The general purpose of this study is to compare the effect of neuromuscular exercises and exercises with the Differential Learning approach in athletes prone to ACL injury
Design
A parallel-group, single-blind, randomized, phase 2 clinical trial on 30 patients. Random Number Generator software will be used for randomization.
Settings and conduct
All tests and exercises will take place in Takhti Sports Complex of Mashhad and Jihad Agricultural Hall of Mashhad. The division of groups will be in such a way that the first group includes neuromuscular exercises, the second group includes Differential Learning exercises.
Participants/Inclusion and exclusion criteria
Entry requirements: 1. 15 to 20 years. 2. Having dynamic knee Valgus of more than 8 degrees in the single leg landing test.
Exit conditions: 1. Deformity in lower and upper limbs. 2. History of hip, knee and ankle fracture or dislocation. 3. History of surgery or neurological disease.
Intervention groups
Group of neuromuscular exercises, group of exercises with Differential Learning approach
Both groups do the exercises for 8 weeks and three sessions every week
Main outcome variables
Dynamic Knee Valgus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230701058639N1
Registration date:2024-08-10, 1403/05/20
Registration timing:retrospective
Last update:2024-08-10, 1403/05/20
Update count:0
Registration date
2024-08-10, 1403/05/20
Registrant information
Name
Javad Mahdizadeh
Name of organization / entity
Buali Sina University
Country
Iran (Islamic Republic of)
Phone
+98 51 3225 3606
Email address
j.mahdizadeh@phe.basu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-09-23, 1402/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of neuromuscular training and training with the Differential Learning approach in athletes prone to ACL injury
Public title
Comparing the effects of neuromuscular training and training with the Differential Learning approach in athletes prone to ACL injury
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
15 to 20 years
Dynamic knee Valgus greater than 8 degrees in single leg landing test
Exclusion criteria:
Deformity of upper and lower limbs
History of fracture or dislocation of hip, knee and ankle
History of surgery or neurological disease
Age
From 15 years old to 20 years old
Gender
Male
Phase
N/A
Groups that have been masked
Investigator
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
We used Random Allocation Software for randomization. Random codes were generated in blocks 4 and 6. We used sequentially numbered sealed opaque envelopes to conceal the allocation. The third researcher, who had no role in data collection and was not aware of the study process, opened the envelopes containing the random codes and handed them to the patients. As a result, patients were randomly assigned to experimental groups with a rate of 1:1.
Blinding (investigator's opinion)
Single blinded
Blinding description
The second researcher, who was not involved in data collection, opened the envelopes containing the random codes and handed them to the subjects. The laboratory technicians were unaware of the purpose of the present study and the allocation of groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Boali Sina University
Street address
Hamedan, Chaharbagh Shahid Mostafa Ahmadi Roshan, Boali Sina University
City
Hamedan
Province
Hamadan
Postal code
6517838695
Approval date
2023-04-11, 1402/01/22
Ethics committee reference number
IR.BASU.REC.1402.014
Health conditions studied
1
Description of health condition studied
Anterior Cruciate ligament
ICD-10 code
S83.5
ICD-10 code description
Sprain of cruciate ligament of knee
Primary outcomes
1
Description
Dynamic Knee Valgus
Timepoint
Before and after 8 weeks of training program
Method of measurement
Single leg landing test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: neuromuscular exercises for 8 weeks and 3 sessions of 1 hour each week. Training sessions will include about 10 minutes of general warm-up, 40 minutes of resistance exercises, and 10 minutes of cooling down in the form of stretching exercises. Exercises include two-legged squats, one-legged squats, two-legged jumps, one-legged cross jumps, one-legged standing on unstable and horizontal bound surfaces, and one-legged standing high jumps.
Category
Prevention
2
Description
Intervention group: exercises with the Differential Learning approach will be for 8 weeks and 3 sessions of 1 hour each week. Training sessions will include about 10 minutes of general warm-up, 40 minutes of resistance training and 10 minutes of cooling down in the form of stretching exercises. The two basic principles considered in this educational model are non-repetition and non-correction, which will be considered in the exercises. In this training method, the nature of the training is preserved and it is performed under different training conditions. Exercises include two-legged squats, one-legged squats, two-legged jumps, one-legged cross jumps, one-legged standing on unstable and horizontal bound surfaces, and one-legged standing high jumps.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Mashhad sports clubs
Full name of responsible person
Javad Mahdizadeh
Street address
No 386- Hashemi Nejad Ave
City
Mashhad
Province
Razavi Khorasan
Postal code
9145778554
Phone
+98 51 3225 3606
Email
j.mahdizadeh@phe.basu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Buali Sina University
Full name of responsible person
Arash Ghorbani
Street address
Chaharbagh Street, Shahid Mostafa Ahmadi Roshan, Boali Sina University Hamedan
City
Hamedan
Province
Hamadan
Postal code
65178-38695
Phone
+98 81 3830 3242
Email
j.mahdizadeh@phe.basu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Buali Sina University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Buali Sina University
Full name of responsible person
Ali Yalfani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Hamedan, Shahid Mostafa Ahmadi Roshan Blvd., Bo Ali Sina University
City
Hamedan
Province
Hamadan
Postal code
6516738695
Phone
009838303242
Email
ali_yalfani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Buali Sina University
Full name of responsible person
Ali Yalfani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Hamedan, Shahid Mostafa Ahmadi Roshan Blvd., Bo Ali Sina University
City
Hamedan
Province
Hamadan
Postal code
6519955189
Phone
+98 81 3830 3242
Email
ali_yalfani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Buali Sina University
Full name of responsible person
Javad Mahdizadeh
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
No 386, Hashemi Nejad Ave.
City
Mashhad
Province
Razavi Khorasan
Postal code
9145778554
Phone
+98 51 3225 3606
Email
j.mahdizadeh@phe.basu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data and documents can be shared, but with the non-identification of people and the preservation of private information of subjects
When the data will become available and for how long
The results of this study will be available 9 months after publication in journals.
To whom data/document is available
The data will be available to academic and scientific researchers
Under which criteria data/document could be used
The presented documentation can be used to prevent anterior cruciate ligament injury.
From where data/document is obtainable
To benefit from the results of the study, individuals can refer to the library of Buali Sina University.
What processes are involved for a request to access data/document