1. Home
  2. Approved trials
  3. » فارسی

Comparison the effect of unihemispheric concurrent dual-Site transcranial direct Current stimulation of primary motor and dorsolateral prefrontal cortices with stimulation of primary motor cortex on postural control of older adult with and without cognitive task

Protocol summary

Study aim
Comparison the effect of concurrent dual-Site of cortex with stimulation of M1 and sham method on postural control and balance of older adult with and without cognitive task
Design
Cross over randomized control trial with single blind on 27 healthy elderly participants. randomization with randomized envelopes.
Settings and conduct
In light of increase in elderly population and decrease of balance in this population due to decrease of cognitive-motor function the risk of falling increase for them. This study will be conducted in biomechanics laboratory of rehabilitation faculty of shahid beheshty medical university. All of participants will receive 3 intervention sessions that containing one session of sham stimulation , one session of M1-DLPFC stimulation and one session of M1 stimulation. Participants will be unaware of intervention they receive.
Participants/Inclusion and exclusion criteria
Healthy participants with 65 to 74 age range without hospital stay at recent 6 month or serious musculoskeletal or neurologic diseases or surgery history.
Intervention groups
This cross over study will be conducted three sessions that all participants will receive sham, M1 and M1-dorsolateral prefrontal cortex(DLPFC) stimulation with random order.
Main outcome variables
Displacement and velocity of center of pressure in(antero posterior ,mediolateral ) and total distance and velocity of center of pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220216054035N1
Registration date: 2022-09-24, 1401/07/02
Registration timing: prospective

Last update: 2022-09-24, 1401/07/02
Update count: 0
Registration date
2022-09-24, 1401/07/02
Registrant information
Name
Monire Alem
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 17 3327 5887
Email address
monireaalem@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-12, 1401/07/20
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effect of unihemispheric concurrent dual-Site transcranial direct Current stimulation of primary motor and dorsolateral prefrontal cortices with stimulation of primary motor cortex on postural control of older adult with and without cognitive task
Public title
Comparison the effect of unihemispheric concurrent dual-Site transcranial direct Current stimulation of primary motor and dorsolateral prefrontal cortices with stimulation of primary motor cortex on postural control of older adult with and without cognitive task
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Healthy elderly with age between 65-74 years old Ability to stand without assistive device Right handed ( according to edinburgh Handeness,old field 1917) Educated enough because our study contain cognitive components
Exclusion criteria:
Any cardiovascular , neurological ( like Parkinson, Alzheimer) , musculoskeletal diseases, surgery history , brain tumor, peripheral neuropathy, any visual or auditory defects that isn't managed, vertigo, any vestibular problems, any metal implant in brain Hospital stay in recent 6 month Using any drug that effect central nervous system Inability to stand or walk without help Any condition that cause abnormality in physical activity
Age
From 65 years old to 74 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 27
Randomization (investigator's opinion)
Randomized
Randomization description
Assessment of static balance is simple randomization. First chose from two sealed envelopes that decide their standing that will be with or without cognitive activity then intervention is on simple randomization thus choosing their intervention method than chose from three envelopes that contain one of three interventions include sham, primary motor cortex (M1) stimulation and, M1-dorsolateral prefrontal cortex (DLPFC) stimulation.After intervention assessment of static balance is simple randomization.
Blinding (investigator's opinion)
Single blinded
Blinding description
We will explain about intervention to participants but they will not aware what type of intervention they will receive in each session.
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of shahid beheshti university of medical university
Street address
7th Floor, Bldg No.2 SBUM, Arabi Ave, Daneshjoo Blvd, Velenjak, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2021-11-07, 1400/08/16
Ethics committee reference number
IR.SBMU.RETECH.REC.1400.498

Health conditions studied

1

Description of health condition studied
Elderly stability
ICD-10 code
R54
ICD-10 code description
Age-related physical debility

Primary outcomes

1

Description
Anteroposterior displacement of center of pressure in stance without cognitive task
Timepoint
Every session before and after intervention
Method of measurement
Force plate

2

Description
Mediolateral displacement of center of pressure in stance without cognitive task
Timepoint
Every session before and after intervention
Method of measurement
Force plate

3

Description
Total displacement of center of pressure in stance without cognitive task
Timepoint
Every session before and after intervention
Method of measurement
Force plate

4

Description
Total velocity of displacement of center of pressure in stance without cognitive task
Timepoint
Every session before and after intervention
Method of measurement
Force plate

5

Description
Mediolateral velocity of displacement of center of pressure in stance without cognitive task
Timepoint
Every session before and after intervention
Method of measurement
Force plate

6

Description
Anteroposterior velocity of displacement of center of pressure in stance without cognitive task
Timepoint
Every session before and after intervention
Method of measurement
Force plate

7

Description
Anteroposterior velocity of displacement of center of pressure in stance with cognitive task
Timepoint
Every session before and after intervention
Method of measurement
Force plate

8

Description
Mediolateral velocity of displacement of center of pressure in stance with cognitive task
Timepoint
Every session before and after intervention
Method of measurement
Force plate

9

Description
Total velocity of displacement of center of pressure in stance with cognitive task
Timepoint
Every session before and after intervention
Method of measurement
Force plate

10

Description
Total displacement of center of pressure in stance with cognitive task
Timepoint
Every session before and after intervention
Method of measurement
Force plate

11

Description
Mediolateral displacement of center of pressure in stance with cognitive task
Timepoint
Every session before and after intervention
Method of measurement
Force plate

12

Description
Anteroposterior displacement of center of pressure in stance with cognitive task
Timepoint
Every session before and after intervention
Method of measurement
Force plate

Secondary outcomes

empty

Intervention groups

1

Description
Control group: electrode will be like M1 stimulation but device would be off after 60 seconds. 60 second is a reliable stimulation for sham due to the fact that transcranial direct current stimulation( tDCS) effect will be forgotten after one minute.
Category
Placebo

2

Description
Intervention group: M1 stimulation , using one tDCS device anode electrode would be placed at M1 and cathode would be placed at supraorbital region.
Category
Rehabilitation

3

Description
Intervention group: concurrent dual-Site of M1-DLPFC, 2 tDCS devices will be used. in left hemisphere anode electrode of one device would be placed at M1 and on the other side anode electrode would be placed at DLPFC and cathode electrode for both devices would be placed at opposite side supraorbital region.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Rehabilitation Faculty of SBMU
Full name of responsible person
Monire alem
Street address
Rehab Faculty, Damavan Str, Immam Hossein Square
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 2057 7754
Email
tavan2020@yahoo.com
Web page address
http://rehab.sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Sedigheh Naimi
Street address
Rehab Faculty, Damavand Str, Immam hossein square
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 2057 7754
Email
tavan2020@yahoo.com
Web page address
http://rehab.sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Minoo KhalkhaliZavieh
Position
دانشیار فیزیوتراپی
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Damavand street, across from Buali hospital, Tehran, Iran. SBMU School of Rehabilitation Sciences.
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 2057 7754
Email
minoo_kh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Minoo KhalkhaliZavieh
Position
Associate Professor of Physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Damavand street, across from Buali hospital, Tehran, Iran. SBMU School of Rehabilitation Sciences.
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 2057 7754
Email
minoo_kh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Minoo KhalkhaliZavieh
Position
Associate Professor of Physiotherapy
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Damavand street, across from Buali hospital, Tehran, Iran. SBMU School of Rehabilitation Sciences.
City
Tehran
Province
Tehran
Postal code
1616913111
Phone
+98 21 2057 7754
Email
minoo_kh@yahoo.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
All of this study data could be shared after making it unrecognizable.
When the data will become available and for how long
Data would be shared one month after publication.
To whom data/document is available
This data only assessable for academic researchers.
Under which criteria data/document could be used
There is no specific qualification for using this study data.
From where data/document is obtainable
To receive this study data please contact Dr.Minoo KhalkhaliZavieh. phone:+98 21 2057 7754 email:minoo_kh@yahoo.comaddress: Damavand street, across from Buali hospital, Tehran, Iran. SBMU School of Rehabilitation Sciences.
What processes are involved for a request to access data/document
Only a request letter would be enough for receiving data.
Comments
Loading...