The purpose of this study is to compare the effects of transcranial direct current stimulation (tDCS) on the lower limb function with & without Step exercise in chronic stroke patients.
Design
Randomized control clinical trial, with parallel groups, blinded subjects, with 30 sample size
Settings and conduct
This study will be performed in Neuromuscular Rehabilitation Research Center in Semnan. In the first group, direct current stimulation is delivered for 20 minutes on the brain motor cortex. In the second group, Step exercise will be performed, after this exercise, direct current stimulation is delivered on the brain motor cortex. In the control group, direct current stimulation is delivered on the brain motor cortex as a placebo. Subjects are blinded in this study, and they do the Timed Up and Go test with different foot positions before and after intervention randomly.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All patients should be able to stand and sit independently on a standard seat, and patients should be in the chronic stage. Exclusion criteria: Medical condition (apart from the stroke) that impair patients balance.
Intervention groups
Intervention group 1: Direct current stimulation is delivered 2 milliamperes (mA) for 20 minutes on the brain motor cortex in one session. Intervention group 2: Step exercise will be performed with the unaffected foot placed on a step and the affected foot placed at ground and subjects will do sit to stand task in this position for 30 minutes. After this exercise direct current stimulation is delivered 2 mA for 20 minutes on the motor cortex. Control group: Direct current stimulation is delivered for 20 minutes on the motor cortex as a placebo, and subjects perceived sensations on the skin, such as tingling, fade usually out in the first 30 seconds of direct current.
Main outcome variables
The time of Timed Up and Go test
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160424027562N8
Registration date:2019-01-25, 1397/11/05
Registration timing:prospective
Last update:2019-01-25, 1397/11/05
Update count:0
Registration date
2019-01-25, 1397/11/05
Registrant information
Name
Roghayeh Mohammadi
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4180
Email address
mohammadipt@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-26, 1397/11/06
Expected recruitment end date
2019-06-20, 1398/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of transcranial direct current stimulation (tDCS) on the lower limb function with and without Step exercise in chronic stroke patients
Public title
Effect of transcranial direct current stimulation (tDCS) in chronic stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients should be able to stand and sit independently on a standard seat
All the patients should be more than 6 months poststroke
The spasticity score of plantarflexor muscles should be smaller than 3 in the modified Ashworth scale
Stroke patients should be in the chronic stage
Exclusion criteria:
Medical condition (apart from the stroke) that impair patients balance
Cognition deficiency
Age
From 45 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization is done. Since the therapeutic method is three models, for the four-block blocks, twenty-four different modes are created and based on the random numbers generated by the computer, the blocks are placed. Allocation concealment will be performed by using random seals enclosed envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will be blind in this study. In spite of explaining to patients about the intervention adequately, they will not be aware of being in which group.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
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
2018-12-18, 1397/09/27
Ethics committee reference number
IR.SEMUMS.REC.1397.201
Health conditions studied
1
Description of health condition studied
Stroke
ICD-10 code
I67.9
ICD-10 code description
Cerebrovascular disease, unspecified
Primary outcomes
1
Description
The time of Timed Up and Go test
Timepoint
Before and immediately after intervention
Method of measurement
By chronometer
Secondary outcomes
1
Description
Berg Balance Scale
Timepoint
Before and immediately after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention group 1: Direct current stimulation is delivered 2 milliamperes for 20 minutes on the brain motor cortex in one session. An active electrode is positioned over the primary motor cortex of the affected side and a returning electrode is located over the contralateral supraorbital area.
Category
Rehabilitation
2
Description
Intervention group 2: Step exercise will be performed with the unaffected foot placed on a step and the affected foot placed at ground level and subjects will do sit to stand task in this position for 30 minutes after this exercise direct current stimulation is delivered 2 milliamperes for 20 minutes on the brain motor cortex. An active electrode is positioned over the primary motor cortex of the affected side and a returning electrode is located over the contralateral supraorbital area.
Category
Rehabilitation
3
Description
Control group: Direct current stimulation is delivered for 20 minutes on the brain motor cortex as a placebo, and subjects perceived sensations on the skin, such as tingling, fade usually out in the first 30 seconds of direct current
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neuromuscular Rehabilitation Research Center
Full name of responsible person
Roghayeh Mohammadi
Street address
Neuromuscular Rehabilitation Research Center, Ghods Blvd, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3519698375
Phone
+98 23 3332 8502
Email
mohamadipt@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. 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
Roghayeh Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty, Semnan University of Medical Sciences, 5 Kilometer of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
mohamadipt@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Roghayeh Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty, Semnan University of Medical Sciences, 5 Kilometer of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
mohamadipt@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Roghayeh Mohammadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Rehabilitation Faculty, Semnan University of Medical Sciences, 5 Kilometer of Damghan Road, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3513138111
Phone
+98 23 3365 4180
Email
mohamadipt@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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available