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IRCT20200101045970N8 IRCT 2023-01-01 Esfahan University of Medical Sciences The effect of exercise therapy on balance in patients with multiple sclerosis MS A Comparative Study of the Effect of Reactive and Proactive Exercises on Balance and Balance Confidence in Multiple Sclerosis Patients : A Randomized Clinical Trial 2023-01-21 anticipated 51 Complete https://irct.ir/trial/65164 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients are randomly divided into one of three reactive, proactive and control groups after examining the inclusion and exclusion criteria. In this study, due to the small number of samples, in consultation with a statistician, it was decided to use the random blocking method. Blocking is usually used to balance the number of samples assigned to each of the groups studied. The statistician used the website https://www.sealedenvelope.com/simple-randomiser/v1/lists, Considering that we had 3 groups, they designed 17 two-person blocks. . A person who divides patients into three groups based on this table is unaware of the study, Blinding description: In this study, because sufficient information about the exercises is given to the participants and it is explained to each of them that they may be randomly placed in one of the three groups, so the participants are not blind. In this study, the evaluator of balance and confidence in balance does not know which group the participant is in, so our evaluator is blind. In addition, the person analyzing the data does not know which person is in which group and only compares the data between the three groups, so they are also blind. N/A Multiple Sclerosis. Intervention 1: Intervention group: Reactive exercises + conventional exercises. The duration of each treatment session for the intervention group is 60 minutes.5 minutes of warm-up, 25 minutes of common balance exercises, 25 minutes of relevant balance exercises (reactive) and 5 minutes of cooling down. Intervention 2: Intervention group: Proactive exercises + conventional exercises. The duration of each treatment session for the intervention group is 60 minutes.5 minutes of warm-up, 25 minutes of common balance exercises, 25 minutes of relevant balance exercises (Proactive) and 5 minutes of cooling down. Intervention 3: Control group: Conventional exercises.5 minutes of warm up, 25 minutes of common balance exercises and 5 minutes of cool down. No - There is not a plan to make this available Justification or reason for not sharing IPD is Because of confidentiality
public Ehsan Ghasemi
Faculty of Rehabilitation Sciences, Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3669 3089 eghasemi@rehab.mui.ac.ir Esfahan University of Medical Sciences scientific Ehsan Ghasemi
Faculty of Rehabilitation Sciences,Isfahan University of Medical Sciences and Health Services, Hezar Jerib St.
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3669 3089 eghasemi@rehab.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Diagnosis of MS by a specialist doctor Age range from 20 to 50 years and being in the remession period At least one year has passed since the diagnosis of the disease having a mild to moderate degree of disability (EDSS=3.5-5.5) determined by a specialist doctor. Being able to stand without assistance for at least 3 minutes 20 years 50 years Both Lack of regular participation in training sessions Recurrence of the disease during the plan and six months before Excessive fatigue so that it is harmful for her to continue training. Biomechanical or neurological disease or any specific disease in the expert's opinion that affects balance. Participation in a specific exercise program in the 3 months before and during treatment Suffering from other diseases such as cardiovascular, arthritis, respiratory, diabetes, cancer and vestibular system disorders according to the opinion of the relevant expert. A deformity in the lower limb that creates a risk of falling for the person. Use of medicinal agents to control fatigue and sedatives that affect balance. Cognitive disorders and depression and sleep that lead to fatigue. G35 Multiple sclerosis Rehabilitation Rehabilitation Rehabilitation Intervention group: Reactive exercises + conventional exercises. The duration of each treatment session for the intervention group is 60 minutes.5 minutes of warm-up, 25 minutes of common balance exercises, 25 minutes of relevant balance exercises (reactive) and 5 minutes of cooling down. Intervention group: Proactive exercises + conventional exercises. The duration of each treatment session for the intervention group is 60 minutes.5 minutes of warm-up, 25 minutes of common balance exercises, 25 minutes of relevant balance exercises (Proactive) and 5 minutes of cooling down. Control group: Conventional exercises.5 minutes of warm up, 25 minutes of common balance exercises and 5 minutes of cool down. Balance. Timepoint: Before the start of treatment, after the end of treatment and 1 months after the end of the last treatment session. Method of measurement: Use of Mini BES Test. Balance Confidence. Timepoint: Before the start of treatment, after the end of treatment and 1 months after the end of the last treatment session. Method of measurement: Use of ABC Scale. Number of falls per week. Timepoint: Before the start of treatment, after the end of treatment and 1 months after the end of the last treatment session. Method of measurement: questionnaire. Esfahan University of Medical Sciences Approved 2022-12-28 Ethics committee of Isfahan University of Medical Sciences Hezar Jrib Isfahan Isfehan Iran (Islamic Republic of)