Investigating the effect of transcranial direct current stimulation before and during mirror visual feedback on the sensory and motor performance of the upper limb in children with spastic hemiplegia cerebral palsy
Investigating the effect of transcranial direct current stimulation before and during mirror visual feedback on the Sensory and Motor performance upper limb in Children with spastic hemipelgia cerebral palsy
Design
In the present study, with within-subjects design, counterbalanced and double-blind design, 12 subjects will be randomly exposed to four different conditions.
Settings and conduct
This research will be done in Medical clinic under the supervision of a neurologist. After selecting the subjects and familiarizing themselves with the research process, each subject will be exposed to four different conditions of electrical stimulation of the brain with a random combination.The principal investigator and subjects will not be aware of the type of stimulation received in each session.
Participants/Inclusion and exclusion criteria
Criteria for entering the research: Children with SHCP based on neurologist diagnosis،Having levels 1 and 2 of manual ability classification system (MACS), cognitive and verbal abilities،Being able to sit unsupervised،Having normal or corrected vision.Criteria for not entering the research: Having the experience of this training program،Having a history of seizures، severe pain in the affected limb، Using drugs that affect the central nervous system، Having any kind of metal implant in the brain
Intervention groups
This study is an intra-group and counterbalanced study in which the subjects are exposed to four different conditions of brain stimulation including: 1) sham stimulation before mirror visual feedback; 2) sham stimulation during mirror visual feedback; 3) Anodal stimulation before mirror visual feedback, 4) Anodal stimulation during mirror visual feedback will be placed.
Main outcome variables
Sensory and Motor performance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230728058946N1
Registration date:2023-11-09, 1402/08/18
Registration timing:prospective
Last update:2023-11-09, 1402/08/18
Update count:0
Registration date
2023-11-09, 1402/08/18
Registrant information
Name
Pegah Farzamfar
Name of organization / entity
The university of Razi
Country
Iran (Islamic Republic of)
Phone
+98 83 3845 8428
Email address
pfarzam76@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-21, 1402/08/30
Expected recruitment end date
2023-12-01, 1402/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of transcranial direct current stimulation before and during mirror visual feedback on the sensory and motor performance of the upper limb in children with spastic hemiplegia cerebral palsy
Public title
Transcranial direct current stimulation before and during mirror visual feedback on the Sensory and Motor performance upper limb
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Children with SHCP based on neurologist diagnosis
Having levels 1 and 2 of manual ability classification system (MACS), cognitive and verbal abilities
Being able to sit unsupervised
Having normal or corrected vision
Exclusion criteria:
Having the experience of this training program
Having a history of seizures
Having untreated attention deficit hyperactivity disorder
suffering from genetic psychiatric diseases,Metabolic and diseases such as epilepsy and cardio-respiratory, vision and sleep disorders, severe pain in the affected limb
Using drugs that affect the central nervous system
Having any kind of metal implant in the brain
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
12
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, in order to randomize the order of subject exposure to four different conditions (4 different types of electrical stimulation of the brain), the Latin square method will be used. For this purpose, first, using the website www.random.org, each subject will be randomly assigned a number between 1 and 12 as an identification code. Then, the English letters A, B, C, D are assigned to four intervention conditions and a Latin square will be created with four rows and four columns. After creating the Latin square, participants number 1 to 3 in the sequence of the first row, participants 4 to 6 in the sequence of the second row, participants 7 to 9 in the sequence of the third row and participants 10 to 12 in the sequence of the fourth row will be placed.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this double-blind study, the researcher and participants will be blinded to the type of transcranial electrical stimulation used and the location of stimulation in each session. In the present study, the Neurostim stimulation device was used to induce direct current electrical stimulation in four separate sessions and four different modes including: 1) sham stimulation before mirror visual feedback; 2) sham stimulation during mirror visual feedback; 3) Anodal stimulation before mirror visual feedback, 4) Anodal stimulation during mirror visual feedback will be used. For this purpose, a person outside the research team will be responsible for applying electrical stimulation in four experimental sessions. In order to blind the participants, after they sit on a special chair, the electrical stimulation device of the brain is hidden from their sight and covered by a cover completely, and the electrodes will be placed on the desired areas by the examiner. In order to blind the researcher, before the intervention, the researcher leaves the laboratory and returns to the test site after the stimulation period has passed and the electrodes are removed and the stimulation device is turned off. Also, in the sham stimulation mode, according to standard protocols, the active current is induced on the head for 30 seconds to induce the same sensation as the active stimulation mode, and then the current is cut off and the stimulation is deactivated.
Placebo
Used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Razi University Research Ethics Committee
Street address
Taq Bostan, University St., Razi University
City
kermanshah
Province
Kermanshah
Postal code
6714414971
Approval date
2023-07-17, 1402/04/26
Ethics committee reference number
IR.RAZI.REC.1402.049
Health conditions studied
1
Description of health condition studied
The participants are spastic hemiplegic cerebral palsy children.
ICD-10 code
G80.2
ICD-10 code description
Spastic hemiplegic cerebral palsy
Primary outcomes
1
Description
Fine Finger Dexterity
Timepoint
before the beginning of the intervention and after the end of the intervention in each session
Method of measurement
Purdue Pegboard Test
2
Description
Hand-eye coordination
Timepoint
before the beginning of the intervention and after the end of the intervention in each session
Method of measurement
Frostig's Advanced Perceptual-Visual Test
3
Description
Range of motion of wrist and elbow joints
Timepoint
before the beginning of the intervention and after the end of the intervention in each session
Method of measurement
goniometer
4
Description
gross hand movements
Timepoint
before the beginning of the intervention and after the end of the intervention in each session
Method of measurement
Box and Block Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Before mirror visual feedback, they will receive 20 minutes of anodal stimulation at 2 mA intensity. In order to stimulate, the Neurostim stimulation device manufactured by Medina Teb Company will be used. The target area in the brain is identified using the 10-20 international brain mapping system and stimulation is performed using special stimulation electrodes and a special electroencephalogram cap.
Category
Treatment - Devices
2
Description
Intervention group 2: During mirror visual feedback, they will receive 20 minutes of anodal stimulation at 2 mA intensity. In order to stimulate, the Neurostim stimulation device manufactured by Medina Teb Company will be used. The target area in the brain is identified using the 10-20 international brain mapping system and stimulation is performed using special stimulation electrodes and a special electroencephalogram cap.
Category
Treatment - Devices
3
Description
Intervention group 3: Before mirror visual feedback, they will receive 20 minutes of sham (control) stimulation at 2 mA intensity. In order to stimulate, the Neurostim stimulation device manufactured by Medina Teb Company will be used. The target area in the brain is identified using the 10-20 international brain mapping system and stimulation is performed using special stimulation electrodes and a special electroencephalogram cap.
Category
Placebo
4
Description
Intervention group 4: During mirror visual feedback, they will receive 20 minutes of sham (control) stimulation at 2 mA intensity. In order to stimulate, the Neurostim stimulation device manufactured by Medina Teb Company will be used. The target area in the brain is identified using the 10-20 international brain mapping system and stimulation is performed using special stimulation electrodes and a special electroencephalogram cap.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic Mostafa Sedighi
Full name of responsible person
Mostafa Sedighi
Street address
Shir Khursheed Crossroads. In front of Mohammad Kermanshahi Hospital. Khurshid building.
City
Kermanshah
Province
Kermanshah
Postal code
6714734439
Phone
+98 903 250 7110
Email
Sedighi-mostafa@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Razi University
Full name of responsible person
Farzaneh Gandomi
Street address
Taqbestan, University St., Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
gandomif@razi.ac.ir
Grant name
Deputy of Research and Technology of Razi University
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi University
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
Razi University
Full name of responsible person
Pegah Farzamfar
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Taqbestan, University St., Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3845 8428
Email
pfarzam76@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Razi University
Full name of responsible person
Pegah Farzamfar
Position
Students
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Taqbestan, University St., Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3845 8428
Email
pfarzam76@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Razi University
Full name of responsible person
Pegah Farzamfar
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Taqbestan, University St., Razi University, Faculty of Sports Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 7605
Email
pfarzam76@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data can be shared after de-identifying subjects.
When the data will become available and for how long
6 months after printing the results
To whom data/document is available
Researchers
Under which criteria data/document could be used
For meta-analytic research
From where data/document is obtainable
If you need to receive documents, email Pegah Farzamfar, the main investigator, with the email address: pfarzam76@yahoo.com.
What processes are involved for a request to access data/document
In case of an official request, stating the relevant reasons and mentioning the complete details, the data will be sent via email after 72 hours.