Effects of stimulating motor and cognitive cortex by transcranial direct current stimulation on standing balance under dual-task condition in people with stroke
Determining the effects of stimulating motor and cognitive cortex by transcranial direct current stimulation (tDCS) on standing balance under dual-task condition in people with stroke
Design
This study is a parallel double-blinded randomized clinical controlled trial. The referred people will be randomly allocated to one of the three groups of motor cortex stimulation, cognitive cortex stimulation and placebo.
Settings and conduct
Initially, a neurologist was asked to refer stroke patients with inclusion criteria and without exclusion criteria to the physiotherapy clinic of Tabriz
Participants/Inclusion and exclusion criteria
Stroke patients under 80 years of age without any other neurological and psychological problems and tDCS contraindications.
Intervention groups
Motor cortex stimulation group
Cognitive cortex stimulation group
Placebo group
Effects of stimulating motor and cognitive cortex by transcranial direct current stimulation on standing balance under dual-task condition in people with stroke
Public title
Effects of transcranial direct current stimulation on balance in stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Knee extensor strength equal or more than 3 in manual muscle test
Mini-Mental State Examination score equal or more than 21
First stroke
At least 4 weeks after stroke
Fugl-Mayer test score less than 18
Less than 80 years of age
Exclusion criteria:
History of seizure or epilepsy
Existence of metal in skull
Using pace-maker
Neurological problems
Skull fracture
History of brain surgery
Psychological impairments
Sensitive head skin
Using cortical facilitating medications such as Antidepressants, Antiepileptics, Neuroleptics and Benzodiazepines
Using medications with facilitating of inhibiting effects on brain plasticity such as Dopamine, Fluoxetin and D-Amphetamin
Age
To 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
A simple individual randomization via a statistical software will be performed.
We will use the RANDBETWEEN function in Excel for making randomization order.
Allocation concealment will be performed by the secretary of the assessment center.
Blinding (investigator's opinion)
Double blinded
Blinding description
All participants in this study will be blind to their allocation to study groups (motor cortex stimulation, cognitive cortex stimulation and placebo). The outcome assessorو before and after intervention, will be blind to the allocation as well. However, the physiotherapist, study designer, statistical analyst and the committee of safety and data supervision will not be blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
29th Bahman Blvd, Tabriz University, Faculty of Rehabilitation Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2019-09-16, 1398/06/25
Ethics committee reference number
IR.TBZMED.REC.1398.62
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I64
ICD-10 code description
Stroke, not specified as haemorrhage or infarction
Primary outcomes
1
Description
Sway area
Timepoint
Before intervention and immediately after intervention
Method of measurement
Force plate apparatus
2
Description
Sway path length
Timepoint
Before intervention and immediately after intervention
Method of measurement
Force plate apparatus
3
Description
Cognitive performance score
Timepoint
Before intervention and immediately after intervention
Method of measurement
Recording and calculation by a special equation
Secondary outcomes
empty
Intervention groups
1
Description
First intervention group: Motor cortex stimulation
Category
Rehabilitation
2
Description
Second intervention group: Cognitive cortex stimulation
Category
Rehabilitation
3
Description
Control group: Placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Physiotherapy Clinic of Tabriz Rehabilitation Faculty
Full name of responsible person
Tabassom Ghanavati
Street address
29 Bahman Blvd, Tabriz University, Faculty of Rehabilitation Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3337 2072
Email
ghanavatit@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Sami'ei
Street address
No. 2 Central Building, Tabriz University of Medical Sciences, University Street
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
iro@tbzmed.ac.ir
Web page address
http://portal-en.tbzmed.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Tabassom Ghanavati
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
29 Bahman Blvd, Tabriz University, Faculty of Rehabilitation Sciences