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IRCT20201102049234N1 IRCT 2020-11-14 Semnan University of Medical Sciences The Effects of Anodal tDCS on Incontinency in Patients with Multiple Sclerosis (MS) tDCS The Effects of Short-Term and Long-Term Anodal tDCS over M1 Cortex Concurrent with Pelvic Floor Muscle Training (PFMT) on Pelvic Floor Muscle Function and Incontinency in Patients with Multiple Sclerosis (MS) 2021-01-20 anticipated 30 Complete https://irct.ir/trial/52036 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization with a random number table such that each person is given a code and they are written in a table. We select one place from the table in a blinded manner. Then we select 12 numbers smaller than the selected number in the same row. The same would be true for the treatment and control group, Blinding description: The researcher will be blind to the intervention using the research assistant and he/she is absent in the treatment room. The outcome evaluator will vary with the researcher and research data be given him with code and is unaware of the participants intervention. N/A Multiple sclerosis. Intervention 1: Intervention group: Anodal tDCS over M1 cortex concurrent group with progressive exercises of pelvic floor muscles. Intervention 2: Intervention group: Anodal sham tDCS over M1 cortex concurrent group with progressive exercises of pelvic floor muscles. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There are not more informations
public Fariba Ramezani
Neuromuscular Rehabilitation Research Center, Tabatabaee Clinic, Qods Blvd., Semnan
Semnan Iran (Islamic Republic of) 3519618375 +98 23 8502 3332 mona.ramezani.sa@gmail.com Semnan University of Medical Sciences scientific Fatemeh Ehsani
Neuromuscular Rehabilitation Research Center, Tabatabaee Clinic, Qods Blvd., Semnan
Semnan Iran (Islamic Republic of) 3519618375 +98 23 8502 3332 fatemehehsani59@yahoo.com Semnan University of Medical Sciences Iran (Islamic Republic of) Women with Definitive Diagnosis of MS with Stable Disease over the Previous 4 Months Definite MS Diagnosis According to the 2010 Revised McDonald Criteria Age Is Between 18 and 45 Years Having Symptoms of Urinary Incontinence Patients Have Received Stable Pharmacological Therapies for the Past 6 Months Patient's Expanded disability status scale (EDSS) Score Should Be Less than 6.5 Patients Have the Cognitive Capacity to Complete the Assessment and Treatment Protocol Minimal Ability to Contract the Pelvic Floor Muscles To Be Willing to Participate in the Study 18 years 45 years Female History of MS Relapse during Treatment Being Pregnant or in the First 6 Months Post-Partum Cesarean Section or Vaginal Delivery within 6 Months Previously to Time of Enrolment Pelvic Organ Prolapse at Vaginal Examination Urinary Tract Infection Having Undergone Surgical Treatment for Urinary Incontinence Having Undergone Prior Physiotherapy for Urinary Incontinence The Presence of Any Other Neurological or Kidney Disease Contraindications of Electrical Stimulation Declining to Participate in the Study Inability to Understand and Comply with the Study Procedures G35 Multiple sclerosis Treatment - Devices Treatment - Devices Intervention group: Anodal tDCS over M1 cortex concurrent group with progressive exercises of pelvic floor muscles Intervention group: Anodal sham tDCS over M1 cortex concurrent group with progressive exercises of pelvic floor muscles Level of urinary incontinence. Timepoint: Before the intervention, 4 and 6 weeks after the start of intervention and one month after the end of intervention. Method of measurement: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form. Pelvic floor muscle function. Timepoint: Before the intervention, 4 and 6 weeks after the start of intervention and one month after the end of intervention. Method of measurement: ultrasonographic device. Semnan University of Medical Sciences Approved 2020-10-27 Ethics committee of Semnan University of Medical Sciences Headquarters of Semnan University of Medical Sciences, Basij Blvd., Semnan Semnan Semnan Iran (Islamic Republic of)