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IRCT20210909052421N4 IRCT 2023-04-23 Prince Sattam bin Abdul-Aziz university Long-term effect of CoDuSe balance exercise program Long-term effect of CoDuSe program on balance, fall risk, and gait in patients with multiple sclerosis 2023-04-23 anticipated 50 Complete https://irct.ir/trial/69712 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A computer-based randomization program, by an independent researcher, allocated the patients randomly into two groups (study and control group) equally, Blinding description: Patients were recruited and allocated randomly into on of the two groups. Based on the randomized block design,a drawing sealed non-transparent envelope with a specific code for each envelope was chosen by all participants for either group (group A and group B ) under the supervision of a blinded independent assessor. N/A multiple sclerosis. Intervention 1: The study group received the CoDuSe balance training combined with the selected exercise program. The CoDuSe balance exercise was given in small groups (two to five people) with at least one physical therapy present. The first 15 min were primarily focused on core stability exercise, that is, controlled leg movements. The participants were then encouraged to maintain a focus on core stability while performing the remaining exercises, which included dual tasking and sensory strategies such as carrying something while walking or walking on an uneven surface. Intervention 2: Control group: The control group received the selected exercise program. The study group and the control group both received the conventional exercise program which included progressive static and dynamic balance exercises, that was presented by the ability to hold trunk against minimal then moderate push in unexpected directions from sitting then standing positions. Yes - There is a plan to make this available What will be shared: patient information sheet , raw data , results When: after publication To whom: public Conditions: statistical analysis Where to obtain: n.radwan@psau.edu.sa How to obtain: via email. research gate Comments:

public Nadia Lotfy Radwan

ALmanifeia, Alraghi building

Alkharj Saudi Arabia 00966 +966 56 172 8094 n.radwan@psau.edu.sa Prince Sattam bin Abdulaziz University scientific Ethics committee of Prince Sattam Bin Abulaziz university

ALmanifeia, Alraghi building

Alkharj Saudi Arabia 00966 +966 11 588 6553 assprofpnu@gmail.com Prince Sattam bin Abdualaziz University Saudi Arabia The age ranged from 20 to 50 years. The body mass index (BMI) was 25 to 35 kg/m2. The duration of illness not more than 10 years, with no relapses over the past three months. Walking ability not exceeding 200 m (with or without a walking aid). Ability to transfer between a wheelchair and a plinth with only slight assistance (in order to be able to participate in the intervention). 20 years 50 years Both Patients with any difficulty to communicate or understand the program instructions. Any other neurological deficits or orthopedic abnormalities or cardiovascular diseases. Patients who have participated in balance exercise administered by health care personnel during the past 30 days. Patients who have started or changed medication with 4-aminopyridine during the past 30 days G35 Demyelinating diseases of the central nervous system- multiple sclerosis Rehabilitation Rehabilitation The study group received the CoDuSe balance training combined with the selected exercise program. The CoDuSe balance exercise was given in small groups (two to five people) with at least one physical therapy present. The first 15 min were primarily focused on core stability exercise, that is, controlled leg movements. The participants were then encouraged to maintain a focus on core stability while performing the remaining exercises, which included dual tasking and sensory strategies such as carrying something while walking or walking on an uneven surface. Control group: The control group received the selected exercise program. The study group and the control group both received the conventional exercise program which included progressive static and dynamic balance exercises, that was presented by the ability to hold trunk against minimal then moderate push in unexpected directions from sitting then standing positions. Static and dynamic balance. Timepoint: All patients were assessed four times, pretreatment, one-week post-treatment, after 6 and 12 months after the rehabilitation program. The rehabilitation program lasted for 8 weeks. Method of measurement: The Berg Balance Test. Fall risk index test. Timepoint: All patients were assessed four times, pretreatment, one-week post-treatment, after 6 and 12 months after the rehabilitation program. The rehabilitation program lasted for 8 weeks. Method of measurement: the Biodex Balance System. Gait speed. Timepoint: All patients were assessed four times, pretreatment, one-week post-treatment, after 6 and 12 months after the rehabilitation program. The rehabilitation program lasted for 8 weeks. Method of measurement: the timed 25-foot walk test. Walking ability. Timepoint: All patients were assessed four times, pretreatment, one-week post-treatment, after 6 and 12 months after the rehabilitation program. The rehabilitation program lasted for 8 weeks. Method of measurement: 12-Item MS walking scale. self funding Approved 2023-01-10 Ethics committee of Prince Sattam Bin Abulaziz university ALmanifeia, Alraghi building Alkharj Riyadh Saudi Arabia