NCT06599164

Brief 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. 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.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Sep 2025

Shorter than P25 for all trials

Status
not yet recruiting

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

Study Progress79%
Sep 2025Aug 2026

First Submitted

Initial submission to the registry

August 21, 2024

Completed
29 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
12 months until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

September 19, 2024

Status Verified

September 1, 2024

Enrollment Period

Same day

First QC Date

August 21, 2024

Last Update Submit

September 12, 2024

Conditions

Keywords

Anthrogenic Muscle InhibitionSoccerAnterior Cruciate LigamentRehabilitation

Outcome Measures

Primary Outcomes (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 (%)

    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)

  • isometric extension maximum knee with traction

    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

  • The Single Leg Vertical Jump exercise

    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

  • assessment surface electromyography

    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

Study Arms (2)

UNINJURED PLAYERS

Players 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.

Other: Anthrogenic Muscle Inhibition (AMI) Assessment Protocol

INJURED PLAYERS

As 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.

Other: Anthrogenic Muscle Inhibition (AMI) Assessment Protocol

Interventions

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.

Also known as: Vastus Medialis AMI Assessment, Isometric Strength Evaluation Protocol
INJURED PLAYERSUNINJURED PLAYERS

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • 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.

    PMID: 22587842BACKGROUND
  • 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

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

    BACKGROUND
  • 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.

    PMID: 17761605BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 15235310BACKGROUND
  • Asociacion Española de Artroscopia. Informe sobre el perfil de la cirugía artroscopia en España. Cuadernos de Artroscopia. 2001; 8:10-21

    BACKGROUND
  • 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.

    PMID: 31895285BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 31171515BACKGROUND
  • 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.

    PMID: 30356460BACKGROUND
  • Schulz KF, Altman DG, Moher, Group C. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar; 340(23): 332.

    BACKGROUND
  • 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.

    BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament InjuriesKnee Injuries

Condition Hierarchy (Ancestors)

Leg InjuriesWounds and Injuries

Central Study Contacts

maria martinez parada

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigador

Study Record Dates

First Submitted

August 21, 2024

First Posted

September 19, 2024

Study Start

September 1, 2025

Primary Completion

September 1, 2025

Study Completion (Estimated)

August 31, 2026

Last Updated

September 19, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share