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Injuries:Knee InjuriesKneeNCT04161222

Effectiveness of a Protocol of Specific Activation.

A study testing Experimental group in people with Injuries:Knee Injuries, run by University of Cadiz at 1 site in Spain.

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

In football, knee is the joint that suffers the most severe injuries. Sometimes, this is produced by poor pre-activation of the musculature that is responsible for knee stability and central stability. Read more about this study

Who is it for?
Ages 18 to 19 years
Conditions the study is for
Injuries:Knee Injuries
What is being tested?
Experimental group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteSpain
Study dates
1 Nov 2019to 15 Jan 2020
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 18 to 19 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Perform soccer sports practice, at least 3 times a week at a competitive level.

Who cannot join

  • Subjects with a knee surgery.
  • Patients who are injured at the time of the study.

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Ciudad Deportiva Bahía de Cádiz

    Puerto Real, Cádiz, 11510

Other trials in Spain

About this study

Official title: Effectiveness of Specific Core Activation Protocol on Lower Limb Stability in Soccer Players

In football, knee is the joint that suffers the most severe injuries. Sometimes, this is produced by poor pre-activation of the musculature that is responsible for knee stability and central stability.

OBJETIVE: Study the efficacy of specific gluteus medius and core activation protocol in knee stability in youth football players.

Read the detailed description

A randomized, longitudinal clinical trial with a blinded and prospective evaluator will be carried out, in which the knee stability will be evaluated with the following tests: Y-balance test and Flamingo balance test. The measurements will be made before and after the intervention. The study will be carried out with patients evaluated by a specialist in Traumatology and will be randomly divided by a system of numerical tables through a computer program between the experimental and control groups. The control group will perform a typical warm-up of competitive football; and the experimental one will do this above, added to a specific activation of gluteus medius and core. Dynamic stability (Y-balance test) and postural and static stability (Flamingo balance test) will be measured before and after the intervention.

Being tested
Experimental group, Control group
Keywords
Knee stability., Core, Gluteus medius, Warm-up, Football

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental groupOther

    Experimental group will perform a typical warm-up of competitive football, added to a specific activation of gluteus medius and core.

  • Control groupOther

    Control group will perform a typical warm-up of competitive football

Study groups in NCT04161222
Study groupRoleWhat they receive
Experimental groupExperimentalThe control group will perform a typical warm-up of competitive football, added to a specific activation of gluteus medius and core.
Receives: Other: Experimental group
Control groupExperimentalThe control group will perform a typical warm-up of competitive football.
Receives: Other: Control group

What is being measured

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

  1. Y-balance test

    Y-balance test Measures the strength of the lower limb, neuromuscular control, flexibility and dynamic balance

    Measured: Baseline

Secondary outcomes (2)

  1. Y-balance test

    Y-balance test Measures the strength of the lower limb, neuromuscular control, flexibility and dynamic balance.

    Measured: Baseline and four weeks.

  2. Flamingobalance test

    Flamingo balance test measures postural balance and static balance.

    Measured: Baseline and four weeks.

Timeline

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

  1. First posted13 Nov 2019
  2. Study start1 Nov 2019
  3. Primary completion15 Dec 2019
  4. Study completion15 Jan 2020

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A specialist physician will be diagnosed the process.
Masking
Single blind
Who is masked
Participant
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04161222
Sponsor's protocol ID
Cádiz CF
Acronym
Knee
Status last verified
Feb 2021
First submitted
5 Nov 2019
Last updated
4 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ekstrand J, Walden M, Hagglund M. A congested football calendar and the wellbeing of players: correlation between match exposure of European footballers before the World Cup 2002 and their injuries and performances during that World Cup. Br J Sports Med. 2004 Aug;38(4):493-7. doi: 10.1136/bjsm.2003.009134.

    PubMed 15273193

  • Rahnama N, Reilly T, Lees A. Injury risk associated with playing actions during competitive soccer. Br J Sports Med. 2002 Oct;36(5):354-9. doi: 10.1136/bjsm.36.5.354.

    PubMed 12351333

  • Falese L, Della Valle P, Federico B. Epidemiology of football (soccer) injuries in the 2012/2013 and 2013/2014 seasons of the Italian Serie A. Res Sports Med. 2016 Oct-Dec;24(4):426-432. doi: 10.1080/15438627.2016.1239105. Epub 2016 Sep 29.

    PubMed 27683952

  • Peterson L, Junge A, Chomiak J, Graf-Baumann T, Dvorak J. Incidence of football injuries and complaints in different age groups and skill-level groups. Am J Sports Med. 2000;28(5 Suppl):S51-7. doi: 10.1177/28.suppl_5.s-51.

    PubMed 11032108

  • Alentorn-Geli E, Myer GD, Silvers HJ, Samitier G, Romero D, Lazaro-Haro C, Cugat R. Prevention of non-contact anterior cruciate ligament injuries in soccer players. Part 1: Mechanisms of injury and underlying risk factors. Knee Surg Sports Traumatol Arthrosc. 2009 Jul;17(7):705-29. doi: 10.1007/s00167-009-0813-1. Epub 2009 May 19.

    PubMed 19452139

  • Zazulak BT, Hewett TE, Reeves NP, Goldberg B, Cholewicki J. Deficits in neuromuscular control of the trunk predict knee injury risk: a prospective biomechanical-epidemiologic study. Am J Sports Med. 2007 Jul;35(7):1123-30. doi: 10.1177/0363546507301585. Epub 2007 Apr 27.

    PubMed 17468378

  • Nguyen AD, Shultz SJ, Schmitz RJ, Luecht RM, Perrin DH. A preliminary multifactorial approach describing the relationships among lower extremity alignment, hip muscle activation, and lower extremity joint excursion. J Athl Train. 2011 May-Jun;46(3):246-56. doi: 10.4085/1062-6050-46.3.246.

    PubMed 21669093

  • Zazulak BT, Hewett TE, Reeves NP, Goldberg B, Cholewicki J. The effects of core proprioception on knee injury: a prospective biomechanical-epidemiological study. Am J Sports Med. 2007 Mar;35(3):368-73. doi: 10.1177/0363546506297909. Epub 2007 Jan 31.

    PubMed 17267766

  • Huxel Bliven KC, Anderson BE. Core stability training for injury prevention. Sports Health. 2013 Nov;5(6):514-22. doi: 10.1177/1941738113481200.

    PubMed 24427426

  • Dello Iacono A, Padulo J, Ayalon M. Core stability training on lower limb balance strength. J Sports Sci. 2016;34(7):671-8. doi: 10.1080/02640414.2015.1068437. Epub 2015 Jul 15.

    PubMed 26177151

  • Leetun DT, Ireland ML, Willson JD, Ballantyne BT, Davis IM. Core stability measures as risk factors for lower extremity injury in athletes. Med Sci Sports Exerc. 2004 Jun;36(6):926-34. doi: 10.1249/01.mss.0000128145.75199.c3.

    PubMed 15179160

  • Panjabi MM. The stabilizing system of the spine. Part I. Function, dysfunction, adaptation, and enhancement. J Spinal Disord. 1992 Dec;5(4):383-9; discussion 397. doi: 10.1097/00002517-199212000-00001.

    PubMed 1490034

  • Akuthota V, Nadler SF. Core strengthening. Arch Phys Med Rehabil. 2004 Mar;85(3 Suppl 1):S86-92. doi: 10.1053/j.apmr.2003.12.005.

    PubMed 15034861

  • Liemohn WP, Baumgartner TA, Gagnon LH. Measuring core stability. J Strength Cond Res. 2005 Aug;19(3):583-6. doi: 10.1519/1533-4287(2005)19[583:MCS]2.0.CO;2.

    PubMed 16095406

  • Haruyama K, Kawakami M, Otsuka T. Effect of Core Stability Training on Trunk Function, Standing Balance, and Mobility in Stroke Patients. Neurorehabil Neural Repair. 2017 Mar;31(3):240-249. doi: 10.1177/1545968316675431. Epub 2016 Nov 9.

    PubMed 27821673

Questions about this trial

What is this clinical trial studying?

A study testing Experimental group in people with Injuries:Knee Injuries, run by University of Cadiz at 1 site in Spain.

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 1 inclusion and 2 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 4 Feb 2021. 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 Spain. 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?

Y-balance test (time frame: Baseline). 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 NCT04161222, which also lists 20 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 4 Feb 2021.

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