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
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.
- 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.