The effect of four weeks of selected rehabilitation exercises before surgery with the emphasis on core stability exercises on knee functional indexes after surgery in athletes with anterior cruciate ligament rupture: clinical trial
The effect of 4 weeks of selected rehabilitation exercises before surgery with the emphasis on core stability exercises on knee functional indexes after surgery in athletes with anterior cruciate ligament rupture
Design
This study is in the form of pre-test and post-test, according to the entry criteria, 40 people will be divided into two groups. Both groups will be pre-tested before surgery, and post-test will be taken from them 4 weeks after surgery
Settings and conduct
Evaluation of the range of motion and TKE using a goniometer, fear of movement using Tampa questionnaire, pain level using the vas questionnaire, and knee function using the IKDC questionnaire these functional evaluations will be done in the IFSM
Participants/Inclusion and exclusion criteria
The inclusion criteria of this research are:
1. Fear of movement between 18 and above 27 according to Tampa fear of movement questionnaire
2. The time from injury to surgery is maximum 3 months
3. Age range between 18 and 35 years
4. Rupture of the anterior cruciate ligament on one side
5. Not participating in any sports activities after tearing the anterior cruciate ligament
The exclusion criteria of this study are:
1. Not using the same graft for each of the studied subjects
2. Intensification of injury, pain and swelling during each of the stages of the research
3. Lack of regular participation in each of the training sessions during each of the stages of the research
4.Dissatisfaction of any of the subjects during the research stages
Intervention groups
At this stage, the subjects will be randomly divided into experimental and control groups. The people of the experimental group will carry out the rehabilitation training program for 4 weeks and 3 days a week, and the control group will have their routine activities
Main outcome variables
Range of motion, pain, fear of movement, terminal knee extension, knee function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231006059636N1
Registration date:2023-10-17, 1402/07/25
Registration timing:registered_while_recruiting
Last update:2023-10-17, 1402/07/25
Update count:0
Registration date
2023-10-17, 1402/07/25
Registrant information
Name
Negar Iranmanesh
Name of organization / entity
Faculty of Physical Education and Sport Sciences,shahid Beheshti University
Country
Iran (Islamic Republic of)
Phone
+98 21 2990 2550
Email address
n.iranmanesh@mail.sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-14, 1402/07/22
Expected recruitment end date
2024-01-12, 1402/10/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of four weeks of selected rehabilitation exercises before surgery with the emphasis on core stability exercises on knee functional indexes after surgery in athletes with anterior cruciate ligament rupture: clinical trial
Public title
The effect of four weeks of selected rehabilitation exercises before surgery with the emphasis on core stability exercises on knee functional indexes after surgery in athletes with anterior cruciate ligament rupture: clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Fear of movement between 18 and above 27 according to the Tampa fear of movement questionnaire
The time from injury to surgery is a maximum of 3 months
Age range between 18 and 35 years
One-sided anterior cruciate ligament rupture
Not participating in any sports activity after tearing the anterior cruciate ligament
Exclusion criteria:
Not using the same graft for each of the studied subjects
Intensification of injury, pain and swelling during each of the stages of research
Lack of regular participation in any of the training sessions during any of the stages of the research
Dissatisfaction of any of the subjects during the research process
Age
From 17 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random - lottery (in this method, the researcher gives a code or a special number to each member of the society. Then he writes down the number of each of them on a piece of paper, then he pours them into a container and shakes them. Then the papers are separated one by one. take them out, write down their numbers and divide them into experimental and control groups
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Ethics Committee of the Research Institute of Physical Education and Sports Sciences
Street address
No.3, 5th Alley, Miremad St., Ostad Motahari St., Tehran
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2023-10-13, 1402/07/21
Ethics committee reference number
SSRI.REC-2305-2220
Health conditions studied
1
Description of health condition studied
Rupture of anterior cruciate ligament
ICD-10 code
S83.5
ICD-10 code description
Sprain and strain involving (anterior)(posterior) cruciate ligament of knee
Primary outcomes
1
Description
Range of motion
Timepoint
4 weeks before ACL reconstruction and 4 weeks after surgery
Method of measurement
Goniometer
2
Description
Terminal knee extension
Timepoint
4 weeks before ACL reconstruction and 4 weeks after surgery
Method of measurement
Goniometer
3
Description
Fear of movement
Timepoint
4 weeks before ACL reconstruction and 4 weeks after surgery
Method of measurement
Tampa questionnaire
4
Description
Pain
Timepoint
4 weeks before ACL reconstruction and 4 weeks after surgery
Method of measurement
Visual Analouge scale
5
Description
Knee joint function
Timepoint
4 weeks before ACL reconstruction and 4 weeks after surgery
Method of measurement
International Knee Documentation Committee questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The experimental group, after reviewing the records and meeting the entry criteria, all of whom have torn the anterior cruciate ligament and are athletes, 20 people will be selected by the surgeon to implement an exercise program to strengthen the muscles of the central region before the operation, and then with written consent will be obtained from these people, then for 4 weeks and 3 sessions a week, all these athletes will receive their exercises under the direct supervision of a physiotherapist, finally, immediately before the operation, in order to assess the level of pain ,The range of motion, terminal knee extension, function of the knee joint and fear of movement of these people will be examined and post-tested, then the experimental group will undergo anterior cruciate ligament reconstruction, and 4 weeks after the reconstruction of the anterior cruciate ligament they will be tested again. The test will be taken and will be compared with the control group.
Category
Rehabilitation
2
Description
Control group: after examining the records and evaluating the patients with anterior cruciate ligament injury, 20 patients were invited by the surgeon to obtain informed written consent from the subjects, and in these 4 weeks, the control group continued their routine activities. given and before the surgery under the direct supervision of the physiotherapist immediately before the operation, the amount of pain, the range of motion, terminal knee extension, the function of the knee joint and the fear of movement of these people will be examined and pre-tested, then the control group will undergo ligament reconstruction. Anterior cruciate ligaments will be placed and 4 weeks after the reconstruction of the anterior cruciate ligament, they will be tested again and will be compared with the experimental group.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Sports Medicine Federation of Islamic Republic of Iran
Full name of responsible person
Farshad Ghazalian
Street address
Sport Medicine Federation, No.17, Varzandeh St.,Tehran