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
To examine the effects of combined WBV and quinoa supplement on physical performance and electromyographic features of lower limb muscles during walking in MS.
Design
The study was conducted at the University of Birjand, Faculty of Physical Education and Sport Sciences (Behavioral Sciences Campus). Participants were recruited from clinics in Birjand. The whole-body vibration therapy intervention was performed in faculty laboratories (such as the Exercise Physiology Laboratory), and electromyographic and functional assessments were also performed at the same location.
Settings and conduct
The study was conducted at the University of Birjand, Faculty of Physical Education and Sport Sciences (Behavioral Sciences Campus). Participants were recruited from clinics in Birjand. The whole-body vibration therapy intervention was performed in faculty laboratories (such as the Exercise Physiology Laboratory), and electromyographic and functional assessments were also performed at the same location.
Participants/Inclusion and exclusion criteria
Participants: ۳۴ patients with relapsing-remitting multiple sclerosis (RRMS) with Expanded Disability Status Scale (EDSS) scores from ۱ to ۶ (mean age ۴۱.۹ ± ۸.۹ years, ۷۹.۴% female) recruited from clinics in Birjand.
Intervention groups
Whole body vibration plus quinoa supplement (n=۱۰)
Whole body vibration (n=۸)
Quinoa supplement (n=۹)
Placebo (n=۷)
Main outcome variables
The main outcome variables included the Timed Up and Go (TUG) test to assess dynamic balance and coordination of movement, the 7.5-meter walk test to measure walking speed, and muscle synergy characteristics based on the NMF index in electromyography (EMG) of the lower limb muscles (tibialis anterior, soleus, rectus/biceps femoris, gluteus medius) at the beginning of walking. Sleep quality and wakefulness were also assessed through a questionnaire!
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250309065000N1
Registration date:2026-03-10, 1404/12/19
Registration timing:registered_while_recruiting
Last update:2026-03-10, 1404/12/19
Update count:0
Registration date
2026-03-10, 1404/12/19
Registrant information
Name
seyyed mojtaba hosseini
Name of organization / entity
University of Birjand
Country
Iran (Islamic Republic of)
Phone
+98 56 3102 7995
Email address
rahbordi2012@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2026-03-01, 1404/12/10
Expected recruitment end date
2026-07-06, 1405/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effect of vibration therapy and the use of Qavoot supplements on MS patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
Personal dissatisfaction
Injury while performing the exercise program
Participation in organized exercise and rehabilitation programs other than the exercise program of the present study
Age
From 20 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
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.
Placebo
Used
Assignment
Factorial
Other design features
Innovation in vibration therapy and the use of traditional Qavot supplements
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
research ethics of univversity of birjand
Street address
End of University Boulevard - Shaukat Abad Campus - Central Organization of Birjand University
City
birjand
Province
South Khorasan
Postal code
9717434765
Approval date
2024-10-29, 1403/08/08
Ethics committee reference number
IR.BIRJAND.REC.1403.014
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
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
2
Description
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
3
Description
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.
4
Description
Sleep Quality Index
Timepoint
Before the start of the intervention and eight weeks after the intervention
Method of measurement
Pittsburgh Sleep Quality Index
5
Description
Quality of life index
Timepoint
Before the start of the intervention and eight weeks after the intervention
Method of measurement
(MSQoL-54)
Secondary outcomes
1
Description
Quality of life score
Timepoint
Before the intervention and eight weeks later
Method of measurement
Quality of life questionnaire
2
Description
Sleep quality score
Timepoint
Before the intervention and eight weeks later
Method of measurement
sleep quality questionnaire
3
Description
25-foot and TUG test
Timepoint
Before the intervention and eight weeks later
Method of measurement
Measuring round trip time
Intervention groups
1
Description
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.
Category
Placebo
2
Description
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.
Category
Treatment - Drugs
3
Description
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
Category
Treatment - Drugs
4
Description
Intervention group: Intervention group 4: Receiving vibration therapy and taking traditional Qavot supplement= Intervention 3+2
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Hazrat Valiasr Hospital
Full name of responsible person
Seyed Mohammad Mousavi Mirzaee
Street address
Ayatollah Ghaffari Street – Birjand University of Medical Sciences
City
Birjand
Province
South Khorasan
Postal code
۹۷۱۷۸۵۳۰۷۶
Phone
+98 56 3239 5000
Fax
+98 56 3239 5000
Email
mousavim903@mums.ac.ir
Web page address
https://www.bums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Birjand
Full name of responsible person
Marziyeh Saghebjoo
Street address
End of University Boulevard - Shaukat Abad Campus - Central Organization of Birjand University
City
birjand
Province
South Khorasan
Postal code
9717434765
Phone
+98 56 3102 0000
Fax
+98 56 3102 0000
Email
m.m.ahmadi2005@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Birjand
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
University of Birjand
Full name of responsible person
Seyyed mojtaba Hosseini
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
End of University Boulevard - Shaukat Abad Campus - Central Organization of Birjand University
City
بيرجند
Province
South Khorasan
Postal code
9717434765
Phone
+98 56 3102 7995
Fax
Email
rahbordi2012@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Birjand
Full name of responsible person
Mohsen Mohammadnia Ahmadi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise physiology
Street address
End of University Boulevard - Shaukat Abad Campus - Central Organization of Birjand University
City
Birjand
Province
South Khorasan
Postal code
9717434765
Phone
+98 56 3102 6917
Email
m.m.ahmadi2005@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
University of Birjand
Full name of responsible person
Seyyed mojtaba Hosseini
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
End of University Boulevard - Shaukat Abad Campus - Central Organization of Birjand University
City
بيرجند
Province
South Khorasan
Postal code
9717434765
Phone
+98 56 3102 7995
Fax
Email
rahbordi2012@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
It is private and confidential.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available