Semi-experimental and prospective study. With the control group, parallel design single blind, 24 patients, 12 experimental group and 12 control group.
Settings and conduct
Subjects will refer to the laboratory of Shahid Beheshti University for pre-test. After performing strength and proprioception tests (isokinetic device system 4), balance (biodex balance system) and ankle range of motion (Seahan goniometer), the experimental group performed FIFA + 11 warm-up exercises for 6 weeks and the control group Continue their routine training for 6 weeks. Then the post-test will be performed in the laboratory of Shahid Beheshti University.
Participants/Inclusion and exclusion criteria
Male gender; age range 14-18 years; exercise at least two sessions per week; semi-skilled level; no chronic ankle sprain.
Intervention groups
The 12 members of the experimental group will perform 6 weeks of FIFA 11+ adjusted warm-up exercises for 20 minutes at the beginning of their volleyball training.The 12 members of the control group will also practice their volleyball routine during these 6 weeks.
Main outcome variables
proprioception; balance; range of motion; strength of ankle
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210801052047N1
Registration date:2021-08-11, 1400/05/20
Registration timing:prospective
Last update:2021-08-11, 1400/05/20
Update count:0
Registration date
2021-08-11, 1400/05/20
Registrant information
Name
sepide moradi nasab
Name of organization / entity
Shahid beheshti university
Country
Iran (Islamic Republic of)
Phone
+98 61 4242 8477
Email address
sepidemoradi75@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-14, 1400/05/23
Expected recruitment end date
2021-09-25, 1400/07/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Six Week Modified FIFA 11+ On Proprioception, Balance, Strength And Range Of Motion of Ankle In Male Adolescent Volleyball Players.
Public title
The Effect Of Six Week Modified FIFA 11+ On Proprioception, Balance, Strength And Range Of Motion of Ankle In Male Adolescent Volleyball Players.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
only males
age between 14 to 18
have exercise at least 2 days in a week
semi skilled level
have no chronic sprain in ankle in 6 month before participate in investigation
having no underlying disease
Exclusion criteria:
Dissatisfaction with the continuation of activities in the present study
Not participating in training sessions as two consecutive sessions per week and three non-consecutive sessions.
Occurrence of any acute injury to the ankle during the present study
Age
From 14 years old to 18 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
After being called to the teams in region one of Tehran, 24 qualified people will enter the study after obtaining their consent and will be randomly divided into two groups: control and experimental. The block randomization method will be used to create a random sequence. Which uses random allocation software. Allocation software (allocation concealment) is used to hide the group before the person is placed in the group. In this method, 4 blocks of all possible combinations (6 possible modes AABB, ABAB, ABBA, BBAA: BABA, BAAB) are created, then these blocks are inserted on opaque and sealed envelopes and randomly selected and back The heads will be placed in a box and the participants will take each envelope and thus divide it into two groups A (intervention) and B (control).
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
no. 10, golestan ave., vahed street. dezfool city
City
dezfool
Province
Khouzestan
Postal code
64616-57514
Approval date
2021-03-13, 1399/12/23
Ethics committee reference number
IR.SBU.REC.1400.047
Health conditions studied
1
Description of health condition studied
none
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
proprioception
Timepoint
Beginning and end of the study
Method of measurement
isokinetic system 4
2
Description
balance
Timepoint
Beginning and end of the study
Method of measurement
biodex balance system
3
Description
range of motion
Timepoint
Beginning and end of the study
Method of measurement
ceahan goniameter
4
Description
strenght
Timepoint
Beginning and end of the study
Method of measurement
isokinetic biodex system 4
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: This group performs 6 weeks of FIFA 11+ adjusted warm-up exercises. These exercises were designed by FIFA in 2006. Which consists of 3 main parts. In the present study, these exercises are performed for 6 weeks and two sessions per week in three sections. In the first part, with slow running exercises combined with active stretching movements and controlled collisions, the players perform the correct landing technique and change direction for 8 minutes. In the second part, the focus of the exercises is on balance, strength, explosive power and strengthening the central muscles. Each exercise has three levels from simple to advanced and lasts 10 minutes. In the third part, running exercises are performed with a change of direction at high and medium speeds in two minutes. Balance board exercises have also been added to this protocol in the second part of the exercises.
Category
Prevention
2
Description
Control group: This group follows its 6-week routine volleyball training.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid beheshti 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
Shahid beheshti university
Full name of responsible person
Sepide Moradi nasab
Position
Master student
Latest degree
Master
Other areas of specialty/work
Sport injury - corrective exercise
Street address
No 10, Golestan ave., Vahed street. Dezfool city
City
Dezful
Province
Khouzestan
Postal code
64616-57514
Phone
+98 61 4242 8477
Fax
Email
sepidemoradi75@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid beheshti university
Full name of responsible person
Sepide Moradi nasab
Position
Master student
Latest degree
Master
Other areas of specialty/work
Sport injury - corrective exercise
Street address
no 10, Golestan ave., vahed street. dezfool city
City
Dezful
Province
Khouzestan
Postal code
64616-57514
Phone
+98 61 4242 8477
Fax
Email
sepidemoradi75@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid beheshti university
Full name of responsible person
Sepide Moradi nasab
Position
Master student
Latest degree
Master
Other areas of specialty/work
Sport injury - corrective exercise
Street address
no 10, Golestan ave., vahed street. dezfool city
City
Dezful
Province
Khouzestan
Postal code
64616-57514
Phone
+98 61 4242 8477
Fax
Email
sepidemoradi75@gmail.com
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
We share data files including personal information and data related to pre-test and post-test in a coded folder by the person in charge, Ms. Sepideh Moradi Nasab, on the website of Shahid Beheshti University.
When the data will become available and for how long
Start the access period as soon as the results are printed.
To whom data/document is available
It will be available to all research groups as well as all other people who are interested.
Under which criteria data/document could be used
The data can be used for future studies as well as in all research groups, and any kind of analysis and research use is allowed on the data, and under the conditions that are cited to us, this data will be provided to them.
From where data/document is obtainable
To the person responsible for answering Ms. Sepideh Moradi Nasab Contact number 989374078354 + email sepidemoradi75@gmail.com Khuzestan address. Dezful city. Unit 10 - Golestan Alley No. 10
What processes are involved for a request to access data/document
The applicant will send his application to the e-mail address of Ms. Sepideh Moradi Nasab (sepidemoradi75@gmail.com) and Ms. Sepideh Moradi nasab will provide information after the necessary checks.