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Anterior Cruciate Ligament InjuriesNEURIBIONCT04736511

Influence of Proprioceptive Reweighting Ability on Lower-limb Biomechanics During Functional Tasks

A study testing Star Excursion Balance Test, Single leg Drop Vertical Jump and Unplanned sidestep cutting manoeuvre in people with Anterior Cruciate Ligament Injuries, run by University Hospital, Brest at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Anterior cruciate ligament (ACL) injuries are frequent in handball especially among young players. Recent investigations highlighted the implication of the central nervous system as a potential risk factor for ACL rupture. Read more about this study

Who is it for?
Ages 15 to 25 yearsHealthy volunteers can take part
Conditions the study is for
Anterior Cruciate Ligament Injuries
What is being tested?
Star Excursion Balance Test, Single leg Drop Vertical Jump and Unplanned sidestep cutting manoeuvre
Could I receive a placebo?
No, everyone receives an active treatment
How many people
41 participants
Where
1 siteFrance
Study dates
15 Feb 2021to 16 Apr 2021
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 25 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Aged from 15 to 25 years
  • Intensive training handball practice for at least two years, mastering the technical gesture of unplanned sidestep cutting manoeuvre
  • Training volume of 5 hours minimum per week
  • Signature of the consent (participants and parents for minors)

Who cannot join

  • Recent osteoarticular pathology (i.e. less than three months) of the lower limbs, whether traumatic or not
  • Unfit to consent or refusal to participate in the study
  • Obvious standing balance disorder or disabling neurological pathology
  • Pain of the musculoskeletal system (joint, tendon or muscle) permanent or during exercise
  • Fatigue (evaluation using the Borg scale) during the clinical examination (> 6) prior to performing the sporting gesture
  • Known skin allergy to any adhesive product

Trial locations and contacts

1 site in 1 country.

France1 site
  • CHRU Brest

    Brest, France, 29200

Other trials in France

About this study

Official title: Study of the Influence of Proprioceptive Reweighting Ability on the Lower-extremity Biomechanics During Functional Tasks and Unplanned Sidestep Cutting Manoeuvre

Anterior cruciate ligament (ACL) injuries are frequent in handball especially among young players. Recent investigations highlighted the implication of the central nervous system as a potential risk factor for ACL rupture.

The ability to dynamically reweight proprioceptive signals according to postural conditions is crucial for balance control.

The aim of this study is therefore to investigate the influence of proprioceptive reweighting on biomechanical determinants of ACL loads during functional tasks and unplanned side cutting manoeuvers.

Read the detailed description

Team Handball is a traumatic sport, especially regarding anterior cruciate ligament (ACL) injuries. Young females are more vulnerable as they are 3 to 5 times more likely to sustain an ACL rupture compare to males.

Several anatomical, biomechanical and sensorimotor risk factors have been clearly identified, however the implication of the central nervous system was recently highlighted. Indeed, it has been shown that individuals who will suffer of ACL ruptures exhibited a decreased functional connectivity between brain regions responsible for postural control and sensorimotor processing. Due to the unanticipated situations that occurred during game situations, the role of the brain (i.e neural control) is now advocated to explain sensorimotor errors leading to injuries during complex tasks such as faking an opponent. Muscle vibration is a reliable tool to assess proprioceptive integration during postural control. The ability to shift from one proprioceptive cue to another when postural conditions are changing is crucial. This dynamic reweighting process allow to obtain an optimal postural control. However, recent investigations revealed that this process is altered among symptomatic populations, elderly patients or even under fatigue conditions. More precisely, some individuals seem able to shift proprioceptive reliance while other doesn't. To our knowledge, no studies have investigated the link between proprioceptive reweighting and biomechanical determinants of ACL loads during functional tasks. Thus, the aim of this study is to compare lower-limb biomechanics during unanticipated side cutting manoeuvres and single leg drop vertical jump among young handball players according to their ability to reweight proprioceptive signals.

Being tested
Star Excursion Balance Test, Single leg Drop Vertical Jump, Unplanned sidestep cutting manoeuvre, Tendon vibration
Keywords
proprioceptive reweighting ability, sidestep cutting manoeuvre, handball
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.

  • Star Excursion Balance TestOther

    Also called SEBT

    The subject will be in unipodal support (only one foot on the ground) on the tested lower limb in the center of the platform. Three lines forming a "Y" will be arranged according to the lower limb in charge in three directions : anterior (ANT), posteromedial (PM) and posterolateral (PL). The goal is then to reach the longest distance possible in all three directions with the tip of the foot in relief before returning to the starting position. The subject will have 4 training trials per direction on each lower limb then 3 trials will be recorded in order to keep the average.

  • Single leg Drop Vertical JumpOther

    Also called SDVJ

    The subject will drop from a step and land on one leg, then jump as high as possible and stabilize again on the same leg. The height of the step is 30 cm. The subject will perform 3 consecutive jumps in the strictest respect of the instructions: drop to the level of the mark on the ground and bounce as high as possible while spending a minimum of time on the ground. The subject must stabilize for 3 seconds during the second contact with the ground so that the instructions and measurements are reproducible.

  • Unplanned sidestep cutting manoeuvreOther

    Also called Unplanned change of direction

    The objective is to create an unanticipated playing situation, close to the daily actions of the subjects in the practice of handball. The subject will make sidestep cutting manœuvre in front of an opponent simulated by a dummy used during usual training.

    The subject will sprint in a straight line and then at the force platform will make a rapid change of direction on the side of his shooting arm or will continue his run in a straight line. A light signal randomly will indicate to the player the direction in which he must carry out his manoeuvre. A computer reconstruction of the kinematics and dynamics (knee moment) will be performed.

  • Tendon vibrationOther

    The subject will be asked to stand, motionless in bipodal (both feet on the ground) support on a stable and unstable ground (foam). A tendon vibration (80Hz) will be randomly applied to the subject in the Achilles tendons or paravertebral muscles. This vibration will cause an alteration of proprioceptive information in the vibrated area leading to a disruption of postural balance. Thus, according to the amount of displacement of the center of pressure (CoP), the proprioceptive weighting ratio (dRPW) is calculated to deduce therefrom the weight assigned by the CNS to the various proprioceptive inputs during the postural task.

Study groups in NCT04736511
Study groupRoleWhat they receive
Healthy volunteersOtherHandball players
Receives: Other: Star Excursion Balance Test; Other: Single leg Drop Vertical Jump; Other: Unplanned sidestep cutting manoeuvre; Other: Tendon vibration

What is being measured

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

  1. Knee abduction moment (quantitative measure) during unplanned sidestep cutting manœuvre.

    The measurement will be the average of the maximum knee abduction moments when the lower extremity is supported on the pushing leg, over the 5 tests carried out with a sidestep cutting manœuvre.

    Measured: Inclusion

Secondary outcomes (4)
  1. Knee abduction moment when landing jumps in the Single leg Drop Vertical Jump.

    The measurement will be made on the average of the abduction moments of the knee when landing the jump on the ground.

    The subject will perform 3 consecutive jumps in the strictest respect of the instructions.

    Measured: Inclusion

  2. Star Excursion Balance Test performance.

    The value obtained (in centimeters or relative to the length of the lower limb) reflects the dynamic postural performance of the lower limb under load without specificity of a particular joint of the lower limb. The subject will have 4 training trials per direction on each lower limb then 3 trials will be recorded in order to keep the average.

    Measured: Inclusion

  3. Angles of ankles, knees, hips, orientation of the pelvis during changes of direction.

    The angles, in degrees, of ankles, knees, hips and orientation of the pelvis during changes of direction will be determined during the unplanned sidestep cutting manœuvre test by computer reconstruction. The values will allow to compare biomechanicals characteristics according to the proprioceptive profile (plastic subjects vs rigid subjects).

    Measured: Inclusion

  4. Percentage of subjects with a proprioceptive plastic profile.

    A dRPW of 1 indicates 100% use of information from the ankle, while a dRPW of 0 indicates 100% use of information from the hip. It is thus possible to calculate an evolution of this dRPW during the passage from a stable to unstable soil. The "plastic" subjects decreases their dRPW on unstable ground (compared to stable) ("normal" behavior). "Rigid" subjects maintain (or even increase) their dRPW when passing over unstable ground.

    Measured: Inclusion

Timeline

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

  1. First posted3 Feb 2021
  2. Study start15 Feb 2021
  3. Primary completion16 Apr 2021
  4. Study completion16 Apr 2021

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
Mono-centric comparative cross-sectional observational study with minimal risks and constraints.
Masking
None (open label)
Enrolment
41 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04736511
Sponsor's protocol ID
29BRC20.0288 NEURIBIO
Acronym
NEURIBIO
Status last verified
Jan 2022
First submitted
29 Jan 2021
Last updated
3 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All collected data that underlie results in a publication

Publications

  • Imwalle LE, Myer GD, Ford KR, Hewett TE. Relationship between hip and knee kinematics in athletic women during cutting maneuvers: a possible link to noncontact anterior cruciate ligament injury and prevention. J Strength Cond Res. 2009 Nov;23(8):2223-30. doi: 10.1519/JSC.0b013e3181bc1a02.

    PubMed 19826304
  • Strand T, Tvedte R, Engebretsen L, Tegnander A. [Anterior cruciate ligament injuries in handball playing. Mechanisms and incidence of injuries]. Tidsskr Nor Laegeforen. 1990 Jun 30;110(17):2222-5. Norwegian.

    PubMed 2375011
  • Majewski M, Susanne H, Klaus S. Epidemiology of athletic knee injuries: A 10-year study. Knee. 2006 Jun;13(3):184-8. doi: 10.1016/j.knee.2006.01.005. Epub 2006 Apr 17.

    PubMed 16603363
  • Giroto N, Hespanhol Junior LC, Gomes MR, Lopes AD. Incidence and risk factors of injuries in Brazilian elite handball players: A prospective cohort study. Scand J Med Sci Sports. 2017 Feb;27(2):195-202. doi: 10.1111/sms.12636. Epub 2015 Dec 10.

    PubMed 26661576
  • Olsen OE, Myklebust G, Engebretsen L, Bahr R. Injury mechanisms for anterior cruciate ligament injuries in team handball: a systematic video analysis. Am J Sports Med. 2004 Jun;32(4):1002-12. doi: 10.1177/0363546503261724.

    PubMed 15150050
  • Petersen W, Braun C, Bock W, Schmidt K, Weimann A, Drescher W, Eiling E, Stange R, Fuchs T, Hedderich J, Zantop T. A controlled prospective case control study of a prevention training program in female team handball players: the German experience. Arch Orthop Trauma Surg. 2005 Nov;125(9):614-21. doi: 10.1007/s00402-005-0793-7.

    PubMed 15703919
  • Boden BP, Torg JS, Knowles SB, Hewett TE. Video analysis of anterior cruciate ligament injury: abnormalities in hip and ankle kinematics. Am J Sports Med. 2009 Feb;37(2):252-9. doi: 10.1177/0363546508328107.

    PubMed 19182110
  • 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
  • Krosshaug T, Slauterbeck JR, Engebretsen L, Bahr R. Biomechanical analysis of anterior cruciate ligament injury mechanisms: three-dimensional motion reconstruction from video sequences. Scand J Med Sci Sports. 2007 Oct;17(5):508-19. doi: 10.1111/j.1600-0838.2006.00558.x. Epub 2006 Dec 20.

    PubMed 17181770
  • Prodromos CC, Han Y, Rogowski J, Joyce B, Shi K. A meta-analysis of the incidence of anterior cruciate ligament tears as a function of gender, sport, and a knee injury-reduction regimen. Arthroscopy. 2007 Dec;23(12):1320-1325.e6. doi: 10.1016/j.arthro.2007.07.003.

    PubMed 18063176
  • Rizzo M, Holler SB, Bassett FH 3rd. Comparison of males' and females' ratios of anterior-cruciate-ligament width to femoral-intercondylar-notch width: a cadaveric study. Am J Orthop (Belle Mead NJ). 2001 Aug;30(8):660-4.

    PubMed 11520024
  • Zeng C, Gao SG, Wei J, Yang TB, Cheng L, Luo W, Tu M, Xie Q, Hu Z, Liu PF, Li H, Yang T, Zhou B, Lei GH. The influence of the intercondylar notch dimensions on injury of the anterior cruciate ligament: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. 2013 Apr;21(4):804-15. doi: 10.1007/s00167-012-2166-4. Epub 2012 Aug 15.

    PubMed 22893267
  • Chaudhari AM, Lindenfeld TN, Andriacchi TP, Hewett TE, Riccobene J, Myer GD, Noyes FR. Knee and hip loading patterns at different phases in the menstrual cycle: implications for the gender difference in anterior cruciate ligament injury rates. Am J Sports Med. 2007 May;35(5):793-800. doi: 10.1177/0363546506297537. Epub 2007 Feb 16.

    PubMed 17307891
  • Hewett TE, Zazulak BT, Myer GD. Effects of the menstrual cycle on anterior cruciate ligament injury risk: a systematic review. Am J Sports Med. 2007 Apr;35(4):659-68. doi: 10.1177/0363546506295699. Epub 2007 Feb 9.

    PubMed 17293469
  • Wojtys EM, Huston LJ, Boynton MD, Spindler KP, Lindenfeld TN. The effect of the menstrual cycle on anterior cruciate ligament injuries in women as determined by hormone levels. Am J Sports Med. 2002 Mar-Apr;30(2):182-8. doi: 10.1177/03635465020300020601.

    PubMed 11912085

Questions about this trial

What is this clinical trial studying?

A study testing Star Excursion Balance Test, Single leg Drop Vertical Jump and Unplanned sidestep cutting manoeuvre in people with Anterior Cruciate Ligament Injuries, run by University Hospital, Brest at 1 site in France.

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 4 inclusion and 6 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: finished, as of the sponsor's last update on 3 Dec 2025. 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 France. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 (quantitative measure) during unplanned sidestep cutting manœuvre. (time frame: Inclusion). 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 NCT04736511, which also lists 77 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 3 Dec 2025.

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