NCT05643261

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 15, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2022

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 8, 2022

Completed
Last Updated

December 8, 2022

Status Verified

December 1, 2022

Enrollment Period

4 months

First QC Date

November 21, 2022

Last Update Submit

December 1, 2022

Conditions

Keywords

ACL injury preventionBiomechanicsSidestep cuttingStrength training

Outcome Measures

Primary Outcomes (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.

    Baseline, second testing 8-10 weeks later

Secondary Outcomes (4)

  • Cutting technique factors. These may affect the main outcome variable, but also performance

    Baseline, follow-up 8-10 weeks later

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

    Baseline, follow-up 8-10 weeks later

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

    Baseline, follow-up 8-10 weeks later

  • Player/trainer knowledge and motivation, implementation likelihood

    2-3 months after the follow-up

Study Arms (2)

Intervention group

EXPERIMENTAL

All 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.

Other: Muscle and technique training

Control group

NO INTERVENTION

Players in the control group only continue their regular handball training.

Interventions

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.

Intervention group

Eligibility Criteria

Age15 Years - 18 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsACL injury risk is higher in female handball players. Therefore the investigators want to investigate especially this vulnerable group.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian School of Sport Sciences

Oslo, 0806, Norway

Location

Related Publications (27)

  • 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.

    PMID: 24385003BACKGROUND
  • 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.

    PMID: 29455243BACKGROUND
  • 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.

    PMID: 25157180BACKGROUND
  • 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.

    PMID: 25042094BACKGROUND
  • 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.

    PMID: 19509415BACKGROUND
  • 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.

    PMID: 17909404BACKGROUND
  • 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.

    PMID: 24318609BACKGROUND
  • 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.

    PMID: 29721837BACKGROUND
  • 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.

    PMID: 27162233BACKGROUND
  • 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.

    PMID: 25102291BACKGROUND
  • 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.

    PMID: 31469584BACKGROUND
  • 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.

    PMID: 20595545BACKGROUND
  • 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.

    PMID: 21824618BACKGROUND
  • 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.

    PMID: 23258848BACKGROUND
  • 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.

    PMID: 24161796BACKGROUND
  • Krosshaug T, Steffen K, Kristianslund E, Nilstad A, Mok KM, Myklebust G, Andersen TE, Holme I, Engebretsen L, Bahr R. Screening Tests for ACL Injury: Response. Am J Sports Med. 2016 Jun;44(6):NP26-7. doi: 10.1177/0363546516651046. No abstract available.

    PMID: 27252550BACKGROUND
  • Krosshaug T, Steffen K, Kristianslund E, Nilstad A, Mok KM, Myklebust G, Andersen TE, Holme I, Engebretsen L, Bahr R. The Vertical Drop Jump Is a Poor Screening Test for ACL Injuries in Female Elite Soccer and Handball Players: A Prospective Cohort Study of 710 Athletes. Am J Sports Med. 2016 Apr;44(4):874-83. doi: 10.1177/0363546515625048. Epub 2016 Feb 11.

    PMID: 26867936BACKGROUND
  • Lie MM, Risberg MA, Storheim K, Engebretsen L, Oiestad BE. What's the rate of knee osteoarthritis 10 years after anterior cruciate ligament injury? An updated systematic review. Br J Sports Med. 2019 Sep;53(18):1162-1167. doi: 10.1136/bjsports-2018-099751. Epub 2019 Apr 1.

    PMID: 30936063BACKGROUND
  • Mok KM, Bahr R, Krosshaug T. Reliability of lower limb biomechanics in two sport-specific sidestep cutting tasks. Sports Biomech. 2018 Jun;17(2):157-167. doi: 10.1080/14763141.2016.1260766. Epub 2017 Mar 10.

    PMID: 28281390BACKGROUND
  • Myklebust G, Bahr R, Nilstad A, Steffen K. Knee function among elite handball and football players 1-6 years after anterior cruciate ligament injury. Scand J Med Sci Sports. 2017 May;27(5):545-553. doi: 10.1111/sms.12842. Epub 2017 Mar 8.

    PMID: 28107551BACKGROUND
  • Pairot-de-Fontenay B, Willy RW, Elias ARC, Mizner RL, Dube MO, Roy JS. Running Biomechanics in Individuals with Anterior Cruciate Ligament Reconstruction: A Systematic Review. Sports Med. 2019 Sep;49(9):1411-1424. doi: 10.1007/s40279-019-01120-x.

    PMID: 31102111BACKGROUND
  • Pasanen K, Rossi MT, Parkkari J, Heinonen A, Steffen K, Myklebust G, Krosshaug T, Vasankari T, Kannus P, Avela J, Kulmala JP, Perttunen J, Kujala UM, Bahr R. Predictors of lower extremity injuries in team sports (PROFITS-study): a study protocol. BMJ Open Sport Exerc Med. 2015 Dec 11;1(1):e000076. doi: 10.1136/bmjsem-2015-000076. eCollection 2015.

    PMID: 27900143BACKGROUND
  • Petushek EJ, Sugimoto D, Stoolmiller M, Smith G, Myer GD. Evidence-Based Best-Practice Guidelines for Preventing Anterior Cruciate Ligament Injuries in Young Female Athletes: A Systematic Review and Meta-analysis. Am J Sports Med. 2019 Jun;47(7):1744-1753. doi: 10.1177/0363546518782460. Epub 2018 Jul 12.

    PMID: 30001501BACKGROUND
  • Sharir R, Rafeeuddin R, Staes F, Dingenen B, George K, Vanrenterghem J, Robinson MA. Mapping current research trends on anterior cruciate ligament injury risk against the existing evidence: In vivo biomechanical risk factors. Clin Biomech (Bristol). 2016 Aug;37:34-43. doi: 10.1016/j.clinbiomech.2016.05.017. Epub 2016 Jun 2.

    PMID: 27286556BACKGROUND
  • Steffen K, Nilstad A, Kristianslund EK, Myklebust G, Bahr R, Krosshaug T. Association between Lower Extremity Muscle Strength and Noncontact ACL Injuries. Med Sci Sports Exerc. 2016 Nov;48(11):2082-2089. doi: 10.1249/MSS.0000000000001014.

    PMID: 27327027BACKGROUND
  • Sugimoto D, Myer GD, Foss KD, Hewett TE. Specific exercise effects of preventive neuromuscular training intervention on anterior cruciate ligament injury risk reduction in young females: meta-analysis and subgroup analysis. Br J Sports Med. 2015 Mar;49(5):282-9. doi: 10.1136/bjsports-2014-093461. Epub 2014 Dec 1.

    PMID: 25452612BACKGROUND
  • Whittaker JL, Woodhouse LJ, Nettel-Aguirre A, Emery CA. Outcomes associated with early post-traumatic osteoarthritis and other negative health consequences 3-10 years following knee joint injury in youth sport. Osteoarthritis Cartilage. 2015 Jul;23(7):1122-9. doi: 10.1016/j.joca.2015.02.021. Epub 2015 Feb 26.

    PMID: 25725392BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Tron Krosshaug PhD

Study Record Dates

First Submitted

November 21, 2022

First Posted

December 8, 2022

Study Start

August 15, 2022

Primary Completion

November 30, 2022

Study Completion

November 30, 2022

Last Updated

December 8, 2022

Record last verified: 2022-12

Data Sharing

IPD Sharing
Will not share

Locations