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IRCT20221124056598N1 IRCT 2022-12-10 Razi University Effect of virtual reality with and without transcranial direct current stimulation in adolescent girls The effects of virtual reality intervention with and without transcranial direct current stimulation on motor and cognitive performances in sedentary adolescent girls 2022-12-21 anticipated 36 Complete https://irct.ir/trial/67029 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, permuted block randomization via the www.randomization.com website will be used. To do so, first, a unique number will be allocated to each subject as the identifier code and, a 36-digit sequence (equal to sample size) will be created. Then, treatment labels including: 1 (virtual reality group + real trans cranial direct current stimulation, 2 (virtual reality group + sham trans cranial direct current stimulation); 3 (The control group: will be defined in the relevant section on the website). After defining the treatment groups and to avoid potential problems associated with equal block sizes, permuted block randomization with different block sizes will be applied. In this case, by knowing the sample size, the block sizes will be unequal and a multiple of the number of treatment groups (for example, block sizes of 2, 4, 6, or 8). The website has the ability to randomly specify the sequence of blocks with different sizes. In the final step and upon performing the 'Generate Plan' on the website, all subjects will be randomly assigned to blocks of different sizes that already have a random sequence. Finally, by using the number (code) assigned to each subject and checking the blocks, the group of each subject will be determined, Blinding description: The present study is a single-blind study, in which participants are blinded about receiving real or sham stimulation while, based on the nature of virtual reality, there will be no blinding for virtual reality interventions. In order to blind the two groups receiving brain stimulation, they do not know the settings of the device whether it is real or sham. Both groups will receive stimulation (sham or real) for 20 minutes. N/A Sedentary adolescent girls. Intervention 1: Intervention group: Virtual reality training combined with real transcranial direct current stimulation for 4 weeks. The exercises will be 3 sessions per week, 20 minutes of real direct current stimulation and one hour of virtual reality exercises. Intervention 2: Intervention group: Virtual reality exercises combined with sham transcranial direct current stimulation for 4 weeks. The exercises will be 3 sessions a week, 20 minutes of direct current sham stimulation and one hour of virtual reality exercises. Intervention 3: Control group: This group had a normal life routine for 4 weeks and did not participate in any sports activities during this time. Yes - There is a plan to make this available What will be shared: All data are shared after the de-identification of the participants When: 3 months after publication To whom: All individuals upon formal request Conditions: Data sharing requests are accepted for any purposes Where to obtain: To obtain any data/document, please send an e-mail to nasrin shahbazi , a PhD student at Razi University, through the following e-mail address: n_shahbazi_69@yahoo.com How to obtain: Upon formal request, mentioning due reasons, and providing full personality details, data will be sent after 72 h via e-mail. Comments:
public Nasrin Shahbazi
Faculty of Sport Sciences, Razi University, Tagh-e-Bostan, University St., Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3845 8428 n_shahbazi_69@yahoo.com Razi University scientific Nasrin Shahbazi
Faculty of Sport Sciences, Razi University, Tagh-e-Bostan, University St., Kermanshah, Iran
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3845 8428 n_shahbazi_69@yahoo.com Razi University Iran (Islamic Republic of) Sedentary girls based on physical activity questionnaire Compliance with the age range of 15 to 18 years Right-handedness of subjects Having normal or corrected vision 15 years 18 years Female Having a history of neurological disease Having cardiovascular disease Having any kind of metal implant in the brain History of balance disorder and frequent positional vertigo and fear of electrical stimulation of the brain Any physical weakness or injury Inability to complete test and practice sessions Any dissatisfaction with doing assignments during the exam Concurrent participation in another study Other Other Other Intervention group: Virtual reality training combined with real transcranial direct current stimulation for 4 weeks. The exercises will be 3 sessions per week, 20 minutes of real direct current stimulation and one hour of virtual reality exercises. Intervention group: Virtual reality exercises combined with sham transcranial direct current stimulation for 4 weeks. The exercises will be 3 sessions a week, 20 minutes of direct current sham stimulation and one hour of virtual reality exercises. Control group: This group had a normal life routine for 4 weeks and did not participate in any sports activities during this time. Change in hand-eye coordination. Timepoint: before the starting the intervention, 2 weeks after the starting the intervention, 4 weeks after the starting the intervention, 2 weeks after the end of the intervention. Method of measurement: Lafayette Instrument Automatic Mirror Trace. Bimanual coordination. Timepoint: Before the starting the intervention, 2 weeks after the starting the intervention, 4 weeks after the starting the intervention, 2 weeks after the end of the intervention. Method of measurement: Lafayette Instrument Two-Arm Coordination Test. Static balance. Timepoint: Before the starting the intervention, 2 weeks after the starting the intervention, 4 weeks after the starting the intervention, 2 weeks after the end of the intervention. Method of measurement: Stork Balance Stand Test. Dynamic balance. Timepoint: Before the starting the intervention, 2 weeks after the starting the intervention, 4 weeks after the starting the intervention, 2 weeks after the end of the intervention. Method of measurement: Y Balance Test. Reaction time. Timepoint: Before the starting the intervention, 2 weeks after the starting the intervention, 4 weeks after the starting the intervention, 2 weeks after the end of the intervention. Method of measurement: Reaction time software. Working memory. Timepoint: Before the starting the intervention, 2 weeks after the starting the intervention, 4 weeks after the starting the intervention, 2 weeks after the end of the intervention. Method of measurement: Nback software. Cognitive flexibility. Timepoint: before the starting the intervention, 2 weeks after the starting the intervention, 4 weeks after the starting the intervention, 2 weeks after the end of the intervention. Method of measurement: Cognitive flexibility questionnaire. Razi University Approved 2022-08-03 Research Ethics Committees of Kermanshah Razi University Ddeputy of research, Razi University, University St., Taq-e-bostan, Kermanshah, Iran Kermanshah Kermanshah Iran (Islamic Republic of)