]>
IRCT20210614051581N1 IRCT 2023-01-25 Kharazmi University effect of exercise treatment in patients with multiple sclerosis. Comparison of the effect of dual task exercise versus combined exercise in water and land on balance and gait of patients with multiple sclerosis. 2023-01-28 anticipated 78 Complete https://irct.ir/trial/67036 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Factorial, Purpose: Supportive, Randomization description: Randomization method: block randomization Randomization unit: it is individual. Randomization type: Randomization will be online randomization using the website http://randomizer.org/. Patients who meet the inclusion criteria will be randomly assigned to the experimental group (exercise in water and exercise on land) and the control groups. In this site, first, the number of sets of random numbers that is needed is determined (six sets of numbers are needed; 1. experimental group A, 2. experimental group B, 3. experimental group C, 4. experimental group D, 5. group Control E, and 6. control group F). The numbers that Research Randomizer needs to generate in each set are determined (six sets of 13 numbers are needed for each group). We specify the minimum and maximum amount of numbers that need to be produced (from 1 to 78). Concealment: Concealment of random assignment using a block randomization table (blocks of 10) generated by computer (number 1 for experimental group 1, number 2 for experimental group 2, number 3 for experimental group 3 and number 4 for experimental group, number 5 for control group and number 6 for control group) will be done before the start of data collection by a researcher who will not participate in calling or treating patients. Randomization tool: Random numerical sequence is placed in non-transparent and sealed envelopes. Another investigator, blinded to the initial assessment, will open an envelope and proceed with treatment as assigned by the group, Blinding description: This study,is doubled blinded, and the outcome assessor and the data analyst will be blind (uninformed) regarding the allocation of groups. Patients will be aware of the type of study. Outcome assessor : In this study, an independent evaluator who does not know the hypothesis and methods of the study will evaluate the results before the interventions and 12 weeks after the interventions. Data analyst: The data analyst is blinded. the collected data will be matched with the codes given to each patient. so, the data analyst will see each patient in the form of a code, and the grouping of patients will not be recognizable to him. N/A multiple sclerosis. Intervention 1: Intervention group: dual-task exercise in water Dual task exercises are exercises in which both cognitive and motor exercises are prescribed to the patient. For example, walking in water while deducting seven numbers from the number 129. Dual task exercises in water are first presented separately in the form of single cognitive exercises, then in the form of movement exercises and finally by combining both of these exercises, dual task exercises are presented to the subject. These exercises are performed in a swimming pool depth of 120 cm and at a water temperature of 30 to 31. The ambient temperature of the pool will be maintained around 26 to 28 degrees Celsius. These exercises last two days a week for 12 weeks (24 sessions) for one hour in each session. Intervention 2: Intervention group: dual task exercise on land These exercises are the same as the dual task exercises in the water, with the difference that they will be performed on land and in the gym.Dual task exercises are exercises in which both cognitive and motor exercises are prescribed to the patient. For example, walking in land while deducting seven numbers from the number 129. Dual task exercises inland are first presented separately in the form of single cognitive exercises, then in the form of movement exercises and finally by combining both of these exercises, dual task exercises are presented to the subject. These exercises last two days a week in a period of 12 weeks (24 sessions) for one hour in each session. Intervention 3: Intervention group: combined exercise in water These exercises will also be performed in water, with the difference that instead of performing dual task, combined exercises (including strength, endurance and stretching exercises) will be used.Therefore, it is not a repetitive intervention. These exercises will be performed in water depth of 120 cm and at a water temperature of 30 to 31 degrees Celsius, and the pool's ambient temperature is maintained at 26 to 28 degrees Celsius. These exercises last two days a week in a period of 12 weeks (24 sessions) for one hour in each session. The specialist considers existing muscle weaknesses and balance defects to prescribe sports exercises. These deficits are determined based on manual muscle testing to assess weakness based on participant observation. All sessions begin with a 10-minute warm-up and end with a 5-minute cool-down. Joint stretching of the muscles plus specific stretching is done according to the specific needs of the participants. Combined exercises in the water include a strength, aerobic and balance training program. Intervention 4: Intervention group: combined exercise on land In this group, combined exercises are performed in the gym and on land. Therefore, it will not be a repeated intervention. These exercises last two days a week in a period of 12 weeks (24 sessions) for one hour in each session. The specialist considers existing muscle weaknesses and balance defects to prescribe sports exercises. These deficits are determined based on manual muscle testing to assess weakness based on participant observation. All sessions begin with a 10-minute warm-up and end with a 5-minute cool-down. Joint stretching of the muscles plus specific stretching is done according to the specific needs of the participants. Combined exercises in the water include a strength, aerobic and balance training program. Intervention 5: Control group: patients with multiple sclerosis walk in water. walking will also be performed in water, with no training protocole. walking in water will be performed in depth of 120 cm and at a water temperature of 30 to 31 degrees Celsius, and the pool's ambient temperature is maintained at 26 to 28 degrees Celsius. walking last two days a week in a period of 12 weeks (24 sessions) for one hour in each session. Intervention 6: Control group: patients with multiple sclerosis walk on land. walking will also be performed on land, with no training protocole. walking on land last two days a week in a period of 12 weeks (24 sessions) for one hour in each session. Yes - There is a plan to make this available What will be shared: Data files such as files related to the biomechanics of walking and motion analysis and gait tests, files related to EMG of worked muscles, dual-task questionnaires Balance scores and battery testsare the data that are examined in this study. will be. Data can potentially be shared after de-identifying individuals. When: The access period starts 6 months after the results are published in validate journals. To whom: Only researchers working in academic and scientific institutions Conditions: 1. if the originality of the work is preserved and the names and information of the authors of this study are mentioned. 2. After the original data are published by the main researchers in a valid journal, permission is given to use the documents. Where to obtain: saharnazary1992@gmail.com saharnazary1992@khu.ac.ir Sahar Nazary Soltan Ahmad How to obtain: After reading the email, the information will be sent to the researchers. Comments:
public Sahar Nazary soltan ahmad
KhU, No. 43. South Mofatteh Ave., Tehran, Iran
TEHRAN Iran (Islamic Republic of) 31979-37551 +98 21 8832 9220 std_saharnazary@khu.ac.ir Kharazmi University scientific Sahar Nazary soltan ahmad
KhU, No. 43. South Mofatteh Ave., Tehran, Iran
TEHRAN Iran (Islamic Republic of) 31979-37551 +98 21 8832 9220 saharnazary1992@khu.ac.ir Kharazmi University Iran (Islamic Republic of) patients with relapsing remitting type of multiple sclerosis. No MS relapse occurred within eight weeks prior to the inclusion Status Scale (EDSS) score ranging from 1.0 to 5.5 lack of regular physical exercise 20 years 60 years Both being unable to comply with the requirements of the protocol. Inability to stand and walk without aids and braces. G35 Multiple sclerosis Rehabilitation Rehabilitation Rehabilitation Rehabilitation Rehabilitation Rehabilitation Intervention group: dual-task exercise in water Dual task exercises are exercises in which both cognitive and motor exercises are prescribed to the patient. For example, walking in water while deducting seven numbers from the number 129. Dual task exercises in water are first presented separately in the form of single cognitive exercises, then in the form of movement exercises and finally by combining both of these exercises, dual task exercises are presented to the subject. These exercises are performed in a swimming pool depth of 120 cm and at a water temperature of 30 to 31. The ambient temperature of the pool will be maintained around 26 to 28 degrees Celsius. These exercises last two days a week for 12 weeks (24 sessions) for one hour in each session. Intervention group: dual task exercise on land These exercises are the same as the dual task exercises in the water, with the difference that they will be performed on land and in the gym.Dual task exercises are exercises in which both cognitive and motor exercises are prescribed to the patient. For example, walking in land while deducting seven numbers from the number 129. Dual task exercises inland are first presented separately in the form of single cognitive exercises, then in the form of movement exercises and finally by combining both of these exercises, dual task exercises are presented to the subject. These exercises last two days a week in a period of 12 weeks (24 sessions) for one hour in each session. Intervention group: combined exercise in water These exercises will also be performed in water, with the difference that instead of performing dual task, combined exercises (including strength, endurance and stretching exercises) will be used.Therefore, it is not a repetitive intervention. These exercises will be performed in water depth of 120 cm and at a water temperature of 30 to 31 degrees Celsius, and the pool's ambient temperature is maintained at 26 to 28 degrees Celsius. These exercises last two days a week in a period of 12 weeks (24 sessions) for one hour in each session. The specialist considers existing muscle weaknesses and balance defects to prescribe sports exercises. These deficits are determined based on manual muscle testing to assess weakness based on participant observation. All sessions begin with a 10-minute warm-up and end with a 5-minute cool-down. Joint stretching of the muscles plus specific stretching is done according to the specific needs of the participants. Combined exercises in the water include a strength, aerobic and balance training program. Intervention group: combined exercise on land In this group, combined exercises are performed in the gym and on land. Therefore, it will not be a repeated intervention. These exercises last two days a week in a period of 12 weeks (24 sessions) for one hour in each session. The specialist considers existing muscle weaknesses and balance defects to prescribe sports exercises. These deficits are determined based on manual muscle testing to assess weakness based on participant observation. All sessions begin with a 10-minute warm-up and end with a 5-minute cool-down. Joint stretching of the muscles plus specific stretching is done according to the specific needs of the participants. Combined exercises in the water include a strength, aerobic and balance training program. Control group: patients with multiple sclerosis walk in water. walking will also be performed in water, with no training protocole. walking in water will be performed in depth of 120 cm and at a water temperature of 30 to 31 degrees Celsius, and the pool's ambient temperature is maintained at 26 to 28 degrees Celsius. walking last two days a week in a period of 12 weeks (24 sessions) for one hour in each session. Control group: patients with multiple sclerosis walk on land. walking will also be performed on land, with no training protocole. walking on land last two days a week in a period of 12 weeks (24 sessions) for one hour in each session The brief repeated battery of neuropsychological tests. Timepoint: before and after intervention. Method of measurement: psychological and cognitive test. Dual task rate. Timepoint: before and after intervention. Method of measurement: dual task questionaire. Static and dynamic Balance rate. Timepoint: before intervention and after intervention. Method of measurement: force plate and motion analyze instrument. Biomechanic gait including movement angles and forces on the ground, which may change with intervention. Timepoint: before intervention and after intervention. Method of measurement: force plate and motion analyze instrument. Evaluation of electromyography during tasks. Timepoint: before intervention and after intervention. Method of measurement: electromyography instrument. Kharazmi University Approved 2022-11-21 Sport Sciences Research Institute (SSRI) No. 3, 5th Alley, Miremad Street, Motahhari Street, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)