NCT04736511

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 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

January 29, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

February 15, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2021

Completed
Last Updated

December 3, 2025

Status Verified

January 1, 2022

Enrollment Period

2 months

First QC Date

January 29, 2021

Last Update Submit

November 26, 2025

Conditions

Keywords

proprioceptive reweighting abilitysidestep cutting manoeuvrehandball

Outcome Measures

Primary Outcomes (1)

  • Knee abduction moment (quantitative measure) during unplanned sidestep cutting manÅ“uvre.

    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.

    Inclusion

Secondary Outcomes (4)

  • Knee abduction moment when landing jumps in the Single leg Drop Vertical Jump.

    Inclusion

  • Star Excursion Balance Test performance.

    Inclusion

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

    Inclusion

  • Percentage of subjects with a proprioceptive plastic profile.

    Inclusion

Study Arms (1)

Healthy volunteers

OTHER

Handball players

Other: Star Excursion Balance TestOther: Single leg Drop Vertical JumpOther: Unplanned sidestep cutting manoeuvreOther: Tendon vibration

Interventions

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.

Also known as: SEBT
Healthy volunteers

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.

Also known as: SDVJ
Healthy volunteers

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.

Also known as: Unplanned change of direction
Healthy volunteers

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.

Healthy volunteers

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Brest

Brest, France, 29200, France

Location

Related Publications (78)

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Related Links

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Condition Hierarchy (Ancestors)

Knee InjuriesLeg InjuriesWounds and Injuries

Study Officials

  • Olivier REMY-NERIS

    CHRU BREST

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: Mono-centric comparative cross-sectional observational study with minimal risks and constraints.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 3, 2021

Study Start

February 15, 2021

Primary Completion

April 16, 2021

Study Completion

April 16, 2021

Last Updated

December 3, 2025

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available after the publication of result and ending fifteen years following the last visit of the last patient
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations