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IRCT20241221064122N1 IRCT 2026-02-23 Ferdowsi University of Mashhad Ankle sprain prevention strategy in 10-13 year old female karate athletes: An exercise-based approach The Effect of Six weeks Selected Ankle Sprain Prevention Exercise Program on Ankle Range of Motion, Proprioception, Ankle Muscle Strength, and Trunk Muscle Endurance in Female Karate Athletes Aged 10 to 13 Years 2026-02-20 anticipated 36 Complete https://irct.ir/trial/89141 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Prevention, Randomization description: In this study, each participant is assigned independently and with equal chance to one of two intervention or control groups. This simple randomization method was chosen for its simplicity, transparency, and the lack of need to consider specific variables to ensure that no known or unknown factors, such as demographic or clinical characteristics, affect the allocation of groups. The required randomization sequence is generated using the RAND function in Excel software. This function generates a random number between 0 and 1 for each individual. Then, based on a predetermined threshold, numbers less than 0.5 are assigned to the control group and numbers equal to or greater than 0.5 are assigned to the intervention group. This randomization sequence is recorded and archived as evidence of the study so that, if necessary, the process can be reviewed and verified.To maintain impartiality and avoid any bias, the allocation process is carried out by an independent observer who has no role or knowledge of the details of the study design, implementation or analysis. Although it is not possible to conceal the grouping from participants and administrative personnel due to the nature of the intervention, both outcome assessors and data analysts are kept unaware of the group allocation until the end of the data collection and analysis phase to reduce bias in the assessment of outcomes. N/A Ankle Injuries. Intervention 1: Intervention group: Participants in the intervention group will perform the selected ankle sprain prevention exercises for six weeks, three sessions per week, with each session lasting 20 minutes. Intervention 2: Control group: Participants in the control group will continue performing standard karate warm-up exercises for six weeks. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is The release schedule is not yet known
public Negin Nosrati Khoreshbari
Azadi Square, Ferdowsi University of Mashhad
Mashhad Iran (Islamic Republic of) 9177948974 +98 51 3880 2000 nnosratikhoreshbarin@mail.um.ac.ir Ferdowsi University of Mashhad scientific Behnaz Shahtahmassebi
Azadi Square, Ferdowsi University of Mashhad
Mashhad Iran (Islamic Republic of) 9177948974 +98 51 3880 5392 shahtahmassebi@ferdowsi.um.ac.ir Ferdowsi University of Mashhad Iran (Islamic Republic of) The subjects were girls aged 10 to 13 who practiced karate regularly Absence of musculoskeletal injury or abnormality in the lower extremities, especially the ankle General health clearance by a doctor 10 years 13 years Female People with musculoskeletal injuries or abnormalities in the lower extremities, especially the ankle People with a specific disease S90 Superficial injury of ankle, foot and toes Prevention Prevention Intervention group: Participants in the intervention group will perform the selected ankle sprain prevention exercises for six weeks, three sessions per week, with each session lasting 20 minutes. Control group: Participants in the control group will continue performing standard karate warm-up exercises for six weeks. Ankle range of motion. Timepoint: Assessments will be conducted at three time points: prior to the intervention, at the end of week three, and following the completion of the six-week protocol. Method of measurement: Inclinometer. Ankle proprioception. Timepoint: Assessments will be conducted at three time points: prior to the intervention, at the end of week three, and following the completion of the six-week protocol. Method of measurement: Inclinometer. Ankle muscle strength. Timepoint: Assessments will be conducted at three time points: prior to the intervention, at the end of week three, and following the completion of the six-week protocol. Method of measurement: Active force 2 digital dynamometer. Trunk muscle endurance. Timepoint: Assessments will be conducted at three time points: prior to the intervention, at the end of week three, and following the completion of the six-week protocol. Method of measurement: McGill's Torso Muscular Endurance Test. Ferdowsi University of Mashhad Approved 2026-01-20 Ethics committee of Ferdowsi University of Mashhad Azadi Square, Ferdowsi University of Mashhad, Central Administration Building Mashhad Razavi Khorasan Iran (Islamic Republic of)