Determining the effect of Trunk and Hip Abductor Muscle Fatigue on Kinetic and Kinematic Variables in Athletes Susceptible to Anterior Cruciate Ligament injury
Design
Clinical trial, randomized, without blinding, on 30 people, Random Allocation Software will be used for randomization.
Settings and conduct
All the tests will be done in the sports rehabilitation laboratory of Bu Ali Sina University in Hamedan by the laboratory's official and experts. The groups will be divided in such a way that the first group includes the fatigue of the trunk muscles and the second group includes the fatigue of the hip muscles.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1.female athletes 18 to 25 years old
2. Having at least a two-year experience of regular sports activity
3. Having a normal body mass index
4. Attending sports for three sessions a week on average
5. Having no fracture or record of surgery on the lower extremity over the past one year
6. Dynamic valgus angle more than 12 angle
Exclusion criteria: 1. Knee injury or surgery 2. Current knee pain 3. Current hip injury 4. History of lower limb injury in the last 6 months
Intervention groups
The first group: The core and trunk muscle fatigue protocol includes 4 consecutive sets of 7 exercises so that the subject will perform each exercise 20 times in 40 seconds with 20 seconds of rest between each exercise.
The second group: the hip abductor fatigue protocol will include three sets of hip joint abduction. Subjects will perform as many repetitions as possible at a rate of 60 beats per minute, controlled by a metronome, until they reach the set goal of 35 degrees of hip abduction.
Main outcome variables
Dynamic Knee Valgus
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240701062295N1
Registration date:2024-07-25, 1403/05/04
Registration timing:prospective
Last update:2024-07-25, 1403/05/04
Update count:0
Registration date
2024-07-25, 1403/05/04
Registrant information
Name
Sarina Minaei
Name of organization / entity
The University Of Bu-Ali Sina
Country
Iran (Islamic Republic of)
Phone
+98 41 3383 1095
Email address
s.minaei@phe.basu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-10, 1403/05/20
Expected recruitment end date
2024-08-22, 1403/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Trunk and Hip Abductor Muscle Fatigue on Kinetic and Kinematic Variables in Athletes Susceptible to Anterior Cruciate Ligament Injury
Public title
The Effect of Trunk and Hip Abductor Muscle Fatigue in Athletes Susceptible to Anterior Cruciate Ligament Injury
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Female athletes 18 to 25 years old
Having at least a two year experience of regular sports activity
Having a normal body mass index
Attending sports for three sessions a week on average
Having no fracture or record of surgery on the lower extremity over the past one year
Dynamic valgus angle more than 12 angle
Exclusion criteria:
Knee injury or surgery
Current knee pain
Current hip injury
History of lower limb injury in the last 6 months
Age
From 18 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Faculty of Health, Shahid Fahmideh St.
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۶۷۸
Approval date
2024-02-27, 1402/12/08
Ethics committee reference number
IR.BASU.REC.1402.096
Health conditions studied
1
Description of health condition studied
Anterior Cruciate Ligament injury
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Dynamic knee valgus
Timepoint
The time period of measuring the outcome before and after the protocol will be implemented.
Method of measurement
To evaluate the dynamic knee valgus will be from the camera.
Secondary outcomes
1
Description
Center of Pressure
Timepoint
The time period of measuring the outcome before and after the protocol will be implemented.
Method of measurement
To evaluate the center of pressure will be used from foot scan device.
2
Description
Pelvic Drop
Timepoint
The time period of measuring the outcome before and after the protocol will be implemented.
Method of measurement
To evaluate the pelvic drop will be from the camera
3
Description
Knee Flexion
Timepoint
The time period of measuring the outcome before and after the protocol will be implemented.
Method of measurement
To evaluate the knee flexion will be from the camera
Intervention groups
1
Description
The first intervention group: The trunk muscle fatigue protocol will be done in 1 session under the supervision of the researcher.The ABT’s trunk muscle fatigue protocol will be used for trunk muscle fatigue.
Category
Diagnosis
2
Description
The second intervention group:The hip abductor muscle fatigue protocol will be done in 1 session under the supervision of the researche
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthopedic clinics of Hamadan province
Full name of responsible person
Sarina Minaei
Street address
Bu Ali Sina University, Faculty of Physical Education and Sports Sciences., Shahid Mostafa Ahmadi Roshan Blvd
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸-۳۸۶۹۵
Phone
+98 81 3140000
Email
s.minaei@phe.basu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The university of Buali sina
Full name of responsible person
Mahbobeh Alemzadeh
Street address
Boali Sina University, Shahid Mostafa Ahmadi Roshan, Chaharbagh, Hamedan
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸-۳۸۶۹۵
Phone
+98 81 3140000
Email
alemzadeh@basu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The university of Buali sina
Proportion provided by this source
1
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
Bu ali Sina University, Hamedan
Full name of responsible person
Dr. Ali Yalfani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports rehabilitation
Street address
Bu Ali Sina University, Faculty of Physical Education and Sports Sciences., Shahid Mostafa Ahmadi Roshan Blvd
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸-۳۸۶۹۵
Phone
+98 81 3140000
Email
ali_yalfani@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bu ali Sina University, Hamedan
Full name of responsible person
Dr. Ali Yalfani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports rehabilitation
Street address
Bu Ali Sina University, Faculty of Physical Education and Sports Sciences., Shahid Mostafa Ahmadi Roshan Blvd
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸-۳۸۶۹۵
Phone
+98 81 3140000
Email
ali_yalfani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Bu ali Sina University, Hamedan
Full name of responsible person
Sarina Minaei
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sports rehabilitation
Street address
Bu Ali Sina University, Faculty of Physical Education and Sports Sciences., Shahid Mostafa Ahmadi Roshan Blvd
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸-۳۸۶۹۵
Phone
+98 81 3140000
Email
s.minaei@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 In Journals 3 Months After Publication.
To whom data/document is available
The Results of The Studies Will Be Accessible to All Individuals in The Community Without Any Restrictions.
Under which criteria data/document could be used
The presented documentation can be used to identify athletes susceptible to anterior cruciate ligament injury.
From where data/document is obtainable
E-mail Sarina Minaei s.minaei@phe.basu.ac.ir
What processes are involved for a request to access data/document
When the applicant provides documents for her field of work related to the subject of the thesis and in case of a reasonable request and a commitment not to misuse the data of this research, the data will be sent to her for 1 working week.