Prevention and Control Clinical Trial
— PENTOfficial title:
Effects of a Neuromuscular Training Program for the Prevention of Ankle Functional Instability in Male Soccer Players Aged 17-20: Randomized Clinical Trial With FIFA 11+
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 |
Verified date | January 2023 |
Source | Universidad Autónoma de Manizales, Colombia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Colombia | Autonoma's University | Manizales | Caldas |
Lead Sponsor | Collaborator |
---|---|
Universidad Autónoma de Manizales, Colombia | Universidad Católica del Maule |
Colombia,
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
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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