The Effectiveness of HABIT-ILE Training on Participation in Activities of Daily Living and Occupational Performance in Patients with Multiple Sclerosis

The Effectiveness of HABIT-ILE Training on Participation in Activities of Daily Living and Occupational Performance in Patients with Multiple Sclerosis

A randomized, single-blind, parallel-group, controlled clinical trial will be conducted on 48 patients who will be classified into two groups: control and intervention. Random Allocation Software (RAS) will be used for randomization.

The necessary therapeutic facilities and equipment, such as occupational therapy clinics, functional and balance tools, and appropriate space for targeted exercises, are available at Ghaem Hospital in Mashhad.

Patients who received a diagnosis of multiple sclerosis (MS) by a physician or based on McDonald criteria; had the ability to perform active movements against gravity in the joints of the upper and lower limbs; had at least 20 degrees of extension in the wrist joint and 10 degrees of extension in the MP and IP joints; patients aged 20 years and older; consented to enter the study; and patients who were able to participate in two-handed exercises and were able to follow the training courses.

The intervention group will receive HABIT-ILE exercises 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.

The main outcomes include the assessment of the individual's ability to participate in activities of daily living and occupational function, which will be measured by the Barthel index, FIM, and COPM in two stages before and after the end of the four weeks of intervention.

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.

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.

If necessary, de-identified data will be published.

De-identified data that led to the study results.

After the study is completed

Researchers

Through correspondence with the corresponding author

correspondence with the corresponding author

The documents will be reviewed first and provided if approved.