The effects of short-term and long-term anodal tDCS over M1 cortex with routine physiotherapy on spasticity and activity of plantar flexor muscles in stroke patients
The effects of short-term and long-term anodal tDCS over M1 cortex with routine physiotherapy on spasticity and activity of plantar flexor muscles in stroke patients
Design
The clinical trial with a control group, community-based and pragmatic, with parallel groups, randomized, without control with placebo, single center trial.
Settings and conduct
Neuromuscular Rehabilitation Research Center.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients stroke 40 to 80 years old; 3 weeks to 6 months of Stroke past: No history of botulism injection. Exclusion criteria: Renal or hepatic impairment; Damage to the head; History of the cerebrovascular aneurysm; History of epilepsy; The stroke areas have affected both hemispheres.
Intervention groups
Intervention group: According to the treatment protocol, direct transcranial flow stimulation (tDCS) is applied to the affected motor cortex and routine physiotherapy is performed for patients. Control group: Based on the treatment protocol, placebo stimulation and routine physiotherapy for patients.
Main outcome variables
Activation and intensity of muscle contraction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151228025732N39
Registration date:2019-05-23, 1398/03/02
Registration timing:registered_while_recruiting
Last update:2019-05-23, 1398/03/02
Update count:0
Registration date
2019-05-23, 1398/03/02
Registrant information
Name
Alireza Emadi
Name of organization / entity
Semnan University of Medical Sciences, Semnan, Iran
Country
Iran (Islamic Republic of)
Phone
+98 23 3345 1336
Email address
are20935@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-21, 1398/02/31
Expected recruitment end date
2020-05-20, 1399/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of short-term and long-term anodal tDCS over M1 cortex with routine physiotherapy on spasticity and activity of plantar flexor muscles in stroke patients
Public title
The effects of short-term and long-term anodal tDCS over M1 cortex with routine physiotherapy on spasticity and activity of plantar flexor muscles in stroke patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients stroke 40 to 80 years old
3 weeks to 6 months of Stroke past
No history of botulism injection
Exclusion criteria:
Renal or hepatic impairment
Damage to the head
History of cerebrovascular aneurysm
History of epilepsy
The stroke areas have affected both hemispheres
Ethics committee of Semnan University of Medical Sciences
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2019-05-22, 1398/03/01
Ethics committee reference number
IR.semums.REC.1398.030
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
Z82.3
ICD-10 code description
Family history of stroke
Primary outcomes
1
Description
Activation and intensity of muscle contraction
Timepoint
Immediately after the intervention and 1 month after the intervention
Method of measurement
Electromyography (EMG)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: According to the treatment protocol, direct transcranial flow stimulation (tDCS) is applied to the affected motor cortex and routine physiotherapy is performed for patients.
Category
Rehabilitation
2
Description
Control group: Based on the treatment protocol, placebo stimulation and routine physiotherapy for patients.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Fatemeh Ehsani
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
fatemehehsani59@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Parviz Kokhaei
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan.
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
P_kokha@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Research Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
fatemehehsani59@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
fatemehehsani@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Fatemeh Ehsani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Neuromuscular Rehabilitation Center, Qods Blvd, Mashahir Aven.
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
fatemehehsani@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
-
When the data will become available and for how long
-
To whom data/document is available
Only available to scholars working in academic institutions.
Under which criteria data/document could be used
In case of relevant studies.
From where data/document is obtainable
Fatemeh Ehsani Neuromuscular Rehabilitation Research Center, Ghods Blvd. +98 9191310755
What processes are involved for a request to access data/document