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IRCT20150411021686N4 IRCT 2023-12-01 Semnan University of Medical Sciences The effect of electrical stimulation of the brain with virtual reality on people with multiple sclerosis Effectiveness of transcranial direct current stimulation with virtual reality ‎training for balance and fear of falling in people with multiple sclerosis, a ‎randomized control trial ‎ 2024-01-21 anticipated 36 Complete https://irct.ir/trial/73826 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the first stage, patients who meet the inclusion criteria are included in the study. Therefore, our sampling method is convenience sampling at this stage of the method. The randomization method in this research is a web-based block randomization, due to having three groups, blocks of 3 and 6 will be used, and the order of the blocks will be obtained using random numbers on the web, so it can be 36 The participant was randomly assigned to the study. Participants are placed in three control, sham and intervention groups based on the order of entry. The assessor will not know about the random allocation and group allocation of the participants in any of the assessment stages. The number of blocks and how they are executed is done by hiding them inside the envelope, Blinding description: A single-blind , the assessor will be blind to group allocation. N/A multiple sclerosis. Intervention 1: Intervention group: receiving virtual reality balance exercises with bright tDCS. To use tDCS, a direct stimulation current will be used by a pair of electrodes (cathode and anode). The current is controlled by an ammeter. Stimulation electrodes are 7x5 cm in size. When using TDCS, a current of 2 mA is applied to the cerebellum for a maximum of 20 minutes. Virtual reality device Visual cues are created by a virtual reality device. A closed loop device is installed on the head. , provides the patient with a virtual tiled floor in a checkerboard arrangement, which dynamically responds to the patient's own movement, much like a real floor, fixed in space. Intervention 2: Sham control group: received virtual reality balance exercises with tDCS off. This group receives only virtual reality treatment and the silent tDCS device is used for them. Intervention 3: Control group: Receive only virtual reality balance exercises. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: The data of this study will be available only to researchers working in academic and scientific institutions Conditions: The data of this study will be available for meta-analysis Where to obtain: Zahra Ahmadizadeh, Mashahir Square, Quds Boulevard, Neuromuscular Rehabilitation Research Center Phone: 00982333654180 Postal Code: 3513138111 ahmadizade.z@gmail.com How to obtain: In order to request the data of this study, it is necessary to send an official written request by e-mail and clearly explain the reason for the request. Comments:
public Zahra Ahmadizadeh
Damghan Road - Semnan Medical Sciences Campus - Faculty of Rehabilitation
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4180 ahmadizade.z@gmail.com Semnan University of Medical Sciences scientific Zahra Ahmadizadeh
Semnan-Kilometer 5 Damghan Road-Semnan Medical Sciences school of Rehabilitation
Semnan Iran (Islamic Republic of) 3513138111 +98 23 3365 4190 ahmadizade.z@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Having MS as diagnosed by a neurologist No history of falling in the last month according to the reference or family report No addiction according to the client's, family or doctor's report Not having obvious orthopedic, rheumatology, or internal problems that the person complains about (such as back pain, hallux valgus, flat feet, foot ulcers) according to the client's report, the family or the client's doctor, if you cause problems in the implementation of the tests People with mild to moderate disability EDSS=1-5 Age range 18-60 years having cognitive impairment (getting a score higher than 21 in the MMSE test) 18 years 60 years Both Corticosteroid use up to 28 days before evaluation based on medical records and patient statements Having mental problems (according to the patient's file) Having a history of attacks and relapses in the last 2 months (according to the patient's file) Having a history of other neurological diseases (according to the patient's file) G35 Multiple sclerosis Rehabilitation Other Other Intervention group: receiving virtual reality balance exercises with bright tDCS. To use tDCS, a direct stimulation current will be used by a pair of electrodes (cathode and anode). The current is controlled by an ammeter. Stimulation electrodes are 7x5 cm in size. When using TDCS, a current of 2 mA is applied to the cerebellum for a maximum of 20 minutes. Virtual reality device Visual cues are created by a virtual reality device. A closed loop device is installed on the head. , provides the patient with a virtual tiled floor in a checkerboard arrangement, which dynamically responds to the patient's own movement, much like a real floor, fixed in space. Sham control group: received virtual reality balance exercises with tDCS off. This group receives only virtual reality treatment and the silent tDCS device is used for them Control group: Receive only virtual reality balance exercises Balance. Timepoint: before the start of the intervention, after the tenth session of the intervention, and 6 weeks after the end of the intervention. Method of measurement: Biodex. Fear of falling. Timepoint: before the start of the intervention, after the tenth session of the intervention, and 6 weeks after the end of the intervention. Method of measurement: Fear of falling questionnaire. Fatigue. Timepoint: Before the start of the intervention, after the tenth session of the intervention, and 6 weeks after the end of the intervention. Method of measurement: Fatigue Severity Scale questionnaire. Activity of daily living. Timepoint: Before the start of the intervention, after the tenth session of the intervention, and 6 weeks after the end of the intervention. Method of measurement: Lawton questionnaire. Postural control. Timepoint: Before the start of the intervention, after the tenth session of the intervention, and 6 weeks after the end of the intervention. Method of measurement: Force Plate. Functional mobility. Timepoint: Before the start of the intervention, after the tenth session of the intervention, and 6 weeks after the end of the intervention. Method of measurement: Time Up & Go test. Semnan University of Medical Sciences Approved 2023-10-30 Research Ethics Committees of Semnan University Of Medical Sciences and Health Services 5 km Damghan Road, school of Rehabilitation Semnan Semnan Iran (Islamic Republic of)