- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06599164
Evaluation of Vastus Medialis Muscle Inhibition in Indoor Soccer Players with and Without ACL Injury
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Maria Martinez Parada
- Phone Number: 34 674566985
- Email: maria.martinezparada@edu.uah.es
Study Contact Backup
- Name: maria martinez parada
- Email: mariamparada2000@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
Other Names:
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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.
|
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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
isometric extension maximum knee with traction
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
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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)
|
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
|
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The Single Leg Vertical Jump exercise
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 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
|
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
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
|
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
|
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
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- 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.
- Schulz KF, Altman DG, Moher, Group C. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar; 340(23): 332.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEIM/2024/4/095
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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