NCT05014009

Brief Summary

Background Knee injuries are common during sports that require fast change-of-direction (COD) movements such as sidestepping and pivoting during soccer, basketball, handball, and related sports. COD movements expose the knee joint to large external forces, particularly if players show a poor COD technique such as lateral trunk lean towards the plant foot or a strong knee valgus of the cutting leg. Larger external forces and moments that act on the knee joint are expected to result in larger strain of the anterior cruciate ligament (ACL) and thus a higher risk of ACL rupture. Consequently, during sports like soccer and basketball, many non-contact ACL injuries occur during COD tasks. While neuromuscular training (NMT) programs have been developed to effectively reduce the risk of sports injury including ACL tears, ACL injury rates have not declined in the last years. One of the reasons for this paradox may be that many NMT programs such as the FIFA11+ program, which were developed to protect from injury do not actually improve COD movement strategies. It may be assumed that FIFA11+ does reduce the overall risk of sports injury through general improvements in strength and balance as well as safer jump landing technique but not through safer COD technique. Further, if training interventions were successful in reducing 'high-risk' movement patterns and in developing knee-stabilizing muscle synergies during COD movements, it remains unclear whether the improved movement strategy, e.g. the reduction in external knee valgus moments, actually corresponds to reduced ACL strain. In consequence, there is the need for a comprehensive investigation to determine whether a NMT program focused on improving COD technique will improve COD movement and muscle activation strategies and whether these improvements are correlated with estimated ACL strain. A second reason for the paradox may be that current experimental protocols to investigate COD movement strategies in the laboratory are not a good indicator for actual player behavior on the field thus masking potential benefits of NMT on lateral movements. Therefore, the sports injury prevention community should aim to move the assessment of COD movement strategy onto the playing field and into a more realistic playing environment while characterizing the kinematics and kinetics of sidestepping based on wearable sensors. In consequence, novel analytical frameworks based on wearables need to be developed, which can capture full-body kinematics and the underlying forces during COD movements on the playing field. In the long run, such systems could facilitate real-time feedback with respect to COD technique on the playing field and thus enhance motor learning of the players as well as characterize real-world player agility. Research objectives \& hypotheses Objective 1: To determine the effect of an 8-week NMT and COD technique modification intervention (multidirection training, MD) on 1) COD movement strategies as characterized by the lateral trunk angle and knee valgus moment and 2) estimated ACL strain during 45- and 135-degree COD movements in comparison to an 8-week NMT and linear sprint training intervention (linear sprint training, LS) in sports science students. Hypothesis 1: There will be a larger reduction in lateral trunk angle and knee valgus moment and an associated reduction in ACL strain in the MD group compared to the LS group following the 8-week intervention, which will be retained four weeks later. Objective 2: To determine the effect of an 8-week NMT and COD technique modification intervention on leg muscle synergies as characterized by the number of muscles and the structure of the synergy vector for each identified muscle synergy in comparison to an 8-week NMT and linear sprint training intervention in sports science students. Hypothesis 2: One or multiple muscle synergy vectors will show an increased contribution of hip abductor muscle activity in the MD group following training and there will be a lower number of activated muscles per identified synergy, i.e. a more selective muscle activation in comparison to the LS group. These improvements will be retained four weeks later. Objective 3: To determine the validity of an analysis framework to estimate COD movement strategy (lateral trunk angle, foot progression angle, knee valgus moment) and ACL strain based solely on inertial motion capture data in comparison to the gold-standard of 3D optimal motion capture.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 6, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 20, 2021

Completed
2 months until next milestone

Study Start

First participant enrolled

October 4, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2021

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

August 6, 2021

Last Update Submit

June 14, 2023

Conditions

Keywords

electromyographyinertial measurement unitneuromuscular trainingmuscle activitymuscle synergysidestepping movementside-cutting movement

Outcome Measures

Primary Outcomes (3)

  • Peak knee abduction moment in Nm assessed through 3D optical motion capture

    Peak external knee moment in the frontal plane during the COD stance phase

    Assessed in October (baseline), December (follow-up), February (retention) over a total duration of 5 months.

  • Peak lateral trunk lean in degrees assessed through 3D optical motion capture

    Peak angle of the trunk with respect to a vertical line in the frontal plane during the COD stance phase. Of interest is the angle opposite to the direction of intended travel.

    Assessed in October (baseline), December (follow-up), February (retention) over a total duration of 5 months.

  • Peak ACL strain in % estimated through finite element simulation

    Peak ACL strain estimated from the EMG-informed musculoskeletal and FE simulation.

    Assessed in October (baseline), December (follow-up), February (retention) over a total duration of 5 months.

Secondary Outcomes (4)

  • Muscle synergy size (number of muscles per synergy) assessed through non-negative matrix factorization of the surface EMG data

    Assessed in October (baseline), December (follow-up), February (retention) over a total duration of 5 months.

  • Hip muscle contribution in % assessed through non-negative matrix factorization of the surface EMG data

    Assessed in October (baseline), December (follow-up), February (retention) over a total duration of 5 months.

  • Linear sprint performance in seconds assessed through a timing gate system

    Assessed in October (baseline), December (follow-up), February (retention) over a total duration of 5 months.

  • COD performance in seconds assessed through a timing gate system

    Assessed in October (baseline), December (follow-up), February (retention) over a total duration of 5 months.

Other Outcomes (1)

  • Peak knee abduction moment in Nm assessed through inertial motion capture

    Assessed in October (baseline), December (follow-up), February (retention) over a total duration of 5 months.

Study Arms (2)

FIFA11+ and multidirectional training (MD)

EXPERIMENTAL

Participants in the MD group will take part in an 8-week NMT intervention known to reduce the risk of sports injury and expected to improve COD movement strategies.

Behavioral: FIFA11+ and multidirectional training (MD)

FIFA11+ and linear sprint training (LS)

ACTIVE COMPARATOR

Participants in the LS group will take part in an 8-week NMT intervention, which is known to reduce the risk of sports injury but is unlikely to improve COD movement strategies and is expected to improve linear sprint performance.

Behavioral: FIFA11+ and linear sprint training (MD)

Interventions

This intervention initially contains a shortened version of the FIFA11+ injury prevention program including running (straight, hip out, hip in, jump-run-ups), strengthening (planks, squats, nordic hamstring curls), and single-leg balance exercises. The initial part is followed by COD technique modification training, which contains exercises aimed at improving COD technique (safer and more effective body re-direction, use of penultimate step, avoiding knee valgus) and COD braking and re-acceleration impulse. The duration of each training session is 25-30 minutes. The training is carried out twice per week under supervision with supervisors providing feedback to participants regarding their COD technique. Participants are encouraged to complete a third training session in their own time.

FIFA11+ and multidirectional training (MD)

This intervention initially contains a shortened version of the FIFA11+ injury prevention program including running (straight, hip out, hip in, jump-run-ups), strengthening (planks, squats, nordic hamstring curls), and single-leg balance exercises. The initial part is followed by a linear sprint training, which contains exercises aimed at improving sprint technique (e.g. sagittal arm and leg movement, trunk lean), use of the stretch-shortening cycle, leg stiffness and propulsive impulse . The duration of each training session is 25-30 minutes. The training is carried out twice per week under supervision with supervisors providing feedback to participants regarding their sprinting technique. Participants are encouraged to complete a third training session in their own time.

FIFA11+ and linear sprint training (LS)

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Enrolled as a student at the Department of Sport Science in Innsbruck

You may not qualify if:

  • Clinical diagnosis of a lower extremity muscle or joint injury within the last six months that led to a disruption of sport participant by at least two weeks
  • Clinical diagnosis of a balance disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Sport Science, University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

Related Publications (19)

  • Turpin NA, Uriac S, Dalleau G. How to improve the muscle synergy analysis methodology? Eur J Appl Physiol. 2021 Apr;121(4):1009-1025. doi: 10.1007/s00421-021-04604-9. Epub 2021 Jan 26.

    PMID: 33496848BACKGROUND
  • McLean SG, Huang X, Su A, Van Den Bogert AJ. Sagittal plane biomechanics cannot injure the ACL during sidestep cutting. Clin Biomech (Bristol). 2004 Oct;19(8):828-38. doi: 10.1016/j.clinbiomech.2004.06.006.

    PMID: 15342155BACKGROUND
  • Benjaminse A, Gokeler A, Dowling AV, Faigenbaum A, Ford KR, Hewett TE, Onate JA, Otten B, Myer GD. Optimization of the anterior cruciate ligament injury prevention paradigm: novel feedback techniques to enhance motor learning and reduce injury risk. J Orthop Sports Phys Ther. 2015 Mar;45(3):170-82. doi: 10.2519/jospt.2015.4986. Epub 2015 Jan 27.

    PMID: 25627151BACKGROUND
  • Delp SL, Anderson FC, Arnold AS, Loan P, Habib A, John CT, Guendelman E, Thelen DG. OpenSim: open-source software to create and analyze dynamic simulations of movement. IEEE Trans Biomed Eng. 2007 Nov;54(11):1940-50. doi: 10.1109/TBME.2007.901024.

    PMID: 18018689BACKGROUND
  • 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
  • Donnelly CJ, Lloyd DG, Elliott BC, Reinbolt JA. Optimizing whole-body kinematics to minimize valgus knee loading during sidestepping: implications for ACL injury risk. J Biomech. 2012 May 11;45(8):1491-7. doi: 10.1016/j.jbiomech.2012.02.010. Epub 2012 Mar 3.

    PMID: 22387123BACKGROUND
  • Dorschky E, Nitschke M, Seifer AK, van den Bogert AJ, Eskofier BM. Estimation of gait kinematics and kinetics from inertial sensor data using optimal control of musculoskeletal models. J Biomech. 2019 Oct 11;95:109278. doi: 10.1016/j.jbiomech.2019.07.022. Epub 2019 Aug 1.

    PMID: 31472970BACKGROUND
  • Dos'Santos T, McBurnie A, Comfort P, Jones PA. The Effects of Six-Weeks Change of Direction Speed and Technique Modification Training on Cutting Performance and Movement Quality in Male Youth Soccer Players. Sports (Basel). 2019 Sep 6;7(9):205. doi: 10.3390/sports7090205.

    PMID: 31489929BACKGROUND
  • Emery CA, Roy TO, Whittaker JL, Nettel-Aguirre A, van Mechelen W. Neuromuscular training injury prevention strategies in youth sport: a systematic review and meta-analysis. Br J Sports Med. 2015 Jul;49(13):865-70. doi: 10.1136/bjsports-2015-094639.

    PMID: 26084526BACKGROUND
  • Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.

    PMID: 17695343BACKGROUND
  • Krosshaug T, Nakamae A, Boden BP, Engebretsen L, Smith G, Slauterbeck JR, Hewett TE, Bahr R. Mechanisms of anterior cruciate ligament injury in basketball: video analysis of 39 cases. Am J Sports Med. 2007 Mar;35(3):359-67. doi: 10.1177/0363546506293899. Epub 2006 Nov 7.

    PMID: 17092928BACKGROUND
  • Lockie RG, Murphy AJ, Callaghan SJ, Jeffriess MD. Effects of sprint and plyometrics training on field sport acceleration technique. J Strength Cond Res. 2014 Jul;28(7):1790-801. doi: 10.1519/JSC.0000000000000297.

    PMID: 24149762BACKGROUND
  • Markolf KL, Burchfield DM, Shapiro MM, Shepard MF, Finerman GA, Slauterbeck JL. Combined knee loading states that generate high anterior cruciate ligament forces. J Orthop Res. 1995 Nov;13(6):930-5. doi: 10.1002/jor.1100130618.

    PMID: 8544031BACKGROUND
  • Oliveira AS, Silva PB, Lund ME, Farina D, Kersting UG. Balance Training Enhances Motor Coordination During a Perturbed Sidestep Cutting Task. J Orthop Sports Phys Ther. 2017 Nov;47(11):853-862. doi: 10.2519/jospt.2017.6980. Epub 2017 Sep 23.

    PMID: 28944715BACKGROUND
  • Rajagopal A, Dembia CL, DeMers MS, Delp DD, Hicks JL, Delp SL. Full-Body Musculoskeletal Model for Muscle-Driven Simulation of Human Gait. IEEE Trans Biomed Eng. 2016 Oct;63(10):2068-79. doi: 10.1109/TBME.2016.2586891. Epub 2016 Jul 7.

    PMID: 27392337BACKGROUND
  • Thompson JA, Tran AA, Gatewood CT, Shultz R, Silder A, Delp SL, Dragoo JL. Biomechanical Effects of an Injury Prevention Program in Preadolescent Female Soccer Athletes. Am J Sports Med. 2017 Feb;45(2):294-301. doi: 10.1177/0363546516669326. Epub 2016 Oct 29.

    PMID: 27793803BACKGROUND
  • Ueno R, Navacchia A, Schilaty ND, Myer GD, Hewett TE, Bates NA. Anterior Cruciate Ligament Loading Increases With Pivot-Shift Mechanism During Asymmetrical Drop Vertical Jump in Female Athletes. Orthop J Sports Med. 2021 Mar 9;9(3):2325967121989095. doi: 10.1177/2325967121989095. eCollection 2021 Mar.

    PMID: 34235227BACKGROUND
  • Walden M, Hagglund M, Magnusson H, Ekstrand J. ACL injuries in men's professional football: a 15-year prospective study on time trends and return-to-play rates reveals only 65% of players still play at the top level 3 years after ACL rupture. Br J Sports Med. 2016 Jun;50(12):744-50. doi: 10.1136/bjsports-2015-095952. Epub 2016 Mar 31.

    PMID: 27034129BACKGROUND
  • Young W, Rayner R, Talpey S. It's Time to Change Direction on Agility Research: a Call to Action. Sports Med Open. 2021 Feb 12;7(1):12. doi: 10.1186/s40798-021-00304-y.

    PMID: 33580424BACKGROUND

Related Links

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Maurice Mohr, PhD

    University of Innsbruck, Austria

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
While the study team will not point participants to the specific differences between the two training programs (MD vs. LS), an exchange between participants about the training elements in each group cannot be avoided given that the participants are all students at the same faculty. Given that the study team will supervise the training sessions, collect the data, and assess the outcomes, blinding of investigators will not be possible but the analysis will be designed to minimize sources of investigator bias.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Participants will be assigned to multidirectional training group (MD) or a linear sprint training group (LS) in a quasi-randomized way. Both groups will complete an 8-week training program and will complete baseline, follow-up, and retention testing (4 weeks post follow-up).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 6, 2021

First Posted

August 20, 2021

Study Start

October 4, 2021

Primary Completion

December 20, 2021

Study Completion

December 20, 2021

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

The raw data (motion capture, EMG, and anonymous participant information) will be shared via an open access data repository along with the publications that present the study results.

Time Frame
Data will be shared via an open access data repository along with the publications that present the study results.
Access Criteria
Open access

Locations