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IRCT20250309065000N1 IRCT 2026-03-10 University of Birjand The effect of vibration therapy and the use of Qavoot supplements on MS patients Effect of whole body vibration training (Vibration Therapy) and Qavoot intake on physical performance and muscles electromyography characteristics involved at the Gait initiation in multiple sclerosis patients 2026-03-01 anticipated 64 Recruiting https://irct.ir/trial/82318 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Other design features: Innovation in vibration therapy and the use of traditional Qavot supplements, Randomization description: Main method: simple randomization (using random.org). Allocation was done individually Randomization was unstratified. Website www.random.org (online random number generator based on atmospheric noise) Sealed envelopes to store allocation sequence How to create a random sequence First draw the groups (possibly determine the order of the groups or choose the type of the first group) Then randomly select individuals to be allocated to the groups This process was done using www.random.org. The generated sequence was stored in sealed envelopes. Allocation concealment The random sequence was stored in sealed envelopes. Decryption was only possible in emergency situations (serious complications) and under the supervision of the responsible physician. The evaluators and training instructors (implementation team and evaluation team) were unaware of the grouping code, Blinding description: Those who were blinded to the allocation: Participants (MS patients) were blinded (participants did not know which group they were in). Reason: The intervention and placebo were designed and prepared in exactly the same way in terms of appearance (shape, color, taste) and method of administration. The study is single-blinded from the participants’ perspective. The exercise trainers (the intervention team/those who performed the vibration exercise) were blinded. “The intervention team (the exercise trainers) … were unaware of the allocation codes.” The assessors/those who collected the data or evaluated the results were blinded. “The assessors (those who collected the data or evaluated the results) were unaware of the allocation codes.” This includes assessors of functional tests (e.g. TUG, 7-meter walk), electromyography, and questionnaires. The principal investigator (and other members of the main research team) were blinded. The principal investigator was aware (open-label to the PI). The health-care personnel (neurologist, physician responsible for monitoring complications) Were aware (not blinded). The referring physician was the specialist. The responsible physician was authorized to decode the envelopes in emergency situations. At least one senior physician was aware or could have been aware of the allocation. 3 Multiple sclerosis. Intervention 1: Control Group: Only placebo will be received! An active placebo with 5% coffee, essence, and chemicals, also prepared with a flavor similar to coffee, will be delivered to the placebo group. Intervention 2: Intervention Group 1: Receiving vibration therapy alone; the exercise intervention will be implemented for 8 weeks with a frequency of 3 sessions per week (on even days to avoid excessive fatigue). Each session will last approximately 30-35 minutes, including warming up, vibration training, and cooling down. Standing on a platform with a 30-degree knee bend but a straight torso, the vibration-to-rest ratio is 1:2. The exercise protocol is designed with innovation and progressive challenges to increase balance difficulties and bring it closer to environmental reality. Each week, specific conditions will be applied to reduce reliance on external support and increase reliance on proprioception and the vestibular system. Intervention 3: Intervention group 3: Receiving and consuming traditional Qavoot supplement aloneThe quinoa was obtained from reputable pharmacies in Kerman, and to prevent oil spoilage and ensure the final mixture's stability, preservatives such as methyl paraben and propyl paraben will be added.The subjects consumed the prepared quinoa as a suspension, three teaspoons (equivalent to 300 milligrams per kilogram of body weight) every other day (four days a week; a total of 32 days) for eight weeks.To prepare the suspension, the daily dose was calculated based on each individual's weight and packaged in 250-milligram bottles for delivery to the subjects.Ingredient Amount/Gram 8-Week Total Quinoa Powder 20 640 grams Methyl Paraben 18.0 mg 76.5 mg Propyl Paraben 2.0 mg 64.0 mg Sucrose 5 grams 160 grams Microcrystalline Cellulose 1 gram 32 grams Sodium Chloride 1.0 mg 2.3 mg Tween 80 0.5 mg 6.1 mg Total 35.26 g 2.843 g. Intervention 4: Intervention group: Intervention group 4: Receiving vibration therapy and taking traditional Qavot supplement= Intervention 3+2. No - There is not a plan to make this available Justification or reason for not sharing IPD is It is private and confidential.
public Seyyed mojtaba Hosseini
End of University Boulevard - Shaukat Abad Campus - Central Organization of Birjand University
بيرجند Iran (Islamic Republic of) 9717434765 +98 56 3102 7995 rahbordi2012@gmail.com University of Birjand scientific Mohsen Mohammadnia Ahmadi
End of University Boulevard - Shaukat Abad Campus - Central Organization of Birjand University
Birjand Iran (Islamic Republic of) 9717434765 +98 56 3102 6917 m.m.ahmadi2005@gmail.com University of Birjand Iran (Islamic Republic of) 1. Age range 20 to55 years Not taking amantadine and dalfira drugs EDSS score ≥5.4 points (4.5-1) Patient approval from the doctor Not receiving other rehabilitation activities during the study period Completed the informed consent form Suffering from relapsing-remitting type No skin sensitivity or flushing due to the use of the ingredients in Qavoot 20 years 55 years Both Personal dissatisfaction Injury while performing the exercise program Participation in organized exercise and rehabilitation programs other than the exercise program of the present study G35 Multiple sclerosis Placebo Treatment - Drugs Treatment - Drugs Treatment - Drugs Control Group: Only placebo will be received! An active placebo with 5% coffee, essence, and chemicals, also prepared with a flavor similar to coffee, will be delivered to the placebo group. Intervention Group 1: Receiving vibration therapy alone; the exercise intervention will be implemented for 8 weeks with a frequency of 3 sessions per week (on even days to avoid excessive fatigue). Each session will last approximately 30-35 minutes, including warming up, vibration training, and cooling down. Standing on a platform with a 30-degree knee bend but a straight torso, the vibration-to-rest ratio is 1:2. The exercise protocol is designed with innovation and progressive challenges to increase balance difficulties and bring it closer to environmental reality. Each week, specific conditions will be applied to reduce reliance on external support and increase reliance on proprioception and the vestibular system. Intervention group 3: Receiving and consuming traditional Qavoot supplement aloneThe quinoa was obtained from reputable pharmacies in Kerman, and to prevent oil spoilage and ensure the final mixture's stability, preservatives such as methyl paraben and propyl paraben will be added.The subjects consumed the prepared quinoa as a suspension, three teaspoons (equivalent to 300 milligrams per kilogram of body weight) every other day (four days a week; a total of 32 days) for eight weeks.To prepare the suspension, the daily dose was calculated based on each individual's weight and packaged in 250-milligram bottles for delivery to the subjects.Ingredient Amount/Gram 8-Week Total Quinoa Powder 20 640 grams Methyl Paraben 18.0 mg 76.5 mg Propyl Paraben 2.0 mg 64.0 mg Sucrose 5 grams 160 grams Microcrystalline Cellulose 1 gram 32 grams Sodium Chloride 1.0 mg 2.3 mg Tween 80 0.5 mg 6.1 mg Total 35.26 g 2.843 g Intervention group: Intervention group 4: Receiving vibration therapy and taking traditional Qavot supplement= Intervention 3+2 Timed Up and Go. Timepoint: Before the start of the intervention and eight weeks after the intervention. Method of measurement: Measuring round trip time using a stopwatch. Timed 25-Foot Walk - T25FW. Timepoint: Before the start of the intervention and eight weeks after the intervention. Method of measurement: Measuring round trip time using a stopwatch. Muscle Synergy Index (Muscle Synergy Index or the number/structure of muscle synergies) calculated from electromyography (EMG) signals during walking. Timepoint: Before the start of the intervention and eight weeks after the intervention. Method of measurement: Extraction of muscle synergies using Non-negative Matrix Factorization (NMF) analysis or similar methods on sEMG data of muscles involved in the gait cycle (e.g. Quadriceps, Hamstrings, Gastrocnemius, Tibialis Anterior).The number of synergies, the contribution of each synergy (muscle weight per synergy), or the amount of variance explained (VAF) by the synergies using Matlab software. Sleep Quality Index. Timepoint: Before the start of the intervention and eight weeks after the intervention. Method of measurement: Pittsburgh Sleep Quality Index. Quality of life index. Timepoint: Before the start of the intervention and eight weeks after the intervention. Method of measurement: (MSQoL-54). Quality of life score. Timepoint: Before the intervention and eight weeks later. Method of measurement: Quality of life questionnaire. Sleep quality score. Timepoint: Before the intervention and eight weeks later. Method of measurement: sleep quality questionnaire. 25-foot and TUG test. Timepoint: Before the intervention and eight weeks later. Method of measurement: Measuring round trip time. University of Birjand Approved 2024-10-29 research ethics of univversity of birjand End of University Boulevard - Shaukat Abad Campus - Central Organization of Birjand University birjand South Khorasan Iran (Islamic Republic of)