Prevention and ControlPENTNCT05688930
Effects of a Neuromuscular Training Ankle Preventive Program in Soccer Player
A study testing PENMT (Experimental Group) in people with Prevention and Control, run by Universidad Autónoma de Manizales, Colombia at 1 site in Colombia.
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. Read more about this study
- Who is it for?
- Ages 17 to 20 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prevention and Control
- What is being tested?
- PENMT (Experimental Group)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteColombia
- Study dates
- 7 Jul 2021to 1 Jul 2022
- Phase
- Interventional
- 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 17 to 20 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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+
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.
Read more
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.
- Conditions
- Prevention and Control
- Being tested
- PENMT (Experimental Group), FIFA 11+ (Control Group)
- Keywords
- Ankle injuries, Physical therapy, Neuromuscular training, Functional ankle instability, Prevention, Unstable joint.
- Medical subject headings
- Ankle Injuries, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PENMT (Experimental Group)Other
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)Other
Treatment or experimental condition. 1: FIFA 11+ Program
| Study group | Role | What they receive |
|---|---|---|
| PENMT (Experimental Group) | Experimental | 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. Receives: Other: PENMT (Experimental Group) |
| FIFA 11+ (Control Group) | Active comparator | Treatment or experimental condition. 1: FIFA 11+ Program Receives: Other: FIFA 11+ (Control Group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preventive program (Type of)
Neuromuscular and functional training protocol
Measured: 12 weeks
Secondary outcomes (4)
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)
Measured: Two measurements: first week and twelfth week
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)
Measured: Two measurements: first week and twelfth week
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)
Measured: Two measurements: first week and twelfth week
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).
Measured: Two measurements: first week and twelfth week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2023
- Study start7 Jul 2021
- Primary completion7 Nov 2021
- Study completion1 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Prevention and ControlStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- G1: Neuromuscular training program of prevention of functional ankle instability PEMNT; G2: FIFA 11+ Program Group (control).
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Autónoma de Manizales, Colombia
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Católica del Maule
- Responsible party
- Sponsor
- Investigators
- Lina Ma Montealegre, Msc, Principal investigator, U.AUTÓNOMA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05688930
- Sponsor's protocol ID
- 703-2020 T.D.
- Acronym
- PENT
- Status last verified
- Jan 2023
- First submitted
- 19 Oct 2021
- Last updated
- 18 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22488285Imai 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.
PubMed 29448292Halasi 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.
PubMed 16244190
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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+
- ClinicalTrials.gov ID
- NCT05688930
- Acronym / sponsor ID
- PENT / 703-2020 T.D.
- Conditions
- Prevention and Control
- Keywords
- Ankle injuries, Physical therapy, Neuromuscular training, Functional ankle instability, Prevention, Unstable joint.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Universidad Autónoma de Manizales, ColombiaUniversity, hospital or other
- Collaborators
- Universidad Católica del Maule
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 7 Nov 2021 (actual)
- Study completion
- 1 Jul 2022 (actual)
- First posted
- 18 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- G1: Neuromuscular training program of prevention of functional ankle instability PEMNT; G2: FIFA 11+ Program Group (control).
| Arm | Type | Receives |
|---|---|---|
| PENMT (Experimental Group) | Experimental | 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. |
| FIFA 11+ (Control Group) | Active comparator | Other: FIFA 11+ (Control Group)Treatment or experimental condition. 1: FIFA 11+ Program |
Who may qualify
- Ages
- 17 to 20 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | PENMT (Experimental Group) |
| FIFA 11+ (Control Group)Treatment or experimental condition. 1: FIFA 11+ Program | Other | FIFA 11+ (Control Group) |
Primary outcome
Preventive program (Type of)
Time frame: 12 weeks
Neuromuscular and functional training protocol
4 secondary outcomes
Ankle instability perception
Time frame: Two measurements: first week and twelfth week
Measurement flexibility (centimeters)
Time frame: Two measurements: first week and twelfth week
Limits of stability - balance (millimeters)
Time frame: Two measurements: first week and twelfth week
Measured with conduction velocity in seconds under maximal voluntary contraction (MVC)
Time frame: Two measurements: first week and twelfth week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Background: PubMed 22488285Brito 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.
- Background: PubMed 29448292Imai 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.
- Background: PubMed 16244190Halasi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lina Ma Montealegre, Msc principal investigator
U.AUTÓNOMA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PENMT (Experimental Group) in people with Prevention and Control, run by Universidad Autónoma de Manizales, Colombia at 1 site in Colombia.
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 8 inclusion and 4 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: finished, as of the sponsor's last update on 18 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preventive program (Type of) (time frame: 12 weeks). 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 NCT05688930, which also lists 3 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 18 Jan 2023.