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Anterior Cruciate Ligament InjuriesNCT06599164

Evaluation of Vastus Medialis Muscle Inhibition in Indoor Soccer Players With and Without ACL Injury

An observational study of Anterior Cruciate Ligament Injuries and Knee Injuries, run by University of Alcala.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The Anterior Cruciate Ligament (ACL) is vital for knee stability, and ACL injuries in futsal can lead to long-term issues. Reconstruction surgery may be affected by Anthrogenic Muscle Inhibition (AMI), especially in the vastus medialis muscle. Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
What is being tested?
Anthrogenic Muscle Inhibition (AMI) Assessment Protocol
How many people
64 participants
Where
No sites listed yet
Study dates
1 Sep 2025to 31 Aug 2026
Phase
Observational
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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Study population: The study population consists of futsal players aged 18-45. This includes two groups: (1) players without ACL injuries who serve as a comparison group, and (2) players who have sustained ACL injuries and are undergoing or have undergone ACL reconstruction surgery. The study aims to compare Anthrogenic Muscle Inhibition (AMI) and muscle function between these two groups.

Who may be able to join

  • Age between 18 and 45 years old
  • Playing in the Spanish National League (first or second category) or in the Madrid Futsal Federation in PRIMERA RFFM and PREFERENTE.
  • Both sexes
  • Have been playing futsal for at least 2 years
  • Enrolled in the Madrid Health System
  • Any language

Who cannot join

  • Operations other than an Anterior Cruciate Ligament injury (Cartilage, Meniscus, Ligaments).
  • Injuries to the knee of the contralateral lower limb. (sprains, fracture)
  • Muscle injuries or conditions in the affected or contralateral limb for less than 2 months (sprains, tibial periostitis, tendinopathies, tears).
  • Any infection must be reported after the intervention and will be excluded from the study.
  • Players will not be allowed to play any kind of team sport other than Futsal in an official way during this season.
  • Players may not have any cardiovascular or respiratory pathology that would affect the study.
  • Players who have already undergone an Anterior Cruciate Ligament rupture in previous years will not be considered.

Trial locations and contacts

No sites are listed yet.

Maria Martinez Parada contact

34 674566985

maria.martinezparada@edu.uah.es

maria martinez parada contact

mariamparada2000@gmail.com

About this study

Official title: Evaluation of Muscular Anthrogenic Inhibition of the Vasto Medialis in Indoor Soccer Players With Anterior Cruciate Ligament (ACL) Injury in Comparison With Non-Injured Players: Observational Cohort Study

The Anterior Cruciate Ligament (ACL) is vital for knee stability, and ACL injuries in futsal can lead to long-term issues. Reconstruction surgery may be affected by Anthrogenic Muscle Inhibition (AMI), especially in the vastus medialis muscle. This study aims to compare AMI in futsal players with ACL injuries to those without injuries, focusing on measurement techniques, sports performance, muscle strength, and recovery time. The research involves evaluating 54 players (27 injured and 27 non-injured) at various stages of the season using strength tests and imaging.

Read the detailed description

Introduction: The Anterior Cruciate Ligament (ACL) is crucial for knee stability and represents a major challenge in sports such as futsal. ACL injuries can carry a risk of long-term complications. While reconstruction surgery is a common method for recovery, it can be affected by Anthrogenic Muscle Inhibition (AMI), especially in the vastus medialis. Research on AMI in futsal players will be fundamental to improve rehabilitation, functionality, and reduce the risk of relapse.

Objectives: To analyze the changes in the Anthrogenic Muscular Inhibition of the vastus medialis in futsal players with Anterior Cruciate Ligament Injury compared to non-injured players. The specific objectives include evaluating measurement techniques, assessing the impact on sport quality, assessing muscle strength, and examining recovery time.

Methodology: The present study uses an observational cohort design to evaluate AMI in indoor soccer players at different stages of the soccer season, compared to players who suffer ACL injuries during competition. The sample size is 54 subjects, with 27 in each group. Accounting for a 15% loss, the final sample will be 64 subjects (32 in each group). Players will be evaluated for isometric strength by electromyography, strength in extensors, single leg vertical jump test, and ultrasound evaluation. These measurements will be taken for all players in the pre-season, after 4 months, and at the end of the season. For ACL injuries, evaluations will be conducted pre-operation, 4 months post-operation, and at the end of the soccer year.

Key words: Anthrogenic Muscle Inhibition, soccer, Anterior Cruciate Ligament, Rehabilitation.

Being tested
Anthrogenic Muscle Inhibition (AMI) Assessment Protocol
Keywords
Anthrogenic Muscle Inhibition, Soccer, Anterior Cruciate Ligament, Rehabilitation
Medical subject headings
Anterior Cruciate Ligament Injuries, Knee Injuries

What participants receive

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

  • Anthrogenic Muscle Inhibition (AMI) Assessment ProtocolOther

    Also called Vastus Medialis AMI Assessment, Isometric Strength Evaluation Protocol

    This study involves evaluating Anthrogenic Muscle Inhibition (AMI) of the vastus medialis muscle in futsal players. The intervention includes assessments of muscle strength, AMI using electromyography, ultrasound evaluation, and single-leg vertical jump tests. These evaluations are conducted at different stages throughout the season: pre-season, 4 months in, and at the end of the season. The goal is to compare AMI levels and muscle function between players with ACL injuries and those without.

Study groups in NCT06599164
Study groupRoleWhat they receive
UNINJURED PLAYERSPlayers will be evaluated for isometric strength by electromyography, extensor strength, single leg vertical jump test and ultrasound evaluation, all of which will be measured on all players in the preseason, at 4 months and at the end of the season.
Receives: Other: Anthrogenic Muscle Inhibition (AMI) Assessment Protocol
INJURED PLAYERSAs for futsal players with ACL injuries, isometric strength is evaluated in pre-operation, at 4 months and at the end of the soccer year by electromyography, extensor strength, single-leg vertical jump test and ultrasound evaluation.
Receives: Other: Anthrogenic Muscle Inhibition (AMI) Assessment Protocol

What is being measured

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

  1. Anthrogenic Muscle Inhibition (AMI) of Vastus Medialis

    This measure evaluates the level of Anthrogenic Muscle Inhibition (AMI) in the vastus medialis muscle. Assessment Tool: Electromyography and Ultrasound Unit of Measure: Percentage (%)

    Measured: First 4 weeks (28 days), 4 months (120 days) after the start of the season, and the last 4 months (120 days) of the season. 3 months (90 days) before the operation, 4 months (120 days) after the operation, and the last 4 months (120 days) of the season

Secondary outcomes (3)

  1. isometric extension maximum knee with traction

    this test is used to obtain strength maximum knee extension. For To be able to measure, a cell of strain gauge load fixed to the stretcher where the test will be performed with the knee fixed at 90º. It will be carried out in the two legs, noting which of them is the dominant. Newton (N)

    Measured: First 4 weeks (28 days), 4 months (120 days) after the start of the season, and the last 4 months (120 days) of the season. 3 months (90 days) before the operation, 4 months (120 days) after the operation, and the last 4 months (120 days) of the season

  2. The Single Leg Vertical Jump exercise

    It is a test used to being able to know the strength, power and capacity that the muscle has where the participant performs a vertical jump with a single leg, in this case it will be 3 times with one and 3 times with the leg contralateral. CM

    Measured: First 4 weeks (28 days), 4 months (120 days) after the start of the season, and the last 4 months (120 days) of the season. 3 months (90 days) before the operation, 4 months (120 days) after the operation, and the last 4 months (120 days) of the season

  3. assessment surface electromyography

    the function neuromuscular and detect imbalances in muscle activation. HE surface electrodes will be used adhesives to the vastus medialis. To obtain electromyographic tracings patient will perform a contraction maximum isometric 6 seconds duration. microvolts

    Measured: First 4 weeks (28 days), 4 months (120 days) after the start of the season, and the last 4 months (120 days) of the season. 3 months (90 days) before the operation, 4 months (120 days) after the operation, and the last 4 months (120 days) of the season

Timeline

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

  1. First posted19 Sep 2024
  2. Study start1 Sep 2025 (estimated)
  3. Primary completion1 Sep 2025 (estimated)
  4. Study completion31 Aug 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06599164
Sponsor's protocol ID
CEIM/2024/4/095
Status last verified
Sep 2024
First submitted
21 Aug 2024
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Márquez Arabia JJ, Márquez Arabia WH. Lesiones del ligamento cruzado anterior de la rodilla. Iatreia. 2009;22:256-71.

  • Noyes FR, Barber-Westin SD. Anterior cruciate ligament primary reconstruction: diagnosis, operative techniques, and clinical outcomes. In: Noyes FR, Barber- Westin SD, eds. Noyes' Knee Disorders Surgery, Rehabilitation, Clinical Outcomes. 2nd ed. Philadelphia, PA: Elsevier; 2017:chap 7

  • Calvo Sanz J. Análisis de la inhibición muscular artrogénica del cuádriceps posligamentoplastia del ligamento cruzado anterior de rodilla y su repercusión en la función del aparato extensor [Internet]. TDX (Tesis Doctorals en Xarxa). 2017. Available from: http://www.tdx.cat/handle/10803/432780

  • Asociacion Española de Artroscopia. Informe sobre el perfil de la cirugía artroscopia en España. Cuadernos de Artroscopia. 2001; 8:10-21

  • Zamora-Navas P. Evaluacion de la evidencia del tratamiento de las lesiones del ligamento cruzado anterior de la rodilla. Rev Esp Cir Orteoartic. 2005 Jun; 40 (222): 59-66.

  • Booth A, Clarke M, Dooley G, Ghersi D, Moher D, Petticrew M, Stewart L. The nuts and bolts of PROSPERO: an international prospective register of systematic reviews. Syst Rev. 2012 Feb 9;1:2. doi: 10.1186/2046-4053-1-2.

    PubMed 22587842

  • Márquez Arabia WH, Márquez Arabia JJ, Gómez JC. ¿Qué ocurre con las lesiones del ligamento cruzado anterior, su tratamiento, la recuperación de la función y el desarrollo de osteoartritis a largo plazo? ¿Hay espacio para el tratamiento conservador? Revisión de conceptos actuales William. Rev Colomb Ortop y Traumatol. 2017;31(2):75-86

  • Lohmander LS, Englund PM, Dahl LL, Roos EM. The long-term consequence of anterior cruciate ligament and meniscus injuries: osteoarthritis. Am J Sports Med. 2007 Oct;35(10):1756-69. doi: 10.1177/0363546507307396. Epub 2007 Aug 29.

    PubMed 17761605

  • Williams GN, Barrance PJ, Snyder-Mackler L, Buchanan TS. Altered quadriceps control in people with anterior cruciate ligament deficiency. Med Sci Sports Exerc. 2004 Jul;36(7):1089-97. doi: 10.1249/01.mss.0000131959.20666.11.

    PubMed 15235310

  • Lopez-Segovia M, Vivo Fernandez I, Herrero Carrasco R, Pareja Blanco F. Preseason Injury Characteristics in Spanish Professional Futsal Players: The LNFS Project. J Strength Cond Res. 2022 Jan 1;36(1):232-237. doi: 10.1519/JSC.0000000000003419.

    PubMed 31895285

  • Lopez-Valenciano A, Ruiz-Perez I, Garcia-Gomez A, Vera-Garcia FJ, De Ste Croix M, Myer GD, Ayala F. Epidemiology of injuries in professional football: a systematic review and meta-analysis. Br J Sports Med. 2020 Jun;54(12):711-718. doi: 10.1136/bjsports-2018-099577. Epub 2019 Jun 6.

    PubMed 31171515

  • Del Coso J, Herrero H, Salinero JJ. Injuries in Spanish female soccer players. J Sport Health Sci. 2018 Apr;7(2):183-190. doi: 10.1016/j.jshs.2016.09.002. Epub 2016 Sep 21.

    PubMed 30356460

  • Schulz KF, Altman DG, Moher D. CONSORT 2010 statement: Updated guidelines for reporting parallel group randomised trials. J Pharmacol Pharmacother. 2010 Jul;1(2):100-7. doi: 10.4103/0976-500X.72352. No abstract available.

    PubMed 21350618

  • Hermens HJ, Freriks B, Merletti R, Stegeman D, Blok J, Günter R, et al. European Recommendations for Surface ElectroMyoGraphy: Results of the SENIAM Project. Enschede: Roessingh Research and Development; 1999;10 (5): 361-74.

Questions about this trial

What is this clinical trial studying?

An observational study of Anterior Cruciate Ligament Injuries and Knee Injuries, run by University of Alcala.

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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Maria Martinez Parada (34 674566985, maria.martinezparada@edu.uah.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Anthrogenic Muscle Inhibition (AMI) of Vastus Medialis (time frame: First 4 weeks (28 days), 4 months (120 days) after the start of the season, and the last 4 months (120 days) of the season. 3 months (90 days) before the operation, 4 months (120 days) after the operation, and the last 4 months (120 days) of the season). 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 NCT06599164, which also lists 14 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 19 Sep 2024.

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