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IRCT20250826067002N1 IRCT 2025-09-05 Mashhad University of Medical Sciences The Effectiveness of HABIT_ILE on Activities of Daily Living The Effectiveness of HABIT-ILE Training on Participation in Activities of Daily Living and Occupational Performance in Patients with Multiple Sclerosis 2025-09-23 anticipated 48 Complete https://irct.ir/trial/85825 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Education/Guidance, Randomization description: In this study, the block randomization method is used to generate the random allocation sequence. The allocation sequence will be generated using Random Allocation Software (RAS). RAS is a simple and practical tool for generating random allocation sequences in randomized clinical trials (RCTs). This software is freely available to researchers. RAS allows for the creation of a variety of randomization methods, such as simple randomization, block randomization, and randomization with unequal allocation. These features make RAS a suitable tool for designing interventional studies. In the block randomization method, RAS allows the size of the blocks (e.g., 4, 6, or 8) to be specified and the sequence of allocation to different groups (e.g., intervention and control) to be randomly determined within each block. The order of groups within blocks can also be set to be fixed or random, which helps to increase the accuracy of the allocation concealment method, Blinding description: To conceal allocation, opaque, randomly numbered envelopes will be used. The order of the envelopes will be in accordance with the sequence generated by the RAS software, and each envelope will contain the corresponding group assignment. The envelopes will be prepared by an individual independent of the research team and will only be opened when the participant enters the study. N/A Multiple Sclerosis. Intervention 1: Intervention group: HABIT-ILE exercises will be given for 4 weeks, 3 one-hour sessions per week, in addition to regular occupational therapy services. HABIT-ILE exercises consist of structured bimanual activities involving the trunk and lower extremities, designed based on the HABIT exercise methodology. Intervention 2: Control group: The control group will only continue the standard occupational therapy interventions they received before the study began. No - There is not a plan to make this available Justification or reason for not sharing IPD is If necessary, de-identified data will be published.
public Alireza Amiri
Occupational Therapy Department, School of Paramedical and Rehabilitation Sciences, Mashhad University of Medical Sciences, Azadi sq., Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9177948964 +98 51 3884 6710 Alireza.Amiri.ot@gmail.com Mashhad University of Medical Sciences scientific Alireza Amiri
Occupational Therapy Department, School of Paramedical and Rehabilitation Sciences, Mashhad University of Medical Sciences, Azadi sq., Mashhad, Iran
Mashhad Iran (Islamic Republic of) 9177948964 +98 51 3884 6710 Alireza.Amiri.ot@gmail.com Mashhad University of Medical Sciences Iran (Islamic Republic of) Diagnosis of multiple sclerosis Ability to active anti-gravity movements in upper and lower extremities At least 20 degrees of extension in wrist At least 10 degrees of extension in IP and MP joints At least 20 years of age Informed consent to participate in the study Participation in two-handed exercises and the ability to follow training sessions 20 years no limit Both Complete paralysis in any of the upper limbs Presence of severe cognitive impairments affecting exercise G35 Multiple sclerosis Rehabilitation Rehabilitation Intervention group: HABIT-ILE exercises will be given for 4 weeks, 3 one-hour sessions per week, in addition to regular occupational therapy services. HABIT-ILE exercises consist of structured bimanual activities involving the trunk and lower extremities, designed based on the HABIT exercise methodology. Control group: The control group will only continue the standard occupational therapy interventions they received before the study began. The main outcomes include the assessment of the individual's ability to participate in activities of daily living and occupational functioning. Timepoint: In two stages, before the intervention and after the end of the four weeks of intervention. Method of measurement: by the Barthel index, FIM, and COPM tools. Mashhad University of Medical Sciences Approved 2025-08-16 Ethics committee of Mashhad University of Medical Sciences Azadi sq. Mashhad University of Medical Sciences Mashhad Razavi Khorasan Iran (Islamic Republic of)