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IRCT20230728058946N1 IRCT 2023-11-09 Razi University Transcranial direct current stimulation before and during mirror visual feedback on the Sensory and Motor performance upper limb 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 2023-11-21 anticipated 12 Complete https://irct.ir/trial/72731 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Supportive, 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 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. N/A The participants are spastic hemiplegic cerebral palsy children.. Intervention 1: 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. Intervention 2: 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. Intervention 3: 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. Intervention 4: 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. Yes - There is a plan to make this available What will be shared: All data can be shared after de-identifying subjects. When: 6 months after printing the results To whom: Researchers Conditions: For meta-analytic research Where to obtain: If you need to receive documents, email Pegah Farzamfar, the main investigator, with the email address: pfarzam76@yahoo.com. How to obtain: 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. Comments:
public Pegah Farzamfar
Taqbestan, University St., Razi University, Faculty of Sports Sciences
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3845 8428 pfarzam76@yahoo.com Razi University scientific Pegah Farzamfar
Taqbestan, University St., Razi University, Faculty of Sports Sciences
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3845 8428 pfarzam76@yahoo.com Razi University Iran (Islamic Republic of) 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 6 years 12 years Both 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 G80.2 Spastic hemiplegic cerebral palsy Treatment - Devices Treatment - Devices Placebo Placebo 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. 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. 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. 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. 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. 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. 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. 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. Razi University Approved 2023-07-17 Razi University Research Ethics Committee Taq Bostan, University St., Razi University kermanshah Kermanshah Iran (Islamic Republic of)