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IRCT20240709062370N1 IRCT 2024-07-15 The University of Isfahan Optimizing Rehabilitation in People with Multiple Sclerosis Optimizing Rehabilitation in People with Multiple Sclerosis 2024-08-05 anticipated 30 Complete https://irct.ir/trial/77831 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: A simple randomization method. For this purpose, the participants were listed alphabetically and each participant was assigned numbers one and two from this list. The unit of randomization was individual, and randomization was produced and applied using Excel software and the combination of two commands, SORTBY and ARRAYRAND. By applying this method, each participant will be randomly replaced in the control or optimal group, and the role of all related/unrelated variables in the selection of participants in the two groups will be randomly neutralized, Blinding description: The participants of both groups of this study will be told in general that they are going to participate in a course of personalized stepping exercises for MS patients. Permission to use this trial was obtained from the ethics committee. It should be noted that the type of exercises of both groups will be exactly the same and the only difference between the groups is the feedback they receive while performing the movement exercises. All items measured in the pre-test and post-test, the instructions given/not given to perform the tests and movement exercises will be exactly the same for all participants. The participants of both groups will be unaware of the exact purpose of doing the exercises that are included in the specific research hypotheses. However, all participants (MS patients) will be blinded in the study. At the time of allocating the participants to the control and optimal groups, according to the method used for randomization, both the participants and the researcher will be unaware of the allocation of the participants in the study groups and has no role in the allocation. However, due to the nature of the trials that will be applied over 8 weeks, there will be differences in the feedback provided to the groups. To avoid the bias of the evaluators/trainers, one person is used for this purpose for both groups. Therefore, during the experiments, the main researcher (evaluator/trainer) will necessarily know which group each participant belongs to. For this reason, the one-sided blind study option was chosen and it cannot be considered completely double-blind. N/A Multiple Sclerosis (MS). Intervention 1: The optimal group (intervention): this group will participate in exactly the same pre-tests and post-tests as the control group. The equipment used, the duration of training sessions, and the length of the trial period of this group will be exactly the same as the control group and will be 8 weeks. The only difference will be in the content of the feedback provided during the practice sessions. Intervention 2: Control group: This group will participate in exactly the same pre-tests and post-tests as the optimal (experimental) group. The equipment used, the duration of training sessions, and the length of the trial period of this group will be exactly the same as the optimal group and 8 weeks. The only difference will be in the content of the feedback provided during the practice sessions. 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 This will be done if there is a request for data.
public Hamid Salehi
The University of Isfahan, Azadi Square, Isfahan
Isfahan Iran (Islamic Republic of) 8174673444 +98 31 3793 2577 Dr.Salehi@gmail.com The University of Isfahan scientific Hamid Salehi
The University of Isfahan, Azadi square, Isfahan
Isfahan Iran (Islamic Republic of) 8174673444 0098 Salehi@spr.ui.ac.ir The University of Isfahan Iran (Islamic Republic of) clinical diagnosis of MS years of age 30-50 patients with a range of disabilities, with scores on the Expanded Disability Status Scale (EDSS) from 2.00 to 4.00 ability to walk without aid (e.g., cane), 30 years 50 years Both cognitive impairments other neurologic disorders severe contracture in the lower limbs G35 Multiple sclerosis Rehabilitation Rehabilitation The optimal group (intervention): this group will participate in exactly the same pre-tests and post-tests as the control group. The equipment used, the duration of training sessions, and the length of the trial period of this group will be exactly the same as the control group and will be 8 weeks. The only difference will be in the content of the feedback provided during the practice sessions. Control group: This group will participate in exactly the same pre-tests and post-tests as the optimal (experimental) group. The equipment used, the duration of training sessions, and the length of the trial period of this group will be exactly the same as the optimal group and 8 weeks. The only difference will be in the content of the feedback provided during the practice sessions. Static and dynamic balance. Timepoint: Pre test, mid test, post test. Method of measurement: Timed Up and Go test. Static and dynamic balance. Timepoint: Pre test, Post test. Method of measurement: Timed Up and Go test (TUG). Depression symptoms. Timepoint: Pre test, Post test. Method of measurement: Beck Depression Inventory. Walking speed. Timepoint: Pre test, Post test. Method of measurement: 25 foot walking. Fatigue. Timepoint: Post test. Method of measurement: The Fatigue Scale for Motor and Cognitive Functions, Multiple Sclerosis. Quality of life. Timepoint: Post test. Method of measurement: Multiple Sclerosis Impact Scale. The University of Isfahan Approved 2023-12-23 Research Ethics Committees of University of Isfahan the University of Isfahan, Azadi square, Isfahan Isfahan Isfehan Iran (Islamic Republic of)