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IRCT20150210021034N10 IRCT 2021-03-30 Esfahan University of Medical Sciences The effectiveness of balance-sensory exercises on motor function in patients with MS The effectiveness of balance exercises on the textured surface on somatosensory, balance and Spatio-temporal parameters of gait in patients with relapsing-remitting multiple sclerosis: A parallel-groups clinical study 2021-04-21 anticipated 30 Complete https://irct.ir/trial/54922 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The samples will be divided into two groups using the blocked randomization method. The choice of this randomization method is according to the sample size of the present study (less than 100 people) to ensure an equal number of people in each group. Randomization unit: individual Randomization tool: Random number table In order to hide random allocation, opaque envelopes sealed and sealed with random sequence are used: In this method, first a random sequence is created using the mentioned method, then based on the sample size of the research, a number of envelopes with aluminum foil (foil) are used. The contents of the envelopes are prepared and each of the random sequences created is recorded on a card and the cards are placed inside the envelopes in the order of placement. In order to maintain a random sequence, the envelopes are numbered in the same way on the outer surface. Finally, the lid of the letter envelopes is glued and placed in a box, respectively. It becomes obvious. Execution of the random allocation process: One person will create a random sequence, the other person will examine the participants in terms of entry and exit criteria for the study and will register them in the study and the third person will participate in the study, Blinding description: In this study, participants are informed that they are in two groups with different programs, but they are not aware that they are in the intervention or control group. The outcome assessor and data analyst are also unaware of the allocation of groups. N/A Multiple sclerosis. Intervention 1: Intervention group: Number: 15 people with multiple sclerosis- Intervention program: Performing balance exercises according to Canadian guidelines Physical activity of adults with multiple sclerosis on a textured surface (material: rubber - 6 mm thick, area 1 in 1.5 m with dentin tissue 3 mm thick And the distance between the dentin 2.5 mm) Duration: 6 weeks (2 one-hour sessions per week). Intervention 2: Control group: Number: 15 people with multiple sclerosis- Intervention program: Performing balance exercises according to Canadian guidelines Physical activity of adults with multiple sclerosis on a tissue-free surface (material: rubber - 6 mm thick, area 1 in 1.5 meters with a tissue-free surface) - Duration: 6 weeks (2 one-hour sessions per week). Yes - There is a plan to make this available What will be shared: The study data (excluding the personal details) can be shred with other researchers or systematic reviewers. When: Data will be shared once findings are come up or summary date is published. To whom: Data will be shared personally and for academic purposes only. Conditions: Data will be shared for teaching or research. Dr Sadeghi (correspondence) will review the requests. Where to obtain: People can sent their request to the correspondence and obtain the data. How to obtain: Request can be sent through an email (sadeghi@rehab.mui.ac.ir). Comments: The kinematic and kinetic information of the gait and data for static balance (forcepate) will be available for researchers who are interested in secondary data analysis.
public Ebrahim Sadeghi
Hezar jerib St
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5053 sadeghi@rehab.mui.ac.ir Esfahan University of Medical Sciences scientific Ebrahim Sadeghi
Hezar Jerib St.
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3792 5053 sadeghi@rehab.mui.ac.ir Esfarayen University of Medical Sciences Iran (Islamic Republic of) Diagnosis of a neurologist Weakness in somatosensory function based on sensory evaluation EDSS score 2 to 5.5 (for the ability to perform or complete gait tests according to previous studies) The ability to walk a distance of 25 feet with or without assistive device Ability to stand independently for 2 minutes no limit no limit Both The underlying illnesses (such as diabetes and epilepsy) or any problems with neuro-musculoskeletal system other than multiple sclerosis (eg, history of surgery, fracture) disrupts the balance and sensory status Receive corticosteroid treatment one month before the study Uncorrected visual disorders Exacerbation of symptoms Changes in medications during the study Attack 30 days before the start of the study or during the study G35 Multiple sclerosis Rehabilitation Rehabilitation Intervention group: Number: 15 people with multiple sclerosis- Intervention program: Performing balance exercises according to Canadian guidelines Physical activity of adults with multiple sclerosis on a textured surface (material: rubber - 6 mm thick, area 1 in 1.5 m with dentin tissue 3 mm thick And the distance between the dentin 2.5 mm) Duration: 6 weeks (2 one-hour sessions per week). Control group: Number: 15 people with multiple sclerosis- Intervention program: Performing balance exercises according to Canadian guidelines Physical activity of adults with multiple sclerosis on a tissue-free surface (material: rubber - 6 mm thick, area 1 in 1.5 meters with a tissue-free surface) - Duration: 6 weeks (2 one-hour sessions per week). Static balance. Timepoint: Before the intervention, a week after the intervention. Method of measurement: Participants are asked to stand quiet on the force-plate while put the feet together and keep the arms relaxed beside the body. The center of pressure is recorded during 60 second of standing. Dynamic balance. Timepoint: Before the intervention, a week after the intervention. Method of measurement: Timed up and go test: Participants sit on a chair to start the test They are asked to walk with maximum speed during test. They rise with a "go" signal and walk until reach a line at 3 meters distance from the chair then turn and walk back to the chair and sit on it. The time is recorded using a stopwatch. Spatial-temporal parameters of gait. Timepoint: Before the intervention, a week after the intervention. Method of measurement: Walking of participant will be recorded using a motion capture system then parameters of the "gait symmetry" calculated and reported using a Visual 3D software. Somatosensory(sense of joint position). Timepoint: Before the intervention, a week after the intervention. Method of measurement: Ankle proprioception was measured using perception of the inclination whilst participants stood over an adjustable slope box with closed eyes. Fatigue. Timepoint: Before the intervention, a week after the intervention. Method of measurement: The level of fatigue will be measured using "Fatigue severity scale". Pain. Timepoint: Before the intervention, a week after the intervention. Method of measurement: The participants' pain will be quantified using "Visual analog scale". Spasticity. Timepoint: Before the intervention, a week after the intervention. Method of measurement: Muscle spasticity will be measured using "Modified Ashworth scale". Esfahan University of Medical Sciences Approved 2021-03-03 Eُthic's committee of Isfahan University of Medical Sciences, Isfahan, Iran Hezar Jerib St. Isfahan Isfehan Iran (Islamic Republic of)