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IRCT20230728058946N2 IRCT 2025-10-17 razi university Transcranial direct current stimulation before and after visual mirror feedback treatment on upper limb motor function in children with spastic hemiplegic cerebral palsy Studying the effect of 10 sessions of transcranial direct current stimulation before and after visual mirror feedback treatment on upper limb motor function in children with spastic hemiplegic cerebral palsy 2025-10-23 anticipated 18 Complete https://irct.ir/trial/86762 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Other, Purpose: Supportive, Randomization description: In this study, the block randomization method was used through the website www.randomization.com. For this purpose, each subject was first assigned a number as a unique identification code and an 18-digit sequence (equal to the sample size) was created. Then, the names of the intervention groups were defined in the relevant section of the website, including: Experimental Group 1, first brain stimulation and then MVF (tDCS offlin-pre), Experimental Group 2, first MVF and then brain stimulation (tDCS-offlin-post), and the control group (sham stimulation group with MVF). After defining the groups and in order to prevent potential problems caused by blocking with fixed-size blocks, the method of randomly selecting blocks of different sizes was used for blocking. In this case, since the sample size was known, the block sizes were unequal and a multiple of the number of intervention groups (for example, blocks of 2, 4, 6, or 8). The website has the ability to randomly create sequences of blocks of different sizes. In the final step, by executing the Plan Generate command on the website, all subjects were randomly assigned to blocks of different sizes that themselves had a random sequence. Finally, by using the number (code) assigned to each subject and examining the blocks, the group of each subject was determined, Blinding description: In this double-blind study, the researcher and participants will be blinded to the type of transcranial electrical stimulation used in each session. In the present study, the Neurostim stimulator will be used to induce direct current electrical stimulation. For this purpose, a person outside the research team will be responsible for applying electrical stimulation in the experimental sessions. In order to blind the participants, after they sit on a special chair, the brain electrical stimulation device is hidden from their sight and is completely covered by a cover, and the electrodes will be placed on the desired areas by the test taker. In order to blind the researcher, the researcher also leaves the laboratory before applying the intervention and returns to the testing site after the stimulation period has elapsed, the electrodes are removed, and the stimulator is turned off. Also, in the sham stimulation mode, according to standard protocols, an active current is induced on the head for 30 seconds to induce a sensation similar to the active stimulation mode, and then the current is interrupted and the stimulation is deactivated. N/A The participants are children with spastic hemiplegic cerebral palsy. Intervention 1: Intervention group: Experimental group 1 (first brain stimulation and then mirror visual feedback (tDCS offline-pre)). Intervention 2: Intervention group: Experimental group 2 (first mirror visual feedback, then brain stimulation (tDCS-offlin-post)). Intervention 3: Control group: Placebo group (first sham stimulation then mirror visual feedback). Yes - There is a plan to make this available What will be shared: All data can be shared after de-identifying the subjects. When: 6 months after results are published To whom: Researchers Conditions: For meta-analytical research Where to obtain: If you need to receive documentation, please send an email to Pegah Farzamfar, research researcher, at the email address: pfarzam76@yahoo.com. How to obtain: Upon formal request, stating the relevant reasons and providing full details, the data will be sent via email after 72 hours. Comments:
public pegah farzamfar
Taghebstan, Daneshgah Street, Razi University, Faculty of Sport Sciences
kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3845 8428 pfarzam76@yahoo.com razi university scientific pegah farzamfar
Taghebstan, Daneshgah Street, Razi University, Faculty of Sport 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 6 to 12 years Possessing Level 1 and 2 of the Manual Ability Classification System (MACS), cognitive, verbal, and visual abilities Being able to sit unsupervised 6 years 12 years Both Having experience in receiving this type of intervention Having a history of seizures Having untreated attention deficit hyperactivity disorder Having genetic, metabolic or degenerative psychiatric diseases and diseases such as epilepsy and cardiorespiratory, visual and sleep disorders, severe pain in the affected limb Use of medications that affect the central nervous system Having any metal implant in the brain G80.2 Spastic hemiplegic cerebral palsy Other Other Other Intervention group: Experimental group 1 (first brain stimulation and then mirror visual feedback (tDCS offline-pre)) Intervention group: Experimental group 2 (first mirror visual feedback, then brain stimulation (tDCS-offlin-post)) Control group: Placebo group (first sham stimulation then mirror visual feedback) Fine finger dexterity. Timepoint: Before the start of the intervention (pre-test), after the fifth session of the intervention (mid-test), after the end of the 10th intervention session (post-test), and two weeks later (recall). Method of measurement: Purdue Pegboard Test. Eye-hand coordination. Timepoint: Before the start of the intervention (pre-test), after the fifth session of the intervention (mid-test), after the end of the 10th intervention session (post-test), and two weeks later (recall). Method of measurement: Beery's Visual-Motor Integration Test. Gross hand movements. Timepoint: Before the start of the intervention (pre-test), after the fifth session of the intervention (mid-test), after the end of the 10th intervention session (post-test), and two weeks later (recall). Method of measurement: Box and Block Test. Grip strength. Timepoint: Before the start of the intervention (pre-test), after the fifth session of the intervention (mid-test), after the end of the 10th intervention session (post-test), and two weeks later (recall). Method of measurement: Digital dynamometer device. razi university Approved 2025-09-22 Razi University Research Ethics Committee Taq Bostan, University St., Razi University kermanshah Kermanshah Iran (Islamic Republic of)