The Combined FIFA 11+ and Change of Direction Training

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+.

Study Overview

• Status: Recruiting
• Conditions: Rehabilitation; Physical Therapy
• Intervention / Treatment: Behavioral: Change of direction training; Behavioral: FIFA 11+ program

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Komsak Sinsurin; Phone Number: +666855547313; Email: komsak.sin@mahidol.edu

Study Locations

• Cambodia
  • Phnom Penh, Cambodia
    • Recruiting
    • FFC league in Cambodia
    • Contact: Komsak Sinsurin, Ph.D.; Phone Number: 20605 +66 024415450; Email: komsak.sin@mahidol.edu
    • Principal Investigator: Chanteng Huoth, M.Sc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Soccer players

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FIFA 11+ program combined with COD training; Participants in an experimental group will perform the FIFA 11+ program combined with COD training.	Behavioral: Change of direction training; The experimental group is implemented FIFA 11+ program combined with COD training; Behavioral: FIFA 11+ program; The experimental group is implemented FIFA 11+ program.
Active Comparator: FIFA 11+; Participants in the control group will perform the FIFA 11+ program.	Behavioral: FIFA 11+ program; The experimental group is implemented FIFA 11+ program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Estimated): June 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: January 30, 2024
• First Submitted That Met QC Criteria: February 8, 2024
• First Posted (Actual): February 15, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MU-CIRB 2023/044.2203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: We will consider in the future.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No