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IRCT20220613055155N1 IRCT 2022-11-12 Shiraz University of Medical Sciences The effect of Action Observation on gait of persons with multiple sclerosis (MS) The effect of Action Observation therapy (AOT) on balance and kinematic parameters of gait in patients with multiple sclerosis. 2023-02-20 anticipated 24 Complete https://irct.ir/trial/64124 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: A simple randomization method will be used to assign people into two groups, which will be done by selecting numbered papers (1-24) that are inside sealed envelopes, and patients will be assigned to intervention and control groups. The patient will choose one of the envelopes, even numbers are assigned to the intervention group and odd numbers to the control group. Then the selected envelope will be removed and this procedure will be repeated for the next patient, Blinding description: The study was designed as a single-blinded study. In this intervention, the health care personnel or the clinical caregiver and the person who is in charge of the evaluation are kept blind. Before the trial started, participants were randomly divided into two groups, and other researchers were unaware of the distribution of patients. The clinical caregiver provides routine rehabilitation in the therapeutic exercise room, separate from the place where the activity observation intervention is offered, assuming that all participants will be subjected to the new intervention. Participants are asked not to discuss the movie they saw with the clinical caregiver. In addition, the evaluator evaluates the participants in a separate laboratory presuming all patients will undergo observation. We ask patients not to discuss the film they have seen with the evaluator. The evaluator and clinical supervisor are unaware of what is happening in the new intervention room as the leading researcher presents videos in a separate room. N/A Multiple Sclerosis. Intervention 1: Action observation intervention group: This group includes 12 patients with MS who are included in the study based on the inclusion criteria. In the first stage, the subjects of this group undergo a 30-minute routine rehabilitation, which will be performed by a blind occupational therapist familiar with the MS rehabilitation program. The physical training programs will focus on stretching exercises, balance, walking, and muscle strengthening. Then, in the second stage, the main researcher shows the video clips to the patients for 15 minutes. Then all the displayed exercises will be practiced by the patient and the main researcher for 15 minutes. To watch videos, a person sits on a comfortable chair in front of a 19-inch monitor 100 cm away from them. While watching the video, people are asked to watch carefully and do nothing. The videos in the intervention group include exercises related to walking, crossing an obstacle, going up and down stairs, and standing up and sitting on a chair, which was performed by a healthy adult man and was taken from the front, back, and side angles. Each exercise is shown for three minutes and the person is given one-minute rest between each series of videos. Both groups will receive three treatment sessions per week for six consecutive weeks. Intervention 2: control group: This group includes 12 patients with MS who are included in the study based on the inclusion criteria after receiving a 30-minute routine rehabilitation that includes stretching, strengthening, and balance exercises, in the second stage, videos include images of landscapes. They will observe nature videos, without any movement content for 15 minutes, and then they will receive the same exercise activities as the action observation intervention group. In fact, patients in the control group will receive the same rehabilitation protocol as the intervention group. During the sessions, they will simultaneously watch a video containing images of natural landscapes without moving content. In order to comply with ethical issues, a few Action observation treatment sessions will be conducted after the project's completion. Both groups will receive three treatment sessions per week for six consecutive weeks. Yes - There is a plan to make this available What will be shared: All the data of this study can be shared after de-identifying the participants. When: The data of this study will be accessible three months after the results are published. To whom: Researchers from academic and scientific institutions will have access to this study's data Conditions: Using this study does not require any special conditions. Where to obtain: To receive data and documents, please refer to Dr. Abolqasem Fallahzadeh, Professor of Shiraz Rehabilitation Faculty. Phone: 07136271551 E-mail: A_Fallahzadeh@Sums.ac.ir Address: Shiraz Faculty of Rehabilitation Sciences, 1 Abivardi Street, Chamran Blvd. How to obtain: A letter of request is enough to receive data. Comments:
public Misagh Rahimi
School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran
Shiraz Iran (Islamic Republic of) 7194733669 +98 71 3627 1551 Misaghrahimi1995@gmail.com Shiraz University of Medical Sciences scientific Abolghasem Fallahzadeh Abarghuei
School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran
Shiraz Iran (Islamic Republic of) 7194733669 +98 71 3627 1551 A_Fallahzadeh@Sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) Diagnosis of spastic primary progressive, secondary progressive, relapsing-remitting MS Extensive Disability Status Scale (EDSS) Score between 3 and 6 Mini–mental state examination (MMSE) test score more than 24 18 years 45 years Both Recurrence of MS during 3 months before intervention Pregnancy and lactation Having a psychiatric disorder or drug / alcohol abuse Inability to sit without torso support Inability to stand for at least 10 seconds with support Other neurological or orthopedic diseases of the lower extremities (musculoskeletal diseases, severe osteoarthritis, peripheral neuropathy, joint replacement) Cardiovascular diseases (recent myocardial infarction, heart failure, uncontrolled hypertension, orthostatic hypotension) participation in other clinical studies G35 Multiple sclerosis Rehabilitation Rehabilitation Action observation intervention group: This group includes 12 patients with MS who are included in the study based on the inclusion criteria. In the first stage, the subjects of this group undergo a 30-minute routine rehabilitation, which will be performed by a blind occupational therapist familiar with the MS rehabilitation program. The physical training programs will focus on stretching exercises, balance, walking, and muscle strengthening. Then, in the second stage, the main researcher shows the video clips to the patients for 15 minutes. Then all the displayed exercises will be practiced by the patient and the main researcher for 15 minutes. To watch videos, a person sits on a comfortable chair in front of a 19-inch monitor 100 cm away from them. While watching the video, people are asked to watch carefully and do nothing. The videos in the intervention group include exercises related to walking, crossing an obstacle, going up and down stairs, and standing up and sitting on a chair, which was performed by a healthy adult man and was taken from the front, back, and side angles. Each exercise is shown for three minutes and the person is given one-minute rest between each series of videos. Both groups will receive three treatment sessions per week for six consecutive weeks. control group: This group includes 12 patients with MS who are included in the study based on the inclusion criteria after receiving a 30-minute routine rehabilitation that includes stretching, strengthening, and balance exercises, in the second stage, videos include images of landscapes. They will observe nature videos, without any movement content for 15 minutes, and then they will receive the same exercise activities as the action observation intervention group. In fact, patients in the control group will receive the same rehabilitation protocol as the intervention group. During the sessions, they will simultaneously watch a video containing images of natural landscapes without moving content. In order to comply with ethical issues, a few Action observation treatment sessions will be conducted after the project's completion. Both groups will receive three treatment sessions per week for six consecutive weeks. The center of pressure velocity (COPV). Timepoint: at the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention) and one month after the end of the intervention. Method of measurement: Force plate. Step length. Timepoint: At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention), and one month after the end of the intervention. Method of measurement: 3D Motion capture cameras and gait analyzing system. Step width. Timepoint: At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention), and one month after the end of the intervention. Method of measurement: 3D Motion capture cameras and gait analyzing system. Step time. Timepoint: At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention) and one month after the end of the intervention. Method of measurement: 3D Motion capture cameras and gait analyzing system. Gait velocity (meters per second). Timepoint: At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention) and one month after the end of the intervention. Method of measurement: 3D Motion capture cameras and gait analyzing system. Stride length. Timepoint: At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention) and one month after the end of the intervention. Method of measurement: 3D Motion capture cameras and gait analyzing system. Stride time. Timepoint: At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention) and one month after the end of the intervention. Method of measurement: 3D Motion capture cameras and gait analyzing system. Gait cadence (steps per minute). Timepoint: At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention) and one month after the end of the intervention. Method of measurement: 3D Motion capture cameras and gait analyzing system. Ankle kinematics. Timepoint: At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention) and one month after the end of the intervention. Method of measurement: 3D Motion capture cameras and gait analyzing system. Knee kinematics. Timepoint: At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention) and one month after the end of the intervention. Method of measurement: 3D Motion capture cameras and gait analyzing system. Hip kinematics. Timepoint: At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention) and one month after the end of the intervention. Method of measurement: 3D Motion capture cameras and gait analyzing system. Pelvis kinematics. Timepoint: At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention) and one month after the end of the intervention. Method of measurement: 3D Motion capture cameras and gait analyzing system. Stance time. Timepoint: At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention) and one month after the end of the intervention. Method of measurement: 3D Motion capture cameras and gait analyzing system. Swing time. Timepoint: At the beginning of the study (before the start of the intervention), after the end of the intervention (6 weeks after the start of the intervention) and one month after the end of the intervention. Method of measurement: 3D Motion capture cameras and gait analyzing system. Shiraz University of Medical Sciences Approved 2022-07-20 Ethics committee of Shiraz Rehabilitation School School of Rehabilitation, Abiverdi 1 St., Chamran Blvd., Shiraz, Fars, Iran Shiraz Fars Iran (Islamic Republic of)