The effect of bihemispheric transcranial direct current stimulation combined with routine physiotherapy on the motor function of upper limb in the ischemic stroke patients with hemiplegia
the potentiated effects of concurrent routine physiotherapy and transcranial direct current stimulation in the ischemic stroke patients with hemiplegia.
Design
A randomized double blind clinical trial,randomized with sealed envelope software,on 50 patients of ischemic stroke with hemiplegia,every group includes 25 individual.
Settings and conduct
patients with hemiplegia who refer to physiotherapy department,are randomized in two groups of intervention(real transcranial stimulation plus physiotherapy) and control (Sham transcranial stimulation plus physiotherapy). Someone other than the patient and examiner adjusts the device to apply or not electrical stimulation, so the examiner and patient are unaware of the assignment of individuals in the sham and real tDCS groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
age:18-65 years,unilateral ischemic stroke in middle cerebral artery,upper limb plegia,stroke onset and intervention starting interval from 2 weeks to 1 month,National institute of health stroke scale less than 20
Exclusion criteria:
Conditions which are not compatible to safety guidelines of brain stimulation.Contraindications with transcranial stimulation.
taking psychoactive drugs and CNS effective drugs except tissue plasminogen activator and medications used for stroke routine treatment.
substance abusers,Concurrent psychiatric and other non-stroke neurological disease,The use of calcium and sodium channel blockers,scalp eczema, clinical instability.
Intervention groups
'' intervention group'' : real transcranial current stimulation with intensity of 1.5 mA plus routine physiotherapy, 10 sessions,5 successive sessions each week ,30 minutes every session
''control group'' : Sham transcranial stimulation without real stimulation plus routine physiotherapy,10 sessions ,30 minutes every session
Main outcome variables
motor function of upper limb based on WMFT test,stroke deficit severity based on NIHSS score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130416013027N3
Registration date:2020-07-11, 1399/04/21
Registration timing:registered_while_recruiting
Last update:2020-07-11, 1399/04/21
Update count:1
Registration date
2020-07-11, 1399/04/21
Registrant information
Name
Sara Ramezani Kapourchali
Name of organization / entity
Guilan Road Trauma Research Centre
Country
Iran (Islamic Republic of)
Phone
+98 13 1323 8373
Email address
s.ramezanislp@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-19, 1398/12/29
Expected recruitment end date
2021-03-19, 1399/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of bihemispheric transcranial direct current stimulation combined with routine physiotherapy on the motor function of upper limb in the ischemic stroke patients with hemiplegia
Public title
The effect of transcranial direct current stimulation on stroke
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age between 18 and 65 years
unilateral ischemic stroke in middle cerebral artery
upper limb plegia
stroke onset and intervention starting interval from 2 weeks to 1 month
National institude of health stroke scale (NIHSS) score less than 20 at the time of intervention
Exclusion criteria:
cognitive state score in mini mental score examination less than 24
Conditions which are not compatible to safety guidelines of brain stimulation
those with tDCS contraindication , such as pregnant patients, patients with metal implants , those having a heart pacemaker
drug history of psychoactive drugs or CNS effective drugs except tPA and medications used for stroke routine treatment .
substance abusers
Concurrent psychiatric and other non-stroke neurological disease
The use of medications blocking voltage-dependent calcium and sodium channels
History or existence of scalp eczema
Clinical instability
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization is performed using sealed envelope software. The samples are assigned to 8 randomized blocks including two groups. Therapist randomly selects one block and based on it, the subject is assigned.
Blinding (investigator's opinion)
Double blinded
Blinding description
During blinding, someone other than the patient and examiner adjusts the device to apply or not electrical stimulation, so the examiner and patient are unaware of the assignment of individuals in the sham and real tDCS groups, and only the person adjusting the device, is aware of this.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan university of medical sciences
Street address
Namjou avenue, Poursina junction, Poursina hospital, Neuroscience research center
City
Rasht
Province
Guilan
Postal code
4193713194
Approval date
2019-08-03, 1398/05/12
Ethics committee reference number
IR.GUMS.REC.1398.247
Health conditions studied
1
Description of health condition studied
patients with unilateral ischemic stroke having paralysis of upper limb
ICD-10 code
I63.9
ICD-10 code description
Cerebrovascular accident-ischemic
Primary outcomes
1
Description
motor function of upper limb
Timepoint
base line, before intervention, final session of intervention
Method of measurement
Wolf motor function test
Secondary outcomes
1
Description
neurological deficit severity
Timepoint
base line and final session of intervention
Method of measurement
National institude of health stroke scale
Intervention groups
1
Description
intervention group: 1.5 mA Anodal transcranial electrical stimulation on primary motor cortex of lesion hemisphere and Cathodal stimulation on anologous area of opposite hemisphere. time of stimulation is 30 minutes stimulation in 10 sessions,successive 5 sessions weekly for two weeks . stimulation device manufactured by Mindalive company from Canada.
Category
Rehabilitation
2
Description
control group : Sham transcranial direct current stimulation with1 mA intensity for 3 seconds, 30 minutes physiotherapy each session for 10 sessions, 5 successive sessions per week.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Poursina hospital, physiotherapy unit
Full name of responsible person
Arezoo Karimzadeh
Street address
Namjou avenue, Poursina junction, Poursina hospital, Neuroscience research center