Investigating the effect of transcranial direct current stimulation on the performance and balance of taekwondo athletes in the context of up dollyo chagi and dwit chagi movements.
Design
A double-blind randomized controlled clinical trial on Taekwondo athletes in Tehran
Settings and conduct
The place of the tests is the Motion Analysis Laboratory of the Medical Sciences Faculty of Tarbiat Modares University. Participants and data analyzers are blinded.
Participants/Inclusion and exclusion criteria
1. Age between 18 and 30 years
2. Body mass index between 20 and 25 kg/m2
3. Professional sports experience with Taekwondo black belt for more than one year
4. Not having a history of neurosurgery
5. Not having a wound in the head and skull
6. Not having a heart condition, using a pacemaker or a battery inside the heart
7. Not having a history of epilepsy
8. Not having a metal object implanted around the skull
Intervention groups
1. Volunteers in the intervention group will receive 20 minutes of transcranial direct current stimulation with a current of 2 mA per session. In this stimulation, the anode (according to the 10-20 System of Electrode Placement in EEG devices) will be placed on C3 and C4 and the cathode will be placed on the supraorbital process. The position of volunteers will be sitting, and the time of stimulation is scheduled one to two hours before the regular exercises of the athletes and three times a week.
2. Volunteers of the control group (sham) in each session will receive unreal (only by connecting the electrodes to the places mentioned above) with the device turned off for 20 minutes without knowing about the other group and the main intervention.
Main outcome variables
Kinematics of the attacker's foot during the execution of two taekwondo techniques
Time of shuttle running and figure of eight hop tests
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230129057266N1
Registration date:2023-03-11, 1401/12/20
Registration timing:prospective
Last update:2023-03-11, 1401/12/20
Update count:0
Registration date
2023-03-11, 1401/12/20
Registrant information
Name
Mohammed Najafi-Ashtiani
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 5054
Email address
mnashtiani@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-05, 1402/02/15
Expected recruitment end date
2023-11-06, 1402/08/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of Nine-session trans-cranial Direct Current Stimulus on Sport Performance and Balance in Professional Taekwondo Athletes
Public title
Cranial Electrical Stimulation in Sports
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
BMI between 20 and 25 kg/m2
history of being more than one-year professional Taekwondo athlete
Exclusion criteria:
neurological or brain surgery
head or skull wound
heart disorder, using pacemaker or heart battery
history of epilepsy
having metal implant near the skull
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Concealment of randomized assignment to the intervention and control groups is done using non-transparent sealed envelopes, each of the random sequences created is recorded on a card and the cards are placed in the envelopes in order. At the time of starting the registration of the participants, according to the order of entry, they will pick one of the envelopes.
Blinding (investigator's opinion)
Double blinded
Blinding description
When entering the study, participants will receive a sealed envelope, the contents of which they will not know before and after randomization.
Participants do not know whether the tDCS device is on or off. The device light is on even with no current connection to the head.
Furthermore, the data analysis will be performed using a computer which is blind to the groups.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tarbiat Modares University Ethics Committee
Street address
Jalal AleAhmad, Nasr Bridge
City
Tehran
Province
Tehran
Postal code
14115-111
Approval date
2022-12-24, 1401/10/03
Ethics committee reference number
IR.MODARES.REC.1401.208
Health conditions studied
1
Description of health condition studied
Taekwondo professional athletes
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Acceleration of the Athlete's leg
Timepoint
before and after 9 sessions of intervention (tDCS)
Method of measurement
Attachment of accelerometer on leg
2
Description
time of shuttle run test
Timepoint
before and after 9 sessions of intervention (tDCS)
Method of measurement
Chronometer
3
Description
time of figure of eight hopping
Timepoint
before and after 9 sessions of intervention (tDCS)
Method of measurement
Chronometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Volunteers will receive tDCS with a current of 2 mA for 20 minutes in each session. In this stimulation, the anode (according to the global standard of 10-20 indicators of EEG devices) will be placed on C3 and C4 and the cathode on the supraorbital process. The position of the volunteers will be sitting, and the stimulus time is scheduled one to two hours before the usual exercises of the athletes and three times a week. Segal Steam device will be used to apply tDCS.
Category
Other
2
Description
Control group: Volunteers will appear in each session in a placebo or sham condition (only by connecting the electrodes to the places mentioned in the intervention group) with the device turned off for 20 minutes without knowing about the other group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tarbiat Modares University
Full name of responsible person
Mohammed N. Ashtiani
Street address
Jalal Ale-Ahmad Hwy, Nasr Bridge
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 5052
Email
mnashtiani@modares.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Amir Abdollahzadeh
Street address
Jalal Ale-Ahmad Hwy, Nasr Bridge
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 2009
Email
zadeh@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares 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
Tarbiat Modares University
Full name of responsible person
Mohammed Najafi-Ashtiani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Engineering
Street address
Jalal AleAhmad Hwy, Nasr Bridge
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 5054
Fax
Email
mnashtiani@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mohammed Najafi-Ashtiani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Engineering
Street address
Jalal AleAhmad Hwy, Nasr Bridge
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 5054
Fax
Email
mnashtiani@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mohammed Najafi-Ashtiani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Engineering
Street address
Jalal AleAhmad Hwy, Nasr Bridge
City
Tehran
Province
Tehran
Postal code
14115-111
Phone
+98 21 8288 5054
Fax
Email
mnashtiani@modares.ac.ir
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
All processed and analyzed data will be released. These data include the questionnaire scores and linear and nonlinear outcomes of the stability, before and after the interventions.
When the data will become available and for how long
from 6 months after the official publication of results
To whom data/document is available
All academic and clinical researchers
Under which criteria data/document could be used
Only for use in neuro-musculoskeletal simulations and sport performance improvements
From where data/document is obtainable
By contacting the corresponding author of the published papers by email, phone or postal address
What processes are involved for a request to access data/document
Process: 1. Determining the data of interest by the applicant 2. contacting the corresponding author to submit the queries by the applicant 3. Reviewing the queries by the research team 4. Responding to the queries till 10 working days by the research team