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IRCT20250629066292N2 IRCT 2025-07-23 Tehran University of Medical Sciences Quantitative assessment and modeling of balance and gait recovery patterns in patients with Multiple Sclerosis for designing therapeutic protocols based on antigravity treadmill training Quantitative assessment and modeling of balance and gait recovery patterns in patients with Multiple Sclerosis for designing therapeutic protocols based on antigravity treadmill training 2025-08-11 anticipated 36 Recruiting https://irct.ir/trial/84768 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, simple randomization will be used for patient allocation, and the unit of randomization is the individual patient. A random allocation sequence for 36 patients will be generated using the RAND() function in Microsoft Excel. Each patient will be assigned a random number, and the list will then be sorted based on these numbers. The first 18 patients on the list will be allocated to the intervention group, and the next 18 will be allocated to the control group. For allocation concealment, the allocation result for each patient (intervention or control group) will be written on a card and placed in a sealed, opaque envelope. These envelopes will be sequentially numbered. After a patient meets the inclusion criteria and signs the informed consent form, the corresponding envelope will be opened by an individual not involved in the assessment or treatment process to reveal the patient's group assignment. N/A Multiple sclerosis - MS disease. Intervention 1: Intervention group: Participants will undergo a modern skill acquisition rehabilitation program using an anti-gravity treadmill for 30 minutes per session, 3 times a week, for a total of 24 sessions over two months. The anti-gravity treadmill enables the patient to walk actively and voluntarily by reducing their body weight (by up to 80%), thereby enhancing their gait skills. The anti-gravity treadmill consists of a standard treadmill enclosed within an inflatable, pressurized chamber. The individual is positioned inside the device while wearing specialized neoprene shorts, which are then zipped into the chamber. Subsequently, the chamber is inflated with air using built-in pumps. The air pressure generated within the chamber creates a lifting force on the body, which reduces the user's effective body weight. The amount of this weight reduction is controlled by adjusting the pressure inside the chamber. When using the device, the body weight reduction allows the patient to walk more easily and with a more normative gait pattern. Consequently, through intensive and consistent training, the patient can learn and reinforce a more correct walking skill. Intervention 2: Control group: The control group in this study will receive a standard occupational therapy program for 30 minutes per session, 3 times a week, for a period of 2 months (total of 24 sessions). The primary focus of this program is on improving endurance and balance.In this group, patients will be under the supervision of occupational therapists and will follow an exercise regimen that includes muscle strengthening, balance, and endurance training. The balance exercises are specifically designed to improve both static and dynamic balance and to prevent falls. This program is delivered regularly, adhering to standard occupational therapy practices, and does not involve the use of the specific technology (the anti-gravity treadmill) employed in the intervention group. 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 At this stage of the project, a formal plan for sharing the de-identified Individual Participant Data (IPD) has not yet been developed. The decision regarding data sharing will be made after the completion of the study, following a thorough review of the participant consent forms and our institution's data sharing policies to ensure that patient confidentiality is fully protected.
public Mohammad Mehdi Mirbagheri
Tehran university of medical science, Poursina st
Tehran Iran (Islamic Republic of) 1417466893 02164051 mehdi.northwestern@gmail.com Tehran University of Medical Sciences scientific Mohammad Mehdi Mirbagheri
Tehran university of medical science, Poursina st
Tehran Iran (Islamic Republic of) 1417466891 +98 21 6646 6383 mehdi.northwestern@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Suffering from moderate to severe MS Ability to stand and take at least 3 steps independently. Age between 18 and 50 years. Informed consent to participate in the study. 18 years 50 years Both Heart or vascular problems that do not allow for sports activities. Serious problems in the knee or hip joints that prevent the use of an anti-gravity treadmill. The patient's lack of cooperation during the treatment period. Severe MS attacks that cause disability or hospitalization of the patient. G35 Multiple sclerosis Rehabilitation Rehabilitation Intervention group: Participants will undergo a modern skill acquisition rehabilitation program using an anti-gravity treadmill for 30 minutes per session, 3 times a week, for a total of 24 sessions over two months. The anti-gravity treadmill enables the patient to walk actively and voluntarily by reducing their body weight (by up to 80%), thereby enhancing their gait skills. The anti-gravity treadmill consists of a standard treadmill enclosed within an inflatable, pressurized chamber. The individual is positioned inside the device while wearing specialized neoprene shorts, which are then zipped into the chamber. Subsequently, the chamber is inflated with air using built-in pumps. The air pressure generated within the chamber creates a lifting force on the body, which reduces the user's effective body weight. The amount of this weight reduction is controlled by adjusting the pressure inside the chamber. When using the device, the body weight reduction allows the patient to walk more easily and with a more normative gait pattern. Consequently, through intensive and consistent training, the patient can learn and reinforce a more correct walking skill. Control group: The control group in this study will receive a standard occupational therapy program for 30 minutes per session, 3 times a week, for a period of 2 months (total of 24 sessions). The primary focus of this program is on improving endurance and balance.In this group, patients will be under the supervision of occupational therapists and will follow an exercise regimen that includes muscle strengthening, balance, and endurance training. The balance exercises are specifically designed to improve both static and dynamic balance and to prevent falls. This program is delivered regularly, adhering to standard occupational therapy practices, and does not involve the use of the specific technology (the anti-gravity treadmill) employed in the intervention group. Stiffness. Timepoint: Before the start of treatment, After one month of receiving the treatment program, Immediately after completing the treatment program, One month after the end of treatment(Follow-up). Method of measurement: Neuromuscular rehabilitation robot device. Center of pressure fluctuations. Timepoint: Before the start of treatment, After one month of receiving the treatment program, Immediately after completing the treatment program, One month after the end of treatment(Follow-up). Method of measurement: Force plate. Timed Up and Go Test. Timepoint: Before the start of treatment, After one month of receiving the treatment program, Immediately after completing the treatment program, One month after the end of treatment(Follow-up). Method of measurement: Stopwatch. Step length. Timepoint: Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), Immediately after completing the treatment program (Post-treatment), One month after the end of treatment (Follow-up). Method of measurement: Using marker positions in the motion capture lab. Walking speed. Timepoint: Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), Immediately after completing the treatment program (Post-treatment), One month after the end of treatment (Follow-up). Method of measurement: Using marker positions in the motion capture lab. Ankle joint angles. Timepoint: Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), Immediately after completing the treatment program (Post-treatment), One month after the end of treatment (Follow-up). Method of measurement: Using marker positions in the motion capture lab. Fluctuations in the center of static pressure. Timepoint: Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), Immediately after completing the treatment program (Post-treatment), One month after the end of treatment (Follow-up). Method of measurement: Force plate. Active ankle range of motion. Timepoint: Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), Immediately after completing the treatment program (Post-treatment), One month after the end of treatment (Follow-up). Method of measurement: Neuromuscular rehabilitation robot displacement recording sensor. Maximum voluntary contraction force. Timepoint: Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), Immediately after completing the treatment program (Post-treatment), One month after the end of treatment (Follow-up). Method of measurement: Torque recording sensor for neuromuscular rehabilitation robot. Speed of voluntary joint movement. Timepoint: Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), Immediately after completing the treatment program (Post-treatment), One month after the end of treatment (Follow-up). Method of measurement: Neuromuscular rehabilitation robot displacement recording sensor. 10-meter walking test time. Timepoint: Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), Immediately after completing the treatment program (Post-treatment), One month after the end of treatment (Follow-up). Method of measurement: Stopwatch. 6-minute walk test. Timepoint: Before the start of treatment (Baseline), After one month of receiving the treatment program (Mid-point), Immediately after completing the treatment program (Post-treatment), One month after the end of treatment (Follow-up). Method of measurement: Meter. Tehran University of Medical Sciences Approved 2025-05-13 Tehran University of Medical Sciences Research Ethics Committee Tehran university of medical science, Poursina st, Tehran Tehran Iran (Islamic Republic of)