The effects of Transcranial direct current stimulation (tDCS) Combined with balance training on postural control and spasticity in chronic stroke patients
( A Randomized Controlled Trial)
Balance impairment and fear of falling negatively impact function of stroke patients. These can be addressed through a tDCS intervention.
To identify combinations effects of tDCS stimulation and balance training on balance control in chronic stroke patients, leg motor area will be stimulated using anodal tDCS. In this syudy intervention group will be Offered Anodal tDCS brain stimulation (20 minutes, 2 mA) and balance training (10-15 minutes) for 5 consecutive days, and in control group participants will recieve 5 days sham tDCS and balance training (10-15 minutes). Based on Offered sample size estimation is 20 chronic stroke patients.
The patients will be assessed before and after 5 sessions of intervention.
After interventon Analysis of postural control using nonlinear methods, in the structure of the time series of the COP using Approximate entropy and Berg balance scale,modified Ashworth and H-reflex latency will be evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013121715840N1
Registration date:2015-06-28, 1394/04/07
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-06-28, 1394/04/07
Registrant information
Name
Fariba Yadolahi
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7756 9900
Email address
fariba.yadolahi@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Shahid Beheshti university of Medical sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2016-02-28, 1394/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Transcranial direct current stimulation (tDCS) Combined with balance training on postural control and spasticity in chronic stroke patients
( A Randomized Controlled Trial)
Public title
Transcranial direct current stimulation (tDCS) and balance rehabilitation in stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age ≥18 years؛first ischemic stroke؛chronic stroke (6 months after stroke)؛romberg test>30second؛not using Botax؛ for spasticity
Exclusion criteria:
Other neurological conditions that affect balance؛use of any neuro- or psycho-active medications that alters balance;ongoing/recent (within 3 months) balance rehabilitation
Age
From 18 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak St. , Shahid Chamran Highway
City
Tehran
Postal code
Approval date
2015-01-04, 1393/10/14
Ethics committee reference number
sbmu.irc.1393.500
Health conditions studied
1
Description of health condition studied
cerebro vascular disease(stroke)
ICD-10 code
166.1
ICD-10 code description
Occlusion and stenosis of anterior cerebral artery
Primary outcomes
1
Description
postural control
Timepoint
Befor intervention-after intervention
Method of measurement
Approximate entropy
Secondary outcomes
1
Description
Spasticity
Timepoint
Before and after intervention
Method of measurement
Modified Ashworth scale and H-reflex
Intervention groups
1
Description
Intervention group:
Brain stimulation with anodal tDCS (20 min, 2 mA) and balance training for five consecutive days
Category
Rehabilitation
2
Description
Control group:
Will be offered sham tDCS with five consecutive days balance training .
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Firozgar Hospital
Full name of responsible person
Street address
City
Tehran
2
Recruitment center
Name of recruitment center
Physical Therapy Clinic, Shahid Beheshti University of Medical sciences
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Minoo Khalkhali zavieh
Street address
Faculty of Rehabilitation,across from Bo-Ali Hospital, Damavand Street
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Shahid Beheshti University of Medical Sciences