Protocol summary
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Study aim
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The comparison of plyometric training with differential learning or nonlinear pedagogy methods on biomechanical and functional factors in athletes with high risk of anterior cruciate ligament injury.
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Design
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The clinical trial has two intervention groups and one control group, with parallel groups, and a single-blind method, randomized by the web method on 48 participants and includes the concealment of random allocation.
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Settings and conduct
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The study will be conducted at the Faculty of Physical Education, Kharazmi University, Karaj Branch. A single-blind method was used where only participants were tried to be blinded from the study. For this purpose, all the participants in the study will continue their daily life after the pre-test and according to the purpose of the research, the intervention groups will receive the exercises, but they will not know the type of exercise interventions. For this purpose, each group's interventions will be done on different days.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
All male university athletes at a competitive level.
Normal body mass index in the range of 18.5 to 25.
Age range from 18 to 26 years.
Exclusion criteria:
Participation in injury risk reduction programs during the past year.
Non-participation of subjects in two consecutive training sessions and three. non-consecutive training sessions.
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Intervention groups
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The first intervention group: plyometric exercises with nonlinear learning pedagogy. The second intervention group: plyometric exercises with differential learning pedagogy. Control group: will continue with daily sports activities.
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Main outcome variables
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Trunk flexion; trunk lateral flexion; knee flexion; knee abduction; hip adduction and internal rotation and ankle dorsiflexion angles. Vertical ground reaction force and knee flexion; knee abduction and hip abduction and external rotation moments.
General information
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Reason for update
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Due to significant structural differences in the training protocols, there is a possibility of bias in blinding participants. Also, due to ethical considerations in research that participants should be aware of the entire research protocol, and outcome assessors will be blinded instead of participants. Due to limitations and personal problems, the date of patient recruitment (participant recruitment) will change.
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Acronym
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ACL
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IRCT registration information
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IRCT registration number:
IRCT20210602051477N3
Registration date:
2025-03-15, 1403/12/25
Registration timing:
prospective
Last update:
2025-07-08, 1404/04/17
Update count:
1
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Registration date
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2025-03-15, 1403/12/25
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2025-09-23, 1404/07/01
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Expected recruitment end date
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2025-10-21, 1404/07/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of Plyometric Training by Differential Learning or Nonlinear Pedagogy Approach on Functional and Biomechanical Factors in Athletes at High Risk of ACL Injury: A Field Trial Study
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Public title
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Comparing the effects of differential learning and nonlinear pedagogy in anterior cruciate ligament injury
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
All male university athletes at a competitive level (futsal, basketball and handball)
Normal body mass index in the range of 18.5 to 25
Having a score equal to or greater than 6 in the tuck jump test
Absence of any visible abnormalities in the trunk (hyper-kyphosis, hyper-lordosis, and severe scoliosis) and lower limbs (genu varum, genu valgum, and severe flat feet) and no acute and chronic musculoskeletal injury during the past year (any injury that causes the athlete to be away for a long time)
There is no history of injury or rupture of the anterior cruciate ligament and no medical history of neurocognitive, metabolic, hearing, and vision defects.
Absence of concussion or concussion-related symptoms (frequent headaches or migraines, eye movement deficits, and balance disorders) within the past five years
Exclusion criteria:
Participation in injury risk reduction programs during the past year
Non-participation of subjects in two consecutive training sessions and three non-consecutive training sessions
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Age
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From 18 years old to 26 years old
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Gender
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Male
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
48
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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To randomize, the online randomization method (http://randomizer.org/Social Psychology Network Middletown, CT, USA, accessed on June 22, 2013) will be used, which is provided to researchers for free. In this way, participants are randomly assigned in a 1:1:1 allocation ratio to one of the groups: 1=non-linear pedagogy, 2=differential learning, and 3=control. To allocate concealment, the table of block random numbers will be used. For this purpose, random numbers will be placed in sealed and opaque envelopes inside the box. The other researcher, who is not aware of the initial assignment of the subjects, opens the envelopes and will continue the exercises after determining the assignment of the groups.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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In the present study, a single-blinded method will be used for blinding, in which only the outcome assessors are blinded. For this purpose, outcome assessors who are unaware of the participant allocation, research method, and hypotheses collect data related to the outcome variables.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2025-02-23, 1403/12/05
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Ethics committee reference number
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IR.KHU.REC.1403.169
Health conditions studied
1
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Description of health condition studied
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Prevention of anterior cruciate ligament injury
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Knee and hip kinematics
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Timepoint
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Knee and hip kinematics will be measured at pre-test (before the start of the intervention) and post-test (after 8 weeks).
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Method of measurement
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A motion capture system with 8 high-speed cameras (Kestrel 8.0 motion analysis, US) with a sampling frequency of 120 Hz will be used to measure 3D kinematics.
2
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Description
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Knee and hip Kinetics
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Timepoint
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Knee and hip kinetics will be measured at pre-test (before the start of the intervention) and post-test (after 8 weeks).
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Method of measurement
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A Bertec force plate device, made in the United States, with dimensions of 60 x 40 cm (Bertec Corporation, Columbus, OH) with a sampling frequency of 1200 Hz will be used to collect kinetic data.
Secondary outcomes
1
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Description
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Triple crossover hop for distance test
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Timepoint
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It will be measured in the pre-test (before the intervention) and post-test (after 8 weeks).
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Method of measurement
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The jump distance (meters) from the starting line to the foot heel will be considered the participant's record.
2
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Description
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Tuck jump test
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Timepoint
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It will be measured in the pre-test (before the intervention) and post-test (after 8 weeks).
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Method of measurement
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10-question scoring form for the tuck jump test
3
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Description
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90 medial rotation hop for distance
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Timepoint
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It will be measured in the pre-test (before the intervention) and post-test (after 8 weeks).
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Method of measurement
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The jump distance will be measured from the medial of the foot when jumping to the toes when landing.
4
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Description
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Medial side triple hop for distance test
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Timepoint
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It will be measured in the pre-test (before the intervention) and post-test (after 8 weeks).
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Method of measurement
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The total jump distance after three consecutive steps is measured from the medial side of the foot when jumping to the medial side of the foot when landing.
5
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Description
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Coordination variability of lower extremity
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Timepoint
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It will be measured in the pre-test (before the intervention) and post-test (after 8 weeks).
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Method of measurement
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A motion capture system (Kestrel 8.0 motion analysis, US) 8 cameras with a sampling frequency of 120 Hz
Intervention groups
1
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Description
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The first intervention group: Plyometric training combined with nonlinear learning pedagogy will be conducted for 8 weeks, 3 sessions per week, each session lasting 60 minutes, for a total of 24 training sessions.
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Category
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Prevention
2
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Description
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Second intervention group: Plyometric exercises combined with differential learning pedagogy for 8 weeks, 3 sessions per week, each session lasting 60 minutes, for a total of 24 training sessions.
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Category
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Prevention
3
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Description
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Control group: Participants will continue with their daily lives and will not receive any intervention.
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Category
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N/A
1
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Sponsor
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Grant name
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Vice President for Research, Kharazmi University, Tehran
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kharazmi University
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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The participant data form, study protocol, informed consent form, and study report will be published anonymously after the research is completed as an attachment to the article, as well as the results as an average of all participants.
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When the data will become available and for how long
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The access period to protocols and results will begin approximately 6 months after the results are published.
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To whom data/document is available
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Researchers working in scientific centers and universities, strength and conditioning coach, physiotherapists, and sports medicine specialists can access the results.
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Under which criteria data/document could be used
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The research results will be published in the form of articles in scientific databases and will be accessible through this means.
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From where data/document is obtainable
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To receive the study results, they can email the corresponding author.
Email address: majidhamoongard@gmail.com
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What processes are involved for a request to access data/document
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After contact, the corresponding author for the article will be responded to as soon as possible.
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Comments
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