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The comparison of whole body vibration with frequency of 20 and 40 Hz on the transmissibility to the lower limb's joints and center of pressure sway in the postmenopausal women

Protocol summary

Study aim
Comparison of 20 and 40 Hz of whole body vibration on the center of pressure sway in postmenopausal women
Design
A clinical trial, self control, in 20 postmenopausal women, in five different modes of vibration frequency and amplitude on the whole body vibration plate. The order of the modes is randomly selected by the independent people by the envelopes in the package.
Settings and conduct
Individuals will participate in the training program voluntarily by installing a public call. The place of study is the movement Disorders Lab of Physical therapy, Tarbiat Modares University. To apply the WBV, the Uniphy Elektromedizin GmbH Fit Vibe (Fitvib) vibrating device. The participants will be placed on the WBV plate barefoot with semi-squat and will have one of the following modes: Off vibration (control), 20 Hz and 2 mm, 20 Hz and 4 mm, 40 Hz and 2 mm, 40 Hz and 4 mm. Except for the base position, which is the control, others will be randomly applied. Before and immediately after each of the above modes, the center of pressure sway will be recorded with Kessler force plate and Mars software. Each mode is composed of two 30-second intervals with a 10-second break between them. During vibration, the transmission of the acceleration (transmissibility) is measured at the level of the lower limb joints (Hip, Knee, and Ankle joints).
Participants/Inclusion and exclusion criteria
Inclusion criteria: At least one year after menopause - Ability to walk independently without aids - ٍExclusion criteria: Osteoporosis - Balance disturbance and fall history - Patient discomfort while working with whole body vibration
Intervention groups
A group of postmenopausal women who receive whole body vibration with frequency of 20 and 40 HZ
Main outcome variables
Transmissibility in hip, knee, ankle COP displacement COP velocity path length

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20101017004952N11
Registration date: 2022-03-05, 1400/12/14
Registration timing: prospective

Last update: 2022-03-05, 1400/12/14
Update count: 0
Registration date
2022-03-05, 1400/12/14
Registrant information
Name
Giti Torkaman
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4509
Email address
torkamg@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-06, 1400/12/15
Expected recruitment end date
2022-05-05, 1401/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The comparison of whole body vibration with frequency of 20 and 40 Hz on the transmissibility to the lower limb's joints and center of pressure sway in the postmenopausal women
Public title
Effect of two frequencies of whole body vibration and transmissibility to the lower limb's joints in the postmenopausal women
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
At least one year after menopause Body mass 25-32 kg/m2 Ability to stand while sitting without aids Ability to walk independently without aids Normal blood pressure and less than 140/90 at rest
Exclusion criteria:
Osteoporosis Balance disturbance and fall history Vestibular disorders History of joint replacement surgery in the lower extremities Neuro-musculoskeletal disorders Cardiovascular problems Use of drugs that upset the balance system Patient discomfort during whole body vibration
Age
From 50 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome measures will record and evaluate by a motion analysis system expert who does not know the steps and specifications of the frequency and amplitude of the whole body vibration device.
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research ethics commeette of Tarbiat Modares University
Street address
Ale-Ahmad
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2019-06-16, 1398/03/26
Ethics committee reference number
IR.MODARES.REC.1398.068

Health conditions studied

1

Description of health condition studied
Balance in postmenopausal women
ICD-10 code
R54
ICD-10 code description
Age-related physical debility

Primary outcomes

1

Description
Center of pressure displacement
Timepoint
Before and after vibration
Method of measurement
Force plate

2

Description
Center of pressure velocity
Timepoint
Before and after of vibration
Method of measurement
Force plate

3

Description
Path length
Timepoint
Before and after vibration
Method of measurement
Force plate

4

Description
Transmissibility in hip joint
Timepoint
Before and after vibration
Method of measurement
Accelerometer

5

Description
Transmissibility in knee joint
Timepoint
Before and after vibration
Method of measurement
Accelerometer

6

Description
Transmissibility in ankle joint
Timepoint
Before and after vibration
Method of measurement
Accelerometer

Secondary outcomes

1

Description
Difficulty score for deafferent modes
Timepoint
10-degree visual analogous scale
Method of measurement
Self report

Intervention groups

1

Description
Intervention group: postmenopausal women. A group of postmenopausal women who receive whole body vibration with frequency of 20 and 40 HZ. The participant will be placed on the WBV plate barefoot with semi-squat and will have one of the following modes: Off vibration (control), 20 Hz and 2 mm, 20 Hz and 4 mm, 40 Hz and 2 mm, 40 Hz and 4 mm. Before and immediately after each of the above modes, the center of pressure sway will be recorded. Each mode is composed of two 30-second intervals with a 10-second break between them. During vibration, the transmission of the acceleration (transmissibility) is measured at the level of the lower limb joints (Hip, Knee, and Ankle joints).
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Physical Therapy Lab, Tarbiat Modares University
Full name of responsible person
Giti Torkaman
Street address
Ale-Ahmad
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4509
Fax
+98 21 8288 4555
Email
Torkamg@modares.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Amir Abdolahzadeh
Street address
Ale-Ahmad
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 2009
Fax
+98 21 8288 2009
Email
Zadeh@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
Proportion provided by this source
100
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
Tarbiat Modares University
Full name of responsible person
Giti Torkaman
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Ale-Ahmad
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4509
Email
Torkamg@modares.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modars University
Full name of responsible person
Giti Torkaman
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Ale-Ahmad
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4509
Email
Torkamg@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Giti Torkaman
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Ale-Ahmad
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 4509
Email
Torkamg@modares.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The data will be presented in the prepared article after coding the participants. At the request of the reviewers, details of data and statistical methods will be provided.
When the data will become available and for how long
Access since May 2022
To whom data/document is available
Researchers in the field of physiotherapy and other health groups
Under which criteria data/document could be used
Researchers in the field of physiotherapy and other health groups can receive it upon formal request
From where data/document is obtainable
Giti Torkaman, Physical Therapy Department, Tarbiat Modares University
What processes are involved for a request to access data/document
Upon receipt of the request, the data will be shared for up to one month
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