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IRCT20240926063172N1 IRCT 2024-11-02 University of Birjand Comparison of two types of balance interventions based on sensory integration in multiple sclerosis (MS) patients. TUG, T25FW, SN,VR, MS Comparing the effectiveness of sensory-motor and virtual reality interventions on gait, balance and quality of life indicators of patients with multiple sclerosis. 2024-11-10 anticipated 30 Complete https://irct.ir/trial/79224 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Randomization method: random grouping through Randomizer Random Pick software Randomization Unit: Individual Randomization tool: Randomizer Random Pick software How to create randomization: Select Randomize List to create a randomization list About concealment: coding the patient and carrying out the entire process by someone who was not aware of the evaluation of the variables and the implementation of the exercises, Blinding description: In general, the participants, clinical caregivers, and outcome evaluators will not have any modification of the nature of the study and study groups, and only the method of implementation for the participants, how to care for the patient, and how to evaluate the variables will be told to them. N/A Multiple sclerosis or MS. Intervention 1: Control group: The control group was not allowed to engage in any physical activity during the trial time, but were encouraged to conduct SN and VR activities after the study was completed. Intervention 2: Intervention group 1: Sensorimotor training is a modified training protocol based on previous studies in which participants go through 18 training stations in a circuit in each session. The exercises were divided into static and dynamic categories. The static part includes 12 stations and the dynamic part (on foot) also includes 6 educational stations. Static exercises include external destabilization and self-destabilization patterns that are performed on the floor surface and cushion foam in three conditions: eyes open, closed, and with a helmet. During external stabilization exercises, the practitioner pushes (shifts) the patient's pelvis forward and to the side, during which the patient must quickly maintain their balance. In self-destabilizing activities, patients shift their weight from one leg to the other to intentionally shift their center of gravity. During walking exercises, the patient is given cognitive activities such as counting numbers, subtracting numbers, and remembering specific human or animal names. Each exercise session begins with a 10-minute warm-up. The last five minutes of each training session are devoted to cooling down. The duration of each station from the first to the sixth week is 30, 35, 40, 45, 50, 55 seconds and 60 seconds in the seventh and eighth weeks. The ratio of work to rest is also considered similar from the first to the eighth week. Intervention 3: Intervention virtual reality group : The virtual reality exercise in the present study was also a modified exercise protocol that was formed based on previous research. Virtual reality games consist of two components: dynamic and static. Dynamic games include one or more of the 12 walking patterns presented in Table 4. The primary priority for the VR dynamics component was to select games that employ 12 different walking patterns. Patterns during a VR training session. The virtual games considered for the dynamic component included Plank rich, Pistol whip, Boxing, Walking dead, Temple Run. Static VR games were also performed in such a way that 6 static movement patterns were used in a VR training session. This component also included Beat saber, Power beat saber, OHSHIP games. The duration of each VR station and the rest between stations were equivalent but different from the SN protocol. However, the total duration of a training session was similar to the SN protocol and was 18, 21, 24, 27, 30, 33 minutes for weeks 1 to 6 and 36 minutes for weeks 7 and 8, respectively. All virtual reality games were played in a 10x10 room. Comprehensive descriptions of dynamic and static movement patterns are shown in Table 4. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Seyed hadi asghari
No. 43, Emamat 19th Street, Sajjadshahr, Birjand, South Khorasan, Iran
Birjand Iran (Islamic Republic of) 9719975134 +98 56 3242 9004 h1370asghari@gmail.com University of birjand scientific Seyed hadi asghari
No. 43, Emamat 19th Street, Sajjadshahr, Birjand, South Khorasan, Iran
Birjand Iran (Islamic Republic of) 9719975134 +98 56 3242 9004 h1370asghari@gmail.com The University of Birjand Iran (Islamic Republic of) MS patients between 18 and 65 years of age Relapsing and relapsing MS patients treated with rituximab with high disease activity Patients with an Extended Disability Status Scale (EDSS) of 2 to 6 Ability to walk without assistance and at least 100 meters 18 years 65 years Both Patients' personal unwillingness to continue the exercises absence in more than 3 training sessions Failure to answer the phone call to continue the treatment G35 Multiple sclerosis Rehabilitation Rehabilitation Rehabilitation Control group: The control group was not allowed to engage in any physical activity during the trial time, but were encouraged to conduct SN and VR activities after the study was completed Intervention group 1: Sensorimotor training is a modified training protocol based on previous studies in which participants go through 18 training stations in a circuit in each session. The exercises were divided into static and dynamic categories. The static part includes 12 stations and the dynamic part (on foot) also includes 6 educational stations. Static exercises include external destabilization and self-destabilization patterns that are performed on the floor surface and cushion foam in three conditions: eyes open, closed, and with a helmet. During external stabilization exercises, the practitioner pushes (shifts) the patient's pelvis forward and to the side, during which the patient must quickly maintain their balance. In self-destabilizing activities, patients shift their weight from one leg to the other to intentionally shift their center of gravity. During walking exercises, the patient is given cognitive activities such as counting numbers, subtracting numbers, and remembering specific human or animal names. Each exercise session begins with a 10-minute warm-up. The last five minutes of each training session are devoted to cooling down. The duration of each station from the first to the sixth week is 30, 35, 40, 45, 50, 55 seconds and 60 seconds in the seventh and eighth weeks. The ratio of work to rest is also considered similar from the first to the eighth week. Intervention virtual reality group : The virtual reality exercise in the present study was also a modified exercise protocol that was formed based on previous research. Virtual reality games consist of two components: dynamic and static. Dynamic games include one or more of the 12 walking patterns presented in Table 4. The primary priority for the VR dynamics component was to select games that employ 12 different walking patterns. Patterns during a VR training session. The virtual games considered for the dynamic component included Plank rich, Pistol whip, Boxing, Walking dead, Temple Run. Static VR games were also performed in such a way that 6 static movement patterns were used in a VR training session. This component also included Beat saber, Power beat saber, OHSHIP games. The duration of each VR station and the rest between stations were equivalent but different from the SN protocol. However, the total duration of a training session was similar to the SN protocol and was 18, 21, 24, 27, 30, 33 minutes for weeks 1 to 6 and 36 minutes for weeks 7 and 8, respectively. All virtual reality games were played in a 10x10 room. Comprehensive descriptions of dynamic and static movement patterns are shown in Table 4. Gait Indicator with T25FW. Timepoint: 2 days before 8 weeks and 2 days after 8 weeks. Method of measurement: In this test, the participant travels 7.5 meters in a straight line without assistance in the shortest possible time. This test is repeated twice and the walking speed is calculated as the average of the two tests. During the test, the tester stays close to the patient to prevent falls or any other accidents. Dynamic balance Indicator with TUG. Timepoint: 2 days before 8 weeks and 2 days after 8 weeks. Method of measurement: A stopwatch is used in this test to measure the time it took the subject to stand up from the armchair and travel a distance of 3 meters as quickly as possible, then turn around and seat back in the chair and lean back. The examiner remains near the patient to keep them from falling. Quality of life for MS patients with MSQOL54. Timepoint: 2 days before 8 weeks and 2 days after 8 weeks. Method of measurement: The MSQoL-54 questionnaire is a health-related self-assessment tool with two components: physical health and mental health scores. Composite scores were calculated by converting item scores to a scale of zero to 100 where zero indicates the worst health condition and 100 indicates the best health condition. Also, the sum of two subscale scores of mental health and physical health was used to calculate the overall score of MSQoL-54. Sleep quality with PSQI. Timepoint: 2 days before and after 8 weeks. Method of measurement: The Pittsburgh Sleep Quality Index (PSQI) was used to evaluate the sleep quality of MS patients. PSQI consists of 9 items that measure seven different aspects including sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disorders, use of sleeping pills and daytime dysfunction. The PSQI score ranges from 0 to 21, with higher scores indicating lower sleep quality. In general, a PSQI score more than 5 indicates poor quality sleep. University of Birjand Approved 2022-12-28 Ethics Committee of Birjand University Central Organization of Birjand University, Shaukatabad Campus, End of University Boulevard, Birjand, South Khorasan, Iran Birjand South Khorasan Iran (Islamic Republic of)