RehabilitationNCT06262087
The Combined FIFA 11+ and Change of Direction Training
A study testing Change of direction training and FIFA 11+ program in people with Rehabilitation and Physical Therapy, run by Mahidol University at 1 site in Cambodia.
Trial summary
The study has investigated the effects of adding change of direction (COD) training to the FIFA 11+ on lower extremity performance in soccer players. The investigators are interested in knee valgus angle during cutting which is typically suggested as a critical risk of anterior cruciate ligament injury. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Rehabilitation, Physical Therapy
- What is being tested?
- Change of direction training and FIFA 11+ program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCambodia
- Study dates
- 15 Feb 2024to 7 Dec 2025
- 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 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Soccer players
Who cannot join
- Having experience of serious injury such as, ACL injury and chronic ankle instability
- Having experience of lower limb surgery such as, bone fracture, tendon rupture, or ligament rupture
- Having current musculoskeletal injuries such as, muscle sprain
- Attending other prevention program or similar study especially on lower extremity
- Soccer player who are unable to perform level 3 of part 2 of the FIFA 11+ prevention program
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Combined FIFA 11+ and Change of Direction Training on Knee Valgus Angle During Cutting in Male Soccer Players
The study has investigated the effects of adding change of direction (COD) training to the FIFA 11+ on lower extremity performance in soccer players. The investigators are interested in knee valgus angle during cutting which is typically suggested as a critical risk of anterior cruciate ligament injury. Peak knee valgus angle during cutting is expected to reduce immediately after adding COD training to the FIFA 11+.
- Conditions
- Rehabilitation, Physical Therapy
- Being tested
- Change of direction training, FIFA 11+ program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Change of direction trainingBehavioural
The experimental group is implemented FIFA 11+ program combined with COD training
FIFA 11+ programBehavioural
The experimental group is implemented FIFA 11+ program.
| Study group | Role | What they receive |
|---|---|---|
| FIFA 11+ program combined with COD training | Experimental | Participants in an experimental group will perform the FIFA 11+ program combined with COD training. Receives: Behavioral: Change of direction training; Behavioral: FIFA 11+ program |
| FIFA 11+ | Active comparator | Participants in the control group will perform the FIFA 11+ program. Receives: Behavioral: FIFA 11+ program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak knee valgus angle
Knee valgus angle during cutting tests will be assessed before and after training for both groups. Two-dimensional analysis will be used to capture cutting movement and knee valgus angle will be extracted in the free software analysis.
Measured: At pre-training and immediate post-training of prevention program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2024
- Study start15 Feb 2024
- Primary completion7 Jun 2025
- Study completion7 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RehabilitationStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Komsak Sinsurin, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06262087
- Sponsor's protocol ID
- MU-CIRB 2023/044.2203
- Status last verified
- Dec 2025
- First submitted
- 30 Jan 2024
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will consider in the future.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combined FIFA 11+ and Change of Direction Training on Knee Valgus Angle During Cutting in Male Soccer Players
- ClinicalTrials.gov ID
- NCT06262087
- Acronym / sponsor ID
- MU-CIRB 2023/044.2203
- Conditions
- Rehabilitation, Physical Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 15 Feb 2024 (actual)
- Primary completion
- 7 Jun 2025 (actual)
- Study completion
- 7 Dec 2025 (actual)
- First posted
- 15 Feb 2024 (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.
The study has investigated the effects of adding change of direction (COD) training to the FIFA 11+ on lower extremity performance in soccer players. The investigators are interested in knee valgus angle during cutting which is typically suggested as a critical risk of anterior cruciate ligament injury. Peak knee valgus angle during cutting is expected to reduce immediately after adding COD training to the FIFA 11+.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FIFA 11+ program combined with COD training | Experimental | Behavioral: Change of direction training, Behavioral: FIFA 11+ programParticipants in an experimental group will perform the FIFA 11+ program combined with COD training. |
| FIFA 11+ | Active comparator | Behavioral: FIFA 11+ programParticipants in the control group will perform the FIFA 11+ program. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Soccer players
Key exclusion criteria (5 listed)
- Having experience of serious injury such as, ACL injury and chronic ankle instability
- Having experience of lower limb surgery such as, bone fracture, tendon rupture, or ligament rupture
- Having current musculoskeletal injuries such as, muscle sprain
- Attending other prevention program or similar study especially on lower extremity
- Soccer player who are unable to perform level 3 of part 2 of the FIFA 11+ prevention program
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 |
|---|---|---|
| Change of direction trainingThe experimental group is implemented FIFA 11+ program combined with COD training | Behavioural | FIFA 11+ program combined with COD training |
| FIFA 11+ programThe experimental group is implemented FIFA 11+ program. | Behavioural | FIFA 11+, FIFA 11+ program combined with COD training |
Primary outcome
Peak knee valgus angle
Time frame: At pre-training and immediate post-training of prevention program
Knee valgus angle during cutting tests will be assessed before and after training for both groups. Two-dimensional analysis will be used to capture cutting movement and knee valgus angle will be extracted in the free software analysis.
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 Dec 2025.
- Individual participant dataSharing planned: Undecided. We will consider in the future.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Change of direction training and FIFA 11+ program in people with Rehabilitation and Physical Therapy, run by Mahidol University at 1 site in Cambodia.
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 1 inclusion and 5 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 Dec 2025. 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 Cambodia. 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?
Peak knee valgus angle (time frame: At pre-training and immediate post-training of prevention program). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2025.