23258848
  • Kristianslund E, Krosshaug T, Mok KM, McLean S, van den Bogert AJ. Expressing the joint moments of drop jumps and sidestep cutting in different reference frames--does it matter? J Biomech. 2014 Jan 3;47(1):193-9. doi: 10.1016/j.jbiomech.2013.09.016. Epub 2013 Oct 11.

    PubMed 24161796

Questions about this trial

What is this clinical trial studying?

A study testing Muscle and technique training in people with ACL Injury, run by Norges idrettshøgskole at 1 site in Norway.

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 1 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 8 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. 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?

Knee Abduction Moment (KAM) (time frame: Baseline, second testing 8-10 weeks later). 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 NCT05643261, which also lists 27 linked publications.

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 8 Dec 2022; AzTrials last refreshed its copy on 31 Oct 2026.

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