The immediate effect of local vibration after quadriceps muscle fatigue on balance and performance in healthy young semi-professional male soccer players
To determine the immediate effect of local vibration after quadriceps muscle fatigue on balance and performance in healthy young semi-professional male soccer players
Design
Clinical Randomized Controlled trial , Two arm parallel group , single blinded , Phase III Trial , 26 Participants .
Settings and conduct
The study is practical in the form of a randomised, controlled clinical trial, single blinded that the participants are not aware of the type of intervention. The place of research is the physiotherapy laboratory of the school rehabilitation of Tehran university of medical sciences .
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
semi-professional soccer players
Men 18 to 35 years old
Absence of neurological, vestibular, orthopedic and respiratory cardiovascular disorders
Exclusion Criteria:
The participant's lack of consent to participate in the trial before or during the research
The participant's inability to complete the research process
The participant's awareness of how to conduct the experiment for himself before the research
Fatigue of the participant before the start of the trial for any reason, including recent intense sports activity
Intervention groups
Intervention Group: Quadriceps Muscle Local Vibration of Dominant Leg , 2 minutes , 50 Hz frequency
Control group: Rest for 2 minutes
Main outcome variables
1- Maximum isometric torque of quadriceps muscle
2- Dynamic Balance
3- Performance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230325057773N1
Registration date:2023-09-12, 1402/06/21
Registration timing:prospective
Last update:2023-09-12, 1402/06/21
Update count:0
Registration date
2023-09-12, 1402/06/21
Registrant information
Name
Mostafa Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6684 4442
Email address
amjidsph007@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2023-10-23, 1402/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The immediate effect of local vibration after quadriceps muscle fatigue on balance and performance in healthy young semi-professional male soccer players
Public title
The immediate effect of local vibration on quadriceps muscle fatigue recovery in soccer players
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
semi-professional soccer players
Men 18 to 35 years old
Absence of neurological, vestibular, orthopedic and respiratory cardiovascular disorders
Exclusion criteria:
The participant's lack of consent to participate in the trial before or during the research
The participant's inability to complete the research process
The participant's awareness of how to conduct the experiment for himself before the research
Fatigue of the participant before the start of the trial for any reason, including recent intense sports activity
Age
From 18 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
26
Randomization (investigator's opinion)
Randomized
Randomization description
General questionnaires have been prepared to the number of sample size and on the back of half of sheets are written "intervention" and the other half are written "control". The participants should be randomly divided into two intervention and control groups of each 13 people. For this purpose, the sheets are placed in a jumbled manner and each participant chooses one of the sheets upon arrival and based on the title on the back of the sheet, it is placed in one of the intervention or control groups. In this way, the sheet chosen by the participant is separated from the questionnaire sheets
Blinding (investigator's opinion)
Single blinded
Blinding description
The assessment of result of the Single Leg Hop test and the Y balance test will be done by the Assessor and the quadriceps torque will be determined by the isokinetic device, and the interventionist will not be present. Also, the Assessor does not know which of the control or intervention groups the participant is in, and the Assessor will not be present during the intervention (rest or local vibration).
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery & Rehabilitation - Tehran University o
Street address
Tehran University of Medical Sciences Headquarters , Qods st. , Corner, Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2023-04-26, 1402/02/06
Ethics committee reference number
IR.TUMS.FNM.REC.1402.006
Health conditions studied
1
Description of health condition studied
Balance and Performance after Muscle Fatigue
ICD-10 code
M62.9
ICD-10 code description
Disorder of muscle, unspecified
Primary outcomes
1
Description
Maximum isometric torque of quadriceps muscle
Timepoint
Before fatigue , Immediately after fatigue , Immediately after intervention / rest
Method of measurement
Isokinetic device Dynamometer
2
Description
Dynamic Balance
Timepoint
Before fatigue , Immediately after fatigue , Immediately after intervention / rest
Method of measurement
Y balance test in anterior, posterior-internal, posterior-external directions
3
Description
Performance
Timepoint
Before fatigue , Immediately after fatigue , Immediately after intervention / rest
Method of measurement
Single leg jump test
Secondary outcomes
empty
Intervention groups
1
Description
Case Group: Quadriceps muscle local vibration of the dominant leg: creation of mechanical vibration in the muscle locally by an electrical mechanical device called vibrator 717A made in Japan. Local vibration is applied to the case group for two minutes with a manual vibrator device without pressure on the quadriceps muscle with a frequency of 50 Hz.
Category
Rehabilitation
2
Description
Control group: Rest for 2 minutes
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Rehabilitation of Tehran University of Medical Sciences
Full name of responsible person
Mostafa Jafari
Street address
Faculty of Rehabilitation ,corner of Safi Alisha St.,Pich Shamiran, Enghelab St.,
City
Tehran
Province
Tehran
Postal code
6511111489
Phone
+98 21 7753 3939
Email
rehabilitation@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Akbar Fotoohi
Street address
Research and Technology Vice-Chancellor , 6th floor, Central Organization of the University, corner of Quds St. , Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical 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
Tehran University of Medical Sciences
Full name of responsible person
Mostafa Jafari
Position
Msc Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation , Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1344763351
Phone
+98 21 6684 4442
Fax
Email
amjidsph007@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mostafa Jafari
Position
Msc Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation , Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1344763351
Phone
+98 21 6684 4442
Fax
Email
amjidsph007@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mostafa Jafari
Position
Msc Student
Latest degree
Bachelor
Other areas of specialty/work
Physiotherapy
Street address
Faculty of Rehabilitation , Enghelab Ave.
City
Tehran
Province
Tehran
Postal code
1344763351
Phone
+98 21 6684 4442
Fax
Email
amjidsph007@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
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Individual data of participants: All data except personal information can be published
When the data will become available and for how long
The start of the access period at the same time as the results are printed
To whom data/document is available
Academic researchers and people working in medical engineering are allowed to access the data.
Under which criteria data/document could be used
Data can be used in new researches and making the vibrator device.
From where data/document is obtainable
Mostafa Jafari
amjidsph007@gmail.com
What processes are involved for a request to access data/document
The request will be sent to the email and the data will be provided to them as soon as possible