Comparison of the effect of neuromuscular training with and without cognitive interventions on landing mechanics, proprioception, balance, strength, and electrocortical activity in female athletes predisposed to ACL injury
Comparison of the effectiveness of eight weeks of neuromuscular exercises with and without cognitive interventions on landing mechanics, proprioception and electrocortical activity of female athletes prone to ACL injury.
Design
A clinical trial with control group (neuromuscular exercises without cognitive interventions), with parallel groups, single-blinded, randomized
Settings and conduct
Athletes with knee dynamic valgus will be included in the study if they are eligible and will be randomly assigned to the intervention and control groups based on allocation concealment using the SNOSE method. This study will be conducted in a single-blind way so that the outcome assessors will not know about the allocation of the study groups and the reason for their presence in this study.
Participants/Inclusion and exclusion criteria
The inclusion criteria included: age range 16 to 26 years, having knee dynamic valgus angle greater than 12 degrees, having at least two years of regular exercise history, and exit criteria including history of mechanical back pain in the past year, history of any damage in the past six months, history of surgery Knee and ankle.
Intervention groups
Groups of neuromuscular exercises without cognitive interventions and neuromuscular exercises with cognitive interventions
Main outcome variables
landing mechanics, proprioception, balance, strength, and electrocortical activity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190224042827N5
Registration date:2024-03-24, 1403/01/05
Registration timing:prospective
Last update:2024-03-24, 1403/01/05
Update count:0
Registration date
2024-03-24, 1403/01/05
Registrant information
Name
Farzane Ramezani
Name of organization / entity
Bu Ali Sina University
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 1423
Email address
f.ramezani@phe.basu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-08, 1403/01/20
Expected recruitment end date
2024-04-19, 1403/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of neuromuscular training with and without cognitive interventions on landing mechanics, proprioception, balance, strength, and electrocortical activity in female athletes predisposed to ACL injury
Public title
Effect of sports training on ACL injury prevention
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Athletes with knee dynamic valgus defect
Having at least two years of regular sports experience
Exclusion criteria:
History of mechanical back pain in the last year
History of any damage in the last six months
History of knee surgery
History of ankle surgery
Age
From 15 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization is based on the Random Number Generator software and uses the SNOSE method to assign double groups based on the allocation concealment. The randomization of subjects was done in two stages. First, each of the subjects chooses a number between 1-30 using a lottery, then fifteen random numbers are selected between the numbers 1-30 using the Random number generator software, and according to the generated numbers, the chosen numbers of subjects are divided into two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, the outcome assessors (laboratory technicians) are asked to take the desired tests from the clients. They will be unaware of the purpose of the research, the allocation of study groups, and the reason for the clients' presence in the laboratory, and they will only evaluate the variables and record their observations.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Bu Ali Sina University-Hamedan
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Approval date
2024-02-27, 1402/12/08
Ethics committee reference number
IR.BASU.REC.1402.076
Health conditions studied
1
Description of health condition studied
Sprain of anterior cruciate ligament
ICD-10 code
S83.512A
ICD-10 code description
Sprain of anterior cruciate ligament
Primary outcomes
1
Description
Electrocortical activity
Timepoint
Before the intervention begins, One day after the end of the intervention
Method of measurement
Electroencephalography device
Secondary outcomes
1
Description
Impairment of brain activity
Timepoint
Before and after intervention
Method of measurement
EEG device
Intervention groups
1
Description
Intervention group: Neuromuscular exercises with cognitive interventions, exercises will be for 8 weeks and 3 sessions of 1 hour each week, equipment such as resistance bands will be used to perform the exercises. The exercise protocol of the present study will be implemented along with dual cognitive tasks.
Category
Prevention
2
Description
Control group: Neuromuscular exercises without cognitive interventions, exercises will be for 8 weeks and 3 sessions of 1 hour each week, equipment such as resistance bands will be used to perform the exercises. The exercise protocol of the present study will be implemented along without dual cognitive tasks.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
committee of volleyball and basketball of Hamedan
Full name of responsible person
Farzane Ramezani
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
f.ramezani@phe.basu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Farzane Saki
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Email
f.ramezani@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
Bu Ali Sina University
Proportion provided by this source
100
Public or private sector
Public
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
Bu Ali Sina University
Full name of responsible person
Farzane Ramezani
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Sport Rehabilitation
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Fax
Email
f.ramezani@phe.basu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Farzane Ramezani
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Sport Rehabilitation
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Fax
Email
f.ramezani@phe.basu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Bu Ali Sina University
Full name of responsible person
Farzane Ramezani
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Sport Rehabilitation
Street address
Bu Ali Sina University, Abu Taleb St, Modares Quarter, Hamedan
City
Hamedan
Province
Hamadan
Postal code
3869565178
Phone
+98 81 3838 1423
Fax
Email
f.ramezani@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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Only data related to demographics and outcomes are shared.
When the data will become available and for how long
After publishing the article/articles extracted from the study
To whom data/document is available
The data can be displayed and shared according to the reasonable request of Iran's Clinical Trial Registration Center, journals and academic people/researchers who are doing research and scientific activities in this field.
Under which criteria data/document could be used
Data analysis and the use of documents can only be done with the condition that their results are mentioned in systematic review articles conducted by academic researchers and authors. The conditions for registering and sending data and documents include: 1. Sending an email (preferably with a valid university address) to one of the researchers of the study. 2. A brief and logical explanation related to the use of data or documents. 3. Ensuring the registration of the protocol of systematic review studies that have given access to data or documents.
From where data/document is obtainable
Through a request from the researcher Farzaneh Ramezani f.ramezani@phe.basu.ac.ir
What processes are involved for a request to access data/document
The applicant can request details from the researchers using the message sent by email within 7 to 10 days.