The Comparison of Different Intensities of Transcranial Direct Current Stimulation on Balance in Healthy Young Adults
Design
Randomized clinical trial, prospective, double blind, parallel group
Settings and conduct
The place of the study is the Research Center of Rehabilitation Faculty of Isfahan University of Medical Sciences. The participants are divided into four groups and each group receives 1, 2 or 3 milliamperes current intensity or placebo stimulation of tDCS. Before and after the intervention, the balance is evaluated with the the force plate. The participants and the assessor are blinded to the type of stimulation
Participants/Inclusion and exclusion criteria
Exclusion criteria:
History of neurological or orthopedic diseases
Treated with any medication that affected the CNS and balance
History of epilepsy, seizures, frequent headaches, brain injury or brain tumor, use of a pacemaker or implanted metal devices in the head, pregnancy
body mass index >30
Participation in professional sports activities
Inclusion criteria:
Age 18_35
Intervention groups
The first to fourth groups receive 1, 2 and 3 milliamperes tDCS and placebo stimulation
Main outcome variables
Excursion, total path length and velocity of center of pressure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230523058270N1
Registration date:2023-07-12, 1402/04/21
Registration timing:registered_while_recruiting
Last update:2023-07-12, 1402/04/21
Update count:0
Registration date
2023-07-12, 1402/04/21
Registrant information
Name
Elham Rahimi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 5759 3784
Email address
e.rahimi999999@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-10, 1402/03/20
Expected recruitment end date
2023-09-20, 1402/06/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of different intensities of transcranial direct current stimulation on balance in healthy young adults
Public title
The comparison of different intensities of tDCS on balance
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18_35
Exclusion criteria:
History of neurological or orthopedic diseases
Treated with any medication that affected the CNS and balance
Participation in professional sports activities
BMI>30
History of epilepsy, seizures, frequent headaches, brain injury or brain tumor, use of a pacemaker or implanted metal devices in the head, pregnancy
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
This study has three intervention groups and one control group. Participants are randomly assigned to one of four groups (tDCS stimulation with intensity of 1, 2 or 3 mA or placebo group). Participants are allocated using a web-based randomization system (http://www.randomization.com) and based on a block randomization method in which the block size is 8 and the number of blocks is 20.
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants and the person who evaluates the balance are blinded to the placebo or the real stimulation and its current intensity
Placebo
Used
Assignment
Parallel
Other design features
prospective
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
rehabilitation school Isfahan university of medical science, hezar jarib street
City
isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2023-05-21, 1402/02/31
Ethics committee reference number
IR.MUI.REC.1402.006
Health conditions studied
1
Description of health condition studied
healthy young adults
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
excursion of center of pressure (balance index)
Timepoint
before and after
Method of measurement
force plate
2
Description
total path length of center of pressure (balance index)
Timepoint
before and after
Method of measurement
force plate
3
Description
velocity of center of pressure (balance index)
Timepoint
before and after
Method of measurement
force plate
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: transcranial direct current stimulation with intensity of 1 mA
Category
Rehabilitation
2
Description
Intervention group 2: transcranial direct current stimulation with intensity of 2 mA
Category
Rehabilitation
3
Description
Intervention group 3: transcranial direct current stimulation with intensity of 3 mA
Category
Rehabilitation
4
Description
Control group: sham stimulation
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Rehabilitation school
Full name of responsible person
Dr javid mostamand
Street address
Rehabilitation school, Isfahan university of medical science, hezar jarib street
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5229
Email
e.rahimi999999@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Javid Mostamand
Street address
hezar jarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5229
Email
e.rahimi999999@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Dr Javid Mostamand
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
hezarjarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5229
Email
e.rahimi999999@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Javid Mostamand
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
hezarjarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5229
Email
e.rahimi999999@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr Javid Mostamand
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
hezar jarib
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3792 5229
Email
e.rahimi999999@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
some data will be published
When the data will become available and for how long
6 month after publishing the articles
To whom data/document is available
academic staff
Under which criteria data/document could be used
for reserch
From where data/document is obtainable
e.rahimi999999@gmail.com
What processes are involved for a request to access data/document