Protocol summary

Study aim
The effect of four weeks of preoperative rehabilitation exercises on Range of motion, strength, balance and Proprioception in athletes with anterior cruciate ligament injury
Design
After reviewing the records according to the inclusion criteria, 30 people will be selected to perform the preoperative rehabilitation training program.the subjects will be randomly divided into two experimental groups and a control group. The experimental group will perform a rehabilitation training program for 4 weeks and 3 days a week, and the control group will have only their routine activities.
Settings and conduct
Estimation of range of motion by Moby Mod, Equilibrium by Biodex balance system and power and estimation of subjects' deep sense will be done using isokinetic device. These functional evaluations will be performed in specialized pathology laboratories Sports of the Faculty of Sports and Health Sciences of Shahid Beheshti University will be performed.
Participants/Inclusion and exclusion criteria
Inclusion criteria 1-No history of combined surgery (acl surgery with pcl, meniscus,) 2- History of sports activities 3-Unilateral rupture of ACL compared to non-injured leg 4-Women and men with an age range of 29 ± 5 5-No preoperative training 6- A maximum of 3 months have elapsed since ACL injury Exclusion criteria 1- Causing pain and swelling2- Exacerbation of injury due to the implementation of the training protocol 3- Inability to perform pre-test sections
Intervention groups
The present research design is in two groups (control and experimental). Evaluation is pre-test and post-test.Dynamic balance and depth sense) are evaluated equally and then the intervention, which includes a specific training program,will be performed on the experimental group for four weeks.The statistical population
Main outcome variables
Range of motion, strength, balance and Proprioception

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220418054584N1
Registration date: 2022-10-05, 1401/07/13
Registration timing: registered_while_recruiting

Last update: 2022-10-05, 1401/07/13
Update count: 0
Registration date
2022-10-05, 1401/07/13
Registrant information
Name
roya talebi
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
ro.talebi@sbu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2022-12-22, 1401/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of four weeks of preoperative rehabilitation exercises on Range of motion, strength, balance and Proprioception in athletes with anterior cruciate ligament injury
Public title
The effect of four weeks of preoperative rehabilitation exercises on Range of motion, strength, balance and Proprioception in athletes with anterior cruciate ligament injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1- No history of combined surgery (anterior cruciate ligament surgery with posterior cruciate ligament, meniscus, etc.) History of sports activities (sports in which this type of injury is very common, such as football, basketball, handball) Existence of a unilateral rupture of the ACL compared to an uninjured leg Women and men with an age range of 24-34 without any training before surgery A maximum of 3 months have passed since the ACL injury
Exclusion criteria:
1- Causing pain and swelling in each stage of the research. Exacerbation of injury due to the implementation of the training protocol. nability to perform pre-test sections (if the patient is not able to perform any of the pre-test sections, they would be excluded from the sample set.)
Age
From 24 years old to 34 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
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
Ethics committee of shahid beheshti University
Street address
Ethics committee, Shahid Beheshti University, Shahid Dr. Shahriari Square (University Square), Rashiduddin Fazlullah St., Yaman St., Velanjak,Chamran Highway,Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2022-04-30, 1401/02/10
Ethics committee reference number
IR.SBU.REC.1401.024

Health conditions studied

1

Description of health condition studied
Rupture of the 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
4weeks
Method of measurement
mobee med (for measure Range of motion)

2

Description
strength
Timepoint
4weeks
Method of measurement
Biodex Systems(for measure strength )

3

Description
balance
Timepoint
4weeks
Method of measurement
Biodex balance Systems (for measure balance)

4

Description
Proprioception
Timepoint
4weeks
Method of measurement
Biodex Systems(for measure Proprioception)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: experimental group 1, after reviewing the records and evaluating the patients with ACL injury, 15 patients will be selected by the surgeon to implement the pre-operative rehabilitation exercise program, and then by obtaining written informed consent and registering the data collection form of the subjects, including Age, sports history, etc., these people will be invited to do the pre-test (measurement of strength, range of motion, balance and proprioception) and follow the training program (for 4 weeks and 3 days a week ) and finally we will be reimbursed.
Category
Rehabilitation

2

Description
Control group: Control group 1, after reviewing the records and evaluation of patients with ACL injury, 15 patients by obtaining written informed consent and registering a form to collect the subjects' information, including age, sports history, etc., by Dr. Jarrah, from this Individuals will be invited to participate in this research. At first, individuals will perform the pre-test (measurement of strength, range of motion, balance, and sense of proprioception) and continue with their routine activities in these 4 weeks, and finally after 4 weeks after the test (measurement of strength, range of motion, balance and proprioception) will be taken.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Akhtar Hospital
Full name of responsible person
‏Hamidreza Aslani
Street address
Akhtar Orthopedic Center, Azar Dead End, Sharifi Menesh St., Romi Pol,Shariati St.,Tehran
City
tehran
Province
Tehran
Postal code
1964714953
Phone
+98 21 2200 1072
Fax
+98 21 2260 8246
Email
akhtarhospital@gmail.com
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University
Full name of responsible person
Afshar Jafari
Street address
School of Sports and Health Sciences, Shahid Beheshti University, Shahid Dr. Shahriari Square (University Square), Rashiduddin Fazlullah St., Yaman St., Velanjak,Chamran Highway,Tehran
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 5824
Email
Af_jafari@sbu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shahid Beheshti University, School of Sports and Health Sciences,
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
Shahid Beheshti University
Full name of responsible person
Fariborz Hovanlo
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
physical education
Street address
Tehran, Chamran Highway, Velanjak, Yaman St., Rashiduddin Fazlullah St., Shahid Dr. Shahriari Square (University Square), Shahid Beheshti University, School of Sports and Health Sciences
City
tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 5821
Email
f_hovanloo@sbu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
‏shahid Beheshti University
Full name of responsible person
Fariborz Hovanlo
Position
‏Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
physical education
Street address
‏Tehran, Chamran Highway, Velanjak, Yaman St., Rashiduddin Fazlullah St., Shahid Dr. Shahriari Square (University Square), Shahid Beheshti University, School of Sports and Health Sciences
City
tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 5821
Email
f_hovanloo@sbu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
‏Shahid Beheshti University
Full name of responsible person
‏Fariborz Hovanlo
Position
‏Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
physical education
Street address
School of Sports and Health Sciences, Shahid Beheshti University, Shahid Dr. Shahriari Square (University Square), Rashiduddin Fazlullah St., Yaman St., Velanjak,Chamran Highway,Tehran
City
tehran
Province
Tehran
Postal code
1983969411
Phone
+98 21 2990 5821
Email
f_hovanloo@sbu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
The information about the subjects is personal and will not be shared with others.
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
No - There is not 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 information except the subjects' personal information.
When the data will become available and for how long
Six months after the results are published.
To whom data/document is available
All researchers.
Under which criteria data/document could be used
The use of research results is unimpeded by acquiring the source.
From where data/document is obtainable
ro.talebi@Mail.sbu.ac.ir
What processes are involved for a request to access data/document
At least two working days.
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