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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05688930
Other study ID # 703-2020 T.D.
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 7, 2021
Est. completion date July 1, 2022

Study information

Verified date January 2023
Source Universidad Autónoma de Manizales, Colombia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Objetive:To determine the effects of a functional ankle instability prevention neuromuscular training (PENMT) program compared to the conventional FIFA 11+ program on the occurrence of ankle sprains, flexibility, balance and muscle activation in 17-year-old male youth soccer players to 20 years. Subjects and Methods: An experimental investigation, controlled, randomized and single-blind clinical trial was carried out in 40 subjects randomized to start the control or experimental group (soccer Players). The trial compared the effects of a differential intervention with a protocol focused on an ankle neuromuscular training program vs the usual FIFA 11+ program, in order to strengthen functional ankle stability in youth soccer in male players. In each subject, 2 measurements were taken: Pre-intervention and Post-intervention. For each measurement, a hypothesis test was performed. Results: The FIFA11+ is expressed as an injury risk factor when buying it with the PENMT after their participation. Conclusion:The neuromuscular training program for the ankle or PENMT applied in the experimental group did not generate a negative effect with respect to the FIFA 11+ program, in addition to the time of departure in the post test, the PENMT program is expressed as a protection factor of player injuries when contrasted with the FIFA 11+ program, that is, it presents effectiveness against the risk factor of functional ankle instability.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 1, 2022
Est. primary completion date November 7, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 17 Years to 20 Years
Eligibility Inclusion Criteria: - Be between the age range of 17 to 20 years old at the time of evaluation and intervention. - Have a minimum of 2 years of semi-professional / professional sports practice. - Be linked to the football club for at least 1 year. - That they practice soccer at least 5 times a week. - That they are playing at least one competitive tournament. - That they have an active or current health promotion entity - EPS and / or occupational risk insurer-ARL. - Players who during the entire period of 2019-2020 have presented at least one episode of lateral ankle sprain (during the last 4 months) (in the time range of 3 to 12 months prior to the first evaluation) who have required immobilization and / or weight loss for at least 3 days; present pain, subjective perception questionnaires of ankle instability). - Soccer players with or without sprained ankle injuries will be taken, but not in the last 3 months. However, the time elapsed since the last episode will be recorded. Exclusion Criteria: - Belonging to another sports club and / or regularly practicing more than one sport with muscular demand of the lower tract (lower limbs). - Who present acute injuries such as: vestibular alterations, history of ankle fracture, acute knee and / or ankle injury during the last 3 months, history of previous surgical interventions in lower limbs or underlying systemic disease at the time of the initial evaluation (pretest). - Who are undergoing treatment for any neuromuscular or other related pathology, in the acute phase and / or who have received a neuromuscular training program in the last 4 months, different from the one that will be applied in this study. - That in the last 4 months they have been in treatment for any neuromuscular pathology or other related to the acute phase and / or receive a neuromuscular training program different from the one that will be applied in this study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
PENMT (Experimental Group)
The neuromuscular injury prevention intervention protocol contains field work activities that involve proprioceptive exercises, flexibility, and specific and general muscle strength of the MMII and trunk soccer players.
FIFA 11+ (Control Group)
Treatment or experimental condition. 1: FIFA 11+ Program

Locations

Country Name City State
Colombia Autonoma's University Manizales Caldas

Sponsors (2)

Lead Sponsor Collaborator
Universidad Autónoma de Manizales, Colombia Universidad Católica del Maule

Country where clinical trial is conducted

Colombia, 

References & Publications (3)

Brito J, Malina RM, Seabra A, Massada JL, Soares JM, Krustrup P, Rebelo A. Injuries in Portuguese youth soccer players during training and match play. J Athl Train. 2012 Mar-Apr;47(2):191-7. doi: 10.4085/1062-6050-47.2.191. — View Citation

Halasi T, Kynsburg A, Tallay A, Berkes I. Changes in joint position sense after surgically treated chronic lateral ankle instability. Br J Sports Med. 2005 Nov;39(11):818-24. doi: 10.1136/bjsm.2004.016527. — View Citation

Imai A, Imai T, Iizuka S, Kaneoka K. A Trunk Stabilization Exercise Warm-up May Reduce Ankle Injuries in Junior Soccer Players. Int J Sports Med. 2018 Apr;39(4):270-274. doi: 10.1055/s-0044-100923. Epub 2018 Feb 15. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Preventive program (Type of) Neuromuscular and functional training protocol 12 weeks
Secondary Ankle instability perception Two measures were performed for each patient; Cumberland Ankle Instability Questionnaire (CAIT): 30 points no instability; less than 27 points presence of ankle instability. (applied pre and post intervention moments) Two measurements: first week and twelfth week
Secondary Measurement flexibility (centimeters) Two measures were performed for each patient; of the ankle joint (Lunge test) and chain of the lower limb (sit and reach: (BSSR); measurement in centimeters (cm), report of negative values or less than 0 cm, presence of retraction was lost. Both before and after the test.(applied pre and post intervention moments) Two measurements: first week and twelfth week
Secondary Limits of stability - balance (millimeters) Two measures were performed for each patient;Dynamic and static balance with eyes open and closed, in a movement analysis laboratory, measured in millimeters -mm. (Applied moments pre and post intervention) Two measurements: first week and twelfth week
Secondary Measured with conduction velocity in seconds under maximal voluntary contraction (MVC) Two measures were performed for each patient; surface electromyography, musculature - at 25 percentage, 50 percentage and 75 percentage of muscle activation. (moments before and after the intervention). Two measurements: first week and twelfth week
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