NCT06262087

Brief 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. Peak knee valgus angle during cutting is expected to reduce immediately after adding COD training to the FIFA 11+.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 30, 2024

Completed
16 days until next milestone

First Posted

Study publicly available on registry

February 15, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

February 15, 2024

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 7, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2025

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

1.3 years

First QC Date

January 30, 2024

Last Update Submit

December 11, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    At pre-training and immediate post-training of prevention program

Study Arms (2)

FIFA 11+ program combined with COD training

EXPERIMENTAL

Participants in an experimental group will perform the FIFA 11+ program combined with COD training.

Behavioral: Change of direction trainingBehavioral: FIFA 11+ program

FIFA 11+

ACTIVE COMPARATOR

Participants in the control group will perform the FIFA 11+ program.

Behavioral: FIFA 11+ program

Interventions

The experimental group is implemented FIFA 11+ program combined with COD training

FIFA 11+ program combined with COD training

The experimental group is implemented FIFA 11+ program.

FIFA 11+FIFA 11+ program combined with COD training

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Soccer players

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FFC league in Cambodia

Phnom Penh, Phnom Penh, Cambodia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 30, 2024

First Posted

February 15, 2024

Study Start

February 15, 2024

Primary Completion

June 7, 2025

Study Completion

December 7, 2025

Last Updated

December 18, 2025

Record last verified: 2025-12

Locations