The role of the premotor and cerebellar in physiological and performance of gymnasts athletic
Design
Randomised, superiority, parallel group trial with ،Triple blinded outcome assessment with 17 sample
Settings and conduct
This study will be performed with a cross-sectional design and Triple blind (researchers and participants and data evaluator) at the Sports Physiology Laboratory of Mohaghegh Ardabili University.
Participants/Inclusion and exclusion criteria
gymnasts / Inclusion criteria: Being in the age range of 18 to 25 years, 10 years of experience in gymnastics, No cardiovascular disease, No injuries/ Exclusion criteria: Being a smoker, Have a competitive race schedule in the next few months, Having a travel plan to other provinces during the measurement period
Intervention groups
Real stimulation of the cerebellum areas of the brain
Real stimulation of the motor areas of the brain
Main outcome variables
Frequency recorded in a muscle electromyography device with Using a muscle electromyography device, Measuring the performance of gymnasts athletes using tests of Broad Jump, Straddle lift to handstand, Double Legs circle, Back Hang Scale, Dips on Parallel Bars, Active Shoulder Felexibility and Sit and Reach tests
General information
Reason for update
Acronym
tDCS
IRCT registration information
IRCT registration number:IRCT20180724040579N2
Registration date:2021-03-16, 1399/12/26
Registration timing:prospective
Last update:2021-03-16, 1399/12/26
Update count:0
Registration date
2021-03-16, 1399/12/26
Registrant information
Name
Asgar Iranpour
Name of organization / entity
University of Mohaghegh Ardebili
Country
Iran (Islamic Republic of)
Phone
+98 45 3371 7240
Email address
iranpoursport@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-25, 1400/01/05
Expected recruitment end date
2021-04-19, 1400/01/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of the premotor cortex and cerebellum in physiological and performance parameters of gymnastic athletes: A randomized, sham control study
Public title
The role of the premotor cortex and cerebellum in physiological and performance parameters of gymnastic athletes
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Being in the age range of 18 to 25 years
10 years of experience in gymnastics
No cardiovascular disease
No injuries
Exclusion criteria:
Being a smoker
Have a competitive schedule in the next few months
Having a travel plan to other provinces during the measurement period
Age
From 18 years old to 25 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
17
More than 1 sample in each individual
Number of samples in each individual:
3
Each participant will participate in three modes of sham electrical stimulation, cerebellar electrical stimulation and pre-motor electrical stimulation at one-week intervals in the form of intra-subject comparisons.
Randomization (investigator's opinion)
Randomized
Randomization description
In order to randomize, simple randomization method with random number Table method was used . This table contains a bunch of numbers that are randomly drawn in the form of a table without a specific pattern and order. The numbers directions(Left, right, up, down) were first determined by the researcher to read the numbers and then the numbers were considered for different research groups. In the next step, the researcher randomly placed on one of the numbers and moved in the preset direction and recorded the numbers for that direction in the target group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In order to eliminate the bias caused by the knowledge of the subject and the evaluator, the results of the muscle electromyography device and the research result of the study on the effect of electrical stimulation of the pre-motor areas and the cerebellum are performed in Double blind. Considering that the recorded frequencies of the muscle electromyography device are interpreted after the measurement and it is not possible to observe the variable during the test, the subject and the evaluator are not aware of the effect of the interfering factor on the muscle electromyography. Normally, Subject only performs his muscle contraction according to the plan and the information is stored in his body by installing the device, and it is in the analysis stage that the researcher himself will have access to the recorded information.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Ardabil University of Medical Sciences
Street address
North Side of Ardabil University of Medical Sciences Administrative Complex, Daneshgah Square, Daneshgah St, Ardabil Town
City
Ardabil
Province
Ardabil
Postal code
۵۶۱۸۹-۸۵۹۹۱
Approval date
2021-03-08, 1399/12/18
Ethics committee reference number
IR.ARUMS.REC.1399.623
Health conditions studied
1
Description of health condition studied
nervous system
ICD-10 code
G90.8
ICD-10 code description
Other disorders of autonomic nervous system
Primary outcomes
1
Description
Frequency recorded in a muscle electromyography device
Timepoint
During stimulate the cerebellum and move forward
Method of measurement
Using a muscle electromyography device
2
Description
Measuring the performance of gymnasts
Timepoint
After electrical stimulation of cerebellar and pre-motor areas
Method of measurement
Measuring the performance of gymnasts athletes using tests of Broad Jump, Straddle lift to handstand, Double Legs circle, Back Hang Scale, Dips on Parallel Bars, Active Shoulder Felexibility and Sit and Reach tests
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Sham stimulation of the cerebellum and motor areas of the brain. In Sham stimulation of the premotor and cerebellum, there will be anodic stimulation in the left and right prefrontal cortex and left and right cerebellar cortex and cathodic stimulation in FP1 and FP2. For electrical stimulation, pads with dimensions of 5 × 7 will be used. Also, the stimulation intensity will be set 2 mA for 20 minutes, But it will turn off automatically after 10 seconds.
Category
Placebo
2
Description
Intervention group: Real stimulation of the cerebellum areas of the brain.In real cerebellar stimulation, the anodic stimulation in the cortical region is left and right cerebellum and the cathodic stimulation will be in FP1 and FP2. For electrical stimulation, pads with dimensions of 5 × 7 will be used. Also, the stimulation intensity will be 2 mA for 20 minutes.
Category
Diagnosis
3
Description
Intervention group: Real stimulation of the pre motor areas of the brain. In real stimulation of the pre motor areas , anodic stimulation will be located in the left and right pre motor cortex and cathodic stimulation will be located in FP1 and FP2. For electrical stimulation, pads with dimensions of 5 × 7 will be used. Also, the stimulation intensity will be 2 mA for 20 minutes.
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
The University of Mohaghegh Ardabili
Full name of responsible person
Sajjad Anoushiravani
Street address
University Street, The University of Mohaghegh Ardabili, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3351 3920
Email
s.anoushirvani@uma.ac.ir
Web page address
https://uma.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Mohaghegh Ardabili
Full name of responsible person
Yousef Abbaspour Gilandeh
Street address
University Street, The University of Mohaghegh Ardabili, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5319
Email
u_abbaspour@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Mohaghegh Ardabili
Proportion provided by this source
50
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
2
Sponsor
Name of organization / entity
Ardabil General Directorate of Sports and Youth
Full name of responsible person
Reza Bakhshi
Street address
Ardabil General Directorate of Sports and Youth -Sports Blvd- Ardabil
City
Ardabil
Province
Ardabil
Postal code
5613663691
Phone
+98 45 3323 4038
Email
ardebil@msy.gov.ir
Web page address
http://ardebil.msy.gov.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil General Directorate of Sports and Youth
Proportion provided by this source
50
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
The University of Mohaghegh Ardabili
Full name of responsible person
Sajjad Anoshirvani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
University Street, The University of Mohaghegh Ardabili, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3351 3920
Email
s.anoushirvani@uma.ac.ir
Web page address
https://uma.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Mohaghegh Ardabili
Full name of responsible person
Sajjad Anoshirvani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
University Street, The University of Mohaghegh Ardabili, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3351 3920
Email
s.anoushirvani@uma.ac.ir
Web page address
https://uma.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Mohaghegh Ardabili
Full name of responsible person
Asgar Iranpour
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
University Street, The University of Mohaghegh Ardabili, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5026
Email
Iranpoursport@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available