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IRCT20210905052374N1 IRCT 2021-11-14 Tehran University of Medical Sciences Effects of rTMS and tDCS in balance of MS patients Comparison of the effects of rTMS and tDCS combined with postural exercises on balance, postural stability and level of fear of falling in patients with Multiple sclerosis: a double-blind randomized controlled trial 2022-04-21 anticipated 60 Complete https://irct.ir/trial/58852 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We will use the Block randomization method of the Restricted randomization method. Block randomization will be done by using Random allocation software and sealed envelopes, Blinding description: All participants are blind to the sham and active applications of the rTMS and tDCS. All outcome measures are taken before and after the intervention by a blinded physiotherapist. N/A Multiple Sclerosis (MS). Participants in intervention group 1(cerebellar rTMS with postural training) receive 20 min of rTMS on their cerebellum during progressive postural training on the Biodex Balance System. Participants in intervention group 2 (cerebellar tDCS with postural training) receive 20 min of rTMS on their cerebellum during progressive postural training on the Biodex Balance System. In the sham rTMS and tDCS group (sham rTMS, and tDCS with postural training), participants receive only 30 s of stimulation at the beginning of a postural training session.. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after unidentified individuals. When: Starting 6 months after publication. To whom: Anyone interested can access the data. Conditions: Any kind of analysis is allowed, provided that if the information is used somewhere, the source will be mentioned. Where to obtain: Mostafa Rahimi rahimim@sina.tums.ac.ir 0098 912 2070616 How to obtain: All he/she has to do is send an email and he/she will receive the information within a month. Comments:
public Mostafa Rahimi
District 12, Enghelab St, Pich-e-Shemiran
Tehran Iran (Islamic Republic of) 11489-65111 +98 21 7753 3939 rahimim@sina.tums.ac.ir Tehran University of Medical Sciences scientific Mostafa Rahimi
District 12, Enghelab St, Pich-e-Shemiran
Tehran Iran (Islamic Republic of) 11489-65111 +98 21 7753 3939 rahimim@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Clinically definite MS Age > 20 and <65 years Disability between 4.5 and 6.5 on the Expanded Disability Status Scale (EDSS) Walking ability according to the EDSS score A minimal leg spasticity score ≤ 1 on the Modified Ashworth spasticity scale 20 years 65 years Both Pregnant women Neurological, orthopedic and severe cardiac comorbidities Peripheral vestibular disorders (i.e., positional paroxysmal vertigo, Meniere’s disease, and acoustic neuroma) Blindness in one or both eyes Exacerbation in the past 2 months Exacerbation during the study Treatment - Devices Participants in intervention group 1(cerebellar rTMS with postural training) receive 20 min of rTMS on their cerebellum during progressive postural training on the Biodex Balance System. Participants in intervention group 2 (cerebellar tDCS with postural training) receive 20 min of rTMS on their cerebellum during progressive postural training on the Biodex Balance System. In the sham rTMS and tDCS group (sham rTMS, and tDCS with postural training), participants receive only 30 s of stimulation at the beginning of a postural training session. The stability indices at both static and dynamic levels of the Biodex Balance System. Timepoint: Before and after the intervention. Method of measurement: The Biodex Balance System (302-950 model, Biodex Medical Systems, Inc., New York, USA). The Berg Balance Scale Score. Timepoint: Before and after the intervention. Method of measurement: Questionnaire. Tehran University of Medical Sciences Approved 2021-06-30 Ethics committee of Tehran University of Medical Sciences District 12, Enghelab St, Pich-e-Shemiran. Tehran University of Medical Sciences - School of Rehabilitation Tehran Tehran Iran (Islamic Republic of)