The aim of this study is investigating the effect of cerebellar transcranial direct current stimulation (tDCS) on Timed Up and Go test with foot placement in chronic stroke patients.
Design
This study is single group design. A 20 chronic stroke patients, available in university clinics will participate in this study.
Settings and conduct
Timed Up and Go test will carried out before and after of intervention with four different types of foot placements including spontaneous foot position, symmetric foot position, affected foot placed behind the unaffected foot position, unaffected foot placed behind the affected foot position and scores will recorded. Patients will receive cerebellar tDCS for 20 minutes. The active anode electrode is placed over ipsilateral cerebellum and returning electrode is placed over right arm. Also each test procedure will be randomly performed by the patients.
Participants/Inclusion and exclusion criteria
Patients should be in chronic phase, more than six months post-stroke;
Any other condition apart from stroke that affects patients gait.
Intervention groups
The study is single group design, and cerebellar transcranial direct current stimulation (tDCS) is intervention.
Main outcome variables
The primary outcome measure is the time of Timed Up and Go test that will be assessed before and after of intervention.
General information
Reason for update
Acronym
tDCS
IRCT registration information
IRCT registration number:IRCT20160424027562N5
Registration date:2018-01-09, 1396/10/19
Registration timing:prospective
Last update:2018-01-09, 1396/10/19
Update count:0
Registration date
2018-01-09, 1396/10/19
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
2018-01-15, 1396/10/25
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of cerebellar transcranial direct current stimulation (tDCS) on Timed Up and Go test with foot placement in chronic stroke patients
Public title
Effects of cerebellar transcranial direct current stimulation in chronic stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All the participants will be in chronic phase, more than six months post-stroke.
The age of patients will be within rang of 45-70 years.
Plantar flexore muscle spasticity should be less than 3.
Lower extremity Fugle-Mayer scale should be more than 22.
Exclusion criteria:
If there is major cognitive problems.
Any condition (either fractures or other disease apart from stroke) that affects patients gait.
If there is sever aphasia.
Age
From 45 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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
2017-12-12, 1396/09/21
Ethics committee reference number
IR.SEMUMS.REC.1396.167
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
Immediately before and after of intervention
Method of measurement
By Chronometer
Secondary outcomes
1
Description
Berg Balance Scale
Timepoint
Immediately before and after intervention
Method of measurement
Berg Questionare
Intervention groups
1
Description
Intervention group: Patients will receive cerebellar transcranial direct current stimulation for 20 minutes with intensity of 1.5 milliampere. The active anode electrode is placed over ipsilateral cerebellum (1 cm below inion of occiputalbone and 1 cm medial to mastoid process) and returning electrode is placed over right arm.
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
Fax
Email
mohamadipt@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr Ali Rashidy-pour
Street address
Semnan University of Medical Sciences, Basij Blvd, Semnan, Iran
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3345 1336
Email
rashidy-pour@semums.ac.ir
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
Fax
Email
mohamadipt@gmail.com
Web page address
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
Fax
Email
mohamadipt@gmail.com
Web page address
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
Fax
Email
mohamadipt@gmail.com
Web page address
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
Analytic Code
Not applicable
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available