to assess the effect of transcranial direct current stimulation on balance in older adults
Design
randomized clinical trial, cross over design, double blinded
Settings and conduct
The center of study is Musculoskeletal Rehabilitation Research Center. Balance will be assessed before and after intervention. Intervention will be based on a randomized cross over design and includes brain stimulation and placebo stimulation. The assessor and subjects are blinded in this study.
Participants/Inclusion and exclusion criteria
inclusion criteria: age above 60; ability to stand without assistive device
exclusion criteria: deformity in lower extremity; cardiac, neurological and metabolic disease; history of neurosurgery
Intervention groups
intervention group which received the electrical stimulation and control group which receive the placebo protocol of stimulation
Main outcome variables
balance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150923024151N7
Registration date:2018-11-13, 1397/08/22
Registration timing:prospective
Last update:2018-11-13, 1397/08/22
Update count:0
Registration date
2018-11-13, 1397/08/22
Registrant information
Name
Hamzeh Baharlouei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 5045
Email address
baharloueih@rehab.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-11-22, 1398/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cerebellar transcranial direct stimulation on motor cortex versus cerebellum on balance indices in faller and non-faller older adults
Public title
The effect of transcranial direct stimulation on balance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age above 60
ability to stand without asistive device
history of falling
Exclusion criteria:
deformity in lower extremity
cardiac, neurological and metabolic disease
history of neurosurgery
vestibular disorders
visual problems
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization by coin
Blinding (investigator's opinion)
Double blinded
Blinding description
The participants and assessors are blinded to assignments.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Golestan Street
City
Ahvaz
Province
Khouzestan
Postal code
33133-61357
Approval date
2018-10-20, 1397/07/28
Ethics committee reference number
IR.AJUMS.REC.1397.507
Health conditions studied
1
Description of health condition studied
balance
ICD-10 code
M99.9
ICD-10 code description
Biomechanical lesion, unspecified
Primary outcomes
1
Description
balance
Timepoint
before and after intervention
Method of measurement
force plate
Secondary outcomes
empty
Intervention groups
1
Description
The intervention is stimulation of cerebellum or primary motor cortex. The Device is ActivaDose which Manufactured by ActivaTeKTM Inc., Taiwan. The intervention includes one session with 20 minutes of duration and 2 mA of intensity
Category
Rehabilitation
2
Description
In sham stimulation the intensity will decrease to zero after 1 minute but the electrode positioning and duration are similar to real intervention.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Musculoskeletal Rehabilitation Research Center
Full name of responsible person
Mohammad Mehravar
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
33133-61357
Phone
+98 61 3374 3101
Email
msr@ajums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Mehravar
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
33133-61357
Phone
+98 61 3374 3101
Email
msr@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz 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
Ahvaz University of Medical Sciences
Full name of responsible person
Hamzeh Baharlouei
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
33133-61357
Phone
+98 61 3374 3101
Email
baharlooh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hamzeh Baharlouei
Position
PhD candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
33133-61357
Phone
+98 61 3374 3101
Email
baharlooh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Hamzeh Baharlouei
Position
PhD Candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
33133-61357
Phone
+98 61 3374 3101
Email
baharlooh@gmail.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
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
Not applicable
Title and more details about the data/document
There is possibility to publish part of data.
When the data will become available and for how long
The data will publish 6 month after publishing main article.
To whom data/document is available
There is no limitation
Under which criteria data/document could be used
After getting the written informed consent from Ahvaz Jundishapur University of Medical Sciences
From where data/document is obtainable
Ahvaz Jundishapur University of Medical Sciences
What processes are involved for a request to access data/document
The researcher will be referred to Musculoskeletal Rehabilitation Research Center